HIV drug resistance surveillance the need

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					Indicators for monitoring ARV treatment
                outcomes
         Information streams and their relationships
                      TREATMENT POLICY


Pharmacovigilance                         Patient                 Drug
                       HIVDR
                                         Monitoring              Supply
                                                               Management




                                         Switching rates

                                          Survival rates

                                          Failure rates
     Severe         Exposed clients
     adverse                                 # SAE/
                                      patients on treatment
      Events
      (SAE)          Naive clients
                                      #patients on treatment   # pills ordered
       Patient monitoring


               George Loth – EIP dept, WHO
(UNAIDS/WHO Working Group on global HIV/AIDS/STI surveillance)
Information flow from patient level to International level


                                                          Standard         International
                                                          Data, Datasets
                                                          & Indicators     National
                           International level            For each level

                                                                            Province
                         National level; federal

                                                                            District
                    Sub-national level; province, region

                                                                            Community
               District level; woreda, local government
                                                                            Patient /
                                                                            Singular unit

 Health Facility & community level; clinic, health centre, hospital



     Patient level; or singular, local unit for not patient related data
                                         National
                                                                                 Information




                          Province                               Province



                                                                               Cohort analysis
           District                  District            District
                                                                               Quarterly reports




Health         Health        Health        Health     Health        Health
facility       facility      facility      facility   facility      facility



                                                                                         Patient
                                                                                        monitoring
                                                                                          cards
                                                                        Patient card
PATIENT MASTER RECORD CARD FOR ARV [ front]: Unique ARV Number___________________                                   Year_______________

Name________________________________________               Age ______      Sex_______       Initial Wt (Kg)_______ Transfer-In (Y/N)________

Address (physical / PO Box)______________________________________________________________________________________________

Name of identifiable guardian_____________________________________ Date and place of positive HIV test____________________________

Date of starting 1st line ARV regimen (specify d4t/3TC/NVP formulation) _____________ Reason for ARV: ______________________________

Date of starting alternative 1st line ARV regimen (specify) ____________ Date of starting 2nd line ARV regimen (specify)____________________


Year   Month Date Wt           Outcome status               Ambulatory Work/school Side
                                                       Of those alive                                           No. Pills in   ARV   ARV not
                  Kg                                                               effects                      Bottle         Given given
                            A D DF Stop TO Start Sbs Switch Amb Bed Yes       No   Y     N                                     P G
       Jan
       Feb
       Mar
       Apr
       May
       Jun
       Jul
       Aug
       Sep
       Oct
       Nov
       Dec

Specify reason for ARV therapy (Stage III, Stage IV, CD4 < 200, PTB, EPTB, Transfer-in)

Outcome status: A =alive; D=dead; DF=defaulted and not seen for 3 months; Stop=stopped medication; TO=transferred out to another unit
Of those alive: Start=alive and on first line regimen; Sbs=alive and substituted to alternative first line regimen;
Switch=alive and switched to a second line regimen because of failure of first line regimen

Ambulatory: Amb=able to walk to/at treatment unit and walks at home unaided; Bed=most of time in bed at home
Work/school: Yes=engaged in previous work / employment or at school; No=not engaged in previous work /employment or not at school
Side effects: If Yes, specify – YES-PN= peripheral neuropathy; YES-HP=hepatitis; YES-SK=skin rash
No.Pills in bottle: if patient comes at 4 weeks count number of pills in bottle (8 pills or less = 95% adherent)
ARV given / not given: tick whether ARV therapy given in the appropriate column P = patient, G = Guardian; if no ARV, then indicate why
                                                              ART register


ARV            Year   Quarter Date of      Name                Sex   Age Address             Date first Reason for Name of ARV
Registration                  registration                                                   started    starting   Guardian Treatment
Number                                                                                       ARV drugs ARV drugs            Unit




Reason for starting ARV Drugs: Stage III, Stage IV, CD4 count < 200/mm3, Stage II with TLC
< 1200/mm3 , Tuberculosis, Transfer-in
                                                       ART register - continued


Outcome (provide dates when change from alive)          Of those alive                    Ambulant   At work or school   Drug adherence > 95%
Alive  Dead       Default Stop       Transfer           Start Substitute      Switch      Yes   No   Yes      No         Yes        No




Alive - alive and on ARV drugs: Dead - whatever the cause: Default - not seen in three months:
Stop - stopped treatment due to side effects/other:
Transfer - transfer-out to another ARV treatment unit

Start - on first line regimen: Substitute - changed to alternative first line regimen: Switch -
changed to second line regimen

Ambulant - yes/no: At work or school - at previous or new employment for adults

Adherence > 95% - pill counts of 8 tablets or less when patient comes for review
    Relevant information for ARVs
   ART Cohort Analysis Report:
    at 6 months, 12 months, yearly

