Gilead's once-daily HIV drug Truvada more effective than twice-daily Combivir, study shows

By Angela McDaniels

Seattle, Nov. 17 - Gilead Sciences Inc. said preliminary clinical data shows that 76% of HIV patients who switched from twice-daily Combivir (150 mg lamivudin/300 mg zidovudine) to Gilead's once-daily Truvada (emtricitabine and tenofovir disoproxil fumarate), both in combination with efavirenz, experience virologic suppression below 50 copies/mL at week 24.

Only 59% of patients had similar virologic suppression when the study began, the company said.

Hemoglobin levels also increased significantly from baseline; 32% of patients experienced an increase of at least 1 g/dL.

"The simplicity, tolerability and virologic benefit provided by a fixed-dose combination backbone are important considerations in helping promote long-term positive clinical outcomes," said executive vice president of research and development Norbert Bischofberger in a company news release.

The phase 4, 198-patient study is being held in multiple centers in the United States. Study endpoints include viral suppression less than 400 and 50 copies/mL, change in CD4 cell count, changes in patients' hemoglobin levels and lipid profile and responses to a questionnaire evaluating symptoms, adherence and treatment satisfaction.

Of the 172 patients who completed a SATS questionnaire, 85% of patients reported being very satisfied with the treatment regimen at 24 weeks, compared to 58% at baseline, the company said.

The results will be presented at the 10th European AIDS Conference in Dublin.

Gilead Sciences is a Foster City, Calif.-based biopharmaceutical company that develops therapeutics for unmet medical needs.

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