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FDA approves single dosage HIV drug

25 August 2014 | Regulatory | By BioSpectrum Bureau

Triumeq alone is not recommended for use in patients with current or past history of resistance to any components of Triumeq

Triumeq alone is not recommended for use in patients with current or past history of resistance to any components of Triumeq

Singapore: The US Food and Drug Administration (FDA) has approved US-based ViiV Healthcare's single dose Triumeq tablets for treatment of HIV-1 infection.

Triumeq is ViiV Healthcare's first dolutegravir-based fixed-dose combination, offering many people living with HIV the option of a single-pill regimen that combines the integrase strand transfer inhibitor (INSTI) dolutegravir, with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine.

Triumeq alone is not recommended for use in patients with current or past history of resistance to any components of Triumeq. Triumeq alone is not recommended in patients with resistance-associated integrase substitutions or clinically suspected INSTI resistance because the dose of dolutegravir in Triumeq is insufficient in these populations. Before initiating treatment with abacavir-containing products, screening for the presence of a genetic marker, the HLA-B 5701 allele, should be performed in any HIV-infected patient, irrespective of racial origin. Products containing abacavir should not be used in patients known to carry the HLA-B5701 allele.

Dr Dominique Limet, chief executive officer, ViiV Healthcare, said, "The approval of Triumeq offers many people living with HIV in the US, the first single-pill regimen containing dolutegravir. ViiV Healthcare is committed to delivering advances in care and new treatment options to physicians and people living with HIV. We are proud to announce this important milestone, marking the second new treatment to be approved in the US from our pipeline of medicines."

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