Second-Line Switch to Dolutegravir for Treatment of HIV Infection

This open-label, multicenter trial in Kenya evaluated switching HIV patients from a ritonavir-boosted protease inhibitor (PI) to dolutegravir, without genotype data, among those with viral suppression. 795 participants were randomized, and at 48 weeks, dolutegravir was noninferior to continued PI therapy for maintaining suppression (5% virologic failure in each group). No resistance to dolutegravir or PI was detected. Adverse events, including grade 3/4 events and serious adverse events, were similar across groups. Dolutegravir improved lipid profiles but slightly increased body mass index. The findings suggest dolutegravir offers a viable, safer, and potentially more cost-effective second-line option in resource-limited settings.

This open-label, multicenter trial in Kenya evaluated switching HIV patients from a ritonavir-boosted protease inhibitor (PI) to dolutegravir, without genotype data, among those with viral suppression. 795 participants were randomized, and at 48 weeks, dolutegravir was noninferior to continued PI therapy for maintaining suppression (5% virologic failure in each group). No resistance to dolutegravir or PI was detected. Adverse events, including grade 3/4 events and serious adverse events, were similar across groups. Dolutegravir improved lipid profiles but slightly increased body mass index. The findings suggest dolutegravir offers a viable, safer, and potentially more cost-effective second-line option in resource-limited settings.