By Myles Helfand
August 22, 2014
The U.S. Food and Drug Administration (FDA) granted approval on Aug. 22 to Triumeq, a fixed-dose combination drug that combines three existing HIV medications into a single, once-daily pill. The tablet consists of the integrase inhibitor dolutegravir (sold separately as Tivicay, abbreviated DTG) and the NRTIs abacavir (Ziagen) and lamivudine (Epivir, 3TC).
Triumeq becomes the fourth FDA-approved, all-in-one combination HIV treatment regimen, alongside Atripla, Complera and Stribild. These combination drugs consist of two nucleoside inhibitors and one or two drugs in other classes. Like Stribild, Triumeq contains an integrase inhibitor. But unlike Stribild -- as well as Atripla and Complera -- "Triumeq is the only recommended single-tablet regimen that does not include tenofovir [Viread]," said Benjamin Young, M.D., Ph.D., the chief medical officer of the International Association of Providers of AIDS Care. "Tenofovir's attendant risks of kidney and bone toxicity are of increasing importance among an aging HIV population," he notes.
In the SINGLE study, the primary clinical trial leading up to its approval, Triumeq was found to be virologically and immunologically superior to Atripla, and was better tolerated. A number of studieshave also suggested that dolutegravir has a more favorable resistance profile than other currently approved integrase inhibitors -- not only in terms of its activity in people with resistance to other integrase inhibitors, but also in terms of the extent to which people develop drug resistance when therapy with a dolutegravir-based regimen fails. "The lack of observed emergent drug resistance is a key attribute" of Triumeq, Young said. However, the tablet is not recommended for individuals with a history of resistance to the component drugs.
"At a time when integrase inhibitor-based regimens look like the best choices of initial therapy, this will be an attractive regimen for patients who have no contraindications to abacavir," noted Joel Gallant, M.D., the associate medical director of specialty services at Southwest CARE Center in New Mexico. Due to the risk of abacavir hypersensitivity reaction, people with HIV who are considering Triumeq will need to undergo genetic testing for the HLA-B*5701 allele prior to taking the pill.
Triumeq's approval was first announced in a press release on the website for ViiV Healthcare, an alliance of the pharmaceutical companies GlaxoSmithKline, Pfizer Inc. and Shionogi & Co.
"If ViiV Healthcare manages to set the price of Triumeq in accordance with the generic status of abacavir and lamivudine, the cost should be substantially lower than the price of the other single-tablet regimens that contain all on-patent components," Young said. "Having a lower price would be welcomed in our financial times, and could offer substantial market advantage for penny-pinching agencies."