Triumeq shows superior efficacy for treatment-naive women with HIV

Triumeq showed superior efficacy after 48 weeks compared with atazanavir boosted with ritonavir plus emtricitabine/tenofovir disoproxil fumarate in treatment-naive women living with HIV, according to data presented at AIDS 2016.

Results from a phase 3b trial also showed that Triumeq (abacavir/dolutegravir/lamivudine, ViiV Healthcare; ABC/DTG/3TC) had a favorable safety profile compared with atazanavir boosted with ritonavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).

The study built on previous data showing that Tivicay (dolutegravir, ViiV Healthcare)-based regimens are effective in a broad range of patients, according to John C. Pottage Jr., MD, chief scientific and medical officer at ViiV Healthcare.

John C. Pottage

The results were important for a number of reasons, Pottage said, including the total inclusion of a population that is consistently underrepresented in HIV clinical trials.

“The most important thing is that it is a treatment study for women,” Pottage said. “The second is that … we wanted to go up against real competitors, so we didn’t stack the deck, so to speak. And third, we wanted to extend where we did the study, so we tried to enroll a larger number of patients outside of the United States and Western Europe. [We] went to South Africa, Thailand, and parts of Latin America.

”It conforms to our principles of really trying to study the drug around the globe in all different situations.”

ARIA was a randomized, open-label, noninferiority study with a pre-specified analysis for superiority. The primary endpoint was an HIV1 RNA viral load of less than 50 copies/mL after 48 weeks.

In 495 treatment-naive women (median age, 37 years), patients in the ARIA trial who took a once-daily, fixed dose of ABC/DTG/3TC achieved viral suppression 82% of the time vs. 71% for those on ATV/r plus FTC/TDF (adjusted difference, 10.5%; 95% CI, 3.1% to 17.8%).

Further, there were fewer drug-related adverse events reported in patients on ABC/DTG/3TC (33%) compared with ATV/r plus FTC/TDF (49%), and no one in the ABC/DTG/3TC group developed resistance.

“I think the biggest message is that integrase inhibitors really should be first-line therapy,” Pottage said. “The medicine has only been on the market for 2 1/2 or 3 years. And there are over 200,000 people getting it. But our job is to continually study it, look at it, and so this is one way we’ve done that.” – by Gerard Gallagher

Reference:

Orrell C, et al. Abstract THAB0205LB. International AIDS Conference. July 18-22, 2016. Durban, South Africa.

Disclosure: Pottage is an employee of ViiV Healthcare.