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--- pharmaceutical-technology com viiv-healthcare-receives-ma-in-europe-f Dovato is approved in the US, Europe, Japan and other countries worldwide Trademarks are owned by or licensed to the ViiV Healthcare group of companies Important Safety Information for Dovato (50mg dolutegravir 300mg lamivudine) Tabletsus gsk com us-fda-approves-viiv-healthcare-s-dovato-dolutegravirlamivudin Issued: London ViiV Healthcare today announced that the US Food and Drug Administration (FDA) approved Dovato , a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either Durham, NC, February 5, 2024 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced Dovato (dolutegravir lamivudine) is now available in a blister pack in the U S Dovato is approved as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current DOVATO is indicated for the treatment of HIV-1 in adults and adolescents above 12 years weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine Dovato is a once-daily, single-pill, 2-drug regimen (2DR) that combines the integrase strand transfer inhibitor (INSTI) dolutegravir with the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine Dovato is approved in the U S , Europe , Japan, Australia and other countries worldwide The 48-week data from the phase III SALSA study represent a diverse patient population, and demonstrate comparable safety for 2-drug regimen Dovato versus continuation of a current antiretroviral regimen of at least 3 drugs, reinforcing its use in a switch setting viivhealthcare com viiv-healthcare-to-present-new-long-term-findingsIssued: London ViiV Healthcare today announced that the US Food and Drug Administration (FDA) approved Dovato, a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either DTG or 3TC Discover DOVATO (dolutegravir lamivudine), a complete HIV-1 treatment for adults See full Safety and Prescribing Information, including Boxed Warning Learn more about DOVATO (dolutegravir lamivudine) --- clinicaltrialsarena com projects dovato-dolutegravir-lamivudineviivexchange com en-gb hiv-medicines dovatoImportant Safety Information for Dovato (50mg dolutegravir 300mg lamivudine) Tablets INDICATION Dovato is indicated as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA viivhealthcare com en-us media-center news dovato-blister-packA marketing authorisation application (MAA) was submitted to the European Medicines Agency (EMA) in September 2018, and the EMA’s Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion in April 2019 Dovato® obtained EU marketing authorisation for the treatment of HIV-1 Infection in July 2019 viivhealthcare com viiv-healthcare-presents-data-from-second-dovatoViiV Healthcare chief scientific and medical officer John C Pottage, Jr, said: “The marketing authorisation of Dovato in Europe marks a significant development for people living with HIV This treatment allows individuals to take a two-drug regimen in a single pill with dolutegravir at the core, building on the established potency and safety Dovato is approved in the U S , Europe, Japan, Australia and other countries worldwide Trademarks are owned by or licensed to the ViiV Healthcare group of companies Dovato (dolutegravir and DOVATO is indicated for the treatment of HIV-1 in adults and adolescents above 12 years weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine DURABLE AND ROBUST [ 2,3 ] The European Commission (EC) has approved ViiV Healthcare’s marketing authorisation application (MAA) for Dovato (dolutegravir lamivudine), which is indicated to treat HIV-1 infection The treatment is suitable for adults and adolescents above the age of 12 that weigh at least 40kg and have no known or suspected resistance to integrase It is not known if DOVATO is safe and effective in people who have HIV-1 and HBV infection Worsening of HBV infection If you have HBV infection and take DOVATO, your HBV may get worse (flare-up) if you stop taking DOVATO A “flare-up” is when your HBV infection suddenly returns in a worse way than before Dovato is indicated as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Dovato --- poz com article hiv-med-dovato-now-available-discreet-packaging--- dovato comDovato blister packs are designed to be small, discreet and portable for people living with HIV, says drugmaker ViiV Healthcare ViiV Healthcare, an HIV pharmaceutical company, has announced that the combination tablet Dovato (consisting of dolutegravir and lamivudine) is now available in a discreet, portable blister pack in the United States --- morningstar com viiv-healthcare-announces-new-packaging-option-now-av