FDA Approves A New & Highly Effective PrEP That Nearly Eliminated HIV Spread

[RAMROD 117,141]

The Food and Drug Administration has approved a highly effective new HIV-prevention medication, Gilead Sciences reported Wednesday. In clinical trials, the drug nearly eliminated HIV’s spread among people given an injection every six months.

Called Yeztugo, the highly effective drug has inspired feverish anticipation among advocates for HIV prevention. The hope is the medication could accelerate the stubbornly slow decline of HIV transmission in the United States.

“This is the single best opportunity in 44 years of HIV prevention,” said Mitchell Warren, executive director of the HIV advocacy nonprofit group AVAC.

Yeztugo (generic name lenacapavir), which is given by health care workers in clinics, is significantly more effective than the existing oral HIV-prevention drugs, experts said, because it appears to address the challenges of sticking to a daily pill regimen for people who are at high risk of HIV.

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

It was approved after astounding results in Gilead’s large clinical trials of the drug. The trials randomly assigned people at risk of HIV to receive either lenacapavir injections every six months or daily Truvada, a pill form of pre-exposure prophylaxis, or PrEP. Among gay and bisexual men and transgender people, the Yeztugo group had an 89% lower HIV rate than a group taking Truvada and a 96% lower rate than Gilead estimated would have been expected absent any PrEP.

In a similar trial among cisgender women in sub-Saharan Africa, no one who received Yeztugo contracted HIV.

The shot is the first in a new class of antiretrovirals which block HIV from infecting and making new copies of itself inside the immune cells it targets. Lenacapavir was first approved in 2022, under the brand name Sunleca, for use with other medications to treat highly drug resistant strains of the virus.

All forms of PrEP work in the same way: If enough of the drug is present in the body when a person is exposed to HIV, it's highly effective at preventing the virus from taking hold and establishing a lifelong infection. Lenacapavir is so long-acting, it only needs to be injected twice a year.

Priced at $14,109 per injection, or $2,352 per month, Yeztugo's cost could be another hurdle. 

Health insurers, at least in the near term, might decline to cover the shots in favor of other forms of PrEP, including the cheaper generic version of Truvada pills, which cost as little as $30 per month. Or insurers might impose higher copays for lenacapavir, said Elizabeth Kaplan, director of health care access at Harvard Law School’s Health Law and Policy Clinic.

A pending Supreme Court decision concerning a pillar of the Affordable Care Act could also be a barrier to insurance coverage for medications that prevent HIV. The ACA, or Obamacare, mandates no-cost coverage for certain preventive interventions like PrEP. 

A Gilead spokesperson said that within two days from Yeztugo’s approval, people should be able to start asking health care providers for the drug. However, putting aside the question of whether insurance will cover the drug, it could take up to two months for people to actually receive their first injection.

https://www.nbcnews.com/health/health-news/fda-hiv-prevention-drug-prep-lenacapavir-rcna208387

[Lucas 31,135]

3 minutes ago, RAMROD said:

Priced at $14,109 per injection, or $2,352 per month, Yeztugo's cost could be another hurdle. 

Americans are such cash cows... it's mindblowing to me that medicine in USA cost that much and it's only because the industry just wants to make full profit 

[ivxn 190]

I'm on the right track baby

[RAMROD 117,141]

4 minutes ago, ivxn said:

I'm on the right track baby

It's not perfect, especially if you're a receiver and not the one using it. Since it can tear and also a top can cheat. They can took it off midway while locking you on a position where you can reject or quietly when you don't see. So it still need to be combined with PrEP. Using both condoms and PrEP offers the most comprehensive protection.

[ivxn 190]

Just now, RAMROD said:

It's not perfect, especially if you're a receiver and not the one using it. Since it can tear and also a top can cheat. They can took it off midway while locking you on a position where you can reject or quietly when you don't see. So it still need to be combined with PrEP. Using both condoms and PrEP offers the most comprehensive protection.

I agree, sadly a lot of people don't want to use it 'cause they are already taking PrEP, as if other STD doesn't even exist, at least in europe

[NemoMyName 2,195]

i hate condoms, they are fine for short time, but when i have been with a **** inside me for 10 min it just feel awful, no matter how much lub i put on it, that's why i can't be a ****ing slut and hook up freely.

[RAMROD 117,141]

25 minutes ago, NemoMyName said:

i hate condoms, they are fine for short time, but when i have been with a **** inside me for 10 min it just feel awful, no matter how much lub i put on it, that's why i can't be a ****ing slut and hook up freely.

Have you tried different brands? 

[meltedplastic 907]

2 hours ago, RAMROD said:

It's not perfect, especially if you're a receiver and not the one using it. Since it can tear and also a top can cheat. They can took it off midway while locking you on a position where you can reject or quietly when you don't see. So it still need to be combined with PrEP. Using both condoms and PrEP offers the most comprehensive protection.

Let’s be clear, if a top non-consensually takes off a condom during intercourse, it’s rape.

[salty like sodium 2,262]

3 hours ago, ivxn said:

I agree, sadly a lot of people don't want to use it 'cause they are already taking PrEP, as if other STD doesn't even exist, at least in europe

or they then couple it with doxypep because drugging your body full of random medicines for prolonged periods of time has never been a bad idea right ? 

[MACATL 2,128]

3 hours ago, Lucas said:

Americans are such cash cows... it's mindblowing to me that medicine in USA cost that much and it's only because the industry just wants to make full profit 

Human healthcare and capitalism is the most twisted combination.  

[NemoMyName 2,195]

1 hour ago, RAMROD said:

Have you tried different brands? 

brands and textures, and no, it's not for me, it doesn't work for me, the rubbed one are the worst of all.

[RAMROD 117,141]

21 minutes ago, meltedplastic said:

Let’s be clear, if a top non-consensually takes off a condom during intercourse, it’s rape.

I am aware of that, but during the session it's hard to know or to let go, especially when you are high on poppers or other substances, since some people do that obviously 

[Argentum 1,705]

I just switched to injectable prep. That is an injection every two months. I would be happy if this was every 6 months now!

[Petie Estie 5,707]

love seeing this progress. I think the cost should come down pretty quickly. It's a shame funding was been messed up on further research so it may delay further progress. we need a cure and a super long lasting vaccine.