EU Panel Gives Nod to Triple Combo Pill for HIV (Triumeq)

Miriam E. Tucker

Disclosures

June 27, 2014

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing of a once-daily combination of the antivirals dolutegravir, abacavir, and lamivudine (Triumeq, ViiV Healthcare UK) for the treatment of HIV infection in adults and adolescents older than 12 years of age weighing at least 40 kg.

The recommendation is for Triumeq in 50-, 300-, and 600-mg film-coated tablets containing the integrase inhibitor dolutegravir and the nucleoside analogues abacavir and lamivudine.

"The benefits with Triumeq are its ability to achieve potent antiretroviral response, with a high barrier to resistance in a once daily, single pill regimen," says a CHMP statement.

The most common adverse effects are headache, diarrhea, nausea, insomnia, fatigue, and hypersensitivity.

The CHMP decision was based on data from 2 phase 3 studies. One showed that dolutegravir plus abacavir-lamivudine had a better safety profile and was more effective through 48 weeks than a regimen of efavirenz-tenofovir disoproxil fumarate-emtricitabine.

The other phase 3 study demonstrated bioequivalence of the fixed-dose combination of dolutegravir/abacavir/lamivudine taken as a single tablet compared with dolutegravir and abacavir/lamivudine as separate pills. That study also showed that the combination can be taken without regard to meals.

Physicians are advised that all HIV-infected patients should be screened for carriage of the HLA-B*5701 allele before initiating treatment with any product containing abacavir, including this new combination. Abacavir should not be prescribed for patients found to carry the allele.

A final decision by the European Commission is anticipated during the third quarter of 2014. If the drug is licensed, a pharmacovigilance plan will be implemented as part of the marketing authorization. The abacavir/dolutegravir/lamivudine combination is under review in the United States, Canada, Australia, Brazil, and Japan.

New Indication

Also today, the CHMP recommended an expanded indication for another antiretroviral medicine, raltegravir (Isentress, Merck Sharp & Dohme Ltd), to include toddlers and infants as young as 4 weeks of age.

The full indication now reads: "Isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents, children, toddlers and infants from the age of 4 weeks."

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