Injections offer females ‘stunning’ protection from HIV

Lois M. Collins
·4 min read
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This electron microscope image made available by the U.S. National Institutes of Health shows a human T cell, in blue, under attack by HIV, in yellow, the virus that causes AIDS.
This electron microscope image made available by the U.S. National Institutes of Health shows a human T cell, in blue, under attack by HIV, in yellow, the virus that causes AIDS. | Seth Pincus, Elizabeth Fischer, Austin Athman

When the first case of HIV/AIDS was reported in 1981 and for years after that, the disease was a death sentence. Later, treatments made it possible to live with the virus, with proper drug maintenance. Now a study published in the New England Journal of Medicine found that twice-yearly injections offer complete protection against transmitting HIV to women.

A phase 3, double-blind randomized controlled trial involving 5,338 HIV-free adolescent girls and young women in South Africa and Uganda showed that getting a shot of lenacapavir, produced by drug company Gilead, every 26 weeks prevented infection from the human immunodeficiency virus (HIV), which causes acquired immunodeficiency syndrome, or AIDS. None of the females in the clinical trial who received the injections got the virus, though about 2% of the comparison group given daily prevention pills caught HIV from infected partners.

It was also noted that compliance was poorer among those who were supposed to take the pills every day.

As CNN reported, “For years, most people have taken prevention tools known as PrEP (it stands for pre-exposure prophylaxis), such as a daily pill called Truvada to prevent infections. ... More recently, some people have received regular injections of the drug Apretude — two shots administered one month apart then every two months thereafter — to reduce their risk of HIV.”

“These stellar results show that twice-yearly lenacapavir for PrEP, if approved, could offer a highly effective, tolerable and discreet choice that could potentially improve PrEP uptake and persistence, helping us to reduce HIV in cisgender women globally,” Linda-Gail Bekker, director of the Desmond Tutu HIV Center at the University of Cape Town in South Africa, and former president of the International AIDS Society, said in a news release.

Testing in other populations

A separate study is being conducted in men to see whether the twice-a-year injections of lenacapavir are effective. Those results are pending.

In announcing the trial results in women, Gilead reported that study results are expected later this year and in early 2025 from a separate study looking at the twice-a-year injections to prevent HIV infection in men, transgender women and those who are nonbinary in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the U.S. who are sexually involved with male partners.

The company hopes those will show the injections are a prevention tool for “multiple populations and communities most in need of additional HIV prevention options.” The drug is not approved for prevention anywhere at this point. The Associated Press reported that the shots “sold as Sunlenca are approved in the U.S., Canada, Europe and elsewhere, but only as a treatment for HIV. The company said it is waiting for results of testing in men before seeking permission to use it to protect against infection.”

Per the article, “The prospect of a twice-a-year shot is ‘quite revolutionary news’ for our patients, said Thandeka Nkosi, who helped run the Gilead research at the Desmond Tutu Health Foundation in Masiphumelele, South Africa. ‘It gives participants a choice and it just eliminates the whole stigma around taking pills’ to prevent HIV.”

CNN reported that “separate research presented Tuesday at the AIDS Conference in Munich suggests that the production of a generic version of lenacapavir could cost under $100 per person.”

AP reported that Gilead hasn’t agreed to a price in the U.S., where “as an HIV treatment, the drug costs more than $40,000 a year, although what individuals pay varies.” AIDS organizations are encouraging Gilead to share its patent on Sunlenca with a United Nations-backed program that helps negotiate contracts with generic drug companies to make cheap versions for poor countries.

About HIV/AIDS

HIV attacks the body’s immune system by targeting white blood cells. People are then much more likely to get sick from other illnesses, including infections, some cancers and tuberculosis.

It’s spread by certain body fluids from someone who has the infection. It’s not, however, spread by kisses, hugs or sharing food. Instead, it can be transmitted from blood, breast milk and through sex. Initially, people get flulike symptoms like fever and headache, which can lead to other signs of illness, including weight loss, swollen lymph nodes, diarrhea and cough. Treatment can prevent some of the susceptibility to more serious illnesses.

HIV/AIDS has killed more than 4 million people and “transmission is ongoing in all countries globally,” per the World Health Organization. Nearly 40 million people were living with AIDS at the end of 2023 worldwide, with about 65% in the WHO African Region.

“There is no cure for HIV infection. However, with access to effective HIV prevention, diagnosis, treatment and care, including for opportunistic infections, HIV infection has become a manageable chronic health condition, enabling people living with HIV to lead long and healthy lives,” the public health giant reported.