Abstract
BackgroundAs stavudine remains an important and widely prescribed drug in resource-limited settings, the effect of a reduced dose of stavudine (from 40 mg to 30 mg) on outcomes of highly active antiretroviral therapy (HAART) remains an important public health question.MethodsWe analyzed prospectively collected data from the Themba Lethu Clinic in Johannesburg, South Africa. We assessed the relationship between stavudine dose and six- and/or 12-month outcomes of stavudine substitution, failure to suppress viral load to below 400 copies/ml, development of peripheral neuropathy, lipoatrophy and hyperlactatemia/lactic acidosis. Since individuals with a baseline weight of less than 60 kg were expected to have received the same dose of stavudine throughout the study period, analysis was restricted to individuals who weighed 60 kg or more at baseline. Data were analyzed using logistic regression.ResultsBetween 1 April 2004 and 30 September 2009, 3910 patients were initiated on antiretroviral therapy (ART) with a recorded stavudine dose and were included in the analysis. Of these, 2445 (62.5%) received a 40 mg stavudine dose while 1565 (37.5%) received 30 mg. In multivariate analysis, patients receiving a 40 mg dose were more likely to discontinue stavudine use (adjusted odds ratio, OR 1.71; 95% confidence limits, CI 1.13-2.57) than those receiving 30 mg by 12 months on ART. Additionally, patients receiving 40 mg doses of stavudine were more likely to report peripheral neuropathy (OR 3.12; 95% CI 1.86-5.25), lipoatrophy (OR 11.8; 95% CI 3.2-43.8) and hyperlactatemia/lactic acidosis (OR 8.37; 95% CI 3.83-18.29) in the same time period. Failure to suppress HIV viral load within 12 months of HAART initiation was somewhat more common among those given 40 mg doses (OR 1.62; 95% CI 0.88, 2.97) although this result lacked precision. Sensitivity analyses accounting for death and loss to follow up generally supported these estimates.ConclusionsLower stavudine dosage is associated with fewer reports of several stavudine-associated adverse events and also a lower risk of stavudine discontinuation within the first year on ART.
Highlights
As stavudine remains an important and widely prescribed drug in resource-limited settings, the effect of a reduced dose of stavudine on outcomes of highly active antiretroviral therapy (HAART) remains an important public health question
Despite changes in country-level antiretroviral guidelines recommending the use of these newer agents, cost has precluded their widespread use in resource-limited settings [6,22]; more than half of individuals receiving antiretroviral therapy have stavudine as part of their first-line regimens in low- and middleincome countries [23]
71% (n = 2785) of patients had a viral load taken within six months and 80% (n = 3139) within 12 months of initiating HAART
Summary
As stavudine remains an important and widely prescribed drug in resource-limited settings, the effect of a reduced dose of stavudine (from 40 mg to 30 mg) on outcomes of highly active antiretroviral therapy (HAART) remains an important public health question. Other antiretroviral agents have been developed and exhibit lower rates of toxicity even among stavudineexperienced individuals. These include improvement of dyslipidaemia on tenofovir [17,18,19] and lipoatrophy on abacavir [20]. Despite changes in country-level antiretroviral guidelines recommending the use of these newer agents, cost has precluded their widespread use in resource-limited settings [6,22]; more than half of individuals receiving antiretroviral therapy have stavudine as part of their first-line regimens in low- and middleincome countries [23]. Alternate strategies need to be sought to reduce stavudine-associated morbidity in these settings
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