ViiV Healthcares scores first twin-drug FDA approval for untreated HIV-1
pharmafile | April 9, 2019 | News story | Manufacturing and Production, Research and Development | GSK, HIV, ViiV Healthcare, pharma
ViiV Healthcare, the pharmaceutical firm owned by Shionogi, Pfizer and predominantly GSK, has announced its two-drug HIV regimen Dovato (dolutegravir and lamivudine) has secured FDA approval for the treatment of HIV-1 infection.
The approval was given specifically in adult patients with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to individual components of the regimen, making it the first FDA-approved two-drug regimen of its kind.
The decision was made based on two identical studies encompassing 1,433 treatment-naïve HIV patients, which demonstrated similar efficacy in reducing HIV levels in the blood to a regimen containing dolutegravir, emtricitabine, and tenofovir.
Labelling on the product indicates that patients with both HIV and hepatitis B should take additional treatment for the latter condition or consider another drug regimen, due to the potential to develop lamivudine-resistant hepatitis B and liver problems.
Today, around 1.1 million US citizens live with HIV, with one in seven unaware that they are infected.
Pedro Cahn, principal investigator for the study programme, commented: “People are now living longer with HIV and will spend a lifetime taking drugs to suppress their virus. The approval of the fixed dose combination of dolutegravir and lamivudine, a complete, single-tablet, two-drug regimen, marks a pivotal moment in the treatment of HIV-1. Treatment-naïve people living with the virus have a powerful option that delivers non-inferior efficacy to a dolutegravir-based three-drug regimen, allowing them to take fewer ARVs and get and remain suppressed.”
Deborah Waterhouse, CEO, ViiV Healthcare, also remarked: “Building on our innovative portfolio of medicines, Dovato is powered by dolutegravir, an antiretroviral included in multiple combination therapies and the most prescribed integrase inhibitor in the world, coupled with the established profile of lamivudine. With Dovato, the first complete, single-tablet, two-drug regimen for treatment-naïve adults, ViiV Healthcare is delivering what patients are requesting – a chance to treat their HIV-1 infection with as few drugs as possible, marking a significant step in HIV treatment.”
Matt Fellows
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