An injectable HIV-prevention drug is highly effective – but very expensive

A landmark clinical trial of a long-acting, injectable HIV-prevention drug that only requires dosing every six months has yielded much-anticipated results.

They are sensational.

Thrilled by Thursday's news that lencapavir is 89% more effective in preventing HIV than daily oral prophylaxis in gay, bisexual and transgender people, plus previous news that the injectable drug was 100% effective in cisgender women, HIV advocates are looking to the future. They hope that if rolled out widely and equitably, Lenkapavir could be the game changer the nation so desperately needs.

“Findings like this are unprecedented,” said Dr. Jared Betten, senior vice president of virology clinical development at Gilead Sciences, maker of lenakapavi. “I have moments where I'm really speechless. What this could mean for the trajectory of the HIV epidemic is something the whole world has imagined for years. We can actually stop new infections.”

And yet, as embattled public health advocates stand on the front lines of more than four decades of efforts to finally end the U.S. HIV epidemic, they look back to find a cold, hard truth: lencapavir is extraordinarily expensive.

Calling the results of the lenacapavir clinical trial “nothing surprising,” Jane Cates, director of global health and HIV policy at the nonpartisan health nonprofit KFF, said the news “underscores the importance of getting this new tool to those who need it.” And around the world. The track record so far has unfortunately not been a good one.

Gilead also makes Truvada and Descovio, two daily oral tablets approved for use as pre-exposure prophylaxis, or PrEP. The pharma giant has already secured approval for an injectable drug to treat highly drug-resistant HIV.

The current list price of Lenacapavir for use as an HIV treatment is $3,450 per month. Gilead has not yet indicated whether it will charge a separate price for the drug's use as PrEP. A company spokesperson told NBC News on Thursday, however, that the reference point for the price of lenacapavir as a PrEP will not be its current use as a treatment. It is not yet clear whether this statement indicates the pharmaceutical giant's desire to bring the price of injectable drugs for use as HIV prevention down to earth.

Since Truvada has been available as a generic since 2020 and now costs as little as $20 per month (Descovi remains on patent and has a $2,200 sticker price), it remains unclear whether, absent some novel form of government intervention, insurers will actually do so. Make lencapavir available in sufficient quantities that epidemiologists predict could have a major public health impact.

Another injectable drug, ViiV Healthcare's Apretude, which is dosed every eight weeks, has a monthly sticker price of $1,965 and has failed to gain traction in the US since hitting the market in December 2021.

Gilead plans to submit lenacapavir to the Food and Drug Administration for approval for use as PrEP by the end of the year. So this powerful new HIV-prevention tool could hit the US market by mid-to-late 2025.

An HIV-defense upgrade is badly needed. Since Truvada was approved 12 years ago as the first form of PrEP, the drug has failed to achieve anything close to its dramatic effect on HIV rates among gay and bisexual men in wealthy Western countries such as Australia and the United Kingdom. Those countries boast the kind of streamlined sexual-health-care systems that the fragmented U.S. health care system lacks.

“The whole PrEP story is a missed opportunity,” said Amy Killelia, a health consultant and prominent HIV advocate in Arlington, Virginia.

Unprecedented clinical trial results

Advanced clinical trials of lenacapavir in gay men were launched in 2021 at 88 sites across the United States and Latin America, and in South Africa and Thailand. It lists more than 3,250 cisgender men and transgender and nonbinary people who have sex with male partners.

Participants were randomized to receive either lencapavir or Truvada on a placebo-controlled, double-blind basis, meaning neither the participants nor the researchers knew who was receiving which drug. They were instructed to return every six months for an injection and to take a daily dose of the prescribed pills.

A planned interim independent analysis of trial results indicated that two of the 2,180 participants who received lencapavir acquired HIV during the trial, as did nine of the 1,087 who received Truvada. For the lenacapavir group, this represented an 89% lower HIV rate than the Truvada group, and Gilead estimated that the infection rate was 96% lower than expected in the absence of the two drugs.

Given the clear statistical superiority of lenacapavir over Truvada, the blinded phase of the trial will now end months earlier. Participants will be told which drugs they have taken and given alternatives to taking them.

