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

Background: The use fixed-dose combination (FDC) is a critical tool in improving HAART. Studies on the effectiveness of combined lamivudine, stavudine and neviraz pine (3TC/d4T/NVP) are scarce. Objective: To analyse 6861 patients in a large observational cohort from 21 Medecins Sans Frontieres (MSF) HIV/AIDS programmes taking 3TC/d4T/NVP, with subcohort analyses of patients at 12 and 18 months of treatment. Methods: Survival was analysed using Kaplan-Meier method and factors associated with progression to death with Cox proportional hazard ratio. Results: Median baseline CD4 cell count at initiating of FDC was 89 cells/mu l [inter-quartile 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, 8991) 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/m(2) and CD4 cell count 15-50 cells/mu l or < 15 cells/mu l. Subcohort analysis of 655 patients after I year of follow-up (M] 2 FDC cohort) revealed that 77% remained on HAART, 91% of A these still on the FDC regimen; 5% discontinued the FDC because of drug intolerance. At 18 months, 77% of the patients remained on HAART. Conclusions: Positive outcomes for d4T/3TC/NVP are reported for up to 18 months in terms of efficacy and safety.