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Two-drug HIV regimen effective in treatment-naive patients
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ViiV Healthcare released data from two phase 3 trials that showed a once-daily, two-drug regimen of dolutegravir and lamivudine was noninferior to a standard three-drug regimen in treatment-naive patients with HIV.
In light of the positive results, ViiV Healthcare announced plans to submit an application seeking regulatory approval of dolutegravir/lamivudine. If approved, it would be the second two-drug HIV regimen available in the United States. The first one, Juluca (dolutegravir/rilpivirine; ViiV Healthcare), was approved by the FDA in November. However, its use is strictly limited to virally suppressed patients who have been on a stable regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to any components of Juluca.
The safety and efficacy of dolutegravir/lamivudine was assessed during the phase 3, parallel group GEMINI 1 and GEMINI 2 trials, which were conducted in Europe, South Africa, Asia Pacific and the Americas, according to a news release. The studies enrolled approximately 1,400 treatment-naive patients with a baseline viral load of less than 500,000 copies/mL. The participants were randomly assigned to receive once-daily dolutegravir/lamivudine or once-daily dolutegravir plus tenofovir disoproxil fumarate/emtricitabine.
At 48 weeks, dolutegravir/lamivudine met its primary endpoint of noninferiority in both trials, which was based on a standard measure of HIV viral suppression, the release said. No treatment-emergent resistance was observed among participants with virologic failure. A ViiV Healthcare representative told Infectious Disease News that additional data from the studies will be presented at the International AIDS Conference, which will take place in Amsterdam from July 23 to 27.
John C. Pottage, Jr., MD, chief scientific and medical officer of ViiV Healthcare, said the new results provide further evidence that HIV can be controlled with two drugs instead of three.
“People with HIV are living longer and more productive lives. However, under current standard of care, many patients still take three or more medicines every day,” he said in the release. “Importantly, the studies show that this two-drug regimen could be an option for treatment-naive patients and can support a broad range of patients living with HIV around the world.”
Last month, the FDA issued a safety alert warning patients and health care providers about a possible link between dolutegravir use during early pregnancy and serious birth defects in babies. The agency recommends that physicians consider using alternative antiretroviral drugs in women with HIV of childbearing age and to test them for pregnancy before prescribing dolutegravir. There also is evidence that dolutegravir can cause “serious toxicities” when combined with certain tuberculosis treatment regimens. – by Stephanie Viguers
References:
Brooks KM, et al. Clin Infect Dis. 2018;doi:10.1093/cid/ciy082.
FDA. FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq). https://www.fda.gov/drugs/drugsafety/ucm608112.htm. Accessed June 14, 2018.
GlaxoSmithKline. ViiV Healthcare reports landmark phase III studies for dolutegravir and lamivudine, demonstrating the ability to control HIV with a two-drug regimen in treatment naïve patients. https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-reports-landmark-phase-iii-studies-for-dolutegravir-and-lamivudine-demonstrating-the-ability-to-control-hiv-with-a-two-drug-regimen-in-treatment-na%C3%AFve-patients/. Accessed June 14, 2018.
Disclosure: Pottage is an employee of ViiV Healthcare.