Twice-Yearly Injection Shows 100% HIV Protection, Study Finds

In a groundbreaking study conducted across South Africa and Uganda, researchers reported that a twice-yearly injection has achieved 100% protection against HIV. The study involved approximately 5,000 young women and girls, all of whom remained free of the virus after receiving the shots.

While traditional HIV prevention methods such as condoms and daily pills have been available, adherence has been a significant challenge in many parts of Africa. The study revealed that only around 30% of participants consistently took Gilead's Truvada or Descovy pills, with adherence rates declining over time.

The new injection, known as Sunlenca, represents a potential game-changer in HIV prevention. Thandeka Nkosi, who played a key role in the research at the Desmond Tutu Health Foundation in Masiphumelele, South Africa, described the development as “quite revolutionary.” She emphasized that the injection offers a crucial alternative to daily pills and helps eliminate the stigma often associated with oral HIV prevention methods.

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Despite the excitement surrounding Sunlenca, there are concerns about its accessibility. Gilead, the drug's manufacturer, has not yet set an affordable price for those in greatest need. The company has announced plans to pursue a “voluntary licensing program,” which could restrict the production of generic versions to a limited number of manufacturers.

Winnie Byanyima, executive director of the U.N. AIDS agency, called on Gilead to share Sunlenca’s patent with a U.N.-backed initiative that negotiates broad contracts for generic drug production. The current cost of Sunlenca in the U.S. exceeds $40,000 per year, although prices vary.

Dr. Helen Bygrave from Doctors Without Borders stressed that affordable access to Sunlenca could be pivotal in reversing the HIV epidemic, particularly in countries with high infection rates. She urged Gilead to announce a pricing strategy that would make the drug accessible globally.

Gilead has indicated that it is in discussions with generic manufacturers and acknowledges the urgency of making Sunlenca available in poorer countries. However, it remains unclear how soon an affordable price might be established.

Another HIV prevention option, Apretude, requires administration every two months and is currently approved in several countries, including parts of Africa. Despite being priced at approximately $180 per year, it remains out of reach for many in developing regions.

Byanyima highlighted that the most vulnerable populations, including women and girls facing domestic violence and men in regions where same-sex relationships are criminalized, stand to benefit greatly from Sunlenca. UNAIDS data from 2022 shows that women and girls account for 46% of new HIV infections globally and are disproportionately affected in Africa.

Drawing a parallel to the historic shift in HIV treatment decades ago, Byanyima compared the potential impact of Sunlenca to the breakthrough in AIDS drug accessibility. At that time, South African President Nelson Mandela's suspension of patents led to a dramatic drop in drug prices, from about $10,000 to $50 per year.

Olwethu Kemele, a health worker at the Desmond Tutu Health Foundation, believes that the introduction of Sunlenca could significantly increase the uptake of HIV prevention services and slow the spread of the virus. Many young women currently face challenges with pill adherence due to societal pressures, making the injection a promising alternative.

A recent UNAIDS report indicated that HIV infection rates in 2023 are the lowest since the late 1980s. Despite progress, about 1.3 million people are infected annually, and more than 600,000 die from AIDS-related causes, predominantly in Africa. Rising infection rates in Eastern Europe, Latin America, and the Middle East underscore the ongoing need for effective prevention methods.

In related research, Andrew Hill of the University of Liverpool projected that expanding Sunlenca production to 10 million people could reduce its cost to around $40 per treatment. He emphasized the critical need for swift action to make Sunlenca available and accessible.

“This is about as close as you can get to an HIV vaccine,” Hill remarked, underscoring the potential of Sunlenca to transform HIV prevention and control efforts worldwide.