CHMP Likes Gilead's TAF-Based HIV Regimen Odefsey

Megan Brooks


April 29, 2016

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Gilead Sciences' fixed-dose HIV combination pill Odefsey containing emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide (TAF) 25 mg.

"TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead's Viread (tenofovir disoproxil fumarate, TDF)," the company notes in a news release.

"TAF has also demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. Data show that because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a much lower dose and there is 90 percent less tenofovir in the bloodstream," they said.

The CHMP recommended Odefsey for treatment of adults and adolescents (aged 12 years and older weighing at least 35 kg) with HIV-1 infection without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor class, tenofovir, or emtricitabine and with a viral load of 100,000 or fewer HIV-1 RNA copies/mL.

"The benefit with Odefsey is its ability to achieve an antiretroviral response with a once daily, single pill regimen," the European Medicines Agency said in a news release. The most common adverse effects are nausea, insomnia, and dizziness.

The CHMP recommends that Odefsey be prescribed by physicians experienced in the management of HIV infection.

Detailed recommendations for the use of Odefsey will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after marketing authorization has been granted by the European Commission.

The US Food and Drug Administration approved Odefsey in March 2016.

The CHMP has also recommended a change to the existing indication for the HIV drug atazanavir (Reyataz, Bristol-Myers Squibb).

The committee has recommended striking out this sentence: "There are very limited data available from children aged 6 to less than 18 years."

If the European Commission grants the change, the indication would read: "Reyataz oral powder, co-administered with low dose ritonavir, is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients at least 3 months of age and weighing at least 5 kg. Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 PI mutations). The choice of REYATAZ in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient's treatment history."

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