Triumeq to End Gilead's Monopoly on Single-Tablet HIV Meds

The recent approval of ViiV Healthcare's once-daily, single-tablet anti-HIV regimen, Triumeq, by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) will mean that the market monopoly currently held by Gilead Sciences will soon come to an end, according to an analyst with research and consulting firm GlobalData.

"Besides having superior antiretroviral efficacy in treatment-na�ve adults compared with Atripla, Triumeq will also benefit from being the first once-daily, single-tablet anti-HIV regimen that does not contain tenofovir disoproxil fumarate (TDF)," said Moritz Herrmann, Ph.D., GlobalData's Analyst covering Infectious Diseases.

Hermann noted that Triumeq is the first drug of its kind to demonstrate a superior clinical profile to Gilead Sciences' Atripla, mostly due to the former's improved tolerability.

"TDF, which is contained in all of Gilead's single-tablet regimens, can induce significant bone toxicity and is not suitable for use in patients with impaired kidney function," said Hermann. "Therefore, Triumeq could expand into these patient populations with high unmet needs."

GlobalData anticipates that while Triumeq will capture some of the market share from Atripla, which generated global sales of more than $3.6 billion in 2013, Gilead will continue to be a major player in this treatment sector, as the company is developing an updated version of its drug Stribild.

"In this new regimen, TDF is substituted with a more potent, novel tenofovir prodrug, tenofovir alafenamide fumarate, which can be administered at doses 30-fold lower than those required with TDF treatment," explained Hermann. "Phase II clinical trial data indicate reduced kidney and bone toxicity from the new regimen compared with Stribild, and if Phase III trials confirm these reduced toxicities, Gilead's upcoming treatment may be well-positioned to compete against ViiV's Triumeq."

The analyst concludes that while Triumeq will be first on the market, Gilead's strong existing presence in HIV therapy will enable it to leverage physician and patient familiarity with Stribild, as offering an improved version of an existing, highly prescribed drug will facilitate uptake.