CAPE TOWN, South Africa (AP) — Injections given twice a year to treat AIDS have been shown to be 100 percent effective in preventing new infections in women, according to results of a study published Monday.
There were no infections among girls and young women who received the doses in a study of 5,000 people in South Africa and Uganda. In a group given daily prevention pills, about 2% contracted HIV from infected sexual partners.
“Seeing this level of protection is impressive,” said Salim Abdool Karim, director of the AIDS research centre in Durban, South Africa, who was not involved in the work.
The drug, made by Gilead and marketed as Sunlenca, is approved in the United States, Canada and countries in Europe and other regions, but only as a treatment for HIV. The company said it would wait for the results of the trial in men before seeking approval for its use as protection against infections.
The results in women were published 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 were company employees. Because of the unexpectedly encouraging results, the trial was stopped early and all participants received the injections, also known as lenacapavir.
While there are other ways to prevent HIV infection, such as using condoms and taking daily pills, consistent use has been a problem in Africa. In the new study, only 30 percent of participants given Gilead’s Truvada or Descovy preventive pills took them, and the number dropped over time.
The prospect of a twice-yearly injection “is pretty revolutionary news” for our patients, said Thandeka Nkosi, who helped lead the research from the Desmond Tutu Health Foundation in Masiphumelele.
“It gives participants a choice and just removes all the stigma around taking the pills” to prevent HIV.
Experts working to stop the spread of AIDS are excited about the Sunlenca shots but concerned that Gilead has not reached an agreement on an affordable price for those who need it most. The company said it would seek a “voluntary licensing program,” suggesting that only a few generic drugmakers would be allowed to make it.
“Gilead has a tool that could change the trajectory of the HIV epidemic,” said Winnie Byanyima, executive director of the Geneva-based UNAIDS agency.
He revealed that his organization had urged Gilead to share the Sunleca patent with a U.N.-backed program that negotiates general contracts for generic manufacturers to make cheap versions of drugs for poorer countries.
As an HIV treatment, the drug costs more than $40,000 a year in the United States, although individual prices can vary.
In a statement last June, Gilead said it was too early to know how much it would cost to use it as a preventative in poorer countries. Dr. Jared Baeten, Gilead’s vice president for clinical development, said they were already talking to generic manufacturers and understood “how deeply important it is that we act quickly.”
Another HIV prevention drug, Apretude, taken every two months, is approved in some countries, including those in Africa. It sells for about $180 per patient per year, which is still too high for most developing countries.
Byanyima stressed that among those most in need of lasting protection are women and girls who are victims of domestic violence and homosexuals from countries where same-sex relations are criminalised.
UNAIDS figures indicate that 46% of new HIV infections in 2022 were among women and girls, who were three times more likely to contract HIV than men in Africa. Byanyima compared the news about Sunleca to the discovery decades ago of AIDS drugs that turned HIV infection from a death sentence into a chronic disease.
At the time, South African President Nelson Mandela suspended patents to allow wider access to the drug. The price was subsequently lowered from about $10,000 per patient to about $50.
Olwethu Kemele, a medical worker at the Desmond Tutu Health Foundation, predicted the injections could increase the number of people seeking HIV prevention and stop the spread of the virus. She said young women often hide the pills to avoid questions from boyfriends and relatives.
“It makes it difficult for girls to continue.”
In a report on the state of the global epidemic released this week, UNAIDS revealed that fewer people will be infected with HIV by 2023 than at any time since the 1980s. Worldwide, 1.3 million people become infected with HIV and more than 600,000 die each year, mostly in Africa.
Although significant progress has been made on the continent, HIV infections are on the rise in Eastern Europe, Latin America and the Middle East.
In other research presented at the AIDS conference, Andrew Hill of the University of Liverpool and colleagues argued that once Sunlenca production is scaled up to treat 10 million people, the price should fall to $40 per treatment. He said it was critical for health authorities to get access to the drug as soon as possible. “This is as close as you can get to an HIV vaccine,” he said.
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2024-09-07 10:26:08
What are the key findings of the recent study on twice-yearly injections of lenacapavir for HIV prevention in women?
Table of Contents
Twice-Yearly HIV Prevention Injections: A Revolutionary Breakthrough
In a groundbreaking study, twice-yearly injections of a new HIV prevention drug, Sunlenca, have been shown to be 100% effective in preventing new infections in women. This breakthrough has sent shockwaves through the medical community, offering a glimmer of hope in the fight against the HIV epidemic.
The Study: A Game-Changer in HIV Prevention
The study, published in the New England Journal of Medicine, involved 5,000 participants in South Africa and Uganda. The results showed that none of the women who received the injections contracted HIV, compared to a 2% infection rate among those taking daily prevention pills. This level of protection is unprecedented and has been hailed as “impressive” by Salim Abdool Karim, director of the AIDS research centre in Durban, South Africa.
