FDA OKs New Triple-Combination Pill (Triumeq) for HIV

Miriam E. Tucker

August 22, 2014

The US Food and Drug Administration has approved a once-daily fixed-dose combination pill of the antivirals dolutegravir, abacavir, and lamivudine (Triumeq) for the treatment of HIV infection in adults aged 18 years and older, according to the manufacturer ViiV Healthcare UK.

The drug combines an integrase strand transfer inhibitor (dolutegravir, 50 mg) with 2 nucleoside reverse transcriptase inhibitors (abacavir, 600 mg, and lamivudine, 300 mg). Once-daily dolutegravir was approved in the United States as monotherapy (under the name Tivicay) in August 2014 and in Europe in January 2014. In June 2014, the Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive opinion on the Marketing Authorisation Application for Triumeq.

Triumeq alone is not recommended in patients with resistance-associated integrase substitutions or clinically suspected integrase strand transfer inhibitor resistance because the dolutegravir dose in the combination is insufficient for those individuals, according to a ViiV statement.

To minimize the risk for sensitivity to abacavir, physicians should screen for the presence of the HLA-B*5701 allele in HIV-infected patients, regardless of race, and should not prescribe products containing abacavir (including Triumeq) for patients known to carry the allele.

The label contains a boxed warning regarding the risk for hypersensitivity reactions to abacavir products, lactic acidosis and severe hepatomegaly, and exacerbations of hepatitis B.

The US Food and Drug Administration approval is based primarily on data from 2 clinical trials, including a 96-week phase 3 study in treatment-naive adults, in which 80% of patients achieved virological suppression of the virus with dolutegravir and abacavir/lamivudine (given separately) vs 72% of those taking the most commonly used single-pill regimen Atripla (Bristol-Myers Squibb and Gilead Sciences; efavirenz, emtricitabine, and tenofovir), according to the ViiV news release.

Treatment-emergent adverse events occurring in 2% or more participants taking the dolutegravir-based regimen were insomnia (3%), headache (2%), and fatigue (2%).

ViiV Healthcare Ltd is a global specialist HIV company with GlaxoSmithKline, Pfizer Inc, and Shionogi Limited as shareholders.

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