Short-term effectiveness and safety of HAART in the form of a generic fixed-dose combination of stavudine, lamivudine and nevirapine (Triviro) in HIV-1-infected adults in Zimbabwe

  • AG Duse
  • A Morar
  • I Landman
  • WJH Vermaak
  • H Schoeman
  • MJ Kruger
  • E Janse van Rensburg
  • R Luthy
  • S Singh

Abstract



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.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.

Southern African Journal of HIV Medicine Vol. 9 (2) 2008: pp. 51-56
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Articles

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