   Alive and on ART
   On original first-line
   Substituted to alternate first-line
   Switched to 2nd-line (or higher)
   Dead, Lost, Transfer Out, Stopped ART
   Functional status
   CD4 median or > 200
   Picked up meds 6/6 or 12/12 months
  Schematic representation of IT configuration for monitoring and evaluating in
  countries scaling up HIV services

                        Software: CRIS, Health
  Monitoring             Mapper, DevInfo etc.            International Agencies
                                                         Central Government
                                                         Sub-national/district
                                                         Local
   Other Data
    Sources
                           HIV Indicators:
                             repository
                                                                    Evaluation
                                         HL7
                                  National/
Country's
  HIS                           sub-national
                               Data-warehouse                           Other Agencies
                                                                          Academic
                                                                             NGOs
                                                                           Industry
                                                     Other Data
                         HL7                                                  etc.
                                                      Sources


   Health Facility 1            Health Facility 2

                       Community
ART Needs: Present and Future
 with scaling up and Universal
             Access


       UNAIDS/WHO Working Group on global
            HIV/AIDS/STI surveillance
                              Estimated ART needs for Africa and Asia

                      12000
Total number in 000




                      10000
                                                                        Africa Low
                      8000
                                                                        Africa High
                      6000
                                                                        Asia Low
                      4000
                                                                        Asia High
                      2000
                         0
                            04
                            05
                            06
                            07
                            08
                            09
                            10
                            11
                            12
                            13
                            14
                            15
                         20
                         20
                         20
                         20
                         20
                         20
                         20
                         20
                         20
                         20
                         20
                         20
                                             years
             Conclusions
 These treatment scenarios suggest that
 globally between 9.5 and 17.3 million
 adults (age 15 to 49 years) and between
 900,000 and 2.3 million children (age 0 to
 14 years) would require antiretroviral
 treatment by 2015.
  Pharmacovigilance


      Marco Vitoria - WHO, HIV department
(input from M Couper, S Pal – QSM unit, PSM department)
    Importance of Pharmacovigilance
             (PV) for ARV
   Impact in selection of preferential/alternative drugs in ART
    guidelines

   Drug toxicity (important cause of switching specific drugs in 1st
    and 2nd line regimens).

   Life threatening side effects, co-morbidities & co-treatments:
    impact on selection of preferential and alternative drugs

   Efficacy is the major focus of drug clinical trials (short duration
    of clinical trials, risk of long term adverse effects)

   Available data on drug toxicity are mainly from industrialized
    world - different clinical and operational context from developing
    countries
What Information Should be Collected for the
       ARV Drug Adverse Reactions
            Protocol/Registry?
   ABC hypersensitivity reactions
   TDF related kidney & bone toxicity
   d4T associated neuropathy & lipodystrophy
   NVP and SQV/r hepatotoxicity with TB drugs
   AZT associated anaemia
   Birth defects and EFV
   ddI related pancreatitis
   NRTIs associated lactic acidosis
   Moving from Adverse Events Reporting to a
Comprehensive Pharmacovigilance Strategy: Which
         Way(s) Should be Followed ?


                          Retrospective Cohorts    Specific
    Active Surveillance                              HIV
                                                  populations


                           Prospective Cohorts

                                                    Non-specific
                                                       HIV
  Passive Surveillance                              populations
                            Spontaneous Report
       Proposed indicators for PV
   Severe adverse events and their outcome/Number
    of patients on treatment

   Number of of reporting centres for
    pharmacovigilance

   Number of personnel trained to conduct
    pharmacovigilance

   Number of reporting AE sites implemented
HIV Drug Resistance


  Cyril Pervilhac – SIR unit, HIV department
  (input from S Bertagnolio, D Sutherland - SIR unit)
          HIV Drug Resistance

   Rapid expansion of ART toward the goal of
    universal access - some level of HIV drug
    resistance (HIVDR) will emerge (given lifelong
    treatment, HIV’s high mutation rate)

   Principles to minimize HIVDR emergence:
      appropriate drug prescribing and usage

      assuring drug quality and uninterrupted drug
       supplies
      fostering access and adherence

      preventing HIV transmission

      appropriate action based on standardized
       HIVDR monitoring and surveillance
      The HIVDR 'essential package'
       for countries scaling up ART

A.   Development of a national HIVDR working
     group and a national HIVDR plan/strategy
B.   HIVDR Transmission Surveillance
C.   HIVDR Monitoring in ART Program sites
D.   HIVDR Database Development
E.   Development of a local WHO HIVDR support
     Laboratory and nomination of the national or
     regional WHO HIVDR genotyping testing lab
      Important indicators HIVDR
               strategy
1)     HIVDR Early Warning Indicators
        Survival at 6, 12, 24 months after treatment
         initiation
        % pf patients on 1st, 2nd line regimen, 12 and
         24 months after treatment initiation

2)     Direct HIVDR measures
         Surveillance of HIVDR transmission
         Monitoring of HIVDR emergence in treatment

				
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