Protease inhibitor and NRTIs safe, effective in HIV treatment
Nicholas I. Paton, M.D., from University College London, and colleagues conducted an open-label trial in sub-Saharan Africa involving 1,277 HIV-infected adults and adolescents with first-line treatment failure. Participants were randomized to receive a ritonavir-boosted protease inhibitor (lopinavir-ritonavir) plus clinician-selected NRTIs (NRTI group; 426 patients); a protease inhibitor plus raltegravir (raltegravir group; 433 patients); or protease-inhibitor monotherapy after 12 weeks of induction therapy with raltegravir (monotherapy group; 418 patients).
The researchers found that good disease control was achieved in 60 percent of the NRTI group, 64 percent of the raltegravir group (P = 0.21 versus the NRTI group; superiority of raltegravir not shown), and 55 percent of the monotherapy group (noninferiority of monotherapy not shown). Rates of adverse events (grade 3 or 4) were similar among the groups (P = 0.82). In the NRTI group, viral load <400 copies per milliliter was achieved in 86 percent of patients, compared with 86 percent in the raltegravir group (P = 0.97) and 61 percent in the monotherapy group (P < 0.001).
"When given with a protease inhibitor in second-line therapy, NRTIs retained substantial virologic activity without evidence of increased toxicity, and there was no advantage to replacing them with raltegravir," the authors write.
Trial medication was donated by pharmaceutical companies.
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