Technical Review Meeting of Country Experiences in ARV Toxicity Surveillance: Sharing Results and Lessons Learnt, Identifying Solutions

Transcription

1 Technical Review Meeting of Country Experiences in ARV Toxicity Surveillance: Sharing Results and Lessons Learnt, Identifying Solutions 7-8 November 2013, Geneva Excellent healthcare locally delivered

2 SURVEILLANCE OF ANTIRETROVIRAL TOXICITY Technical Brief on Surveillance of ARV drug toxicity within ART programmes WHO/HIV/2013 Presented by Dr Françoise Renaud Department of HIV & AIDS

3 1. Why it is important 2. Goal and objectives 3. Approaches 6. Challenges and how to address them 7. What is WHO doing 4. Important considerations 5. Improving care and informing policies

4 01 Why is surveillance of ARV toxicity within ART programmes important? WHO 2013 Consolidated Guidelines on the use of ARVs Increased and prolonged exposure to ART Risk of harm largely outweighed by benefits Toxicity concerns (box 1) Need for active surveillance

5 02 Goal and objectives Improving ARV treatment outcomes and informing national and global ART policies determine and minimize the incidence of ARV drug (and new ARVs) toxicities monitor the impact of toxicities on treatment outcomes determine the impact of HIV comorbidities and other medicines identify rare toxicities or associated with long-term use

6 03 Surveillance approaches Targeted spontaneous reporting Elicits reports of specified toxicities with one/few ARVs Selected ART sites, geographical region or all ART sites Determines nature and seriousness/severity Does not produce incidence Box 2: Targeted Spontaneous Reporting in in South Africa in 2005

7 03 Surveillance approaches Active surveillance for specific toxicities within ART sentinel cohorts Nesting within existing ART cohorts Focus on few/one ARV and few toxicities Reliable system for capturing clinical and toxicity data Determines incidence with reliable denominator Box 3: Active surveillance of specific toxicities in ART sentinel cohorts in South Africa

8 03 Surveillance approaches Cohort event monitoring for ARVs Prospective observational cohort study All adverse events collected for all ARVs Produces rates of events, early detection of signal, fewer missing data Inclusion in existing HIV cohorts may be reasonably cost efficient Box 4: Cohort event monitoring for ARVs in Tanzania

9 04 Important considerations National priorities and local context Technical requirements esp. data collection, management and analysis, reporting data outputs Use of existing systems e.g. facility based records, patient monitoring systems Platform of exchange with programme managers, pharmacovigilance and drug regulators, academic researchers, manufacturers

10 05 Inform national treatment policy and improve patient care Ensuring continual feedback and communication with patients and communities, health-care staff, and district/national health authorities Platform of exchange with programme managers, drug regulators, academic researchers, manufacturers

11 06 Challenges and how to address them Underreporting, poor quality of reports and fatigue of reporters (TSR) Poor quality of denominator (sentinel cohorts) Lab monitoring vs. clinical monitoring capacity vary among ART sites Standardized and reliable causality assessment Sustainability

12 What WHO is doing Steering Group of ARV experts Technical guidance to countries Collaboration with scientific and research agencies New GFATM financing model and PEPFAR framework