ARV Therapy in Adults _amp; Adolescents by dfgh4bnmu

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									                                                                                                     CP=Child-Pugh Score (see Child-Pugh Score Calculation table to the right)
                       Renal Dose Adjustments14                                                                                                                                                                         Child-Pugh (CP) Score Calculation19                                         Antiretroviral Regimens or Components
                                                                                                                            Hepatic Dose Adjustments17                                                                                                                                                  Not Recommended at Any Time
   AGENT(S)                               DOSE ADjUSTMENT                                                                                                                                               Score                               1                   2                  3
                                                                                                          AGENT(S)                               DOSE ADjUSTMENT                                                                                                                                REGIMENS/
                                         nrtis                                                                                                                                                          Encephalopathy20                 None             Grade 1 - 2         Grade 3 - 4                                           COMMENTS
                                                                                                                                               nrtis                                                                                                                                           COMPONENTS
 Zidovudine             CrCl < 15 or HD15: 100 mg tid or 300 mg q24h                                                                                                                                                                                        Mild or           Moderate or
                                                                                                                                 CP A: 200 mg bid;                                                      Ascites                          None            controlled by        refractory to                          Rapid development of resistance; inferior
                        ≥ 60 kg: CrCl 30-59: (EC) 200 mg q24h;                                        Abacavir                                                                                                                                                                                Monotherapy (AII)
                                                                                                                                 CP B or C: contraindicated                                                                                                                                                          to ≥ 3 drugs
                           CrCl 10-29: (EC) 125 mg q24h;                                                                                                                                                                                                   diuretics            diuretics
                           CrCl < 10, HD15 or CAPD: (EC) 125 mg q24h;                                                                        nnrtis                                                                                                                                                                  Adverse events and drug-drug
 Didanosine                                                                                                                                                                                             Albumin                      > 3.5 g/dL 2.8 - 3.5 g/dL                 < 2.8 g/dL     Dual-NNRTI (AI)
                        < 60 kg: CrCl 30-59: (EC) 125 mg q24h;                                                                                                                                                                                                                                                       interactions prevent benefit
                           CrCl 10-29: (EC) 125mg q24h;                                               Delavirdine or                                                                                    Total Bilirubin or           < 2 mg/dL            2 - 3 mg/dL          > 3 mg/dL
                                                                                                                                 Use with caution-no recommendation                                                                                                                                                  Rapid development of resistance;
                           CrCl < 10, HD15 or CAPD: 75 mg q24h (oral soln)                            Efavirenz
                                                                                                                                                                                                        Modified Total                                                                        Dual-NRTI (AI)         inferior to ≥ 3 drugs. May be considered
                        CrCl 30-49: 200 mg cap q48h or                                                                           CP A or B: no adjustment;                                                                           < 4 mg/dL            4 - 7 mg/dL          > 7 mg/dL
                                                                                                      Etravirine                                                                                        Bilirubin21                                                                                                  for PEP.
                          120 mg soln q24h;                                                                                      CP C: no recommendation
                        CrCl 15-29: 200 mg cap q72h or                                                                                                                                                  Prothrombin Time                  <4                  4-6                 >6          Triple NRTI (AI)
 Emtricitabine                                                                                        Nevirapine                 CP B or C: contraindicated                                                                                                                                                          Consider exceptions when preferred/
                          80 mg soln q24h;                                                                                                                                                                                                                                                    exceptions:
                        CrCl < 15 or HD15: 200 mg cap q96h or                                                                                                                                           or INR                           < 1.7              1.7 - 2.3            > 2.3                               alternative not feasible;
                                                                                                                                 CP A or B: no adjustment;                                                                                                                                    ABC/AZT/3TC (BI)
                          60 mg soln q24h                                                             Rilpivirine                                                                                                                                                                                                    ↑ early virologic non-response with
                                                                                                                                 CP C: no data                                                         19. Class A: Score 5-6; Class B: Score 7-9; Class C: Score > 9                         and possibly TDF/
                                                                                                                                                                                                       20. Grade 1: mild confusion, anxiety, restlessness, fine tremor, slowed                                       ABC/TDF/3TC or TDF/ddl/3TC
                        CrCl 30-49: 150 mg q24h;                                                                                                 PIs                                                                                                                                          AZT/3TC (BII)
                                                                                                                                                                                                           coordination; Grade 2: drowsiness, disorientation, asterixis; Grade 3:
                        CrCl 15-29: 150 mg x 1 then 100 mg q24h;                                                                                                                                           somnolent but rousable, marked confusion, incomprehensible speech,                 d4T + AZT (AII)        Both thymidine analogs; antagonistic
 Lamivudine                                                                                                                      CP B: 300 mg once daily (no ritonavir boosting);
                        CrCl 5-14: 150 mg x 1 then 50 mg q24h;                                        Atazanavir                                                                                           incontinent, hyperventilation; Grade 4: coma, decerebrate posturing, flaccidity
                        CrCl < 5 or HD15: 50 mg x 1 then 25 mg q24h                                                              Class C: not recommended                                              21. Modified Total Bilirubin used to score pts with Gilbert’s Syndrome or taking                              Toxicities: pancreatitis, neuropathy, ↑
                                                                                                                                                                                                           IDV or ATV                                                                                                lactate. Fatalities (lactic acidosis w/
                        ≥ 60 kg: CrCl 26-50: 20 mg q12h, CrCl ≤ 25                                                               CP A or B: no adjustment;                                                                                                                                    d4T + ddl (AII)
                           or HD15: 20 mg q24h;                                                       Darunavir                                                                                                                                                                                                      hepatic steatosis w/ or w/o pancreatitis) in
 Stavudine                                                                                                                       CP C: not recommended                                                            ARV Components Not Recommended
                        < 60 kg: CrCl 26-50: 15 mg q12h, CrCl ≤ 25                                                                                                                                                                                                                                                   pregnancy
                           or HD15: 15 mg q24h                                                                                   PI-naïve-CP A or B: 700 mg bid;                                                       as Part of Initial Therapy
                                                                                                                                 CP C: 350 mg bid;                                                                                                                                                                   ↑ ddl levels and toxicity, ↑ virologic failure/
                                                                                                                                                                                                                   AGENT(S)                                    COMMENTS
                        CrCl 30-49: 300 mg q48h;                                                                                 PI-naïve or exp-CP A: 700 mg bid + RTV                                                                                                                                              resistance, potential for immunologic
                        CrCl 10-29: 300 mg twice weekly;                                              Fosamprenavir                                                                                     ABC/AZT/3TC ± TDF (BI) ↓ virologic efficacy                                           ddI + TDF              nonresponse/CD4 ↓; consider altering
