Injectable, Long-Acting PrEP Could be Next in Combatting HIV

News the “London patient” has become the second-person ever found in remission of HIV has been hailed as a medical triumph, but new developments with pre-exposure prophylaxis, or PrEP, could mark additional steps in combatting the disease.

In the works for potential approval in the next couple of years is medicine based on PrEP, but for long-acting treatment, such as an injectable drug and antibodies that block HIV infection as well as PrEP-on-demand for use on a case-by-case basis for sexual encounters.

Anthony Fauci, an immunologist and head of the National Institute of Allergy & Infectious Disease, said during an interview with the Washington Blade a number of studies are ongoing to develop drugs for patients at risk of contracting HIV so they don’t need to take a pill every day.

“People sometimes get pill fatigue, and it becomes onerous to have to take the medicine every single day of your life, particularly a medicine that you know is important for a disease that’s potentially lethal,” Fauci said.

One alternative evaluated in clinical trials, Fauci said, is a long-acting injectable drug version of PrEP a patient would take at first take every four weeks or so, and then every two months, and then every four to six months.

“So instead of having the obligation of remembering to take a pill every day, you hopefully, we’re not there yet, can have an injection that you get maybe two or three times a year to allow you to essentially suppress the virus,” Fauci said.

The same drug, Fauci said, would be able to work for both HIV prevention and treatment, so patients both with HIV looking to suppress the viral loads and patients at risk of contracting HIV would have use for the medication.

Fauci said the injectable drug is “the most common and optimistic one and promising one,” but other options are in the works.

A large study, Fauci said, is taking place in developing countries, mostly in Southern Africa, where individuals would have to use a device intermittently about every eight weeks that would transfer a broadly neutralizing antibody, or a natural protein, that acts against HIV.

“And you give that to people who are at risk of getting infected, so that’s for prophylaxsis,” Fauci said. “So instead of taking that single pill every day to prevent infection, you can get an infusion of any antibody about every eight to 12 weeks or so to prevent infection.”

Another possible alternative, Fauci said, is PrEP-on-demand that individuals would take on an intermittent basis when they expect they would have a sexual encounter.

But Fauci cautioned PrEP-on-demand is “a little bit risky” because it might require expecting a sexual encounter before it happens and “often people, they get into situations where they can’t anticipate what’s going to happen.”

Carlos del Rio, chair of the Hubert Department of Global Health at Emory University’s Rollins School of Public Health, told the Blade new medications would be effective as a compliment to existing treatment.

“I think it’s another strategy,” del Rio said. “I think it’s something that we can clearly do, and I think it’s something that needs to be looked at. For some populations that may be the way to go. If I was infected, maybe I’d rather take a pill a day, but some other people may want to get an injection once a month.”

For each of the possible medications, Fauci said the timeline for approval is “tough to say” with trials ongoing. The medication, he said, won’t be made available to the public for “at least a year or two.”

“Nonetheless, that PrEP-on-demand is a study that is being conducted to see how effective it is,” Fauci said. “It might be as effective as a pill a day. We don’t know. Hopefully it will be because we could save people the obligation of taking a pill every day.”

“You’d have to have a clinical trial that shows that it’s highly effective in preventing HIV infection, or, in the case of the people who are infected, and using it as a treatment, you’d have to show that compared to taking a pill every day that the people who get the injection every several months, they suppress their virus as well as if you take a pill every day,” Fauci said. “That’s the data that are generally end points of the study.”

James Driscoll, a Nevada-based HIV activist who supported Donald Trump for president in 2016, said the long-acting medicine for HIV prevention and treatment is “an essential tool” for combatting the disease.

“Current efforts are not doing the job,” Driscoll said. “An aggressive campaign to get out long-acting PrEP, will reduce new infections, but also increase AIDS awareness and lower stigma.”

The Food & Drug Administration, Driscoll said, should move expeditiously on the approving the medication.

“In the 1990s, FDA delays in approving new treatments resulted in unnecessary deaths,” Driscoll said. “It is crucial that President Trump and Secretary Azar stress to FDA the urgency of avoiding the errors of the past with this critical new weapon in the war against AIDS.”

The new medications are being studied as news recently broke in The New York Times an individual known as the “London patient” has become the second person found to have been in remission after HIV infection. (The first was the “Berlin Patient,” whose apparent remission was announced in 2008.) The treatment consisted of a bone marrow transplant from donors with a genetic makeup resistant to HIV infection.

Del Rio, however, said the treatment provided to the “London Patient” is “not feasible” for widespread treatment of HIV.

“That’s a very nice science discovery, but it’s not a feasible result,” del Rio said. “You are not going to be able to do bone marrow transplants for 35 million people globally. It’s a good science study, we’re learning a lot from it, but this is not something that can be implemented.”

The achievement, del Rio said, was comparable to John Glenn becoming the first American to orbit the Earth in 1962.

“From that to say that we’re going to be traveling in space, all of us, is not the case,” del Rio said.

Del Rio said the existing medication and long-acting treatments in development, on the other hand, are practical in combatting HIV.

“But at the end of the day, we do need to find a cure, and I think research and cure has advanced with this patient, but there’s still a lot of research to be done.”

Development of these medications to treat and prevent HIV occur as President Trump announced in his State of the Union address his administration’s plan to end new HIV infections by 2030.

The effort will target areas in the United States where new infections are taking place: 48 counties in the United States, D.C., and San Juan, Puerto Rico, as well as seven states where the epidemic is mostly in rural areas. The seven states are Missouri, Kentucky, Oklahoma, Arkansas, Mississippi, Alabama and South Carolina.

Fauci said the development of alternative treatment for HIV and prevention “certainly could wind up being helpful” in achieving the administration’s goal of ending new infections.

“Obviously, if it’s an improved way to treat the disease, any improvements in that always help the program that you’re involved with,” Fauci said. “Right now, we think we can do with the currently available drugs. If we get a situation where it’s more user-friendly.”

The private sector, Fauci said, is “absolutely an essential component” of developing long-acting PrEP because they’re responsible for manufacturing the medication. For PrEP, the manufacturer of the drug is Gilead, but other companies, such as ViiV, are involved.

“Although the NIH does the research that develops the concept and often does the clinical trial, the fact is it’s absolutely essential to partner with the pharmaceutical industry,” Fauci said.

Gilead didn’t respond to repeated requests from the Washington Blade to comment for this article, nor did ViiV respond to a request for comment.

The new drugs are being developed amid calls for Gilead to make the existing product generic, and therefore less expensive for purchase. Although Gilead offers a coupon for Truvada and many insurance companies cover the medication, the average retail cost is $2,000 a bottle and many say the existing mediation is out of reach.

Leading the charge calling on Gilead to make Truvada generic is New York City Speaker Corey Johnson, who’s openly gay and HIV positive. During a news conference last month at an AIDS Memorial Park event, Johnson said the current system is unfair, according to the New York Daily News.

“It’s life or death for people who do not get access to this live-saving medication that they need,” Johnson was quoted as saying. “Other countries pay $100 year for PrEP. Americans end up paying more than $20,000 a year for the same medication.”

Asked about Gilead making Truvada generic, Fauci said “whenever you can get a drug at a less expensive price, it always helps matters,” but declined to comment specifically on whether Gilead should make that move.

“I can’t comment on that,” Fauci said. “That’s a legal issue. It’s purely legalize to determine if that can be done. I really can’t comment on it.”

Del Rio said some Truvada drugs are “already becoming generic” and that will “help us decrease costs of these medications, right?”

Story courtesy of the Washington Blade.