ICRH Kenya PharmAccess African Studies to Evaluate Resistance (PASER) on Monitoring of HIV drug resistance in patients on highly active antiretroviral therapy (PASER-M) Study: ICRHK023 In Africa the emergence of HIV drug resistance (HIVDR) may be increased by insufficient health care infrastructure and inadequately trained medical personnel, both due to lack of funds. Unless an effort is undertaken to support the needed infrastructure, treatment programmes may fail due to widespread HIVDR, thus limiting future therapy options. HIVDR is one of the most important determinants of long term treatment success. It is vital to increase knowledge on HIVDR and its patterns, over time. However, few countries in Africa have either the technical expertise or the financial resources to undertake the required monitoring and surveillance to provide this essential information. PASER-M is a prospective, multi-centre, observational cohort study in up to 15 geographic settings in Sub-Saharan Africa. Each clinical centre will enroll 240 HIV infected adults starting first-line or switching to second-line (Highly Active Anti-Retroviral Therapy) HAART. Cross-sectional genotypic HIVDR testing will be performed at baseline, 12 and 24 months follow-up, when switching HAART regimen due to treatment failure, and at endline. Follow-up period for participants was extended to 96 months from 24 months due to the fact that HIV drug resistance testing is best interpreted on long term followup schedules. Within the first 24 months, HIV drug resistance for 1st line therapy is not significant and a long term follow-up will give a more credible and reliable results for long term HIV patient management, especially when there is need to switch therapy to 2nd, 3rd line and salvage therapy. The study also aims to build capacity on monitoring and surveillance of HIVDR in Sub-Saharan Africa. Two clinical centres are running the PASER M study in Kenya; Coast Provincial General Hospital (CPGH), Mombasa and Mater Hospital, Nairobi. Currently ICRH provides technical support and implementation of the study in CPGH, Mombasa and Mater Hospital, Nairobi. PASER-M CPGH Mombasa initiated the study in October 2007. All of the 240 participants had been enrolled by July 2008. The study enrolled 220 participants on first line regimen and 20 on second line regimen.
PASER - M Study Funding Agency PharmAccess Foundation, the Netherlands ICRH Project Manager Irene Muhache Jao (irene.jao@icrhk.org) ICRH PI Dr Kishor Mandaliya (kishor.mandaliya@icrhk.org )
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Kenya
AN N UAL RE P ORT 2009