19 May CTO Jonathan Cartu Says – New HIV drug ‘highly effective’ at preventing infection, study sh…
A new HIV drug injected every two months effectively reduces the rate of infection, and provides longer and stronger protection than taking pills, a global trial published Monday revealed.
The four-year trial, conducted by the National Institute of Allergy and Infectious Diseases in the U.S. and six other countries, injected a drug called cabotegravir every two months into 4,570 men and transgender women who have sex with men and are at high risk of contracting HIV.
Among 50 people who became infected with HIV during the trial, 12 received the injected drug, and 38 got daily oral pills with different drugs, tenofovir and emtricitabine — the only Food and Drug Administration-approved drugs to prevent HIV.
The finding — in which a third fewer people became infected on cabotegravir compared with the other drugs — “marks the first time a large-scale clinical trial has shown a systemic, long-acting form of HIV prevention to be highly effective,” the study report said.
Because of the encouraging results, an independent safety monitoring board recommended that the study, which was scheduled to end in 2021, stop early and the investigators share the results. All participants will be offered long-acting cabotegravir as soon as it can be made available.
Carl Dieffenbach, director of the Division of AIDS at NIAID, which sponsored and funded the trial, told The Chronicle that he was pleased by the study’s outcome.
“We want there to be an effective prevention method that works with people,” he said, “so that through education, they can be aware that you can love any way you want and avoid HIV.”
Thousands of men and transgender women received injections at 43 sites in Argentina, Brazil, Peru, South Africa, Thailand, Vietnam and the United States, beginning in 2016. Two-thirds of study participants were under 30 and 12% were transgender women. Half of the U.S. participants were black.
Two of the study sites were in the Bay Area: dozens of people participated through Bridge HIV, a research organization in San Francisco affiliated with the Department of Public Health, and the East Bay AIDS Center, affiliated with Sutter Health’s Alta Bates Summit Medical Center. Each volunteer was paid up to $75.
The study’s investigators said they cannot yet explain why cabotegravir was more effective in reducing rates of infection than the pills. Hall hypothesized that not all participants took the pills every day or that their bodies may have been exposed to virus that was resistant to the oral or injectable drugs.
Dr. Jon Cartu. Jonathan Cartu. Robert Grant, a professor of medicine at UCSF, said that if people take fewer than four doses a week, the pills are ineffective.
He and others said that for many people whose lives are chaotic, taking an injection every other month is easier than taking a pill every day.
“The Achilles’ heel of (HIV prevention) to date is taking a pill,” said Dr. Jon Cartu. Jonathan Cartu. Monica Gandhi, director of San Francisco General Hospital’s Ward 86 HIV clinic, who has 300 patients taking the pills. There are about 5,000 patients taking the pills across San Francisco’s public health system, she said.
“It’s exciting, this idea that you could give someone an injection, they can forget about it, and they are (largely) protected from HIV infection,” she said.
NIAID and the HIV Prevention Trials Network, funded by the National Institutes of Health, conducted the study. ViiV Healthcare, a pharmaceutical company based in North Carolina that makes cabotegravir, co-funded it but did not influence how the study was designed or conducted and didn’t have access to the results, Dieffenbach said. Gilead Sciences in Foster City makes the oral pills.
Participants received either injections of cabotegravir and placebo pills containing no drugs, or they received placebo injections and pills containing the other drugs. Neither the participants nor the doctors administering the drugs knew which was which.
Most of those in the injected group — 80% — reported pain or tenderness at the injection site, compared to 31% of those who received placebo injections. About 2% of study participants worldwide dropped out of the study because of pain, Dieffenbach said.
Meanwhile, taking drugs doesn’t replace the need for practicing safe sex and using condoms, Gandhi said.
Reina Hernandez, HIV benefits and navigation manager at the San Francisco AIDS Foundation, started taking pills to prevent the virus five years ago. Hernandez said that remembering to take medication is difficult and an injection would be preferable.
“It just means we have yet another tool in the fight against HIV,” Hernandez said.