According to Gilead, lencapavir has been shown to be safe and tolerable, with no major safety concerns. One catch is that injecting the drug under the skin, or under the skin, in the abdominal area leaves a small deposit that may be visible in people with low body fat. It's possible that in real-world usage, some would find it insulting or stigmatizing.

When taken as prescribed, Truvada is more than 99% effective in preventing HIV; Descovi is relatively efficient. But poor adherence to the daily oral PrEP regimen compromises the efficacy of oral PrEP. And gay and bisexual black men in particular — groups with the highest HIV rates — have often posted particularly low adherence rates in oral PrEP studies.

The Centers for Disease Control and Prevention estimated in May that between 2018 and 2022, annual U.S. HIV infections will decline by 12% from 36,200 to 31,800 cases. About 7 in 10 new HIV infections are among gay and bisexual men, with black men and Latinos in this group acquiring the virus at much higher rates than their white counterparts. Transgender women, especially women of color, are also at considerable risk of the virus

A problem that has vexed the CDC and HIV advocates for more than a decade is that, especially given the disproportionately high rates of the virus in their respective population groups, black and Latino gay and bisexual men have never adopted PrEP use in the critical mass of need. Among them is to truly overcome the US epidemic. Meanwhile, PrEP has accelerated long-term declines in HIV among their white counterparts, widening the gap between the groups.

HIV advocates worry that lenakapavir could widen such racial disparities.

“Oral PrEP has been around since 2012. Look at our failure,” said Jirair Retvosyan, an associate research scientist at the Yale School of Nursing. “How do we learn from the past so we don't squander the opportunity?”

Excitement about the potential of lenacapavir

Dr. Hansel Tokes, professor of infectious diseases at the University of Miami Miller School of Medicine, was the strongest HIV expert to speak to NBC News about the potential for lenacapavir.

“I'm borderline paranoid,” Tokes says of his excitement about how Lenakapawi could benefit, specifically, southern gay men of color he's accused of protecting from HIV.

The South, where HIV treatment and prevention efforts have been hampered by the rejection of Medicaid expansion under the Affordable Care Act in seven of 11 states, accounts for half of all new HIV cases, according to the CDC.

“Right now, the challenge is getting people to take a pill every day to prevent something they don't have,” Tex said, noting the difficulty of engaging young people in particular in such a simple, forward-thinking routine. “Getting an injection twice a year is an easy sell.”

Dr. Bojuma Titanji, an infectious disease specialist at Emory University, said he often sees new HIV diagnoses in Atlanta, where his university is based, especially among young black and Latino men who have sex with men.

“These groups often lack access and information about existing PrEP options,” she said. “While lenacapavir is a valuable addition to our toolkit, to reach its full potential, it must be made accessible to those who would most benefit from its effectiveness.”

After Gilead released its preliminary results from an advanced clinical trial of lencapavir in cisgender women and adolescent girls in sub-Saharan Africa in June, HIV advocates immediately pressed Gilead to provide the drug at a scalable cost to low-income countries. This chorus is sure to be even louder now that Lenakapawi is officially so effective in protecting gay and bisexual men and trans people. Results from ongoing clinical trials of the drug in the US among people who inject the drug and cisgender women are still to come

On Thursday, Gilead said in a release that the company is “committed to providing rapid, sustained and adequate supply of lenakapavi, if approved, to high-affinity, resource-limited countries, primarily low- and lower-middle-income countries.” The company said about the plan “HIV Active dialogue with the community”.

“If the cost and other structural challenges of lencapavir prevent access domestically or globally, this is not progress,” said Tim Horne, director of drug access at the public health nonprofit NASTAD. “The results of drug clinical trials, he said, “must be for the benefit of all people at risk for HIV, including cutting-edge prevention and cost-related barriers to care.”

Correction (September 12, 2024, 3:15 p.m. ET): An earlier version of this article incorrectly stated the monthly sticker price for ViiV Healthcare's injectable drug Aprity. That's $1,965 monthly, not $3,930. The cost per injection, which is administered every two months, is $3,930.

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