 Tenofovir16                                                                                                                     100 mg once daily;
                        CrCl < 10, not on HD: no recommendation;                                                                                                                                                                                                                                                     regimen even if clinically stable on
                        HD15: 300 mg qweek                                                                                       CP B: 450 mg bid + RTV 100 mg once daily;                              ABC + (ddI or TDF) (BIII) Insufficient data in ARV-naïve
                                                                                                                                 CP C: 300 mg bid + RTV 100 mg once daily                                                                                                                                            ddI/TDF containing regimen
                                  Combo Products                                                                                                                                                                                                Lipoatrophy, peripheral
                                                                                                                                 CP A or B with cirrhosis: 600 mg q8h;                                                                                                                        FTC + 3TC (AIII)       Similar resistance profile; no benefit
                                                                                                      Indinavir                                                                                                                                 neuropathy, symptomatic lactic
 AZT/3TC                CrCl < 50: Combo product cannot be used;                                                                 CP C: no data                                                          d4T + 3TC (BI)                                                                        EFV in 1st trimester
 (Combivir®)              see dosing for individual agents                                                                                                                                                                                      acidosis, hepatic steatosis, and                                     Teratogenic - use only if no other options
                                                                                                      Lopinavir                  Use with caution-no recommendation                                                                             pancreatitis                                  or if pregnancy
                                                                                                                                                                                                                                                                                                                     and potential benefits > risks (BIII)
                        CrCl 30-49: One tab q48h;                                                                                                                                                                                                                                             potential (AIII)
 FTC/TDF                                                                                                                         CP A: no adjustment;                                                                                           ↓ virologic efficacy; inconvenient
                        CrCl < 30: Combo product cannot be used;                                      Nelfinavir                                                                                        DLV (BII)
 (Truvada®)16                                                                                                                    CP B or C: not recommended                                                                                     dosing                                        ETR + all
                          see dosing for individual agents
                                                                                                                                                                                                                                                                                              unboosted PIs,         Do not combine; standard dosing with
 FTC/TDF/EFV            CrCl < 50: Not recommended;                                                   Ritonavir                  Refer to recommendations for the primary PI                            ETR (BIII)                              Insufficient data in ARV-naïve                ATV/r, FPV/r, or       DRV/r, LPV/r, or SQV/r
 (Atripla®)16             see dosing for individual agents                                                                                                                                                                                      Nephrolithiasis, meal/fluid                   TPV/r (AIII)
                                                                                                                                 CP A or B: use with caution;
                                                                                                      Saquinavir                                                                                        IDV (± RTV) (BIII)
                                        nnrtis                                                                                   CP C: contraindicated                                                                                          requirements                                  NVP in ARV-naïve
                                                                                                                                                                                                                                                                                                                     ↑ symptomatic hepatic events; use only if
                        Severe renal impairment or HD: use with caution                                                          CP A: use with caution;                                                NFV (BI)                                ↓ virologic efficacy; ↑ diarrhea               w/ CD4 > 250 or
 Rilpivirine                                                                                          Tipranavir                                                                                                                                                                                                     potential benefits > risks
                        and monitor for adverse effects                                                                          CP B or C: contraindicated                                                                                                                                    w/ CD4 > 400 (BI)
                                                                                                                                                                                                        RTV as sole PI (BIII)                   Pill burden; GI intolerance
                                           PIs                                                                                         CCR5 INHIBITOR                                                                                                                                         ATV + IDV (AIII)       Potential for additive hyperbilirubinemia
                                                                                                                                                                                                        TPV/r (BI)                              ↓ virologic efficacy
                        ARV-naive on HD: ATV 300 mg + RTV                                                                                                                                                                                                                                     TPV + PIs (± RTV)      Do not combine
                                                                                                                                 No adjustment recommendation                                           ENF (BIII)                              Insufficient data in ARV-naïve
                          100 mg once daily;                                                                                     (concentrations likely ↑);                                                                                                                                   Unboosted DRV,
 Atazanavir                                                                                                                                                                                                                                                                                                          Should only be used with low-dose RTV
                        ARV-exp on HD: ATV not recommended                                                                       evidence of systemic allergic reaction                                                                                                                       SQV, TPV (AII)
                          (unboosted or boosted)                                                      Maraviroc 18
                                                                                                                                 (pruritic rash, eosinophilia or elevated IgE)                          ALSO AVAILABLE FOR ORDER AND DOWNLOAD:
 Lopinavir/r            HD: Avoid once daily dosing                                                                              may occur prior to hepatotoxicity;                                                                 ARV therapy in Pediatrics                                                             To order additional copies, visit:
                                  CCR5 INHIBITOR                                                                                 monitor closely for toxicity
                                                                                                                                                                                                                          opportunistic infections (ois) in HiV/AiDS                                                      www.FcAetc.org/treatment
                        CrCl < 30 or HD: Without potent CYP3A                                                                     INTEGRASE INHIBITOR                                                                   oral Manifestations Associated with HiV/AiDS                                                          or call: (866) 352-2382
                        inhibitor or inducer, ↓ dose to 150 mg;                                                                  CP A or B: no adjustment;                                               Post-exposure Prophylaxis (PeP) & Pre-exposure Prophylaxis (PreP)
 Maraviroc                                                                                            Raltegravir
                        Not recommended for use with potent CYP3A
                                                                                                                                 CP C: no recommendation                                                Post-exposure Prophylaxis (PeP) in Pediatrics/Adolescents (Coming Soon)                                    SPECIAL THANkS TO:
                        inhibitor or inducer
                                                                                                     17. There are no hepatic dose adjustment recommendations for other NRTIs,                                           treatment of tuberculosis (tB) in HiV/AiDS
14. No renal dose adj recommendations for ABC, PIs (except ATV), NNRTIs,                                 or for T-20                                                                                                                                                                          the Colorado AIDS Education and Training Center for
    RAL, or T-20                                                                                     18. Selzentry ® (maraviroc) Product Information. Pfizer Labs, May 2010                                               treatment of StDs in HiV-infected Patients                          medication images (images are not actual size and colors may vary),
15. Dose after hemodialysis (HD) on HD days                                                              www.viivhealthcare.com/products/~/media/Files/G/GlaxoSmithKline-Plc/
16. CAUTION: consider TDF as possible cause for renal dysfunction                                                                                                                                                    UP-TO-DATE VERSIONS AVAILABLE ONLINE                                     and to www.AIDSmeds.com for phonetic pronunciations.
                                                                                                         Attachments/pdfs/products/selzentry_maraviroc_tablets_5May2010.pdf
  complete AV block.
  PR and QT prolongation, baseline ECG before start. Do not use if QT > 450 msec, refractory ↓ K+ or ↓ Mg++, tx with other drugs that prolong QT, complete AV block w/o pacemaker, risk of       13.   individual treatment decisions for their patient.
  Ritonavir-boosted FPV preferred. Virologic failure with unboosted FPV may → cross-resistance with DRV.                                                                                         12.
                                                                                                                                                                                                                                                                                                       866-FLC-AETC (866-352-2382)
                                                                                                                                                                                                       the literature for the most up-to-date information to assist in
  Use NVP and ABC together with caution since both can cause HSRs; Early virologic failure and ↑ resistance with TDF/FTC (or 3TC).                                                               11.
  Tropism test prior to use and use if CCR5-tropic only virus (i.e. no CXCR4)                                                                                                                    10.   are encouraged to consult with their local experts or research                                       www.FCAETC.org
  Didanosine EC available in generic formulation.                                                                                                                                                9.    Recognizing the rapid changes that occur in this field, clinicians
  Once daily lopinavir/r not recommended in pregnant ♀. See Perinatal Guidelines for detailed recommendations for treating HIV in pregnancy. www.aidsinfo.nih.gov/ContentFiles/PerinatalGL.pdf   8.                                                                                                  For training opportunities in your local area:
  Do not initiate NVP in pts with moderate-severe hepatic impairment or in ART-naïve ♀ or ♂ with pre-ART CD4 > 250 or > 400 cells/mm3, respectively.                                             7.
  Zidovudine available in generic formulation.                                                                                                                                                   6.
                                                                                                                                                                                                       side effects, and important patient counseling points.
  Do not use ABC in pts who test (+) for HLA-B*5701; use caution in pts with high CVD risk or with pre-ART viral load > 100,000 copies/mL.                                                       5.    renal and hepatic dosing recommendations), available dosage forms,
  Significant interaction with proton pump inhibitors and other acid-reducing agents. See table under Atazanavir.                                                                                4.    included. Information summarized includes adult dosing (including                            health care professionals throughout the region.
  FTC may replace 3TC and vice versa (co-formulation is major determining factor).                                                                                                               3.
                                                                                                                                                                                                       agents currently approved for use in adults and adolescents is                                   consultation, and resource materials to
  Do not use EFV in 1st trimester of pregnancy or in sexually active ♀ with child-bearing potential not using adequate contraception. Caution with unstable psychiatric disease.                 2.
  See Table 2 of DHHS guidelines for Rating Scheme for strength of recommendations/quality of evidence. www.aidsinfo.nih.gov/contentfiles/AA_Tables.pdf#page=3                                   1.    above referenced guidelines. Critical information regarding antiretroviral                      Providing state-of-the-art HIV education,
                                                                                                                                                                                                       This convenient pocket-sized guide summarizes information from the
     CIII1                          (abacavir5 + lamivudine3) or (zidovudine6 + lamivudine3)                            +                              Saquinavir/r13
                                                    3                                                                                           13
     CI1                                                tenofovir + emtricitabine                                       +                         Saquinavir(Invirase®)/r                                       Pocket-SizeD ADAPtAtion
     CIII1           (abacavir5 + lamivudine3) or (zidovudine6 + lamivudine3) or (tenofovir + emtricitabine3)           +                            Fosamprenavir12
                                                                                                                                                                                                                florida/caribbean aetc
                                                                                      PI-based (alphabetical)
     CIII1                          (abacavir5 + lamivudine3) or (tenofovir + emtricitabine3)                           +                              Nevirapine7,11
                                                                                           NNRTI-based
  REGIMENS THAT MAy BE ACCEPTABLE BUT SHOULD BE USED WITH CAUTION: Virologic efficacy demonstrated in some studies but safety, resistance, and/or efficacy concerns exist
                            (abacavir5 + lamivudine3) or (tenofovir + emtricitabine3)                                   +                               Maraviroc10                                                                                                                                        www.USFCenter.org/Perinatal
                                                                                      CCR5 Inhibitor-based:                                                                                                                                                                                                    Community Website
                            (abacavir5 + lamivudine3) or (zidovudine6 + lamivudine3)                                    +                               Raltegravir
                                                                                                                                                                                                                                                                                                             Perinatal HIV Prevention
                                                                                    Integrase Inhibitor-based:
                                                                                                                                                                                                                                                                                                              888-HIV-8765 (448-8765)
                            (abacavir5 + lamivudine3) or (zidovudine6 + lamivudine3)                                    +                               Darunavir/r
                                                                                                                                                                                                                                                                                                          Consultation and Referral Service
                                                                                            PI-based:
                                                                                                                                                                                                                                                                                                               National Perinatal HIV
                                          REGIMENS THAT MAy BE ACCEPTABLE (ALL CIII1): May be acceptable but more definitive data needed
                                           zidovudine6 + lamivudine3                                                    +                       Maraviroc10 (Selzentry ®)                                                                January 2011
                                                                                                                                                                                                                                                                                                              www.FCAETC.org/RTC
                                                                                      CCR5 Inhibitor-based:
                                                                                                                                                                                                                                                                                                          Resistance Testing Consultation
                            (abacavir5 + lamivudine3) or (zidovudine6 + lamivudine3)                                    +                               Atazanavir4
                                                                                            PI-based:                                                                                                                                                                                                            800-933-3413
                      didanosine9 (Videx ®, Videx EC ®) + (lamivudine3 or emtricitabine3)                               +                               Efavirenz2                                                                                                                               National HIV Telephone Consultation Service
                                                                                          NNRTI-based:
                                     ACCEPTABLE REGIMENS (CI1): May be selected for some patients but less satisfactory than preferred or alternative                                                                                                                                                       888-HIV-4911 (448-4911)
                                                                                                                                       Lopinavir/r (Kaletra ®)8 once or twice daily                                                                                                               National Post-Exposure Prophylaxis Hotline
             (abacavir5 + lamivudine3) or (zidovudine6 + lamivudine3) or (tenofovir + emtricitabine3)                   +
                                                                                                                                    Fosamprenavir (Lexiva ®)/r once or twice daily or
                            (abacavir5 + lamivudine3) or (zidovudine6 + lamivudine3)                                    +                              Atazanavir/r4                                   Available at http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf                             www.FCAETC.org/OC
                                                                                                                                                                                                       of Health and Human Services. January 2011.
