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European Panel Recommends Releasing Biktarvy

Biktarvy

A European panel gave the thumbs up to market a new once-daily pill in European Union Member States.

A European panel gave its seal of approval for Biktarvy — a fixed-dose combination drug for HIV — with flying colors. The drug recently received approval from the Food and Drug Administration (FDA), one of the biggest hurdles any new drug candidate faces, on February 7.

On April 26, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended granting the marketing authorization for Biktarvy, a three-drug HIV-1 combination  containing bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg. A marketing authorization is defined as an approval to market a medicine in one, several or all European Union Member States.The panel’s complete Summary of Opinion with the full explanation can be accessed here.

Biktarvy is one of the latest offerings from Gilead Sciences International Limited, the makers of many standard first-line combination drugs that are commonly prescribed in the United States and in Europe. The drug is intended for people living with HIV who have no prior evidence of resistance to emtricitabine or tenofovir.

The mechanisms behind the drug are complex and should be explained by a doctor. “Bictegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration that is essential for the HIV replication cycle,” the panel explains. “Emtricitabine and tenofovir alafenamide are substrates and competitive inhibitors of HIV reverse transcriptase. After phosphorylation, they are incorporated into the viral DNA chain, resulting in chain termination.”

Through this mosaic of complex processes, Biktarvy decreases viral load while increasing the number of precious immune cells in the blood (CD4 count).

The panel approved the drug based on its long list of merits. “The benefits with Biktarvy are its ability to achieve a potent antiretroviral response in a once daily, single pill regimen,” the panel wrote in its opinion. “The most common side effects are diarrhoea, headache, nausea, fatigue, dizziness and abnormal dreams.”

The drug’s official indication is "Biktarvy is indicated for the treatment of adults infected with human immunodeficiency virus 1 (HIV 1) without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.”

Directions for the use of Biktarvy will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all European Union languages once the marketing authorization has been granted by the European Commission

Drugs like GIlead Sciences’ Truvada have been a backbone in modern HIV treatment. In 2018, one of drugmakers’ goals is to reduce the side effects that damage kidneys and minimize bone density loss over time, and that are less harsh during aging. For instance, a less-toxic formulation of tenofovir was released, and included in newer versions of Gilead Sciences drugs. While Tenofovir alafenamide has similar tolerability, safety, and effectiveness as tenofovir disoproxil fumarate, studies show there are less adverse events related to renal and bone density. With each new drug offering that is approved, improvements are made to make aging with HIV more livable and enjoyable.

It’s always wise to research and pick out the best or latest treatment options that are available. There are many options soon to be available that won't rely on daily pill regimen. Learn more about what you can add to your regimen HERE

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Benjamin M. Adams

Editor

Ryan is the Digital Director of The Advocate Channel, and a graduate of NYU Tisch's Department of Dramatic Writing. She is also a member of GALECA, the LGBTQ+ society of entertainment critics. While her specialties are television writing and comedy, Ryan is a young member of the LGBTQ+ community passionate about politics and advocating for all.

Ryan is the Digital Director of The Advocate Channel, and a graduate of NYU Tisch's Department of Dramatic Writing. She is also a member of GALECA, the LGBTQ+ society of entertainment critics. While her specialties are television writing and comedy, Ryan is a young member of the LGBTQ+ community passionate about politics and advocating for all.