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An injectable treatment that has until now been used on AIDS patients is 100% effective in preventing HIV infection in women, a study just published shows, according to the Associated Press, antena3.ro. The study of about 5,000 people in South Africa and Uganda showed that young women and girls who received the injections did not become infected. “It’s amazing to see this level of protection,” Salim Abdul Karim said of the injections. He is the director of an AIDS research center in Durban, South Africa, which was not involved in the study. Sunlenca, an injection made by the US company Gilead, is approved in the United States, Canada, Europe and other countries, but only for the treatment of HIV. The company said it is awaiting the results of tests on men before seeking permission to use them to prevent infection.
The women’s findings were published Wednesday in the New England Journal of Medicine and discussed at an AIDS conference in Munich. Gilead paid for the study, and some of the researchers are employed by the company. The study was stopped early because of the surprisingly encouraging results, and all participants received the injection, also known as lenacavir.
“To provide participants with a choice and remove any stigma from taking the pill”
While there are other ways to prevent HIV infection, such as condoms or daily birth control pills, consistent use of these methods has been a problem in Africa. In the new study, only about 30% of participants who took Gilead’s Truvada or Descovy birth control pills actually took them, and that number declined over time. The prospect of twice-yearly injections is “pretty revolutionary news for our patients,” said Thandeka Nkosi, who helped conduct the Gilead study for the Desmond Tutu Health Foundation in Masiphumelele, South Africa. It “gives participants choice and removes all the stigma associated with taking birth control pills” to prevent HIV. Experts working to stop the spread of HIV are excited about the Sunlenca shot but are concerned that Gilead has not yet agreed on a price that’s affordable for those who need it most. The company said it would pursue a “voluntary licensing program,” suggesting only a limited number of generic drugmakers would be allowed to make them.“Gilead has a tool that could change the trajectory of the HIV epidemic,” said Winnie Byanyima, executive director of the Geneva-based UNAIDS program. “It is extremely important that we act quickly.” She said her organization has urged Gilead to share the Sunlenca patent with a U.N.-backed program that negotiates broad contracts to allow generic drugmakers to make cheaper versions of the drug for poor countries around the world. The drug costs more than $40,000 a year in the United States as a treatment for HIV, although the amount people pay varies. Dr. Helen Bygrave of Doctors Without Borders said in a statement that the shot “could potentially turn the tide if given in countries with the highest rates of new infections.” She urged Gilead to publish a price for Sunlenca that all countries can afford. Gilead said in a statement last month that it was too early to tell how much Sunlenca would cost to prevent disease in poorer countries. Dr. Jared Baeten, Gilead’s senior vice president of clinical development, said the company is already in talks with generic drugmakers and understands “how important it is to act quickly.”Another HIV prevention injectable, Apretude, which is given every two months, has been approved in some countries, including in Africa. It costs about $180 per patient per year, which is still too expensive for most developing countries. Byanyima said those who need long-term protection most include women and girls who experience domestic violence and gay men in countries where same-sex relations are criminalized. According to UNAIDS, 46% of new HIV infections worldwide in 2022 will be among women and girls, and in Africa they are three times more likely to be infected with HIV than men. “This is the closest HIV vaccine there is” Byanyima compared the news of Sunlenca to the discovery of an AIDS drug decades ago that turned HIV infection from a death sentence into a chronic disease. South African President Nelson Mandela then suspended the patent to allow wider access to the drug; the price later fell from about $10,000 per patient per year to about $50. Olwetu Kemerle, a health worker at the Desmond Tutu Health Foundation, estimates that the shot could increase the number of people coming forward to prevent HIV and slow the spread of the virus. She says young women often hide the pills to avoid questions from boyfriends and family members. “It makes it hard for girls to move on,” she says. By 2023, there will be fewer people infected with HIV than at any time since the late 1980s, UNAIDS said in a report on the global state of the epidemic released this week. Globally, HIV infects about 1.3 million people a year and kills more than 600,000. , mostly in Africa. Despite major progress in Africa, HIV infections are still rising in Eastern Europe, Latin America and the Middle East. In another study presented at the AIDS conference, Andrew Hill of the University of Liverpool and his colleagues estimated that once Sunlenca’s production is scaled up to treat 10 million people, the price per treatment should fall to about $40. He says health authorities must get Sunlenca as soon as possible. “It’s the closest thing to a vaccine for HIV,” he says.
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