HCV On-Treatment Virologic Monitoring Impact on Treatment Decisions by erq11535

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									HCV On-Treatment Virologic
Monitoring: Impact on
Treatment Decisions

  Ruth J. Corbett, MSN, ARNP, CCRC
  Gastroenterology Advanced Practice Nurse,
  Specialty Care
  Department of Veteran Affairs
  Kansas City, Missouri




This program is supported by an educational grant from
HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions




Faculty and Disclosures
Program Director                                     Faculty
Emmet B. Keeffe, MD, MACP                            Ruth J. Corbett, MSN, ARNP, CCRC
Professor of Medicine                                Gastroenterology Advanced Practice
Co-Director, Liver Transplant Program                Nurse, Specialty Care
Chief of Hepatology                                  Department of Veteran Affairs
Stanford University School of Medicine               Kansas City, Missouri
Palo Alto, California



Faculty
Ruth J. Corbett, MSN, ARNP, CCRC, has disclosed that she is a member of the speakers’
bureau for Roche and Schering-Plough.
Emmet B. Keeffe, MD, MACP, has disclosed that he has received grants or research
support from Roche. He has received consulting fees from Idenix, Roche, and Valeant. He
has received fees for non-CME services from Roche and Schering-Plough.
Staff
Jenny Schulz, PhD, has no significant financial relationships to disclose.
Gordon Kelley has no significant financial relationships to disclose.
Edward King, MA, has no significant financial relationships to disclose.
                                                                              clinicaloptions.com/hep
Goals and Benefits of
   HCV Therapy
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Hepatitis C Virus Infection:
 Magnitude of the Problem
  Nearly 4 million persons in United States infected
       – Approximately 35,000 new cases yearly
       – 85% of new cases become chronic
  10,000-20,000 HCV-related deaths per year
       – Number expected to triple in next 10-20 years
  Leading cause of
       – Chronic liver disease
       – Cirrhosis
       – Liver cancer
       – Liver transplantation
CDC. MMWR Morb Mortal Wkly Rep. 1998;47;1-39. NIH Consensus Conference Statement.
Available at: http://consensus.nih.gov/2002/2002HepatitisC2002116html.htm. Accessed
September 25, 2006.                                                                   clinicaloptions.com/hep
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions




 Goals of HCV Therapy
  Primary goal of treatment is to eradicate the virus
  Additional goals
       – Slow disease progression
       – Minimize risk of hepatocellular carcinoma
       – Improve liver histology
       – Enhance quality of life
       – Prevent transmission of virus
       – Reduce extrahepatic manifestations

Lindsay KL. Hepatology. 2002;36(suppl 1):S114-S120.                     clinicaloptions.com/hep
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Overview of Current FDA-Approved
 Treatments for HCV
 Drug                                     Recommended Dosage
 Pegylated interferons
  Peginterferon alfa-2b                   1.5 µg/kg SQ once weekly combined with RBV;
                                            1.0 µg/kg SQ once weekly monotherapy
  Peginterferon alfa-2a                   180 µg SQ once weekly combined with ribavirin or
                                            as monotherapy
 Interferon alfacon-1                      9 µg SQ TIW; 15 µg TIW for nonresponders
 Ribavirin                                 800-1400 mg PO daily depending on weight and
                                            genotype




PEG-IntronTM [package insert]. Kenilworth, NJ: Schering Corporation; 2003. Pegasys [package
insert]. Nutley, NJ: Hoffmann-La Roche Inc; 2003. Modified from Strader DB et al. Hepatology
2004;39:1147-1171.                                                                             clinicaloptions.com/hep
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 SVR Rates: Progress in the Treatment
 of Chronic Hepatitis C
                                 SVR Rates With Standard Interferon
                         100

                         80
          Patients (%)




                         60
                                                                                      43
                         40

