Dolutegravir with boosted darunavir noninferior to triple therapy for HIV
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Among virologically suppressed patients with HIV, study results showed that switching to dolutegravir with boosted darunavir was noninferior to continuing a triple therapy, making it a “valuable option” for these patients, researchers said.
The DUALIS study compared switching to dolutegravir plus ritonavir-boosted darunavir (DTG+bDRV) with continuing therapy with two nucleoside reverse transcriptase inhibitors (2NRTI) plus ritonavir-boosted DRV.
“This two-drug combination has not been studied in an adequately powered, prospective interventional trial and only limited data for that suitable switch option for [people living with HIV (PLWHIV)] were available when the study was planned,” Christoph D. Spinner, MD, a physician at the Technical University of Munich’s School of Medicine, told Healio.
According to the study, virally suppressed (HIV RNA less than 50 copies/mL) PLWH taking a three-drug combo (3DR) for 24 weeks or longer were randomly assigned to either switch to DTG 50 mg with DRV 800 mg (boosted with 100 mg ritonavir) or continue on their current therapy.
In total, 263 individuals were randomly assigned and treated (2DR, n = 131; 3DR, n = 132). Study results demonstrated that at week 48, 86.3% (n = 113) of 2DR and 87.9% (n = 116) of 3DR patients were virally suppressed a difference of –1.6% between arms. According to the study, six individuals from the 2DR arm and one from the 3DR arm discontinued treatment because of adverse events. Additionally, Kaplan–Meier estimates of confirmed HIV RNA 50 copies/mL or greater at week 48 were 1.6% (n = 2) in the 2DR and 3.1% (n = 4) in the 3DR group.
“In conclusion switching to DTG+bDRV was noninferior to continuing 3DR and the combination well tolerated and safe,” Spinner concluded.
Perspective
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Rajesh T. Gandhi, MD, FIDS
The DUALIS study shows that people with HIV who are virologically suppressed on three-drug therapy are able to safely switch to a two-drug combination of dolutegravir + ritonavir-boosted darunavir with high rates of continued virologic suppression. Unlike some other switch trials, this one allowed people with HIV to enter even if they had previous drug resistance, as long as there was no major integrase inhibitor or darunavir resistance. This result gives clinicians and people with HIV more antiretroviral options, in this case, a regimen that does not include any NRTIs (a “nuke-free” regimen). Although this extra flexibility is welcome, it is not as commonly needed now that we have NRTIs like tenofovir alafenamide that have relatively little effects on the bone and kidney. Nevertheless, for a person with HIV in whom toxicity to a NRTIs develops or in someone who has NRTI resistance, it is good to know that the combination of dolutegravir plus darunavir/ritonavir will continue to suppress viral replication. The more choices, the better.
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