A shot to protect against HIV: Single shot of this drug every two months helps preventing disease

A single shot every two months prevents HIV better than the most commonly used daily pill, Truvada, researchers reported Tuesday.

At the moment, Truvada and Descovy, made by Gilead Sciences, are the only drugs approved by the Food and Drug Administration for prevention of HIV infection, a strategy called PrEP. Gilead has heavily been criticized for setting a high price for the pills.

Additional options for prevention are sorely needed, to say nothing of a cure. About 1.7 million people became infected with HIV in 2019, bringing the global total to 38 million.

Many people are unable or unwilling to take a daily pill to prevent HIV infection, particularly in low-income countries where the coronavirus pandemic is disrupting services and access to antiretroviral drugs.

“I think it’s revolutionary,” Dr. Rochelle Walensky, a researcher at Harvard University, said of the findings.

“It’s exciting to have another pharma company in the PrEP mix,” she added. “This will create competition and ideally drives costs down.”

The randomized, double-blind trial of the drug, called cabotegravir, was conducted by the HIV Prevention Trials Network, a scientific collaborative. The trial included nearly 4,600 cisgender men and transgender women who have sex with men and was conducted at 43 sites in seven countries.

Each of the participants got a shot every two months, either cabotegravir or a placebo. Each participant also took either Truvada or a placebo pill every day.

The trial was expected to continue well into 2022, but it was stopped in May after an interim analysis showed that cabotegravir was highly effective.

In the final analysis, 13 participants who got the injections every eight weeks were infected with HIV, compared with 39 who were infected among those who took the daily pill. The shot was 66% more effective than Truvada.

In a subset of 372 people receiving Truvada, blood tests showed that just 75% faithfully took the pills. The injection proved more effective than the pills for these participants, too.

Dr. Kimberly Smith, head of research and development at Viiv Healthcare, maker of the drug, said the company expected to file for FDA approval in early 2021.

Truvada is expected to be available in generic form next year, Walensky said, and Viiv Healthcare should set a low price for cabotegravir, because the competitors will be increasingly inexpensive.

“I would say the competition here is generic Truvada, not branded Truvada,” she said.