If only the names were simple Truvada and Epzicom, a duo of two-in-one combo nukes, have hit pharmacy shelves, challenging Combivir (3TC/AZT). Truvada, Gilead Sciences’ fixed-dose combination (FDC) capsule, mixes 300 mg Viread (tenofovir) with 200 mg Emtriva (FTC). GlaxoSmithKline’s Epzicom combines 600 mg Ziagen (abacavir) and 300 mg Epivir (3TC). Both FDCs conveniently require only one pill daily, taken typically with a non-nuke or protease inhibitor (PI). “The only thing better would be to get a full regimen into a fixed-dose combination,” says Tom Gegeny of the AIDS Treatment Activists Coalition.
Hold that thought Gilead, Bristol-Myers Squibb and Merck say they’re teaming up on a once-daily Sustiva (efavirenz)/Viread/Emtriva tablet to meet adherence demands in nations rich and poor. (Merck markets efavirenz in some parts of the world.)
Not so simple Abbott filed for FDA approval to study Kaletra (lopinavir/ritonavir) as a once-daily—but only for new-to-HAART HIVers (once-a-day doses may not keep drug levels consistent enough to overcome resistant HIV in others). Another party pooper: In tests, the once-a-day sent more people running for the loo than its twice-daily ancestor.
Alive in 2005 Tipranavir, Boehringer Ingelheim’s PI, is likely to be the only new HAART med approved next year—along with its doesn’t-play-well-with-other-PIs, needs-a-big-boost limitations (see “Trouble for Tipranavir,” POZ, September 2004).
Coming Attraction Reverset, from HIV newcomers Pharmasset and Incyte, may help HIVers with multi-nuke resistance. The new nuke trounces many resistant HIV strains but can cause—and is less active against—the dreaded K65R mutation (think Viread resistance). In a recent study, eight much-treated HIVers added once-daily Reverset to a failing regimen. Ten days later, four had undetectable viral loads; 20 days after the drug was stopped, viral loads were still below their pre-Reverset levels. But “we need long-term data,” Gegeny says. “Many promising candidates have fallen by the wayside when data from larger studies show unexpected and unsafe results.” Phase II studies are underway, with larger Phase III studies expected next summer.