The Lancet HIV, 3(6), pp.e247-e258

Raltegravir in second-line antiretroviral therapy in resource-limited settings (SELECT): a randomised, phase 3, non-inferiority study

La Rosa, A.M., Harrison, L.J., Taiwo, B., Wallis, C.L., Zheng, L., Kim, P., Kumarasamy, N., Hosseinipour, M.C., Jarocki, B., Mellors, J.W. and Collier, A.C.

The study aimed to evaluate the non-inferiority of a regimen consisting of ritonavir-boosted lopinavir (LPV/r) plus raltegravir compared to LPV/r combined with nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs) for virological suppression in resource-limited settings. Conducted as a randomized, open-label phase 3 trial across 15 sites in nine countries, the study included HIV-positive adults with a plasma HIV-1 RNA concentration of at least 1000 copies/mL after prior non-NRTI therapy. A total of 515 participants were assigned to either the raltegravir group or the NRTI group, with follow-up revealing a cumulative probability of virological failure of 10.3% in the raltegravir group and 12.4% in the NRTI group after 48 weeks, demonstrating that raltegravir was non-inferior to NRTIs. The study also noted that while both regimens had similar rates of adverse events, the data support the use of LPV/r plus raltegravir as a viable alternative in scenarios where NRTI use is limited by toxicity or resistance. These findings align with WHO recommendations and highlight the importance of flexible treatment options in managing HIV in resource-limited settings.