Publication Title:M. W. Karara, F. A. Okalebo, M. N. Oluka, J. Ombega, A. N. Guantai and G. O. Osanjo (2010). Comparative tolerability and efficacy of stavudine 30 mg versus stavudine 40 mg in patients on combination antiretroviral therapy in Kenya. Journal of AIDS and HIV Research, vol 2 (2) pages 024-031.
This study compared the efficacy and tolerability of stavudine at the two dose levels in patients attending HIV Comprehensive Care Centre, in the largest public hospital in Kenya. Data on CD4 cell counts, drug adverse events and opportunistic infections were collected retrospectively from the records of 810 adult patients distributed in three study groups: patients weighing ≥ 60 kg receiving 40 mg BD stavudine; patients weighing ≥ 60 kg receiving 30 mg BD stavudine; and patients weighing < 60 kg receiving 30 mg BD stavudine. Fewer stavudine related adverse effects were seen in patients weighing ≥ 60 kg treated with 30 mg stavudine compared to those who received 40 mg stavudine in the same weight category (4.2 % vs 16.7 %, p < 0.001). Patients weighing < 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 reactions was also significantly associated with age greater than 45 years (HR = 2.16, CI:1.41-3.31, p<0.001), co-morbidities (HR = 2.16, CI:1.06-4.38, p < 0.001), treatment with isoniazid (HR = 2.07, CI:1.09-3.96, p<0.001) and severe (WHO stage IV) immunosuppression (HR=1.45,CI:0.86-2.45, p<0.001). The onset of drug related toxicities, for all study arms, was principally in the first year of commencing therapy, for example 76 % of all cases of peripheral neuropathy were diagnosed within 12 months of treatment. The study demonstrated similar immunologic outcomes in the treatment groups given either 30 or 40 mg stavudine, 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.
Low-dose stavudine, combination antiretroviral therapy, HIV, stavudine tolerability