F.D.A. Approves Month-to-month Photographs to Deal with H.I.V.

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F.D.A. Approves Monthly Shots to Treat H.I.V.

It's what a lot of people with H.I.V. have been waiting a long time: monthly injections to keep the virus at bay instead of the three pills they have to take now.

The Food and Drug Administration on Thursday approved a combination of two monthly admissions for the treatment of H.I.V. in stable patients. The treatment is called Cabenuva.

One version of the combination has also been shown to be effective in preventing H.I.V. Infection as a pill taken daily, a treatment strategy called pre-exposure prophylaxis, or PrEP. However, Thursday's approval only applies to the use of Cabenuva for treatment.

Many people have difficulty taking the pills they need every day for a variety of reasons. The consequences for people with H.I.V. can be of concern as missing pills give the virus an opportunity to become resistant to the drugs.

And then there's the stigma of daily pill use, which is both social and psychological, said Dr. Tom Giordano, chief infectious disease chief at Baylor College of Medicine in Houston, who was not involved in the studies.

Nine out of ten people in a study with Cabenuva said they prefer monthly injections to taking a pill every day. "You get your shot and forget it until next month," said Dr. Giordano. "This is great and will help people who don't want to be reminded of stigma or taking pills every day."

Cabenuva is a combination of two drugs: cabotegravir and rilpivirine. Each is injected separately at the same time. In clinical trials, the treatment suppressed H.I.V. for two years to undetectable values.

A later study found that the treatment was just as effective when given every two months instead of monthly. The F.D.A. The approval is valid for the monthly use of the drug. However, a spokeswoman for ViiV Healthcare, which makes one of the drugs in the combination, said the company plans to apply for approval for the bimonthly administration.

Experts said that while the approval was good news, it was unclear whether monthly injections outside of clinical trials would come in handy.

In the studies, the drug was tested on people who took tablets daily and had undetectable H.I.V. Levels – just a slice of those with H.I.V. "The problem is that the drug has been approved in trials that have included people who are already doing well," said Dr. Giordano. "However, we have no data on how we can better help people who are not stable and doing well."

An attempt is currently being made to test the recordings on people who cannot take their medication regularly.

People with H.I.V. Stop taking your medication for a number of reasons. They can lose their insurance, drop out of drug assistance programs for lack of documentation, have substance use or mental health problems, or end up in jail.

In people who stop taking the H.I.V. Pills, the likelihood that the virus they carry will become drug resistant is not high. However, the injectables leave behind a "long tail" of antiviral drugs that remain in the body in small amounts, even if the doses are not met. This can provide the right conditions for the virus to adapt and become resistant.

"Low drug levels will last a long time," said Dr. Giordano. "That is the benefit and the Achilles heel of a long-tail drug."

In the two-year study, 10 people developed resistance to the combination. However, some of them may have been resistant because they had previously taken other related drugs.

In order to inject the drugs regularly, doctors offering the treatment must know H.I.V. Patients far more frequently than they are today – a requirement that the pandemic is making even more difficult.

Another problem is cost. According to a spokeswoman for ViiV Healthcare, doses of the combination cost approximately $ 4,000 per month plus $ 6,000 for an initial oral treatment. Some people with H.I.V. He may not be able to afford the treatment, said Mark Harrington, leader of the Treatment Action Group, an advocacy group.

Cabenuva may have side effects that will only become apparent after widespread use of the medicine. But the treatment has been approved in the European Union and Canada and appears to be safe so far, Harrington said.

The injections are not trivial. The needles required are wider and longer than those used, for example, for a flu shot, and the barrels hold several times their volume.

"Patients really liked that," said Dr. Susan Swindells, one of the investigators at the University of Nebraska Medical Center in Omaha. Women in the study in particular liked the injections because the competing demands on their time and attention – and the possible stigma – made it harder for them to take a daily pill, she said.

More privacy is also a boon for anyone who wants their H.I.V. Status. Steven Harris, 41, a participant in one of the proceedings, worked as an international trade attorney and had traveled frequently to countries where people with H.I.V. "I was so afraid of being stopped at customs," he said.

After receiving the injections, Mr. Harris gave his H.I.V. Status to his family. The long-acting combo "was really cool," he said last year. "It got me off the pill bottle both physically and mentally – and that's the part I wasn't really expecting."

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