Abstract
Nevirapine (NVP) and Efavirenz (EFV) have generally comparable clinical and virologic efficacy. However, data comparing NVP durability to EFV are imprecise. We analyzed cohort data to compare durability of NVP to EFV among patients initiating ART in Mbabane, Swaziland. The primary outcome was poor regimen durability defined as any modification of NVP or EFV to the ART regimen. Multivariate Cox proportional hazards models were employed to estimate the risk of poor regimen durability (all-cause) for the two regimens and also separately to estimate risk of drug-related toxicity. We analyzed records for 769 patients initiating ART in Mbabane, Swaziland from March 2006 to December 2007. 30 patients (3.9%) changed their NVP or EFV-based regimen during follow up. Cumulative incidence for poor regimen durability was 5.3% and 2.7% for NVP and EFV, respectively. Cumulative incidence for drug-related toxicity was 1.9% and 2.7% for NVP and EFV, respectively. Burden of TB was high and 14 (46.7%) modifications were due to patients substituting NVP due to beginning TB treatment. Though the estimates were imprecise, use of NVP - based regimens seemed to be associated with higher risk of modifications compared to use of EFV - based regimens (HR 2.03 95%CI 0.58 - 7.05) and NVP - based regimens had a small advantage over EFV - based regimens with regard to toxicity - related modifications (HR 0.87 95%CI 0.26 - 2.90). Due to the high burden of TB and a significant proportion of patients changing their ART regimen after starting TB treatment, use of EFV as the preferred NNRTI over NVP in high TB endemic settings may result in improved first-line regimen tolerance. Further studies comparing the cost-effectiveness of delivering these two NNRTIs in light of their different limitations are required.
Highlights
Non-nucleoside reverse transcriptase inhibitor (NNRTI)-based antiretroviral therapy (ART) has been the most affordable regimen for HIV-infected patients in resource limited settings
CD4 cell count, World Health Organization (WHO) clinical stage, weight and age were largely similar among the two groups at the time of ART initiation (Table 1)
There was no significant difference in outcome between the two regimens (HR 0.93, 95%CI 0.65 -1.44). This result may suggest that if lost to follow up (LTFU) did affect our main estimates, this bias was minimal. In this observational study in which patients were followed up to 12 months after initiating first-line ART in Mbabane, Swaziland, the hazard estimates suggest that being on a NVP- based regimen may be associated with increased risk of poor regimen durability compared to a EFV - based regimen though the imprecise nature of the estimate does not allow us to infer the association with confidence
Summary
Non-nucleoside reverse transcriptase inhibitor (NNRTI)-based antiretroviral therapy (ART) has been the most affordable regimen for HIV-infected patients in resource limited settings. Combination ART with either efavirenz (EFV) or nevirapine (NVP), both NNRTIs, and two nucleoside reverse transcriptase inhibitors (NRTI) is recommended by the World Health Organization (WHO) as first-line therapy in resource-limited countries [1]. Most data are based on patient populations from developed countries who exhibit different clinical and demographic characteristics in comparison to patients initiating ART in resource limited settings. Data from these patient populations may not be generalizable to different clinical settings
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