The Drug: Lenacapavir
The injection, also known as lenacapavir, is a capsid inhibitor that has been approved by the FDA for treating HIV infection. It is administered every six months and has been shown to be effective in combination with other HIV medicines [1]. Lenacapavir is the first of its kind to be approved for treating HIV, and its potential as a prevention drug is significant.
The Benefits: Convenience and Stigma-Free
The twice-yearly injection offers a convenient alternative to daily pills, which have been shown to have low adherence rates in Africa. Thandeka Nkosi, who helped lead the research, described the injection as “pretty revolutionary news” for patients, as it removes the stigma associated with taking daily pills to prevent HIV.
The Challenges: Affordability and Access
While the results of the study are promising, concerns have been raised about the affordability and accessibility of the drug, particularly in developing countries. Gilead, the manufacturer of Sunlenca, has not yet reached an agreement on pricing, and experts worry that the cost may be prohibitively high for those who need it most. Winnie Byanyima, executive director of UNAIDS, has urged Gilead to share the patent with a U.N.-backed program to negotiate general contracts for generic manufacturers, making the drug more accessible to poorer countries.
The Context: HIV Epidemic and Prevention
HIV remains a significant global health issue, with 1.3 million people becoming infected and over 600,000 dying each year, mostly in developing countries [3]. Pre-exposure prophylaxis (PrEP) is a crucial tool in preventing HIV infection, reducing the risk of sexual transmission by 99% and injection drug use transmission by at least 74%. The development of a twice-yearly injection offers a new avenue for prevention, particularly for women and girls who are disproportionately affected by the epidemic.
The Future: Increased Access and Prevention
The success of this study has the potential to increase the number of people seeking HIV prevention and stop the spread of the virus. Olwethu Kemele, a medical worker at the Desmond Tutu Health Foundation, predicts that the injections could make a significant impact, especially among young women who often hide their pills to avoid questions from boyfriends and relatives.
As the world continues to battle the HIV epidemic, the development of a twice-yearly injection offers a beacon of hope. With increased access and affordability, this breakthrough could be a game-changer in the fight against HIV.
Breakthrough in HIV Prevention: Long-Acting Injections Show 100% Efficacy in Women
A recent study has revealed a groundbreaking discovery in the fight against HIV/AIDS. Injections given twice a year have been shown to be 100% effective in preventing new infections in women. This breakthrough has sent shockwaves of excitement throughout the medical community, and experts are hailing it as a potential game-changer in the battle against the disease.
The Study
The study, published in the New England Journal of Medicine, involved 5,000 participants in South Africa and Uganda. The results showed that none of the women who received the injections contracted HIV from infected sexual partners. In contrast, about 2% of participants who were given daily prevention pills contracted HIV.
The Drug: Lenacapavir (Sunlenca)
The drug, made by Gilead and marketed as Sunlenca, is currently approved in the United States, Canada, and other regions as a treatment for HIV. However, this study has demonstrated its potential as a preventative measure against infections. Gilead has stated that it will wait for the results of the trial in men before seeking approval for its use as protection against infections.
Convenience and Effectiveness
The prospect of a twice-yearly injection is seen as a revolution in HIV prevention. Thandeka Nkosi, who helped lead the research from the Desmond Tutu Health Foundation, stated that “it gives participants a choice and just removes all the stigma around taking the pills” to prevent HIV. The injections eliminate the need for daily pill-taking, which has been a major barrier to consistent use in Africa.
Cost and Accessibility
While the results are promising, concerns have been raised about the affordability of the drug for those who need it most. Gilead has not yet reached an agreement on an affordable price for developing countries. UNAIDS has urged Gilead to share the Sunlenca patent with a U.N.-backed program that negotiates general contracts for generic manufacturers to make cheap versions of drugs for poorer countries. As an HIV treatment, the drug costs more than $40,000 a year in the United States.
Global Impact
The implications of this breakthrough are far-reaching. According to UNAIDS figures, 46% of new HIV infections in 2022 were among women and girls, who are three times more likely to contract HIV than men in Africa. This new development has the potential to significantly reduce the spread of the virus among vulnerable populations.
Other HIV Prevention Options
In addition to the Sunlenca injections, another HIV prevention drug, Apretude, taken every two months, is approved in some countries, including those in Africa. However, it sells for about $180 per patient per year, which is still too high for most developing countries.
Conclusion
The discovery of a 100% effective HIV prevention method is a milestone in the fight against the disease. While concerns about cost and accessibility remain, the potential impact of this breakthrough cannot be overstated. As experts continue to work towards making this and other HIV prevention methods more widely available, we may be on the cusp of a major turning point in the battle against HIV/AIDS.
Related Resources
Pre-Exposure Prophylaxis (PrEP) | HIV Risk and Prevention [[[1]]
Clinicians’ Quick Guide: What Is Injectable HIV PrEP? [[2]]
* WHO recommends long-acting cabotegravir for HIV prevention [[[3]]
