Brief report: effectiveness of combination antiretroviral therapy on survival and opportunistic infections in a developing world setting: an observational cohort study.

BACKGROUND: The prolonged effectiveness of antiretroviral therapy (ART) in a developing country is not well established. METHODS: An observational database was established at the HIV clinic of the Almenara Hospital in Lima, Peru in 1996. All 564 initially antiretroviral-naive HIV-infected persons (mean CD4 count of 91 cells/mm3) who received combination ART were followed over time. RESULTS: The overall survival rate was 96% at year 2, 94% at year 4, and 91% at year 5. Among persons who initiated therapy with CD4 counts <100 cells/mm3, the overall survival rate at 3 years was 95%. Opportunistic infections while on ART occurred in 20% of persons. Patients who received 2 reverse transcriptase (RT) inhibitors plus a protease inhibitor had slightly better survival rates and less opportunistic disease in the first year of therapy as compared with those receiving 2 RT inhibitors and a nonnucleoside reverse transcriptase inhibitor or 3 RT inhibitors. CONCLUSIONS: This study demonstrates the long-term effectiveness of ART in a developing country urban setting. It provides evidence of the importance of continuing global financing initiatives to provide widespread HIV therapy for countries in the developing world.

The natural history of untreated HIV infection in Lima, Peru: implications for clinical trial endpoints for HIV vaccines.

Most candidate HIV vaccines are directed at priming memory T cell responses and are being evaluated on their effects on post acquisition viremia and/or disease progression. These vaccines are being studied in areas of high HIV-1 prevalence. As such, we evaluated the frequency of CD4+ T cell decline and time course of opportunistic infections of patients presenting at a major metropolitan hospital in Lima, Peru, an area where such candidate vaccines are being tested. We examined 92 patients with untreated HIV-1 in calendar year 2002: 35% presented with CD4+ T cell counts of <200, 25% between 201 and 400, and 17% with >400 cells/mm3, 30 of 92 patients presented with overt AIDS, 6 were without an AIDS defining OI but CD4 counts <200. Over the course of follow-up, CD4 count decreased by a mean of 31 cells/mm3/year in women and 28 in men (p>0.5). Among persons presenting with CD4 counts >250 cells/mm3, the median time to first OI was 3.5 years. If clinical endpoints are required to evaluate the clinical effectiveness of T cell based vaccines, extended clinical follow-up of subjects enrolled in such trials will be required.