Virological Response Following Anti-Retroviral Therapy Employing Once-A-Day 30 mg of Stavudine in HIV-Infected Patients: A 24- Week Randomized Controlled Study in Dar Es Salaam, Tanzania

Abstract

Background Stavudine at a dose of 30mg has been in use for more Thana decade. Its toxicity remains a challenge and phase out has picked up. However, the information about viral load suppression (VLS) at once-a-day dosing is lacking. A prospective open-label randomized controlled study was conducted. Methods: Naïve HIV infected patients were equally randomized either to receive stavudine 30mg once-daily or zidovudine standard dose regimens. Viral load, hemoglobin (Hb), alanine amino transferase (ALT), Body Mass Index (BMI), opportunistic infections (OIs) at baseline and six months were determined. Changes at baseline and six months were compared within and between-groups. Our outcome was the proportion of patients who attained VLS< 400 copies/mL at six months. Results: Four hundred and eighty three patients aged ≥ 18 years were analyzed. The overall mean standard deviation (SD) age was of 39 (9) years, 41 (9) and 38 (9) for males and females respectively. The two groups were similar in demographic, clinical and other laboratory indices at baseline. At six months, VLS< 400 copies/mL was 73.2%, there was no statistically significant differences been groups. There was no statistically significant differences been males and females. Patients with age >40 years were more likely to have VLS by 8% compared to young ones, risk ratio (95% CI) being 0.921 (0.829, 1.023; p=0.1275) Conclusion: Viral load suppression for stavudine 30 mg once-a-day was similar to zidovudine standard regimen. However, long follow up period is recommended to determine efficacy and long term side effects at our recommended dose