Complete Regimen Tablet Gets FDA Approval for HIV

The latest drug for certain patients with the human immunodeficiency virus (HIV) — emtricitabine, rilpivirine, and tenofovir alafenamide (Odefsey/Gilead Sciences) – will be hitting the market soon.

The Food and Drug Adminstration (FDA) gave the green light on the complete regimen tablet on March 1. The drug is indicated as initial therapy for patients with HIV-1 who are at least 12 years old and weigh at least 78 pounds. They must also have a creatinine clearance of at least 30 mL per minute. In addition, they should fall into one of two categories.

1. No antiretroviral treatment (ART) history and RNA less than or equal to 100,000 copies per mL

2. To replace a stable ART regimen in patients whose virologically-suppressed (RNA less than 50 copies per mL) for at least six months with no history of treatment failure and no known resistance to the individual components of Odefsey

The tablet is a fixed-dose combination tablet of emtricitabine, rilpivirine, and tenofovir alafenamide (200/25/25 mg).

“The approval is supported by a bioequivalence study demonstrating that Odefsey achieved similar drug levels of emtricitabine and TAF in the blood as Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) and similar drug levels of rilpivirine as Edurant (rilpivirine 25 mg),” explained the FDA news release.

• Related: ART Impacts How HIV Establishes Itself in the Female Reproductive Tract

Clinical trials confirmed the safety, efficacy, and tolerability of Odefsey in adults in adolescents, including treatment-naïve patients and those who switched from other regiments.

It’s recommended that patients be tested for hepatitis B before starting this treatment. Those with severe renal impairment are not advised to take Odefsey.

Patients who meet the drug’s criteria should take one tablet a day with meal. The most common adverse effects are nausea, headache, insomnia, and depressive disorders.

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