ViiV Healthcare announced that the US FDA has approved Apretude (cabotegravir sustained-release injection suspension), which is the first and only long-acting injection option for HIV prevention – QNT Press Release

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  • It is only given 6 times a year, and it is superior to the daily oral PrEP option (FTC/TDF tablet) in reducing the risk of HIV infection
  • Approved in the United States for adults and adolescents weighing at least 35 kg who are at risk of acquiring HIV through sex, including men who have sex with men and women and trans women who have sex with men

ViiV Healthcare, a global professional HIV company controlled by GlaxoSmithKline (GSK), Pfizer and Shionogi as shareholders, announced today that the U.S. Food and Drug Administration (FDA) has approved Hunch, The first and only long-acting injection pre-exposure prophylaxis (PrEP) option to reduce the risk of sexually acquiring HIV-1. Long-acting injections are approved for adults and adolescents weighing at least 35 kilograms, who are at risk of contracting HIV during sexual activity and tested negative for HIV-1 before starting. The drug has been studied among men who have sex with men and women and transgender women who have sex with men, who have an increased risk of contracting HIV during sex.

This press release features multimedia. View the full version here: https://www.businesswire.com/news/home/20211220005863/en/

Apreude (cabotegravir sustained-release injection suspension) (Photo: Business Wire)

The long-acting Cabotegravir for PrEP is provided in the form of injections, with as few as 6 injections per year, starting with 600 mg (3 ml) for two consecutive months, one month apart. After the second initial injection, the recommended continuous injection dose is 600 mg (3 ml) once every two months. vocabulary (Cabotegravir oral tablet) can be administered about one month before starting the first injection to assess the tolerability of the drug.

Deborah Waterhouse, CEO of ViiV Healthcare stated: “People who are susceptible to HIV, especially those in the black and Latino communities that are disproportionately affected in the United States, may need alternatives to daily oral medication. This is why ViiV Healthcare is proud Hunch Research has been conducted in one of the most diverse and comprehensive HIV prevention trials to date, which also includes some of the largest number of trans women and men who have sex with men who have ever participated in HIV prevention trials.and Hunch, People only need to inject 6 times a year to reduce the risk of HIV infection. Today’s approval is the latest example of ViiV Healthcare’s commitment to developing long-acting drugs that provide consumers with different choices. ”

The US FDA’s approval is based on the results of two international phase IIb/III multicenter, randomized, double-blind, active controlled trials HPTN 083 and HPTN 084, which evaluated the effects of long-acting Cabotvir PrEP in HIV-male sexual relations Negative men, transgender women, and cisgender women have an increased risk of contracting HIV through sex. In these trials, a total of more than 7,700 participants from 13 countries demonstrated that long-acting PrEP of cabotravir is superior to daily oral emtricitabine/emtricitabine/tenofovir disoproxil fumarate The role of ester (TDF/FTC) tablets in preventing HIV infection of study participants. Compared with the FTC/TDF tablet in HPTN 083, the clinical trial participants who received cabotegravir long-acting PrEP had a 69% reduction in the incidence of HIV, and compared with the FTC/TDF tablet in HPTN 084, the incidence of HIV was reduced By 90%.

The most common adverse reactions (all grades) observed in at least 1% of clinical trial participants receiving Cabotvir long-acting PrEP were injection site reactions, diarrhea, headache, fever, fatigue, sleep disturbance, nausea, dizziness, flatulence, abdominal pain , Vomiting, myalgia, skin rash, loss of appetite, lethargy, back pain and upper respiratory tract infection. Adverse events caused 6% of participants in HPTN 083 and 1% of participants in HPTN 084 to discontinue medication.

In HPTN 083, American participants include the black/African and Latino male communities and the men who have sex with men and transgender women’s communities who are disproportionately affected by the HIV epidemic and have been affected by new HIV diagnoses. Accounted for the largest proportion. In HPTN 084, all participants were cisgender women from sub-Saharan Africa. Women in the region bear a disproportionate burden of the HIV epidemic and may be twice as likely to contract HIV as men.

Richard Elion, MD, Director of Research at the Washington Institutes of Health said: “We have the tools to end the HIV epidemic…

The full story can be found on Benzinga.com

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