Efficacy and tolerability of stavudine plus lamivudine in treatment-naive and treatment-experienced patients with HIV-1 infection

Background: A combination of two nucleoside analogues is currently the core of any antiretroviral regimen for HIV-1 infection. Stavudine plus lamivudine has shown an additive effect in vitro, as well as an absence of overlapping toxicity and cross-resistance. Objective: To evaluate the antiviral efficacy of stavudine plus lamivudine in treatment-naive patients and in patients previously treated with other nucleoside reverse transcriptase inhibitors. Design: Prospective, open-label pilot study. Setting: Three urban clinical centers in Paris. Patients: 83 patients with [CD4.sup.+] cell counts between 50 and 400 cells/[mm.sup.3] (42 treatment-naive and 41 treatment-experienced patients). Interventions: Stavudine, 40 mg twice daily (30 mg twice daily in patients with a body weight [is less than or equal to] 60 kg), and lamivudine, 150 mg twice daily. Measurements: Primary end points for efficacy included changes in plasma viral load and [CD4.sup.+] cell count at 24 weeks compared with baseline. Results: Therapy with stavudine plus lamivudine resulted in a median decrease of 1.66 [log.sub.10] ([10.sup.1.66]) (range, -3.04 to -0.79 [log.sub.10]) in plasma HIV-1 RNA; the median increase in [CD4.sup.+] cell count was 108 cells/[mm.sup.3] (range, -58 to 406 cells/[mm.sup.3]) at week 24 in treatment-naive patients. In treatment-experienced patients, the median reduction in plasma HIV-1 RNA was 0.55 [log.sub.10] (range, -2.86 to 0.52 [log.sub.10]), and the median increase in [CD4.sup.+] cell count was 46 cells/[mm.sup.3] (range, -188 to 311 cells/[mm.sup.3]). The percentages of patients with less than 3000 HIV-1 RNA copies/mL and less than 400 copies/mL at 24 weeks were, respectively, 57% (95% CI, 41% to 72%) and 26% (CI, 12% to 40%) among treatment-naive patients and 22% (CI, 10% to 38%) and 5% (CI, 1% to 17%) among treatment-experienced patients. Of 82 patients, 14 (17%) experienced grade 3 or 4 toxicity and 2 discontinued therapy because of intolerance toward treatment. Conclusion: Stavudine plus lamivudine seems to have a potent antiviral effect in treatment-naive and treatment-experienced patients. No major drug-limiting toxicity was found. This two-nucleoside combination should be considered in multidrug therapy for HIV.
The AIDS drugs stamuvidine and lamivudine appear to be effective when used together. Researchers evaluated 83 HIV patients who began taking the drugs. Forty-two had never been treated and 41 had taken other AIDS drugs. The drugs lowered blood levels of the virus and increased CD4+ T cell counts. The patients who had never been treated were more likely to benefit. Seventeen percent of the 83 patients developed side effects and two stopped taking the drugs for that reason.