                                                                                      PI-based (alphabetical):
                                                                                                                                                                                                       use of antiretroviral agents in HIV-1-infected adults and adolescents. Department                           Online Consultation
                                           zidovudine6 + lamivudine3                                                    +              Nevirapine7 (Viramune ®, Viramune XR ®)                         Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the
 (abacavir5 + lamivudine3), available as Epzicom® or (zidovudine6 + lamivudine3), available as Combivir ®               +                        Efavirenz2 (Sustiva ®)                                Funded in part by DHHS-HAB Grant No. H4AHA00049                                                           Online Training Modules
                                                                                    NNRTI-based (alphabetical):
                                                                                                                                                                                                                     Ashley Vandonkelaar, BFA
                                                                                                                                                                                                                     Maximo Lora, BA                                Layout:                                     Routine Testing Guidelines
                                                                                                                    1
                                       ALTERNATIVE REGIMENS (ALL BI ): Effective/tolerable but have potential disadvantages compared to preferred
                                                                                                                                                                                                                               Kim Molnar, MAcc          Managing Editor:
                                            tenofovir + emtricitabine3                                                  +                       Raltegravir (Isentress ®)                                                                                                                               Perinatal HIV Prevention Program
                                                                                                                                                                                                        Joanne J. Orrick, PharmD, AAHIVE
                                                                                    Integrase Inhibitor-based:                                                                                          Jeffrey Beal, MD, AAHIVS                                 Editors:                                            Preceptorships
                                      tenofovir + emtricitabine3 (Truvada ®)                                            +    Atazanavir (Reyataz ®)/r4 or Darunavir (Prezista ®)/r once daily                                                      June 2011                                           Treatment Guidelines • Chart Tools
                                                                                      PI-based (alphabetical):
                                                                 Efavirenz2 + tenofovir + emtricitabine3 (Available as Atripla ®)                                                                                                                                                                   HIV CareLink Newsletter • HIV Updates
                                                                                          NNRTI-based:


                                                                                                                                                                                                       Adolescents
                                                                                                                                                                                                                                                                                                    Specialty Conferences • Chart Reviews
                                            PREFERRED REGIMENS (ALL AI1): Optimal/durable efficacy, favorable tolerability/toxicity, ease of use
                                                                                                                                                                                                                                                                                                    Case Conferences • Annual Conference
                                                       Note: (/r) indicates low-dose ritonavir (Norvir ®) for boosting

                                                                                                                                                                                                       in Adults &
                   Regimens below assume no baseline resistance. Resistance testing recommended for all patients upon entry into care and prior to starting ARVs.
                                             Regimens for Treatment of HIV-1 in Antiretroviral-Naïve Patients
                                                                                                                                                                                                       ARV Therapy
NUCLEOSIDE/NUCLEOTIDE REVERSE                                             NON-NUCLEOSIDE REVERSE                                                           (PIs)(Continued)                                                             (PIs)(Continued)
TRANSCRIPTASE INHIBITORS (NRTIs)                                          TRANSCRIPTASE INHIBITORS (NNRTIs)                                                Atazanavir (Reyataz®, ATV) (Continued)                                      Saquinavir (Invirase®-HGC or tab, SQV)
                                                                                                                                                                Important Points:                                                       (sa-kWIH-nuh-veer)
 class adverse effects: Lactic acidosis with hepatic steatosis.            class adverse effects: rash (rarely Stevens-Johnson
                                                                           Syndrome), ↑ LFTs, many drug interactions.                                           • AEs: ↑ unconjugated bili (common), jaundice or scleral                  Dosage form:      200 mg hard gel cap or ♦500 mg tab
Abacavir (Ziagen®, ABC)                                                                                                                                           icterus (less common); less adverse effects on lipid profile;           Adult dose:       1000 mg + RTV 100 mg po bid
(uh-BACk-ah-veer)                                                         Delavirdine (Rescriptor®, DLV)                                                          prolonged PR interval, asymptomatic 1st degree AV block                 Combining         With EFV, ETR, or NVP (standard dosing),
                                                                          (deh-LAH-ver-deen)                                                                      (rare); nephrolithiasis (rare)                                          with NNRTIs:      use SQV standard dosing (1000 mg + RTV
  Dosage form: 300 mg tab, 20 mg/mL soln (240 mL/bottle)
                                                                            Rarely, if ever, used                                                                                                                                                           100 mg po bid)
  Adult dose:        300 mg po bid or 600 mg po once daily                                                                                                 Darunavir (Prezista®, DRV)
  Note: Peform HLA-B*5701 test prior; only use if negative                                                                                                                                                                                Important Points:
                                                                          Efavirenz (Sustiva®, EFV)                                                        (da-ROO-nuh-veer)
  Important Points:                                                                                                                                                                                                                       • Take within 2 hrs of a meal
  • Alcohol ↑ ABC levels 41%; potential for adverse effects               (eh-FAH-vih-rehnz)             oc  27
                                                                                                                                                                Dosage form:   75, 150, ♦400, ♦600 mg tab                                 • Grapefruit juice ↑ SQV level, garlic supplements ↓ SQV level
  • Possible ↑ risk of CVD in pts with multiple CV risk factors             27. ♀ with child-bearing potential should use 2 forms of birth control              Adult dose:    800 mg + RTV 100 mg po once daily [ARV-naïve                 (potential interaction with all PIs/NNRTIs)
                                                                                since EFV is teratogenic; consider pregnancy test prior to use                                 or exp if no DRV mutations (V11I, V32I, L33F,              • Precaution: ↑ QT interval in healthy volunteers; do not
  • AEs: HSR (2-9%), characterized by sign/symptom from ≥ 2                                                                                                                                                                     32
    groups: G1: fever; G2: rash; G3: N/V/D, or abd pain; G4: malaise,       Dosage form: 50, 200 mg cap, ♦600 mg tab                                                           I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V)]             use in pts with QT prolongation, preexisting conduction
    fatigue, or achiness; G5: dyspnea, cough, or pharyngitis (onset 4-6     Adult dose:        600 mg po once daily at bedtime                                                 600 mg + RTV 100 mg po bid (ARV-naïve or exp)                system disease, ischemic heart disease, cardiomyopathy,
    weeks) Discontinue drug promptly and DO NOT RECHALLENGE!                Important Points:                                                                   Combining with DRV/r standard dosing with ETR and NVP; with                 or underlying structural heart disease; do not use in pts
                                                                            • Take at bedtime w/o food to ↓ CNS side effects                                    NNRTIs:        EFV, standard DRV/r dose but monitor closely                 taking Class IA (e.g. quinidine) or Class III (e.g. amiodarone)
Didanosine (Videx EC®, ddI)                                                 • False + cannabinoid or benzodiazepine test (usually on                                           (DRV Cmin ↓ 31% and EFV AUC ↑ 21%)                           antiarrhythmics.
(dye-DAH-no-seen)                                                             screening, confirmatory test should be negative)                                  32. www.prezista.com/sites/default/files/pdf/us_package_insert.pdf        • AEs: GI intolerance (nausea, diarrhea, abdominal pain,
                                                            ®               • Use with caution in pts with unstable psych disorder                              Important Points:                                                           dyspepsia)
  Dosage form: 125, 200, 250, ♦400 mg cap (Videx EC ,
                                                                            • AEs: Drowsinesss, dizziness, insomnia, abnormal dreaming,                         • Take with food
                generic available)                                                                                                                                                                                                      Tipranavir (Aptivus®, TPV)
                                                                              agitation (generally resolves in 2-4 weeks), hallucinations                       • AEs: Rash 10%, abd pain, headache, hepatotoxicity, caution
                Ped powder for soln 10 mg/mL (2 or 4 g bottle)
                                                                              (rare), ↑ lipids                                                                    with sulfa allergy (not contraindicated)                              (ti-PRAN-a-veer)
  Adult dose22: ≥ 60 kg: 400 mg po once daily
                < 60 kg: 250 mg po once daily                             Etravirine     (Intelence®,       ETR)                                           Fosamprenavir (Lexiva®, FPV)                                                   Dosage form:      250 mg cap
                BID dosing preferred with oral soln                                                                                                                                              33                                                         100 mg/mL soln (95 mL/bottle)
                                                                          (eh-truh-VIGH-reen)                                                              (foss-am-PREH-nah-veer)
                (total daily dose divided into 2 doses)                                                                                                                                                                                   Adult dose:       500 mg + RTV 200 mg po bid
  22. ddI + (3TC or FTC) + ATV: ↓ virologic response; DHHS                  Dosage form:        100, ♦200 mg tab                                              33. Suspension: adults without food; peds with food                         Combining         With EFV or NVP (standard dosing) use
                                                                            Adult dose28:       200 mg po bid                                              Prodrug of amprenavir
      recommends ddI + (3TC or FTC) as an acceptable but inferior                                                                                                                                                                         with NNRTIs:      TPV/RTV standard dose; with ETR,
      NRTI backbone to be used only with EFV                                28. Do not use ETR with unboosted PIs, ATV/r, FPV/r, TPV/r.                         Dosage form:     700 mg tab, 50 mg/mL susp (225 mL/bottle)
                                                                                                                                                                                                                                                            do not use TPV/RTV
  Important Points:                                                             Standard dosing with DRV/r, LPV/r, SQV/r.                                       Adult dose:      1400 mg po bid or
                                                                                                                                                                                                                                          Important Points:
  • Empty stomach, 30 min ac or 2 hr pc                                     Important Points:                                                                                    1400 mg + RTV 100-200 mg po once daily
                                                                                                                                                                                                                                          • Antacids ↓ TPV; take TPV 2 hrs before or 1 hr after antacids
  • Swallow Videx EC® capsules whole; do not crush, chew or break open      • Take following a meal                                                                              (ARV-naïve only)
                                                                                                                                                                                                                                          • AEs: Hepatotoxicity-monitor LFTs closely; Rash 8% ♂, 10%
  • AEs: Peripheral neuropathy, pancreatitis, diarrhea, nausea,             • May disperse tabs in water, stir well, drink immediately and                                       700 mg + RTV 100 mg po bid
                                                                                                                                                                                                                                            ♀, > in women taking estrogen; N/V/D; caution in pts. at
    possible association with noncirrhotic portal hypertension                rinse glass several times and drink rinse                                                          (PI-exp or naïve)
                                                                            • AEs: Nausea, hypersensitivity reactions with rash,                                                                                                            risk for ↑ bleeding (intracranial hemorrhage reported rarely);
                                                                                                                                                                Combining        With EFV (standard dose), use FPV
Emtricitabine (Emtriva®, FTC)                                                 constitutional findings, hepatic failure have been reported                       with NNRTIs:     1400 mg + RTV 300 mg once daily or FPV                     caution with sulfa allergy (not contraindicated)