                                                            19
                         20
                                    6

                           0
                                  IFN                     IFN                    IFN/RBV
                               24 Weeks                48 Weeks                  48 Weeks
McHutchison J, et al. N Engl J Med. 1998;339:1485-1492. Poynard T, et al. Lancet. 1998;352: 1426-
1432.                                                                                               clinicaloptions.com/hep
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 SVR Rates: Progress in the Treatment
 of Chronic Hepatitis C
  Peginterferon alfa-2b                                       Peginterferon alfa-2a 180 µg/wk
   1.5 µg/kg/wk + ribavirin                                     + weight-based ribavirin (1000
   800 mg/d for 48 weeks                                        or 1200 mg/d) for 48 weeks
                       100
                                                     82
 Sustained Virologic




                        80                                                                                 76
   Response (%)




                        60                                                  56
                               54
                                                                                              46
                                         42
                        40

                        20

                             n = 511   n = 348    n = 163               n = 453         n = 298       n = 140
                         0
                             Overall   Genotype   Genotype               Overall       Genotype        Genotype
                                          1         2/3                                   1              2/3
Manns M, et al. Lancet. 2001;358:958-965. Fried MW, et al. N Engl J Med. 2002;347: 975-982.        clinicaloptions.com/hep
Predicting Response
  to HCV Therapy
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Factors That May Influence the
 Outcome of Hepatitis C
                                                                             Host
                                Virus
                                                                              Sex
                            Viral load                                        Age
                          HCV genotype                                       Race
                          Quasispecies                                     Genetics
                                                                       Immune response
                                                                      Duration of Infection
                                                   Environment
                                                   Alcohol or drugs
                                                   HBV coinfection
                                                   HIV coinfection
                                                      Steatosis
                                                         Iron
                                                        NASH
Alberti A, et al. J Hepatol. 1999;31(suppl 1):17-24.                                     clinicaloptions.com/hep
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Predictors of Sustained Virologic
 Response: Fixed Factors
 Baseline Factor                                           Sustained Virologic Response Rates
                                                      PegIFN alfa-2a + RBV OR PegIFN alfa-2b + RBV
 HCV RNA, %[1,2]
  < 2 x 106 copies/mL                                                           62-78
  > 2 x 106 copies/mL                                                           42-53
 Genotype, %[1,2]
  2 or 3                                                                        76-82
 1                                                                              42-46
 Genotype 1 and high viral load, %                                               30-41
 Liver histology, %[1,2]
  Stage 0-2                                                                   55-57
  Stage 3-4                                                                   41-44
 Age[1,2]                                                              Older age, lower SVR*
 Weight[1,2]                                                         Higher weight, lower SVR*
 Race, %[3,4]
  Black                                                                          52
  White                                                                         19-28
  *Logistic regression analysis, P ≤ .002.
1. Manns MP, et al. Lancet. 2001;358:958-965. 2. Fried MW, et al. N Engl J Med. 2002;347: 975-982.
3. Muir AJ, et al. N Engl J Med. 2004;350:2265-2271. 4. Conjeevaram HS, et al. 2006;131:470-477.     clinicaloptions.com/hep
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Virologic Monitoring Markers and
 Definitions of Response to Treatment
 Rapid Virologic
                                  HCV RNA undetectable by Week 4
 Response (RVR)
 Early Virologic
                                  ≥ 2 log decline in HCV RNA by Week 12
 Response (EVR)
 End of Treatment
                                  Undetectable HCV RNA at end of treatment
 (EOT) Response
 Partial Virologic                ≥ 2 log decline in HCV RNA by Week 12, but HCV RNA
 Response                         detectable at Week 24
 Sustained Virologic
                                  HCV RNA negativity 12-24 weeks after treatment end
 Response (SVR)



Pawlotsky JM. Hepatology. 2002;36(suppl 1):S65-S73.
Sethi A, et al. Clin Liver Dis. 2005;9:453-471.                              clinicaloptions.com/hep
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Virologic Monitoring Markers and
 Definitions of Response to Treatment
 Null Response                    HCV RNA decline < 2 log10 IU/mL by Week 12
                                  Failure to achieve HCV RNA undetectability at any time
 Nonresponse
                                  point during therapy
 Virologic                        Decline in HCV RNA to undetectable levels followed by
 Breakthrough                     return of HCV RNA despite continued treatment
                                  End of treatment response followed by return of HCV
 Relapse
                                  RNA after treatment discontinuation
 Positive Predictive              Given a positive response, what the chance is that an
 Value (PPV)                      SVR will occur
 Negative Predictive              Given a negative response, what the chance is that an
 Value (NPV)                      SVR will not occur


Pawlotsky JM. Hepatology. 2002;36(suppl 1):S65-S73.
Sethi A, et al. Clin Liver Dis. 2005;9:453-471.                               clinicaloptions.com/hep
HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Patterns of Response to Initial
 Antiviral Therapy

          7
                                                                             Nonresponder
          6      First phase

          5
HCV RNA




                                                                        Flat-partial responder
          4                                Second phase                Slow-partial responder
          3
              Limit of
          2 detection
                                                                             Rapid responder
          1
              0123         7             14               21              28
                               Days on Treatment
                                                                                 clinicaloptions.com/hep
     HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



     Treatment of Chronic HCV Infection:
     Nonresponse, Breakthrough, Relapse
                      8
                      7                      PegIFN/RBV
HCV RNA (log IU/mL)




                                                                Breakthrough
                      6                                                             Relapse
                      5                                       Nonresponse
                      4
                                                                               2 log decline
                      3
                      2
                               Limit of
                      1        detection
                      0
                          -6      0    6   12 18 24 30 36 42 48 54 60 66 72 78
                                                      Weeks
                                                                                     clinicaloptions.com/hep
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Benefits of a Thorough Virologic
 Monitoring Strategy
  Virologic monitoring to predict response can provide the
   following benefits to the patient and clinician
       – Limits unnecessary exposure to therapy
       – Identifies treatment failure
       – Justifies early discontinuation in those responding poorly
       – Limits treatment toxicity
       – Limits cost for those unlikely to respond
       – Identifies optimal duration of treatment
       – Provides incentive to continue therapy
Sanchez-Tapias JM. AASLD 2004. Abstract 125. Jensen DM, et al. N Engl J Med.
2000;343:1673-1680. Davis GL, et al. Hepatology. 2003;38:645.                  clinicaloptions.com/hep
The Predictive Value of Week 12
     and Week 4 HCV RNA
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Week 12 Stopping Rule: Patients
 Without EVR Unlikely to Achieve SVR
  Week 12 viral kinetics predictor of SVR
       – Only 1.6% of patients who fail to meet EVR criteria
         achieve SVR (NPV: 98.4%)

       – 2 log cutoff at Week 12 optimal for predicting response

  Poor PPV of Week 12 EVR (68%)
       – Week 12 HCV RNA predictor of treatment failure but not
         predictor of success in achieving SVR

  Week 12 stopping rule included in current guidelines
       – ~ 20% of patients can stop early, lowering total treatment costs by 16%
         and decreasing unnecessary side effects

Davis GL. Hepatology. 2002;36(suppl 1):S145-S151. NIH Consens State Sci Statements.
2002;19:1-46. Fried MW, et al. N Engl J Med. 2002;34:7975-7982. Manns MP, et al. Lancet.
2001;358:958-965.                                                                          clinicaloptions.com/hep
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Time to Undetectable HCV RNA
 Identified as Best Predictor of SVR
  Pooled data from PegIFN alfa-2b/RBV and PegIFN alfa-
   2a/RBV phase III trials
                                                       PPV of HCV RNA
                                                Undetectability Determining SVR
                                          100
                        PPV for SVR (%)




                                                   86
                                                              80          76
                                          80

                                          60
                                          40

                                          20
                                           0
                                                Week 4     Week 12    Week 24
                                                Time to Undetectable HCV RNA
Davis GL. Hepatology. 2002;36(suppl 1):S145-S151. Fried MW, et al. N Engl J Med.
2002;34:7975-7982. Manns MP, et al. Lancet. 2001;358:958-965.                      clinicaloptions.com/hep
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Relationship Between SVR and Time to
 HCV RNA Undetectability
  Retrospective analysis of genotype 1 patients receiving
   48 weeks of PegIFN alfa-2a + RBV
                                                                              End-of-treatment response
                             100   91 91          90             90           SVR
                             80
              Patients (%)




                                                       60
                             60                                       48
                             40

                             20                                                   13
                                                                                       2
                  0
             Week 4                Negative     < 2 log drop   < 2 log drop      Any drop
             Week 12               Negative      Negative      > 2 log drop      Any drop
             Week 24               Negative      Negative       Negative         Positive

Ferenci P, et al. J Hepatol. 2005;43:425-433.                                               clinicaloptions.com/hep
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Longer Duration of Undetectability on
 Treatment Increases Chance for SVR
  Retrospective analysis of PegIFN alfa-2b/RBV dataset
   evaluated predictors of SVR in genotype 1[1]
        – 32 weeks of HCV RNA negative: 80% chance of SVR
        – 36 weeks of HCV RNA negative: 90% chance of SVR
  Prospective study of viral kinetics and SVR evaluated in
   genotype 1 patients on PegIFN alfa-2a/RBV[2]
        – Minimum time of HCV RNA negativity on therapy to achieve
          high SVR rates (80%) was 24 weeks


1. Drusano GL, et al. J Infect Dis. 2004;189:964-970.
2. Tang KH, et al. EASL 2005. Abstract 609.                             clinicaloptions.com/hep
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Rate of Viral Decline Determines
 Period of HCV RNA Negativity
 Wk 0 Wk 4                Wk 12                  Wk 24                       Wk 48 (EOT)


                                         HCV RNA undetectable for 44 weeks



                                             HCV RNA undetectable for 36 weeks



                                                      HCV RNA undetectable for 24 weeks


          Time to HCV RNA negativity

Modified from figure by Michael Fried, MD.                                   clinicaloptions.com/hep
Shorter Treatment Duration
 for Genotype 1 Patients
      Reaching RVR
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Shorter Treatment Duration in
 Genotype 1 Patients With RVR
  Retrospective analysis of multinational, randomized, phase III
   study: PegIFN alfa-2a + weight-based RBV (N = 740)
                       Outcomes in Patients With RVR                         Outcomes in Patients Without RVR
                       According to Treatment Length                          According to Treatment Length
                                                 24 weeks                  48 weeks

                     100   97   93                                         100
                                         88      91
                      80                                                    80    70
      Patients (%)




                                                            Patients (%)
                                                                                        63
                      60                                                    60
                                                                                                     44
                      40                                                    40
                                                                                               23
                      20                                                    20

                       0                                                     0
                            EOT           SVR                                         EOT       SVR
Jensen DM, et al. Hepatology. 2006;43:954-960.                                                  clinicaloptions.com/hep
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Week 4 Response as a
 Predictor of SVR
  Patients with undetectable HCV RNA by Week 4 on
   PegIFN alfa-2a + RBV treated for total of 24 weeks
        – SVR rate for Week 4 responders (per-protocol analysis)
                      – Overall: 87%          – Genotype 1: 84%        – Genotype 4: 100%
  Higher baseline, Week 4 viral load predictive of relapse
                                       Relapse Rate Based on Week 4
                           100            Viral Load (ITT Analysis)
                            80
            Patients (%)




                                                                              Week 4 HCV RNA
                            60
                                                                       38        < 10 IU/mL
                            40
                                        22                                       10-49 IU/mL
                            20                         10         15
                                   7               5
                            0
                                 All Patients     < 600,000       ≥ 600,000
                                         Baseline Viral Load (IU/mL)
Ferenci P, et al. EASL 2006. Abstract 8.                                              clinicaloptions.com/hep
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Shorter Treatment for Genotype 1 and
 Low Baseline Viral Load
  24 vs 48 weeks PegIFN alfa-2b + RBV in genotype 1 patients with
   low viral load (< 600,000 IU/mL)
    – 24-week group received weight-based RBV
    – 48-week group received 800 mg/day RBV (historical controls)

                                   SVR According to Time to First Negative HCV RNA
                               100   89 85           93
           Patients With SVR




                                80                                67          71
                                                                                 Treatment Duration
                                60                                       50           24 weeks
                                40                                                    48 weeks
                                                  25
                                20                           17
                                 0
                                     Week 4    Week 12      Week 24      Total
                                          Time to First Negative HCV RNA
Zeuzem S, et al. J. Hepatol. 2006;44:97-103.                                           clinicaloptions.com/hep
Extended Treatment Duration
      for Genotype 1
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Longer Treatment Duration May Be
 Beneficial for Slow Responders
  48 vs 72 weeks of PegIFN alfa-2a + RBV 800 mg/day in
   genotype 1 patients
                                                         SVR Among Patients HCV RNA
                              Overall SVR                     Positive at Week 12
                      100                              100

                       80                               80
                                   P = NS
       Patients (%)




                       60     53             54         60
                                                                        P = .04
                       40                               40
                                                                                  29
                       20                               20       17

                        0   n = 230     n = 225          0   n = 100          n = 106
                            Week 48     Week 72              Week 48          Week 72
Berg T, et al. Gastroenterology. 2006;130:1086-1097.                                   clinicaloptions.com/hep
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Longer Treatment Duration May Be
 Beneficial for Slow Responders
  Patients who failed to achieve RVR randomized to 48 or
   72 weeks of PegIFN alfa-2a + RBV 800 mg/day
                                   48 weeks (n = 161)       72 weeks (n = 165)
                             100
                              80
              Patients (%)




                                     P = .014        P = .005
                              60                     48.0
                                           45.0
                              40    32.0
                                                                           18.0
                              20                         13.0
                                                                     4.8
                               0
                                      SVR            Relapse     Discontinuation

Sanchez-Tapias J, et al. AASLD 2004. Abstract 126.                                 clinicaloptions.com/hep
Evaluating Shorter Treatment
  Duration in Genotype 2/3
     Rapid Responders
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Shorter Treatment in Genotype 2/3
 Patients Achieving RVR
  PegIFN alfa-2b + weight-based RBV
                 – 14 weeks for patients with RVR; 24 weeks for patients
                   without RVR
                100      90                             RVR, received 14 weeks (n = 95)
                 80                                     No RVR, received 24 weeks (n = 27)
 Patients (%)




                 60             56

                 40
                                                        26
                 20                                10
                  0
                           SVR                     Relapse

Dalgard O, et al. Hepatology. 2004;40:1260-1265.                             clinicaloptions.com/hep
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Shorter Treatment in Genotype 2/3
 Patients Achieving RVR
  Patients with RVR received 16 or 24 weeks PegIFN
   alfa-2a + weight-based RBV


                          100                                        16 weeks (n = 71)
                                82       80
                           80                                        24 weeks (n = 71)
           Patients (%)




                           60
                           40
                           20                              13
                                                                5
                            0
                                   SVR                     Relapse

Von Wagner M, et al. Gastroenterology. 2005;129:522-527.                         clinicaloptions.com/hep
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Shorter Treatment in Genotype 2/3
 Patients Achieving RVR
  PegIFN alfa-2b + weight-based RBV
                 – 12 weeks for patients with RVR; 24 weeks for patients
                   without RVR

