Pharmaceutical giant Gilead Sciences announced the detailed 48-week results from two Phase 3 studies (Studies 1489 and 1490) on Monday at the IAS 2017 Conference on HIV Science in Paris, France. The studies evaluated the efficacy and safety of a fixed-dose combination of an investigational treatment regimen for HIV. The researchers examined the effects of substituting bictegravir-based regimen for commonly-prescribed dolutegravir-based regimens.
Though dolutegravir is often well-tolerated, some recent research has shown it may be vulnerable to resistence. Gilead continues to study bictegravir for its apparent ability to avoid drug resistance. Early studies showed that bictegravir has potent activity against both wild-type (non-mutated) and drug-resistant HIV, and it has low potential to be either a “victim” or “perpetrator” of drug-drug interactions, according to Dr. Joseph Custodio, from Gilead.
The results of the two studies conclude that the bictegravir-containing regimen is “non-inferior to regimens containing dolutegravir.” In Study 1489, 92.4 percent of participants were successful in achieving viral suppression after 48 weeks. In Study 1490, 89.4 percent achieved viral suppression after 48 weeks.
Physicians continue to look for treatment regimens with simple, convenient dosing that can sustain virologic suppression with a safety profile that is appropriate for most HIV patients,” said Dr. Joel Gallant, Medical Director of Specialty Services at Southwest CARE Center in Santa Fe, N.M. and lead author of Study 1489.
“Combinations of an integrase inhibitor plus a dual-NRTI backbone have become a standard of care for initial treatment of HIV. In clinical trials, the investigational [bictegravir-containing regimen] has been well tolerated with low rates of discontinuations due to adverse events, a high barrier to resistance and few drug interactions.”
“These data reinforce the safety and efficacy profile consistently seen in other trials evaluating regimens based on the FTC/TAF combination,” said Dr. Paul Sax, Professor of Medicine at Harvard Medical School and lead author of Study 1490. “These results suggest that the combination of bictegravir with FTC/TAF has the potential to be appropriate for a broad range of HIV patients, including those with mild to moderate renal impairment.”
Ultimately, what all this technical talk amounts to is good news. It means science continues to research and develop new treatment options so that everyone living with HIV can find a regimen with fewer side effects and drug resistance issues—and live long, happy, and productive lives.