The most common side effects are headache, diarrhoea, nausea (feeling sick) and difficulty sleeping. The most common serious side effects are allergic reactions, including rash and severe liver problems. It contains dolutegravir, an integrase inhibitor, and lamivudine, a reverse-transcriptase inhibitor. Dolutegravir stops the activity of an enzyme called integrase (and is known as an integrase inhibitor), while lamivudine stops the activity of another enzyme called reverse transcriptase (and is known as a nucleoside reverse transcriptase inhibitor or NRTI).
In the EU dolutegravir/lamivudine is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.
Two main studies, involving 1,441 subjects, have shown that the combination of dolutegravir and lamivudine is as effective at lowering the amount of HIV in the blood as a triple combination therapy (dolutegravir plus tenofovir plus emtricitabine).
In these studies, 91% of subjects with HIV-1 who took the dolutegravir/lamivudine combination no longer had detectable levels of HIV (below 50 copies per ml) after 48 weeks compared with 93% of those who were taking the triple combination. In both studies there were no cases of resistance to treatment after 48 weeks.
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