New Fixed-Dose Tabs Approved for HIV-1 Infection

The Food and Drug Administration (FDA) has approved Dutrebis (lamivudine and raltegravir; Merck) tablets for the treatment of HIV-1 infection in patients aged ≥6 years old weighing ≥30kg, in combination with other antiretrovirals.

The approval was based on an open-label, single-dose, randomized, two-period, crossover study (n=108). The fixed-dose combination tablet of lamivudine and raltegravir demonstrated comparable levels of exposure to one lamivudine (Epivir; GlaxoSmithKline) 150mg tablet plus one raltegravir (Isentress; Merck) 400mg tablet. Clinical trials have not been conducted specifically for Dutrebis.

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Dutrebis combines lamivudine, a nucleoside analogue (reverse transcriptase inhibitor), and raltegravir, a HIV-1 integrase strand transfer inhibitor. Lamivudine works by inhibiting HIV-1 reverse transcriptase via DNA chain termination after incorporation of the nucleotide analogue into viral DNA. Raltegravir works by inhibiting the catalytic activity of HIV-1 integrase, which prevents the covalent insertion of unintegrated linear HIV-1 DNA into the host cell genome and prevents the formation of the HIV-1 provirus.

At this time, Merck has no plans on making Dutrebis available in the United States.

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