FDA Okays Another Once-Daily HIV Pill
By Joyce Frieden, News Editor, MedPage Today
August 10, 2011
WASHINGTON -- The FDA has approved a second once-daily tablet for HIV -- this one combining three medications: emtricitabine, rilpivirine, and tenofovir.
The pill, manufactured by Gilead Sciences, combines that company's Truvada -- itself a combination of the two nucleoside reverse transcriptase inhibitors emtricitabine and tenofovir -- with rilpivirine (Edurant), a recently approved non-nucleoside reverse transcriptase inhibitor made by Tibotec Pharmaceuticals.
The new pill will be called Complera.
"In the 30 years since the first AIDS cases were reported, we've made incredible strides in the treatment of this disease," said Tony Mills, MD, a participating investigator in ongoing Complera studies.
"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," Mills said in a press release.
The first once-daily HIV pill, a combination of efavirenz, emtricitabine, and tenofovir (Atripla), was approved by the FDA in July 2006. Atripla is marketed by Gilead and Bristol-Myers Squibb.
Complera's approval is based on data from two phase III trials, ECHO and THRIVE, which compared the safety and efficacy of rilpivirine with efavirenz. The studies included a background drug regimen, and most patients in the rilpivirine arms were also taking Truvada.
A bioequivalence study conducted by Gilead demonstrated that the co-formulated single-tablet regimen achieved the same levels of medication in the blood as emtricitabine plus rilpivirine plus tenofovir, the company said, noting that Complera does not cure HIV-1 infection or help prevent the transmission of HIV to others.
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir, one of Complera's ingredients, in combination with other antiretrovirals, the company noted.
Complera is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of the drug has not been established in patients coinfected with HBV and HIV-1.
Complera should not be co-administered with certain anticonvulsants (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin), certain antimycobacterials (such as rifabutin, rifampin, and rifapentine), or proton pump inhibitors such as lansoprazole and omeprazole, because these could result in loss of virologic response and result in resistance to the drug, according to the company.
The most common side effects from rilpivirine included insomnia and headache; the most common adverse events with emtricitabine and tenofovir were diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.
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