                                                                                                                                                                                 700 mg + RTV 100 mg bid; With ETR do not                 • Keep caps in refrigerator (stable until label date) or store
(em-trih-SIGH-ta-been)
                                                                          Nevirapine (Viramune®,                                                                                 use FPV (± RTV) ; With NVP (standard dose),                at room temp (max 25°C/77°F) for up to 60 days; Oral
  Dosage form: 200 mg cap, 10 mg/mL soln (170 mL/bottle)
                                                                          Viramune XR®, NVP)                                                                                     use FPV 700 mg + RTV 100 mg bid                            soln should be kept at room temp for up to 60 days-do not
  Adult dose:      200 mg cap or 240 mg (24 mL) soln po once daily
                                                                          (nah-VAIR-ah-peen)                                                                    Important Points:                                                           refrigerate or freeze soln
  Important Points:
  • Abrupt withdrawal can cause chronic active Hep B flares                 Dosage form:        200 mg tab, 400 mg tab (XR),                                    • OCs ↓ FPV levels; do not coadminister
  • AEs: Generally well-tolerated, ↑ pigmentation of palms/soles                                10 mg/mL suspension (240 mL bottle)                             • Acid-reducing Agents: PPI coadministration allowed; H2RA              ENTRY INHIBITORS
    (> in black and Hispanic pts)                                           Adult dose29:       200 mg po once daily x 14d, then                                  use with caution due to ↓ APV levels; separate administration         Fusion Inhibitor
  • Refrigerate soln or room temp if used w/in 3 mos                                            [200 mg po bid or 400 mg (XR) po once daily]                    • AEs: Skin rash (19%), N/V/D, caution with sulfa allergy (not          Enfuvirtide (Fuzeon®, T-20, ENF)
                                                                            29. If NVP discontinued ≥ 7d, restart at lower dose x 14d; pts taking                 contraindicated)                                                      (en-FEW-ver-tide)
Lamivudine (Epivir ®, 3TC)                                                      NVP immediate release (200 mg bid or 400 mg once daily) can                     • Refrigeration of susp not required but may improve taste,
                                                                                                                                                                                                                                          Dosage form:      Powder for SC inj, mix with 1.1 mL
(la-MI-vue-deen)                                                                switch to XR 400 mg once daily without 200 mg daily lead-in                       shake well before each use
                                                                                dosing; If mild rash occurs and hepatotoxicity ruled out, can                                                                                                               sterile water for final conc 90 mg/mL
  Dosage form: 150 mg, ♦300 mg tab, 10 mg/mL soln (240 mL/bottle)               continue 200 mg daily lead-in dose for up to 28d.                          Indinavir (Crixivan®, IDV)                                                     Adult dose:       90 mg SC bid
  Adult dose:     300 mg po once daily or 150 mg po bid                         See Viramune XR® Package Insert (March 2011)                                                            34                                                Important Points:
  Important Points:                                                                                                                                        (in-DIH-nuh-veer)
                                                                            Important Points:                                                                                                                                             • Must instruct pt on reconstitution and administration techniques
  • Abrupt withdrawal can cause chronic active Hep B flares                                                                                                   34. If given without RTV (rarely if ever done), take 1 hr ac or 2 hr pc
                                                                            • 400 mg XR tabs are extended-release and should not be                                                                                                       • Administer SC in upper arm, upper leg, or stomach (do not
  • AEs: Generally well-tolerated                                                                                                                                 or with low fat/protein snack.
                                                                              crushed, chewed, or broken                                                                                                                                    inject into naval area, scar tissue, bruise, mole, or area with
                                                                                                                                                                Dosage form:     100, 200, 333, ♦400 mg cap
                                                                            • AEs: Rash - mild to severe, usually within 1st 6 wks, D/C if                                                                                                  injection site reaction)
Stavudine (Zerit®, d4T)                                                                                                                                         Adult dose:      800 mg + RTV 100-200 mg po bid
                                                                              severe; ↑ LFTs (Monitor LFTs - baseline, 2 wks, then q4wks x                                                                                                • Rotate injection sites
(STA-vue-deen)                                                                                                                                                  Combining        With EFV (standard dose), use IDV
                                                                              1st 3 mos, then q3mos); Hepatotoxicity often rash-associated,                                                                                               • AEs: Injection site reactions (mild/moderate, can be severe),
                                                                                                                                                                with NNRTIs:     1000 mg q8h or IDV 800 mg + RTV
  Dosage form:      15, 20, 30, ♦40 mg cap, 1 mg/mL soln                      check LFTs in any pt with rash; ♀ and ♂ w/ pre-ART CD4 > 250                                                                                                  itching, swelling, redness, pain/tenderness, induration,
                                                                                                                                                                                 100-200 mg bid, do not use IDV with ETR
                    (200 mL/bottle); generic available                        and > 400, respectively and pts with chronic active Hep B or C                                                                                                nodules, cysts; ↑ bacterial pneumonia; HSR (< 1%) - sxs.
                                                                                                                                                                                 (no data with IDV/RTV)
  Adult dose23:     ≥ 60 kg: 40 mg po bid; < 60 kg: 30 mg po bid              co-infection are at ↑ risk for ↑ LFTs                                                                                                                         include rash, fever, N/V, chills, rigors, ↓ BP, or ↑ LFTs
  23. WHO recommends 30 mg bid regardless of body weight                                                                                                        Important Points:
                                                                                                                                                                                                                                            DO NOT RECHALLENGE!
  Important Points:                                                       Rilpivirine (Edurant™, RPV)                                                           • Drink 6 eight oz glasses fluid each day (water preferred)
                                                                                                                                                                                                                                          • Store unopened vials at room temp (max 25°C/77°F).
