Combination Antiviral Recommended in EU for HIV Treatment

Miriam E. Tucker


January 23, 2015

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended 150 mg lamivudine/300 mg raltegravir (Dutrebis, Merck Sharp & Dohme Limited) for the treatment of HIV 1 infection in adults, adolescents, and children from the age of 6 years and weighing at least 30 kg.

The film-coated tablets combine the antivirals lamivudine, a substrate and competitive inhibitor of HIV reverse transcriptase, and raltegravir, an HIV integrase inhibitor. The former works by terminating the viral DNA chain, and the latter by disrupting the HIV replication cycle.

The combination's expected benefits include a reduction in daily pill burden while retaining comparable efficacy compared with dosing with the individual agents, according to a CHMP statement.

The most common adverse effects seen with lamivudine and raltegravir taken individually are headache, nausea, malaise, fatigue, nasal signs and symptoms, diarrhea, and cough.

The CHMP panel proposes that the product be prescribed by physicians experienced in the management of HIV infection.

The specific wording of the indication is: "Dutrebis in combination with other anti-retroviral medicinal products for the treatment of [HIV1] infection in adults, adolescents, and children from the age of 6 years and weighing at least 30 kg without present or past evidence of viral resistance to antiviral agents of the InSTI (Integrase Strand Transfer Inhibitor) and NRTI (Nucleoside Reverse Transcriptase Inhibitor ) classes."

A pharmacovigilance plan will be implemented as part of the product's marketing authorization.


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