I like to give good news

The US Food and Drug Administration (FDA) approved the drug this week Dovato, a new single-tablet antiretroviral regimen containing the dolutegravir integrase inhibitor (sold separately as Tivicay) and the nucleoside reverse transcriptase inhibitor lamivudine.

Dovatoof ViiV Healthcare is the first combined two-drug pill to provide a complete once-a-day regimen for people starting HIV treatment for the first time.

Dovatoof ViiV Healthcare is the first combined two-drug pill to provide a complete once-a-day regimen for people starting HIV treatment for the first time.

ViiV's medicine Juluca, containing dolutegravir plus rilpivirine, is approved as an exchange option for those currently under treatment with an undetectable viral load but not for first-line therapy.

Other single-tablet based therapeutic schemes using Integrase inhibitors include:

  1. Triumeq (dolutegravir / abacavir / lamivudine) from, ViiV
  2. Biktarvy (bictegravir / tenofovir alafenamide / emtricitabine)
  3. Genvoya (elvitegravir / cobicistat / tenofovir alafenamide / emtricitabine) Gileade Science.

The approval of the Dovato was based on the results of the 1 and 2 GEMINI 3 studies, which together recorded more than 1400 participants. They were randomly assigned to receive Dovato or dolutegravir plus tenofovir disoproxil fumarate (TDF) and emtricitabine (the Truvada).

As reported at the International AIDS Conference last summer, 91% of Dovato and 93% of dolutegravir / TDF / emtricitabine receptors had undetectable HIV RNA in 48 weeks in a pooled analysis of both assays.

Doluca Is A Complete Daily Treatment With Two Drugs In One Pill Hip Hip: Urra !!!!!
Complete daily treatment with two drugs in one pill! It is a major breakthrough from my point of view, that of the person who took more than forty tablets a day "

The approval of the Dovato, which is the first combined pill that provides a complete daily regimen

Response rates were comparable for people who started with low or high viral load at baseline. Confirmed virological failure was uncommon in both treatment groups (less than 1%) and no new mutation of drug resistance was detected.

Both regimens were generally safe and well tolerated. Dovato was associated with fewer side effects than the triple regimen (18% vs. 24%, respectively), but abstinence rates due to adverse events were the same in both groups (2%). The most common side effects associated with Dovato were headache, diarrhea, nausea, insomnia and fatigue.

Dovato Had A Harmful Efeitomenos In Biomarkers.

Dovato avoids the potential kidney and bone problems associated with tenofovir, especially the older formulation of TDF. In the GEMINI studies, the Dovato had a less detrimental effect on serum and urinary biomarkers of renal function and markers of bone loss. Changes in blood lipid levels were similar in both groups.

Medication With Black Band In The Box (!!!)

O Dovato label includes a "black box" warning for people with HIV and hepatitis B coinfection (HBV).

I, Claudius, Never Seen An Antiretroviral With Black Belt

Lamivudine is active against both viruses and can lead to the development of drug resistant HBV and worsening of inflammation of the liver by stopping the Dovato. People with HIV / HBV co-infection should therefore consider adding treatment for hepatitis B or choosing an alternative HIV regimen, the label says.

Dolutegravir, one of the components of Dovato, which has been associated with a small risk of neural tube defects in infants born to women who used during early pregnancy. Dovato should not be used at the time of conception until the first trimester of pregnancy, according to the FDA.


The Two-Antiretroviral Pill Is A Safe Option

Despite these restrictions, the Dovato offers a safe and easy-to-use option for people with recent HIV diagnosis.

A long way!

"With this approval, patients who have never been treated have the option of taking a two-drug regimen in a single pill, eliminating additional toxicity and potential drug interactions from a third-party drug," said Debra Birnkrant, director of FDA's Food Division . Antiviral products.

"Having a drug-sparing treatment available that consumes fewer drugs is beneficial for patients who may have problems taking multiple medications over a long period of time."

Translated by Cláudio Souza in 11 of April of 2019 of Original in US regulators approve new two-drug combination pill for HIVUS regulators approve new two-drug combination pill for HIV written by Liz Highleymancuja original publication occurred in 11 in April, 2019


Gilead Sciences. US FDA approves ViiV Healthcare's Dovato (dolutegravir / lamivudine), the first once-a-day, once-daily, two-drug regimen for HIV-1 adults without prior treatment. Press release. April 8 of 2019.


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