                100                                      RVR, received 12 weeks (n = 133)
                         85
                 80                                      No RVR, received 24 weeks (n = 80)
 Patients (%)




                               64
                 60
                 40
                 20                                 10   6
                  0
                           SVR                      Relapse

Mangia A et al. N Engl J Med. 2005;352:2609-2617.                             clinicaloptions.com/hep
 HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



 Poorer Responses With 16 vs
 24 Weeks in Genotype 2/3 Patients
  Genotype 2/3 patients treated with PegIFN alfa-2a + RBV
   800 mg/day for 16 vs 24 weeks
                                   SVR Rates in Patients With or Without SVR:
                                         16 vs 24 Weeks of Treatment
                                        P = .0007
                             100              90                         16 weeks (n = 732)
                                        82
                                                                         24 weeks (n = 732)
                              80
              Patients (%)




                                                             P < .001
                              60                                    49
                              40
                                                             27
                              20

                              0
                                    Patients With RVR   Patients Without RVR
Shiffman M, et al. EASL 2006. Abstract 734.                                         clinicaloptions.com/hep
HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



Summary of Shortened Treatment
Duration for Genotypes 2 and 3
 Mixed results on probability of SVR in patients with
  24 weeks of therapy vs shorter durations
     – Higher relapse rate with shorter duration
     – Largest study suggests need for 24 weeks of therapy
 Need more data on how shorter duration affects patients
  with cirrhosis, high HCV RNA levels at baseline




                                                                       clinicaloptions.com/hep
Summary: Using Virologic
Monitoring in Your Practice
HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



Using Virologic Monitoring in
Your Practice
                                 Genotype 1                            Genotype 2/3


Week 4 RVR                Reduction to 24 weeks                   Data mixed: continue
reached                    total treatment time                    through Week 24 if
                             may be possible                          RVR achieved


Week 12 EVR              Guidelines recommend                    Guidelines recommend
not reached               treatment be stopped                    treatment be stopped


Slow response            Extension of treatment
(EVR, not HCV             duration to 72 weeks
RNA undetectable         may improve SVR rates
until Week 24)

                                                                              clinicaloptions.com/hep
HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



Summary: Benefits of Virologic
Monitoring
 In addition to host and environmental predictors of SVR,
  frequent virologic monitoring has key impact on treatment
  decisions
 By using Week 4 and Week 12 HCV RNA markers,
  treatment failures can be predicted early
 Predictive negative value from Week 4 and Week 12 HCV
  RNA levels justify early discontinuation
 Early virologic monitoring can limit unnecessary exposure,
  toxicity, and cost from treatment
 Early responses can provide incentive to continue therapy
                                                                       clinicaloptions.com/hep
HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



Summary: Virologic Monitoring in
Genotype 1 and 4 Patients
 Virologic monitoring can identify optimal duration of
  treatment in genotype 1 and 4
     – Week 12 HCV RNA showing a drop of ≤ 2 log10 now
       commonly used to identify those unlikely to respond
     – Emerging data suggest that 24 weeks of therapy may be
       effective for genotype 1 patients who achieved an RVR
     – Patients who do not achieve undetectable HCV RNA before
       Week 24 have ~ 50% chance of relapsing after 48 weeks of
       therapy
           – Studies show that these slow responders may benefit from extended
             treatment

                                                                       clinicaloptions.com/hep
HCV On-Treatment Virologic Monitoring: Impact on Treatment Decisions



Summary: Virologic Monitoring in
Genotype 2 and 3 Patients
 Virologic monitoring can identify optimal duration of
  therapy in genotypes 2 and 3
     – Mixed results on whether genotype 2/3 patients achieving
       RVR can reduce treatment duration to < 24 weeks
     – Largest study to date suggests 24 weeks optimal duration
 HCV on-treatment virologic monitoring can have a positive
  impact on treatment decisions and patient outcomes




                                                                       clinicaloptions.com/hep
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