This HIV Prevention Drug Could Change the Game

A new, long-lasting drug could be a game-changer for preventing HIV infections, experts say. Advocates are hopeful that those who need it most in low- and middle-income countries will not have to wait for it as long as they have for previous HIV drugs. But questions remain about access and price. The drug is called cabotegravir and is delivered as a shot once every other month. In clinical trials, it did a better job at preventing infection than another option — a pill taken once a day. The bimonthly injection seems to be an easier treatment regimen to stick to than daily pills, according to Mitchell Warren, executive director of AVAC, an HIV prevention advocacy organization. "If you can take a pill every day, that's great. But if you can't, we see a lot of people who start [taking the pills] who don't continue," he said. Aside from the inconvenience, there can be a stigma attached to taking the pills, Warren said. The drugs for prevention, called pre-exposure prophylaxis, or PrEP, are the same as the drugs used to treat HIV infection. "If you're a young person and your parents find your pill bottle, they say, 'Why are you taking this pill? Are you HIV infected?' And the young person may say, 'No, I'm protecting myself,'" Warren said. "And they say, 'Well, why are you having sex?'" Long-lasting drugs like cabotegravir or another new product, a once-a-month vaginal ring, offer patients more choices, he added. About 1.5 million people were newly infected with HIV in 2021, according to the World Health Organization, about 60% of them in Africa. Uganda and Zimbabwe approved cabotegravir for PrEP earlier this year. They are the first countries in sub-Saharan Africa to do so. These approvals come less than a year after the U.S. Food and Drug Administration authorized it. That's progress, Warren said. FDA approved PrEP pills in 2012, but "it took three years before any African regulatory agency approved it. So, we've already seen a condensing of that timeline." Cabotegravir costs $22,000 per year in the United States. ViiV Healthcare, the company that makes the drug, has not officially announced what it will cost in low- and middle-income countries, but it is expected to be much lower. Some aid groups have indicated that ViiV will offer the drug at $250 per year. "The problem is that actually that won't be really affordable for countries who need to roll it out and scale up," said Jessica Burry, a pharmacist with humanitarian group Doctors without Borders. PrEP pills cost about $54 per year, Warren said. "The hope is that early in 2023, we can see a price point that is much closer to that 54 [dollars] than to the 250 [dollars]," he said. "Hopefully, in the $100 range per year." ViiV said it is working with the U.N.-backed Medicines Patent Pool to allow generic manufacturers to produce cabotegravir at a lower price for low- and middle-income countries. ViiV said cabotegravir is more complicated to manufacture than most HIV drugs. No generic manufacturers have been selected yet. Once they are, it will take about three to five years before a generic version is on the market. The company has filed for regulatory approval in 11 countries so far. Burry says there should be more. "If they're going to be the only supplier for the next four or five years until generics are available, then they really need to step up to the plate and actually file, register and get that drug available," she said. Demand for the drug is unclear. PrEP pills have been slow to catch on. About 845,000 people in more than 50 countries took them in 2020, but the United Nations was aiming for 3 million by that time. "We don't have a ton of PrEP users, so if you're ViiV, you're looking at a very small market," Warren said. Warren said providers and advocates need to help grow that market. They need to do a better job connecting people at risk with programs that offer PrEP, he added. "Some of the early PrEP programs began with us thinking that if you just bought the product, people would magically show up," he said. Warren hopes to change that as part of a coalition that includes ViiV, the Bill and Melinda Gates Foundation, the World Health Organization and others. "There's a huge effort in this coalition to bring in civil society from day one, and the communities that this product is meant to help and support," he said. The slow uptake means PrEP has not yet shown that it can make much of a real-world impact, Warren noted. He hopes to see research programs launch next year to find the best ways to reach the communities most at risk and lower infection rates. "If we can't show that in the next three years, then we don't necessarily need all these generic manufacturers, because there will not be a market for this product," he said.