Safety and Efficacy of a Simplified Fixed-Dose Combination of Stavudine, Lamivudine and Nevirapine (GPO-VIR(cid:31)) for the Treatment of Advanced HIV-Infected Patients: A 24-Week Study
Thanomsak Anekthananon MD*, Winai Ratanasuwan MD*, Wichai Techasathit MD*, Areeaue Sonjai BS*, Surapol Suwanagool MD*
Affiliation : * Department of Preventive and Social Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
Objective : To determine the efficacy and safety of the fixed-dose combination of stavudine (d4T), lamivudine
(3TC) and nevirapine (NVP) in the treatment of antiretroviral na(cid:31)ve HIV-infected Thai adults.
Patients and Method : An open-label, single arm trial was conducted. Baseline clinical assessment and
blood test was done on 101 antiretroviral na(cid:31)ve HIV-infected patients, who then received a fixed dose combi-
nation of d4T, 3TC and NVP (GPO-VIR(cid:31), Thai Government Pharmaceutical Organization, Bangkok, Thai-
land). Nevirapine was given as 200 mg once daily for the first 2 weeks. The patients were followed up at 2, 4,
8, 12 and 24 weeks. A CD4 cell count and HIV-RNA assay were done at 12 and 24 weeks.
Results : One hundred and one patients were enrolled. The mean baseline CD4 cell count and mean HIV RNA
were 58.7 (57.7) cells/mm3 and 5.3 (0.5) log10 copies/mL respectively. At week 24th, the mean decrease in log
HIV RNA was 3.6 (0.7) log10 copies/mL [P < 0.001; 95% confidence interval (CI), 2.70-3.03]. Eighty one
(80.2%) patients had HIV RNA < 400 copies/mL by intention-to-treat analysis (ITT) and 97.6% had HIV RNA
< 400 copies/mL by on-treatment analysis (OT). Sixteen (84.2%) patients with baseline HIV RNA < 100,000
copies/mL and 65 (82.3%) patients with baseline HIV RNA > 100,000 copies/mL had viral load < 400
copies/mL by ITT (P = 0.842; 95% CI, -20.9%-16.2%). Sixteen (94.1%) patients with baseline HIV RNA <
100,000 copies/mL and 65 (98.5%) patients with baseline HIV RNA > 100,000 copies/mL had viral load <
400 copies/mL by OT (P = 0.295; 95% CI, -25.5%-3.8%). The mean CD4 cell count at week 24 was 155.1
(89.0) cells/mm3 (range 13-402). The mean increase in CD4 cell count from baseline was 96.5 (63.5) cells/
mm3 (P < 0.001). A total of 12% of the patients receiving d4T + 3TC + NVP developed skin rashes. Grade 3
or 4 hepatotoxicity was recognized in 7% of the patients.
Conclusion : Fixed-dose combination of d4T + 3TC + NVP (GPO-VIR(cid:31)) is safe, well tolerated and effective in
increasing CD4 cell counts and suppression of HIV RNA at 24 weeks in advanced HIV-infected patients in
Thailand.
Keywords : Safety, Efficacy, Antiretroviral treatment, AIDS
