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FDA Approves Complera, New Single-Pill Regimen for HIV

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The U.S. Food and Drug Administration today approved a new once-daily all-in-one pill for treatment-naive people with HIV containing tenofovir/emtricitabine/rilpivirine, to be marketed under the brand name Complera.

Complera combines Gilead Sciences' double nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) backbone tenofovir/emtricitabine (the drugs in Truvada) plus Tibotec/Janssen's next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine.

Rilpivirine (brand name Edurant, formerly TMC278) was approved in May for people starting antiretroviral therapy for the first time. Complera joins Atripla (tenofovir/emtricitabine/efavirenz), a collaboration between Gilead and Bristol-Myers Squibb, as the second complete single-tablet regimen.

Complera contains 300 mg tenofovir, 200 mg emtricitabine, and 25 mg rilpivirine. The fixed-dose combination pill does not allow for dose adjustment of any of the component drugs. It should be taken once-daily with a meal. Complera is not yet approved for treatment-experienced HIV patients.

The Phase 3 ECHO and THRIVE trials showed that rilpivirine works as well as efavirenz (Sustiva) for treatment-naive patients, but causes fewer side effects, especially neuropsychiatric symptoms. Overall, at 48 weeks, 83% of rilpivirine recipients and 81% taking efavirenz achieved HIV RNA < 50 copies/mL. The most common side effects in the rilpivirine arm were insomnia and headache. Data presented at the IAS 2011 conference last month in Rome showed that rilpivirine continued to demonstrate good safety and efficacy at 96 weeks.

Studies indicate that rilpivirine may not work as well for people with high baseline viral load (> 100,000 copies/mL). Individuals who experience treatment failure may develop resistance mutations, some of which confer cross-resistance to other drugs in the NNRTI class. In ECHO and THRIVE combined, 44% of people who experienced virological failure in the rilpivirine arm and 23% in the efavirenz arm developed resistance to their respective NNRTIs.

"The concept of a single-tablet regimen has become a goal in HIV drug development, and the standard of care in medical practice in the United States," said study investigator Tony Mills, MD, in an announcement issued by Gilead. "However, no one therapy is appropriate for all patients. Given its efficacy, safety and convenience, the availability of Complera represents an exciting milestone in addressing the individual needs of patients new to HIV therapy."

Because tenofovir has been linked to kidney problems, Complera should not be prescribed for people with moderate or severe kidney impairment (creatinine clearance < 50 mL/minute). Tenofovir has also been associated with bone loss.

Tenofovir and emtricitabine are active against hepatitis B virus (HBV) as well as HIV, but the safety and efficacy of Complera have not been established in HIV/HBV coinfected people. Flares, or severe acute worsening of liver inflammation, have been reported in coinfected patients who discontinue tenofovir and emtricitabine. Liver function should be monitored regularly in such patients.

The full Gilead press release, which includes important information about safety, contraindications, and drug-drug interactions, is available at http://www.gilead.com/pr_1595280.

U.S. full prescribing information for Complera is available at www.Gilead.com.

Labeling information also will be posted soon to the FDA web site at Drugs@FDA.

8/9/11

Sources

R Klein and Y Belew, U.S. Food and Drug Administration. Approval of Complera: emtricitabine/rilpivirine/tenofovir DF fixed dose combination. HIV/AIDS Update. August 10, 2011.

Gilead Sciences. U.S. Food and Drug Administration Approves Gilead Sciences’ Complera, a New Complete Once-Daily, Single-Tablet Regimen for HIV-1 Infection in Treatment-Naive Adults. Press release. August 10, 2011.