  • AEs: Peripheral neuropathy, pancreatitis (esp w/ ddI),                (ril-pih-VIGH-reen)                                                                   • AEs: Nephrolithiasis, ↑ unconjugated bili
                                                                                                                                                                                                                                            Reconstituted soln should be refrigerated and used within
    lipoatrophy, ↑ lipids, rapidly progressing ascending                                                                                                        • Store in original container with desiccant
                                                                            Dosage form:        25 mg tab                                                                                                                                   24 hours
    neuromuscular weakness, osteopenia (rare, multifactorial)               Adult dose30:       25 mg once daily with food                                 Lopinavir/Ritonavir (Kaletra®, KAL, LPV/r)
  • Refrigerate soln and shake well                                         30. Approved for use in ARV-naïve patients only (Use in patients                                                                                            CCR5 Inhibitor
                                                                                                                                                           (lo-PIN-uh-veer/rih-TAH-nuh-veer)
                                                                                with VL > 100,000 copies/mL associated with more failures                                                                                               Maraviroc (Selzentry®, MVC)
Tenofovir (Viread®, TDF)                                                        and resistance)                                                                 Dosage form:     ♦200/50 mg, 100/25 mg tab
(ten-OH-foh-veer)                                                                                                                                                                400/100 mg per 5 mL soln (160 mL/bottle)               (mah-RAV-er-rock)
                                                                            Important Points:
  Nucleotide RTI                                                            • Take with food                                                                    Adult dose35:    2 tabs po bid (PI-naïve or exp) or                       Dosage form: ♦150 mg, 300 mg tab
  Dosage form: 300 mg tab                                                   • Interacts with acid-reducing agents                                                                4 tabs po once daily (PI-naïve or exp                    Note: Do not use in pts with dual/mixed tropic or CXCR4-tropic
  Adult dose:      300 mg po once daily                                       ◦ Proton pump inhibitors (e.g. omeprazole, lansoprazole):                                          with ≤ 3 significant mutations36)                              virus. Perform tropism assay prior to use.
  Important Points:                                                              Contraindicated, do not combine                                                35. Once daily dosing should not be used in pregnant women
                                                                                                                                                                                                                                                   CONCOMITANT MEDICATIONS                      ADULT DOSE
  • Interacts with ATV (see ATV for dosing)                                                                                                                     36. Dose LPV/r bid in pts with ≥ 3 of the following PI mutations:
                                                                              ◦ H2-receptor blockers (e.g. famotidine, ranitidine) should                                                                                                CYP3A inhibitors
                                                                                                                                                                    L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V,
  • Abrupt withdrawal can cause chronic active Hep B flares                      be taken at least 12 hours before or 4 hours after RPV                                                                                                  (w/ or w/o a CYP3A inducer):
                                                                                                                                                                    V82A/C/F/S/T, and I84
  • AEs: Flatulence, headache, renal insufficiency, Fanconi                   ◦ Antacids (e.g. aluminum or magnesium hydroxide, calcium                                                                                                  • protease inhibitors (except TPV/r), DLV
                                                                                                                                                                Combining         With EFV or NVP (standard dosing), ↑ LPV                                                                       150 mg po bid
    Syndrome (rare), ↓ PO4, osteopenia (rare, multifactorial)                    carbonate) should be taken at least 2 hours before or 4                                                                                                 • ketoconazole, itraconazole, clarithromycin
                                                                                                                                                                with NNRTIs:      to 500/125 mg (two 200/50 mg and one                   • other strong CYP3A inhibitors
                                                                                 hours after RPV                                                                                  100/25 mg) tabs bid or 533/133 mg soln
Zidovudine (Retrovir ®, AZT, ZDV)                                           • Caution with drugs that prolong the QTc interval
                                                                                                                                                                                                                                            (e.g., nefazadone, telithromycin)
(zye-DOE-vue-deen)
                                                                                                                                                                                  bid; with ETR, use standard dosing of each             CYP3A inducers
                                                                            • AEs: Depression, insomnia, headache, rash                                         Important Points:                                                        (w/o a strong CYP3A inhibitor) including:
  Dosage form:    ♦300 mg tab, 100 mg cap, 10mg/mL IV soln,                                                                                                     • Swallow tablets whole; cannot be chewed, broken, or crushed            • EFV, ETR                                              600 mg po bid
                  10 mg/mL syrup (240 mL/bottle)                          PROTEASE INHIBITORS (PIs)                                                             • May take tablets without food, soln should be taken with food          • rifampin
  Adult dose:     300 mg po bid or 200 mg po tid                           class adverse effects: ↑ glucose, ↑ lipids (less with ATV),                          • Oral soln contains 42% alcohol                                         • carbamazepine, phenobarbital,and phenytoin
  Intrapartum:    2 mg/kg IV over 1 hr then 1 mg/kg/hr until               lipodystrophy, ↑ LFTs, ↑ bleeding in hemophiliacs. All undergo                       • AEs: GI intolerance (N/V/D), asthenia, prolonged PR, rare              Other concomitant medications, including:
                  cord clamping                                                                                                                                                                                                                                                                  300 mg po bid
                                                                           hepatic metabolism mostly CYP3A4 - Many drug interactions!                             cases of 2nd/3rd degree AV block; prolonged QT interval, rare          TPV/r, NVP, all NRTIs, T-20, RAL
  Important Points:
                                                                                                                                                                  cases of torsade de pointes (causality not established)                 Important Points:
  • AEs: Headache, nausea, ↑ pigmentation skin/nails,                     Atazanavir (Reyataz®, ATV)
                                                                                                                                                                • Do not take tabs out of container for > 2 wks especially in             • AEs: Hepatotoxicity: may be preceded by a systemic
     ↓ H/H, ↓ WBC, myopathy                                               (ah-ta-ZA-na-veer)                oc     31
                                                                                                                                                                  areas of ↑ humidity                                                       allergic reaction (↑ LFTs, pruritic rash, ↑ eos, other systemic
Combination Products:                                                       31. ATV/r: OC dose minimum 35 mcg ethinyl estradiol (EE);                           • Refrigerate soln (stable until label date) or store at room               symptoms), dizziness/postural hypotension, cough, pyrexia,
(see individual drug components for important points)                           ATV: OC dose maximum 30 mcg EE;                                                   temp (max 25°C/77°F) for up to 60 days
                                                                                OCs with < 25 mcg EE, progestins other than norethindrone or
