ViiV Healthcare’s Dovato (dolutegravir/lamivudine) Receives MHLW’s Approval to Treat HIV 1 Infection

Shots:

• The approval is based on GEMINI 1 & 2 studies assessing dual drug regimen (dolutegravir 50 mg/lamivudine 300 mg) vs dolutegravir + two NRTIs [tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)] in 1400 patients with HIV-1 infection aged> 12yrs. weighing at least 40kg
•  The GEMINI 1 & 2 study results demonstrated non-inferior efficacy based on plasma HIV-1 RNA <50copies/ml @48wks., safety is consistent with product labeling  
• Dovato (qd) is a single-pill, 2-drug regimen to treat naïve HIV infection, combining an integrase inhibitor (INI) with the nucleoside reverse transcriptase inhibitor (NRTI) and is an authorized therapy in the EU for HIV-1 infection

Click here ­to­ read full press release/ article | Ref: GSK | Image: ViiV Healthcare