Implementing a tenofovir-based first-line regimen in rural Lesotho: clinical outcomes and toxicities after two years

Authors: Bygrave, Helen MBChB; Ford, Nathan MPH, PhD; Cutsem, Gilles van MBChB, MPH; Hilderbrand, Katherine MSc; Jouquet, Guillaume MBA; Goemaere, Eric MBChB, PhD; Vlahakis, Nathalie MBChB; Triviño, Laura MBChB; Makakole, Lipontso MBChB; Kranzer, Katharina MBBS, MSC

The latest World Health Organization guidelines recommend replacing stavudine with tenofovir or zidovudine in first-line antiretroviral therapy in resource-limited settings. We report on outcomes and toxicities among patients on these different regimens in a routine treatment cohort in Lesotho.

Methods:

All adult patients initiating antiretroviral therapy from 1 January 2008, to 31 December 2008, were included in the analysis and followed until December 31, 2009. Choice of regimen was determined by clinical criteria.

Results:

Of 1124 patient records analyzed, median age was 39 years, and the majority (67.7%) were women. Five hundred eighty-seven patients were started on tenofovir, 255 on zidovudine, and 282 on stavudine. Patients on zidovudine were more than twice as likely to experience a toxicity-driven regimen substitution compared with tenofovir (adjusted hazard ratio: 2.32, 95% confidence interval: 1.23 to 4.40); for patients on stavudine, the risk of a toxicity-driven regimen switch was almost 6 times higher than tenofovir (adjusted hazard ratio: 5.43, 95% confidence interval: 3.31 to 8.91).

Conclusions:

Our findings support the latest World Health Organization Guidelines, in particular the adoption of tenofovir in first line, given the advantages in terms of tolerability and availability as a once-daily formulation.