A groundbreaking study has revealed that twice-yearly injections used to treat AIDS were 100% effective in preventing new HIV infections in women.
The results, published on Wednesday, July 24 have sparked significant excitement among researchers and healthcare professionals.
The study, conducted in South Africa and Uganda, involved around 5,000 young women and girls. The participants who received the injections showed no new infections.
In contrast, about 2% of those taking daily prevention pills contracted HIV from infected sex partners.
Salim Abdool Karim, director of an AIDS research center in Durban, South Africa, described the findings as “stunning.”
Although he was not involved in the research, Karim highlighted the remarkable level of protection offered by the injections.
Manufactured by the U.S. drugmaker Gilead and sold under the name Sunlenca, these shots are currently approved in the U.S., Canada, Europe, and other regions as a treatment for HIV.
Gilead is now awaiting the results of testing in men before seeking approval for its use as a preventive measure.
The study’s promising results were published in the New England Journal of Medicine and presented at an AIDS conference in Munich.
Funded by Gilead, the study was halted early due to the impressive outcomes, and all participants were subsequently offered the injections, also known as lenacapavir.
While there are existing methods to prevent HIV infection, such as condoms and daily pills, consistent usage has proven challenging, particularly in Africa.
In the study, only about 30% of participants taking Gilead’s Truvada or Descovy prevention pills adhered to the regimen, with adherence decreasing over time.
Thandeka Nkosi, who assisted in conducting the Gilead research at the Desmond Tutu Health Foundation in Masiphumelele, South Africa, described the twice-a-year shot as “quite revolutionary news” for patients.
“It gives participants a choice and eliminates the stigma around taking pills to prevent HIV,” she noted.
Despite the enthusiasm surrounding Sunlenca, experts are concerned about its affordability for those who need it most. Gilead has stated it will pursue a “voluntary licensing program,” allowing only selected generic producers to manufacture the drug.
Affordable Access to Sunlenca Urgently Needed
Winnie Byanyima, executive director of the U.N. AIDS agency in Geneva, emphasized the potential impact of Sunlenca on the HIV epidemic.
“Gilead has a tool that could change the trajectory of the HIV epidemic,” she stated. Byanyima’s organization is urging Gilead to share Sunlenca’s patent with a U.N.-backed program that negotiates broad contracts for generic drug production, making affordable versions of the drug accessible to poorer countries.
Currently, the drug costs over $40,000 annually in the U.S., though individual costs vary.
Dr. Helen Bygrave of Doctors Without Borders echoed the call for affordability, stating that the injections could “reverse the epidemic if made available in countries with the highest rates of new infections.”
She urged Gilead to set a price for Sunlenca that is accessible to all countries.
In a statement last month, Gilead mentioned that it was too early to determine the cost of Sunlenca for prevention in poorer nations.
Dr. Jared Baeten, Gilead’s senior vice president of clinical development, assured that the company was in discussions with generic manufacturers and recognized the urgency of making the drug widely available.
Another HIV prevention shot, Apretude, administered every two months, is already approved in some countries, including in Africa.
However, its cost of about $180 per patient per year remains too high for most developing nations.
Byanyima emphasized that those most in need of long-lasting protection include women and girls who are victims of domestic violence and gay men in countries where same-sex relationships are criminalized.
According to UNAIDS, 46% of new HIV infections globally in 2022 were in women and girls, who are three times more likely to contract HIV than males in Africa.
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