Generic fixed-dose combination antiretroviral treatment in resource-poor settings: multicentric observational cohort

Abstract

The use fixed-dose combination (FDC) is a critical tool in improving HAART. Studies on the effectiveness of combined lamivudine, stavudine and nevirapine (3TC/d4T/NVP) are scarce. To analyse 6861 patients in a large observational cohort from 21 Médecins Sans Frontieres (MSF) HIV/AIDS programmes taking 3TC/d4T/NVP, with subcohort analyses of patients at 12 and 18 months of treatment. Survival was analysed using Kaplan–Meier method and factors associated with progression to death with Cox proportional hazard ratio. Median baseline CD4 cell count at initiating of FDC was 89 cells/μl [interquartile range (IQR), 33–158]. The median follow-up time was 4.1 months (IQR, 1.9–7.3). The incidence rate of death during follow-up was 14.2/100 person-years [95% confidence interval (CI), 13.8–14.5]. Estimates of survival (excluding those lost to follow-up) were 0.93 (95% CI, 92–94) at 6 months (n = 2,231) and 0.90 (95% CI, 89–91) at 12 months (n = 472). Using a Cox model, the following factors were associated with death: male gender, symptomatic infection, body mass index < 18 kg/m2 and CD4 cell count 15–50 cells/μl or < 15 cells/μl. Subcohort analysis of 655 patients after 1 year of follow-up (M12 FDC cohort) revealed that 77% remained on HAART, 91% of these still on the FDC regimen; 5% discontinued the FDC because of drug intolerance. At 18 months, 77% of the patients remained on HAART. Positive outcomes for d4T/3TC/NVP are reported for up to 18 months in terms of efficacy and safety.