HIV and AIDS Current Topics in HIV and AIDS

Two AIDS Meds Formally Approved

The Food and Drug Administration formally approved two AIDS drugs after a large study found that they were as safe and effective as initially suggested. The two treatments, Viread and Truvada, are already available for people with HIV, based on an expedited review that speeds the approval of life saving treatments before longer studies are completed.

Following more than 500 previously untreated patients for four months, researchers found that Truvada, which combines Viread and Emtriva, was highly effective at suppressing the AIDS virus when combined with Sustiva, another antiretroviral drug. In fact, this combination was more effective than adding Sustiva to Combivir, which is based on a combination of AZT and 3TC, two older AIDS drugs.

Compared to the Combivir and Sustiva regimen, in which 73 percent of patients responded, the newer triple combination suppressed the AIDS virus in 84 percent of patients, with fewer side effects and more potent immune effects. The findings were recently published in the New England Journal of Medicine.

"The superior outcome," the study authors write, "provides further support for the use of this regimen in patients who have not previously received antiretroviral therapy." Government guidelines list Viread and Truvada among the "preferred" regimens for people who have not been previously treated for HIV.

In a statement, Gilead, the company that makes Truvada, said they plan to submit a new drug application to the FDA for combining Truvada and Sustiva. If accepted, patients could soon have the option of taking only one pill a day to control HIV, down from the 12 to 24 pills once needed.