                                                                                                                                                                                                                                            URI, rash, musculoskeletal symptoms, abd pain, ↑ CV events
                                                                                                                                                           Nelfinavir (Viracept®, NFV)                                                      (MI, ischemic events)
Atripla®                                                                        norgestimate; other hormonal contraceptives (e.g. patch, ring,
                                                                                injectable) not studied, alternative contraception recommended
(uh-TRIP-luh)         25
                                OC   24
                                                                            Dosage form:        100, 150, 200, ♦300 mg cap
                                                                                                                                                           (nell-FIH-nuh-veer)
                                                                                                                                                                                                                                        INTEGRASE INHIBITOR
  24. ♀ with child-bearing potential, consider pregnancy test before                                                                                            Dosage form:     250 mg, ♦625 mg tab, 50 mg/g oral powder
                                                                            Adult dose:         400 mg po once daily (ARV-naïve only)
                                                                                                                                                                                 (144 g/bottle)
                                                                                                                                                                                                                                        Raltegravir (Isentress®, RAL)
      use and 2 forms of birth control; EFV is teratogenic                                      300 mg + RTV 100 mg po once daily
  Each tablet contains: 600 mg EFV + 200 mg FTC + 300 mg TDF                                                                                                    Adult dose:      1250 mg po bid, 750 mg po tid                          (ral-TEG-ra-veer)
                                                                                                (naïve, exp, or w/TDF)
  Adult dose:                   1 tab po once daily at bedtime              Combining           Do not use ATV (± RTV) with ETR, NVP, or                        Combining        With EFV or NVP (standard dosing) using                  Dosage form: 400 mg tab
                                                                            with NNRTIs:        EFV (in ARV-exp pts); can use ATV/r with                        with NNRTIs:     NFV standard dose; with ETR, do not use NFV              Adult dose37:   400 mg po bid
Combivir ®                                                                                                                                                      Important Points:                                                         Important Points:
                                25                                                              ↑ dose with EFV but not a DHHS
(COM-bih-veer)                                                                                                                                                  • Take with meal or snack                                                 • AEs: Diarrhea, nausea, headache, and pyrexia; ↑ ALT, AST,
                                                                                                recommended regimen in ARV-naïve pts
  Each tablet contains:         300 mg AZT + 150 mg 3TC                                                                                                         • Do not use PPIs with NFV (based on data indicating                        CPK; myopathy and rhabdomyolyis have been reported
  Adult dose:                   1 tab po bid                                  acID-                                                                               omeprazole → ↓ NFV levels)                                              37. 800 mg po bid if used with rifampin
                                                                                                treATMENT-                       trEATMENT-
                                                                            REDUCING                                                                            • AEs: Diarrhea (can use OTC loperamide to treat diarrhea;
                                                                                                  NAïVE                         ExPERIENCED
Epzicom®                                                                     AGENTS                                                                               calcium carbonate 1-2 tabs with each dose may lessen diarrhea)         ♦ = dosage in photo, when multiple dosage forms are available
                           25
(EP-zih-com)                                                                antacids     • ATV or ATV/r: Give             • ATV/r: Give
                                                                           or buffered     ≥ 2 hrs before or                ≥ 2 hrs before or              Ritonavir (Norvir®, RTV)                                                         = Take with food         = Take without food
  Each tablet contains:         300 mg 3TC + 600 mg ABC
                                                                           medications     1 hr after antacid               1 hr after antacid             (rih-TAH-nuh-veer)
  Adult dose:                   1 tab po once daily                                                                                                                                                                                             = Take with or without food
                                                                                         • ATV: Give ≥ 2 hrs before       • ATV/r: Give simultaneously          Dosage form: ♦100 mg tab, ♦100 mg cap,
Trizivir ®                                                                                 or 10 hrs after H2RA. Max        with or ≥ 10 hrs after H2RA.                     80 mg/mL soln (240 mL/bottle)                                  = Hepatic Adjustment (See table)
                            25                                                             dose of famotidine 20 mg         Max dose of famotidine 20
(TRy-zih-veer)                                                                                                                                                  Used only at low doses with other PIs
                                                                           H2 Receptor     bid (not to exceed 20 mg in      mg bid [or equivalent]                                                                                          = Renal Adjustment (See table)
  Each tablet contains:         300 mg AZT + 150 mg 3TC + 300 mg ABC       antagonists     single dose) [or equivalent]   • ATV/r (400/100 mg) with             (see primary PI for dosing and adverse effects)
  Adult dose:                   1 tab po bid                                (H2RAs)      • ATV/r: Give simultaneously       TDF: Give simultaneously            Important Points:                                                                    = Pregnancy Category
  25. Do not use these combo products if CrCl is < 50 mL/min                               with or ≥ 10 hrs after H2RA.     with or ≥ 10 hrs after H2RA.        • Store tabs at room temp; refrigerate caps (stable until label
                                                                                           Max dose of famotidine 40        Max dose of famotidine 20                                                                                          = ↑ Combination Oral Contraceptive Level
                                                                                           mg bid [or equivalent]           mg bid [or equivalent]                date), can store caps at room temp (max 25°C/77°F) for up
Truvada®                                                                                                                                                          to 30 days; do not refrigerate soln                                              ↓ Combination Oral Contraceptive Level;
(true-VAH-duh)                  26
                                                                                         • ATV: not recommended           • ATV/r: not recommended                                                                                             =
                                                                                                                                                                                                                                                   Use alternate/additional form of birth control
                                                                                         • ATV/r: Max dose of
  Each tablet contains:         200 mg FTC + 300 mg TDF                        PPIs        omeprazole 20 mg once                                                                                                                               = Do not coadminister with Combination Oral Contraceptive
  Adult dose:                   1 tab po once daily                                        daily [or equivalent] taken                                                                   www.facebook.com/FCAETC
  26. Do not use this combo product if CrCl is < 30 mL/min                                 ≥ 12 hrs prior to ATV/r                                          s                                                                            NOTE: Medication images are NOT actual size, and colors may vary.

								
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