Comparative tolerability and efficacy of stavudine 30 mg versus stavudine 40 mg in patients on combination antiretroviral therapy in Kenya

Monicah Wanjiru Karara, Faith Apolot Okalebo, Margaret Ng’wono Oluka, James Ombega, Anastasia Nkatha Guantai and George Oyamo Osanjo*

School of Pharmacy, College of Health Sciences, University of Nairobi, P.O. Box 19676-00202 Nairobi, Kenya.

*Corresponding author. E-mail: gosanjo@uonbi.ac.ke.  Tel: +254 721 794 666.

Accepted 5 February, 2010

   Abstract

Stavudine- containing regimens are currently the most widely used first-line anti-HIV treatment option in Kenya. This study compared the efficacy and tolerability of stavudine at two dose levels in patients attending a HIV Comprehensive Care Centre in Kenya. Data were collected retrospectively from the records of 810 adult patients. Fewer stavudine related adverse effects were seen in patients ≥ 60 kg treated with 30 mg stavudine compared to those who received 40 mg (4.2 vs 16.7%, p < 0.001). Patients < 60 kg were more likely to experience drug toxicity than those ≥ 60 kg when given 30 mg stavudine (12.8 vs 4.2%, p < 0.001). Occurrence of any adverse drug reaction was significantly associated with severe immunosuppression (HR =1.45, CI: 0.86 - 2.45, p < 0.001), co-morbidities (HR = 2.16, CI: 1.06 - 4.38, p < 0.001) and treatment with isoniazid (HR = 2.07, CI: 1.09 - 3.96, p < 0.001). The onset of drug related toxicities was principally in the first year of commencing therapy. Similar immunologic outcomes were demonstrated across all the treatment groups with median CD4 cell counts after 12 months of treatment more than doubling for patients in all the study cohorts. The findings support the use of combination antiretroviral therapy regimens containing low dose stavudine in Kenya.

Key words: Low -dose stavudine, combination antiretroviral therapy, HIV, stavudine tolerability.