The FDA approves a vaccine for HIV prevention that demonstrated great effectiveness in clinical trials

NBC News

The Food and Medicines Administration (FDA) has approved a new highly effective drug in HIV prevention, the pharmacist Gilead Sciences reported Wednesday.

In clinical trials, the drug almost eliminated the spread of the virus among the people who received an injection every six months.

Called Yeztugothe drug has raised expectation among the defenders of HIV prevention. The hope is that the medication can accelerate the stubbornly slow decrease in the transmission of the virus in the United States.

“This is the best opportunity in 44 years of HIV prevention,” said Mitchell Warren, executive director of the non -profit organization Avac.

Yeztugo or Lenacapavir (its generic name) is much more effective than oral drugs of existing HIV prevention, because according to experts it seems to solve the problems posed by having to take daily pills, in the case of people with a high risk of contracting HIV.

Gilead’s president and executive director, Daniel O’Day, suggested Wednesday in a statement that the drug could “end the HIV epidemic once and for all.”

The drug was approved after registering amazing results in clinical trials. Essays administered people at risk of contracting HIV injections of Lenacapavir every six months, or daily truvada pills, known as PREP or pre -exposition prophylaxis pill.

Among the gay, bisexual and trans men, the group that received the Injection of Yeztugo had an 89% lower than that of Truvada.

In a similar essay among women’s sub -Saharan Africa women, none of those received by Yeztugo contracted HIV.

A revolutionary drug

Injection is the first of a new kind of antiretrovirals that prevent HIV infecting and making new copies of itself within the immune cells to which it is directed. The Lenacapavir was approved for the first time in 2022, under the Sunjet brand, for use with other medications in the treatment of virus strains very resistant to drugs.

All forms of PRE function in the same way: if there is enough drug in the body when a person is exposed to HIV, it is very effective in preventing the virus from rooting and establishing a life infection. Lenacapavir has such a prolonged action that it is only necessary to inject it twice a year.

However, the use of yeztugo as PREP against HIV arises in a political climate that, according to some experts, could derail the advances against the propagation of the virus. }

Recent cancellation cancellations of research by Donald Trump’s government and cuts in the personnel of disease control and prevention centers (CDC) have dramatically affected the field of HIV prevention in particular.

The cost can be an obstacle

HIV experts fear that Yeztugo’s potential will not be used.

With a price of $ 14,109 per injection, or 2,352 dollars per month, the cost of yeztugo could be another obstacle.

Insurers could refuse to cover injections in favor of other forms of PRE, including the cheapest generic version of Truvada pills, which cost only 30 dollars per month. Or they could impose higher copagogues by Lenacapavir, according to Elizabeth Kaplan, director of access to health care of the Harvard Law Faculty Clinic and Policy.

A pending decision of the Supreme Court on one of the pillars of the Asequible Health Assistance Law (ACA) could also be an obstacle to the insurance coverage of medications that prevent HIV. ACA, better known as Obamacare, demands the free coverage of certain preventive interventions such as PREP.

The mixed success of the pills Prep

The oldest forms of PREP have had an unequal success.

Truvada, also manufactured by Gilead, was in 2012 the first drug of this approved nature, followed by a similar oral medication of the company, Decovy, in 2019.

These pills have gained popularity among gay and bisexual men who, according to CDCs, represent 7 out of 10 new cases of HIV and constitute the vast majority of PREP users.

However, taking into account that the HIV rate is much higher among black and Latin gay men than among their white counterparts, the use of PREP among them has remained disproportionately low.

Experts believe it is very likely that the PREP has accelerated the considerable descent of HIV between gay and white bisexual men, but the HIV rate between gay and black and Latin bisexuals has persisted in markedly high tasas. In addition, when they are prescribed, it is less likely that black gays take the pill as they have been prescribed.

When they are taken daily, Truvada and Decovy reduce the risk of HIV by at least 99%. But irregular use decreases efficacy.

At the end of 2021, approved approved, by Viiv Healthcare, as a PRE injectable and administered every two months.

Despite being much more effective than truvada when reducing HIV cases among gay and bisexual men and trans women in an important clinical trial, he has barely gained adherents until recently.

Only about 21,000 people are taking it, Viiv reported. It is possible that, in part, people are not obtaining the apprehension of the requirement to visit a clinic every two months, instead of every three months in the case of the Oral prescription of PREP.