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

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.