Efficacy of a generic fixed-dose combination of d4T/3TC/NVP (GPO-VIR) in Thai HIV-infected patients

Background: Accessibility for HAART in developing countries is limited by the high cost of antiretroviral drugs (ARV). In April 2002, Thai Government Pharmaceutical Organization had launched a low cost (30 USD/month) ARV, fixed-dose combined pill of d4T/3TC/NVP (GPO–VIR), but its efficacy has not yet to be determined.
Methods: A retrospective cohort study of HIV-infected patients who had recieved GPO-VIR at Ramathibodi Hospital during April 2002-December 2003 was conducted. The outcome of interest was time of initiation to either HIV RNA <50 cps/mL or 50% increase of CD4. Tolerability and adverse events were assessed. Kaplan–Meier was used to estimate probability.
Results: Ninety-one naive patients were included in the cohort. Mean age was 35 (SD = 7) years and 51% were female. Median CD4 baseline was 29 (range = 0–410) cells/mm³ and median HIV RNA was 236000 (range = 5820–> 750000) cps/mL. Sixty-two (67%) patients had previous OIs. Follow-up period was 2-66 weeks. Forty patients (54%) achieved the goal of therapy. Probabilities of achieving goal at 12, 24, 36, and 48 weeks of treatment were respectively 8.5 (95% CI: 3.9, 18.0), 62.7 (95% CI: 50.8, 74.6), 80.0 (95% CI: 67.3, 90.1), and 93.3 (95% CI: 76.3, 99.4). Median time of achieving goal was 21 weeks (95% CI: 17, 23). Median time of achieving goal was 21 weeks in patients with baseline CD4 < 100 cells/mm³ and 15 weeks in patients with CD4 ≥ 100 cells/ mm³; 23 weeks in patients with baseline HIV RNA < 100000 cps/mL and 16 weeks in patients with HIV RNA ≥ 100000 cps/mL. Prognostic factors (gender, age, previous OIs, baseline CD4, and HIV RNA) were not associated with achieving goal. Adverse events (rash, hepatitis, and nausea/vomiting) were found in 13 (14%) patients.
Conclusions: GPO-VIR may be a drug for treating HIV-infected patients in developing countries. Further prospective clinical trials with a larger sample size are needed to confirm its efficacy.

Kiertiburanakul, S
S Kiertiburanakul1, S Khongnarasat1, S Sungkanuparph1, A Vibhagool1, S Rattanasiri2, A Thakkinstian2
1Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; 2Clinical Epidemiology Unit, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand