GSK's complete two-drug solution, Dovato, was approved by the FDA.

Dovato is a complete, once-daily, monotablet, two-drug solution (2DR) consisting of a fixed dose of dolutegravir (DTG, 50mg) and ramifdin (3TC, 300mg), of which: DTG is an HIV integrated Enzyme chain transfer inhibitors (INSTI), which block HIV replication by blocking viral DNA from integrating into the genetic material of human immune cells (T cells), and 3TC is a nucleoside retrovirus inhibitor (NRTI), often used in combination with other antiretroviral drugs for hiv infection treatment.
Dovato was first approved by the U.S. FDA in April 2019 as a complete program for HIV-1 adults who had not previously received treatment (initial treatment).
specific: No aRV treatment history, DTG or 3TC are not known to be resistant to HIV-1 adult infections.
2019, the U.S. Department of Health and Human Services (DHHS) Guidelines for Adult and Adolescent Antiretroviral Treatment included Dovato in the list of first-line treatment options, the first time DHHS has recommended a complete 2-drug treatment in first-line treatment.
in the European Union and other countries, Dovato has been approved for initial treatment (first-line therapy) and virological inhibition (second-line treatment) of HIV-1 infected persons, specifically: age 12 years, weight of 40 kg, integration enzyme inhibitors or 3TC no known or suspected resistance to HIV-1 infection in adolescents and adults infected with.
as a result of advances in treatment, HIV-infected people can now expect to live as long as the general population, but these patients still face lifelong antiretroviral therapy to maintain virological inhibition.
Dovato is the first complete, once-daily, monotablet, two-drug solution (2DR) approved to reduce exposure to ARV drugs from the initial treatment (first-line treatment), while maintaining the efficacy of the traditional standard three-drug solution and a high resistance barrier.
fda-approved expansion of indications, Dovato will enable HIV-1 adults to reduce the number of ARV drugs they take each day, while maintaining a high efficacy and high resistance barrier comparable to the tenofovir program that contains at least three drugs.
the drug will allow HIV-1 adults to manage the virus without taking a third ARV.
Dovato does not contain promanophenol-noofovir (TAF), Fumaatininovir difuran (TDF), Abakawe (ABC). Lynn Baxter, North America director at
ViiV Healthcare, said: "As HIV treatment and care advances, people living with HIV will need decades of medication, which will require solutions to the challenges that long-term use of ARV therapy can pose.
we have shown that Dovato can reduce the number of ARV drugs they take per day in adults with HIV without compromising efficacy or resistance barriers.
this dramatic and innovative approach challenges the idea that three or more drugs are needed to maintain virology, and today's FDA approval turns the treatment into a virally suppressed HIV carrier.
" FDA approved Dovato for use in HIV-1 adult sepsis (second-line therapy) that has achieved virological inhibition, based on the results of the 48-week study of Phase III TANGO.
the study was conducted in HIV-1 adults who had been treated with a complete programme containing TAF (at least three drugs) that sustained at least 6 months of virological suppression, and the 48-week data showed that patients who switched to Dovato were able to maintain similar virological inhibition rates compared to those who continued to use the original protocol (Dovato group 93.2% (344/369) and the TAF programme group 93.0% (346/372) compared to those who continued to use the original protocol.
no patients in the Dovato group, 1 patient in the TAF group (-lt;1%) met the virological failure standard, and no drug-resistant mutations were observed at the time of failure.
in patients who switched to Dovato, the safety results were consistent with the product labels of DTG and 3TC.
original source: ViiV Healthcare announces FDA approval of an oedd oed d'oedd for Dovato (dolutegravir/lamivudine), a complete two-drug regimen for viroly suppressed adult HIV-1 original title: HIV second-line new drug! GlaxoSmithKline's complete two-drug solution, Dovato, has been approved by the FDA for viral inhibition in adult patients!