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

It’s what many people with HIV have been waiting for: monthly injections to keep the virus in check instead of the three pills they now have to take every day.

The Food and Drug Administration Thursday approved a combination of two monthly admissions for the treatment of HIV in stable-condition patients. The treatment is called Cabenuva.

Some version of the combination has also been shown to be as effective at preventing HIV infection as taking a daily pill, a treatment strategy known as 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 living with HIV can be significant, as missing pills allow the virus 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 of infectious diseases 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 daily pill. “You get your shot and forget about it until next month,” said Dr. Giordano. “This is great and will help people who don’t want to be reminded of stigma or take 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 HIV to undetectable levels for two years.

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

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

The studies tested the drug on people who took pills every day and had undetectable levels of HIV – only a fraction of those infected with HIV. “The problem is that the drug has been approved in trials that include people who are already doing well,” said Dr. Giordano said. “But we don’t have any data on how we can better help people who are not stable and are not doing well.”

An attempt to test the recordings in people who cannot take their medication regularly is underway.

People with HIV take their medication off 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.

People who stop taking HIV pills are not likely to become drug resistant to the virus they carry. 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 adhered to. 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.

To inject the drugs regularly, doctors offering the treatment need to see HIV patients far more often than they do now – a requirement made even more difficult by the pandemic.

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 HIV may not be able to afford treatment, said Mark Harrington, leader of the Treatment Action Group, an advocacy group.

Cabenuva may have side effects that only become apparent after widespread use of the drug. 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 blessing for those who do not want to reveal their HIV status. Steven Harris, 41, attending one of the court hearings, worked as an international trade attorney and had traveled frequently to countries where people with HIV were not allowed. “I was afraid of being stopped at customs,” he said.

After receiving the injections, Mr. Harris disclosed his HIV 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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