1 / 22

Indicators for monitoring ARV treatment outcomes

Indicators for monitoring ARV treatment outcomes. Information streams and their relationships. TREATMENT POLICY. Pharmacovigilance Severe adverse Events (SAE). HIVDR Exposed clients Naive clients. Patient Monitoring Switching rates Survival rates Failure rates # SAE/

todd-moon
Download Presentation

Indicators for monitoring ARV treatment outcomes

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Indicators for monitoring ARV treatment outcomes

  2. Information streams and their relationships TREATMENT POLICY Pharmacovigilance Severe adverse Events (SAE) HIVDR Exposed clients Naive clients Patient Monitoring Switching rates Survival rates Failure rates # SAE/ patients on treatment #patients on treatment Drug Supply Management # pills ordered

  3. Patient monitoring George Loth – EIP dept, WHO (UNAIDS/WHO Working Group on global HIV/AIDS/STI surveillance)

  4. Information flow from patient level to International level

  5. District District District Health facility Health facility Health facility Health facility Health facility Health facility Patient monitoring cards National Information Province Province Cohort analysis Quarterly reports

  6. Patient card

  7. ART register

  8. ART register - continued

  9. 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

  10. Schematic representation of IT configuration for monitoring and evaluating in countries scaling up HIV services Software: CRIS, Health Mapper, DevInfo etc. Monitoring International Agencies Central Government Sub-national/district Local HIV Indicators: repository Other Data Sources Evaluation HL7 National/ sub-national Data-warehouse Country's HIS Other Agencies Academic NGOs Industry etc. Other Data Sources HL7 Health Facility 1 Health Facility 2 Community

  11. ART Needs: Present and Future with scaling up and Universal Access UNAIDS/WHO Working Group on global HIV/AIDS/STI surveillance

  12. 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.

  13. Pharmacovigilance Marco Vitoria - WHO, HIV department (input from M Couper, S Pal – QSM unit, PSM department)

  14. 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

  15. 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

  16. Retrospective Cohorts Specific HIV populations Active Surveillance Prospective Cohorts Moving from Adverse Events Reporting to a Comprehensive Pharmacovigilance Strategy: Which Way(s) Should be Followed ? Non-specific HIV populations Passive Surveillance Spontaneous Report

  17. 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

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

  19. 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

  20. The HIVDR 'essential package' for countries scaling up ART • Development of a national HIVDR working group and a national HIVDR plan/strategy • HIVDR Transmission Surveillance • HIVDR Monitoring in ART Program sites • HIVDR Database Development • Development of a local WHO HIVDR support Laboratory and nomination of the national or regional WHO HIVDR genotyping testing lab

  21. Important indicators HIVDR strategy • 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 • Direct HIVDR measures • Surveillance of HIVDR transmission • Monitoring of HIVDR emergence in treatment

More Related