OBJECTIVES. To assess the effectiveness and safety of a twice-daily regimen of a generic fixed-dose combination
(FDC) of stavudine, lamivudine and nevirapine (Triviro) in a cohort of Zimbabwean HIV-1-positive adults.
DESIGN: A prospective, open-label, one-arm study of antiretroviral-naïve adults with CD4 counts <200 cells/μl.
Fifty-three intention-to-treat (ITT) patients were enrolled and monitored for 4 months.
SETTING: Three primary health care facilities in Zimbabwe.
Outcome measures. Efficacy criteria included plasma HIV-1 RNA load, CD4 counts, patient weight and Karnofsky
performance scores. Toxicity was assessed by clinical evaluation and laboratory tests.
RESULTS: There was a significant 3.0 log10 decrease in viral load at weeks 8 and 16 for both groups. Viral loads ≤400
copies/ml were achieved in 96% of per protocol (PP) and 85% of ITT patients at 8 and 16 weeks. At 4 months
85% of the PP group and 76% of the ITT group achieved undetectable viral loads. There was a significant increase
in median CD4 counts of 101 cells/μl for PP and 86 cells/μl for the ITT analysis. The number of PP patients with
Karnofsky scores of 100 improved from 10 (21%) to 38 (81%) and BMI increased by an average of 1.15 kg/m2. Of
the 134 adverse events recorded, 4 (3%) were severe. Of 16 adverse drug reactions in 10 patients, 13 were ascribed
to nevirapine. One adverse reaction resulted in withdrawal from the study.
CONCLUSION: The effectiveness and safety of Triviro was comparable to that seen with other formulations, and our
results support the use of this FDC in Zimbabwe and elsewhere.