according to new data.
ISL is a first-in-class nucleoside reverse transcriptase translocation inhibitor (NRTTI), Jean-Michel Molina, MD, PhD, of Saint‐Louis and Lariboisière Hospitals in Paris, explained at the annual HIV drug therapy meeting in Glasgow, Scotland. The randomized, double-blind, dose‐ranging trial compared ISL+DOR to a fixed‐dose combination of DOR, lamivudine, and tenofovir disoproxil fumarate (DOR/3TC/TDF) daily in 121 patients.
Patients in the ISL+DOR group initially received 0.25, 0.75, or 2.25 mg of ISL along with 100 mg of DOR and 200 mg of 3TC. Beginning at week 20, participants achieving HIV viral loads of 50 copies/mL or less discontinued 3TC but continued on their assigned dose of ISL+DOR for at least 24 weeks. At that point the investigators noted a greater number of discontinuations in the 2.25-mg group and settled on the 0.75-mg ISL dose. All patients in the ISL group were transitioned to that dose between weeks 60 and 72.
At week 96, 81.1% of the patients in the combined ISL group maintained viral loads <50 copies/mL, comparable to the 80.6% of those in the DOR/3TC/TDF group.
ISL+DOR appeared to be “well tolerated,” the investigators noted. They found drug-related adverse events in 7.8% of the patients in the ISL+DOR group compared with 22.6% of patients in the DOR/3TC/TDF group. In addition, among the 90 patients in the ISL+DOR group, no more than 5% of participants experienced any specific drug-related adverse event.
Source:: Abstract O415. Oct. 5-8, 2020.
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