FDA Approves Daily HIV Pill for Treatment-Naive Adults

The U.S. Food and Drug Administartion has approved Gilead Sciences' Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) for treatment of HIV-1 in adults who are new to treatment. The daily tablet consists of a fixed-dose combination of Truvada and NNRTI rilpivirine.

The FDA's clearance of the new drug was based on Phase III active-controlled studies Echo and Thrive. The studies were used to confirm safety and efficacy of rilpivirine compared with efavirenz. The single tablet was also found to achieve the same blood levels as when the three drugs are administered separately, another study said.

Complera became Gilead's second combination HIV drug to receive FDA approval. Atripla, with global sales of $2.93 billion in 2010, is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate.

Federal officials said earlier this month that the number of new infections was about 50,000 per year over the past decade and continues to persist.

Officials also said the epidemic remains concentrated in gay men. Rates of new infection have also been steeply rising among young black men.

Activists said that government prevention policy is ineffective and federal officials said that the epidemic will persist if prevention is not improved.

A Canadian HIV researcher said July 14 that pre-exposure prophylaxis, preventing rather than treating a disease, can derail the AIDS epidemic. Two HIV studies in Africa revealed that antiretroviral drugs used in combination with anti-retroviral therapy treats HIV and prevents transmission. The studies also found that taking a daily antiretroviral pill can decrease risk of transmission by 75 percent in heterosexual couples.

Elly Katabira, president of the International AIDS Society, said: "Fifteen years ago, even the most optimistic members of the scientific community were silent about the prospect of an HIV cure or vaccine. Today, there is a reemergence of hope that the long-term remission of an infected individual is a realistic objective. The IAS is proud to be leading the coordination of the research effort and we look forward to the unveiling of the global scientific strategy at the XIX International AIDS Conference in Washington next year," he added.

Complera is Gilead's second combination HIV therapy to gain FDA approval. The first, Atripla, is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate.