Mauro Schechter, MD, PhD
A multinational, randomized trial documents similar efficacy with WHO-recommended second-line antiretroviral therapy and a raltegravir-based regimen.
For HIV-infected patients in resource-limited settings, the WHO recommends using easily administered first-line antiretroviral therapy (ART): a non-nucleoside reverse transcriptase inhibitor (NNRTI) plus two nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs). For patients who require second-line ART, the WHO recommends ritonavir-boosted lopinavir plus two or three NRTIs.
In an open-label trial spanning 37 sites on five continents, researchers randomized 541 HIV-infected adults with confirmed virologic failure after ≥24 weeks on first-line ART to receive either the WHO's recommended second-line regimen (control group) or boosted lopinavir plus raltegravir, an integrase inhibitor. Sites with access to resistance testing had to use it to guide NRTI choices; sites without such access used a simple algorithm to guide NRTI choices. In all, 479 of 492 patients (97%) who underwent resistance testing had at least one major resistance mutation to an NRTI.
In a modified intention-to-treat analysis, a viral load <200 copies/mL was achieved at 48 weeks by 81% of the control group and 83% of the raltegravir group, a nonsignificant difference. The finding persisted whether or not resistance testing was used to select the NRTI backbone, patients were stratified according to baseline viral load, or the viral-load outcome threshold was lowered to <50 copies/mL. Rates of death, overall adverse events, and serious adverse events were similar between the two treatment groups.
Citation(s):
SECOND-LINE Study Group. Ritonavir-boosted lopinavir plus nucleoside or nucleotide reverse transcriptase inhibitors versus ritonavir-boosted lopinavir plus raltegravir for treatment of HIV-1 infection in adults with virological failure of a standard first-line ART regimen (SECOND-LINE): A randomised, open-label, non-inferiority study. Lancet 2013 Jun 15; 381:2091.
