Abstract
ObjectiveThis study aims to describe the virological, immunological and clinical efficacy of protease inhibitor (PI)-based second-line antiretroviral therapy (ART) in rural South Africa.MethodsAn observational cohort study was performed on 210 patients (including 39 children) who initiated PI-based second-line therapy at least 12 months prior to data collection. Biannual clinical, immunological and virological monitoring was performed. Primary endpoints were adequate virological response (plasma HIV-1 RNA<400 copies/ml), full virological suppression (plasma HIV-1 RNA<50 copies/ml) and treatment failure (virological failure (plasma HIV-1 RNA>1000 after initial virological response) or on-going viremia (plasma HIV-1 RNA never<400 copies/ml for more than six months)). Data were analyzed by an on-treatment (OT) and intention-to-treat (ITT) approach. Analyses were primarily performed on the group of patients who switched following first-line virological failure.ResultsMedian duration of follow-up after switch to second-line treatment was 20 months [IQR 11–35]. 191 patients had switched to second-line ART due to first-line virological failure. 139/191 of them (72.8%, ITT) were in care and on treatment at the end of follow-up and 11/191 (5.8%, ITT) had died. After twelve months, an adequate virological response was seen in 92/128 patients (71.9%, OT), of which 78/128 (60.9%, OT) experienced full virological suppression. Virological response remained stable after 24 months. Virological efficacy was similar amongst adult and pediatric patients. As in first-line ART, we observed a lack of correlation between virological failure and WHO-defined immunological failure.ConclusionsGood virological outcomes following first-line failure can be achieved with PI-based, second-line antiretroviral therapy in both adult and pediatric patients in rural South Africa. Retention rates were high and virological outcomes were sustainable during the two-year follow-up period, although persisting low-level viremia occurred in a subset of patients. The observed viro-immunological dissociation emphasizes the need for virological monitoring.
Highlights
Most of the people who are HIV-infected globally, reside in subSaharan Africa
[2] early outcomes are generally worse, as a result of high mortality rates soon after treatment start. [3,4] Studies performed in resource-limited settings (RLS) are typically set in urban areas
[5] Virological treatment failure was seen in twenty percent of patients who survived the first three months of therapy, which is comparable to other reports on the efficacy of first-line antiretroviral therapy (ART) in RLS. [2,6,7]
Summary
The massive roll-out of antiretroviral therapy (ART) that has taken place in this region since 2003, resulted in a stark increase in the number of HIV-infected patients receiving treatment. Despite these impressive achievements, treating HIVinfected people in resource-limited settings (RLS) remains challenging. We analyzed the efficacy of first-line ART in a cohort of HIV-infected patients in a rural setting in South Africa. [5] Virological treatment failure was seen in twenty percent of patients who survived the first three months of therapy, which is comparable to other reports on the efficacy of first-line ART in RLS. We analyzed the efficacy of first-line ART in a cohort of HIV-infected patients in a rural setting in South Africa. [5] Virological treatment failure was seen in twenty percent of patients who survived the first three months of therapy, which is comparable to other reports on the efficacy of first-line ART in RLS. [2,6,7]
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