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Johns Hopkins Medicine
Media Relations and Public Affairs
Media contact: David March
August 12, 2006
THREE-IN-ONE COMBINATION THERAPY CONTINUES TO SET NEW GOLD STANDARD IN ANTIRETROVIRAL THERAPY, LATEST DATA SHOW
A once-daily dose of three antiretroviral drugs works better as an initial treatment for HIV infection than another three-drug combination long considered to be the gold standard, according to the latest, year-two results from an international study being led by researchers at Johns Hopkins and elsewhere. About 40,000 Americans each year are infected with HIV, the virus that causes AIDS.
Results showed that a daily regimen of a so-called triple cocktail, consisting of tenofovir DF (Viread) and emtricitabine (Emtriva), and efavirenz (Sustiva), suppressed the virus to undetectable levels in 75 percent of patients, compared to 62 percent of those who took another widely used combination of antiretrovirals, zidovudine and lamivudine (AZT and 3TC, or Combivir), plus efavirenz.
The U.S. Food and Drug Administration approved on July 12 the combination of tenofovir, emtricitabine and efavirenz as a once-a-day, single-pill HIV therapy, called Atripla.
Results from Study 934, which is expected to continue for another year, come after 96 weeks of therapy (two years in clinical terms) and involved 517 patients in the United States, France, Germany, Italy, Spain and the United Kingdom. The latest results support the initial, 48-week findings that were published in The New England Journal of Medicine on Jan. 19, 2006. Participants included both men and women, with an average age of 36, none of whom had been previously treated for their HIV infection. Each was randomly assigned to start treatment with either the tenofovir-emtricitabine or zidovudine-lamivudine regimen, each in combination with efavirenz. Their progress was monitored through blood tests, pill counts and regular check-ups at their medical clinic.
While both regimens were generally well tolerated, more patients in the zidovudine-lamivudine group dropped out of the study due to side effects, especially anemia. Some evidence of progressive lipoatrophy, a loss of fat in the limbs and face, which is not being seen in the tenofovir-emtricitabine group, was also observed in this group.
According to the lead study author, Joel Gallant, M.D., M.P.H., professor and associate director of the AIDS Service at The Johns Hopkins University School of Medicine, the tenofovir-emtricitabine combination shows superior activity due to better tolerability. Gallant says the body-fat results after two year suggest that even patients doing well on the zidovudine-lamivudine combination may benefit from switching to the newer combination.
Efficacy and safety of tenofovir DF (TDF), emtricitabine (FTC), and efavirenz (EFV) compared to fixed dose zidovudine/lamivudine (CBV) and EFV through 96 weeks in antiretroviral treatment-naïve patients. Joel Gallant, Anton Pozniak, Edwin DeJesus, José Arribas, Raphael Campo, S.S. Chen, Damian McColl, Jeffrey Enejosa, and Andrew Cheng.
- JHM -
(Scheduled for presentation at 12:30 p.m. ET, Tuesday, Aug. 15; poster presentation #TUPE0064, Poster Exhibition Area, Level 800, South Building of Metro Toronto Convention Center.)