Abstract

BackgroundSince 2010, World Health Organization (WHO) guidelines discourage using stavudine in first-line regimens due to frequent and severe side effects. This study describes the implementation of this recommendation and trends in usage of antiretroviral therapy combinations in a cohort of HIV-positive patients in rural Tanzania.MethodsWe analyzed longitudinal, prospectively collected clinical data of HIV-1 infected adults initiating antiretroviral therapy within the Kilombero Ulanga Antiretroviral Cohort (KIULARCO) in Ifakara, Tanzania from 2007-2011.ResultsThis analysis included data of 3008 patients. Median age was 38 (interquartile range [IQR] 31-45) years, 1962 (65.2%) of all subjects were female, and median CD4+ cell count at enrollment was 168 cells/mm3 (IQR 81-273). The percentage of prescriptions containing stavudine in initial regimens fell from a maximum of 75.3% in 2008 to 10.7% in 2011. TDF/FTC/EFV became available in 2009 and was used in 41.9% of patients initiating cART in 2011. An overall on-treatment analysis revealed that d4T/3TC/NVP and AZT/3TC/EFV were the most prescribed combinations in each year, including 2011 (674 [36.5%] and 641 [34.7%] patients, respectively). Of those receiving stavudine in 2011, 659 (89.1%) initiated it before 2011.ConclusionsInitial cART with stavudine declined to low levels according to recommendations but the overall use of stavudine remained substantial, as individuals already on cART containing stavudine were not changed to alternative drugs. Our findings highlight the critical need to exchange stavudine in treatment regimens of patients who initiated therapy in earlier years.

Highlights

  • Since 2010, World Health Organization (WHO) guidelines discourage using stavudine in first-line regimens due to frequent and severe side effects

  • This drug was crucial in rolling out combined antiretroviral therapy in low-income setting as in Sub-Saharan Africa (SSA) for its low price and good efficacy in suppressing replication of HIV

  • The goal of phasing out stavudine still competes in budgetary terms with other priorities in advancing combined antiretroviral therapy (cART) as direct drug costs of stavudine were still at around 50% compared to alternative regimens in 2011 [5]

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Summary

Introduction

Since 2010, World Health Organization (WHO) guidelines discourage using stavudine in first-line regimens due to frequent and severe side effects. Among them was a strong statement about progressing to less toxic antiretroviral drugs in first-line regimens, i.e. discouraging the use of stavudine in initial drug combinations. This drug was crucial in rolling out combined antiretroviral therapy (cART) in low-income setting as in Sub-Saharan Africa (SSA) for its low price and good efficacy in suppressing replication of HIV. Prices for generic formulations of more modern pharmaceuticals such as tenofovir have declined substantially This should assist efforts to achieve the WHO goal of phasing out the use of stavudine containing regimens. In some settings, replacing stavudine with tenofovir or zidovudine was judged cost-effective [6,7,8] and further price reductions for these pharmaceuticals are to be expected

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