Title: Breakthrough HIV Prevention Drug Could Be Affordable at $40 a Year, Study Finds

A groundbreaking drug that offers significant protection against HIV may soon be available at a fraction of its current price, according to new research. Lenacapavir, marketed as Sunlenca by Gilead Sciences, is currently priced at a staggering $42,250 for the first year of treatment. However, experts believe that it could be made accessible worldwide for just $40 per year, significantly lowering the financial burden on patients.

Lenacapavir is administered through an injection every six months and has shown the potential to prevent infection and suppress HIV in individuals who are already infected. In a recent trial conducted in South Africa and Uganda, the drug demonstrated 100% protection in over 5,000 women. These promising results have led UNAids to express hope that lenacapavir could mark a breakthrough in HIV prevention if it becomes rapidly available and affordable.

Although lenacapavir is currently licensed for treatment purposes rather than prevention, researchers presented a study at the 25th International Aids Conference in Munich showing that a generic version of the drug could be produced for $40 per year. This estimation is based on the costs of its ingredients and manufacturing, allowing for a reasonable profit margin of 30%, assuming that 10 million people would use the drug annually. Considering the long-term scenario, experts predict that around 60 million people would require lenacapavir preventatively to effectively reduce HIV transmission rates.

Dr. Andrew Hill, who led the research at Liverpool University, described lenacapavir as "as close as we've ever been to an HIV vaccine." Currently, most HIV prevention methods rely on daily pills and barrier measures like condoms. The introduction of a twice-yearly injectable drug with such high efficacy could revolutionize HIV prevention efforts.

At present, Gilead Sciences has been called upon to make lenacapavir available at a drastically reduced price worldwide. Campaigners are urging the company to consider generic licensing through the UN-backed Medicines Patent Pool, particularly for low- and middle-income countries, which account for 95% of HIV infections. Historically, similar mechanisms have been implemented in the HIV treatment market, with wealthier nations paying higher prices than poorer ones.

If Gilead does not cooperate, Dr. Hill suggested that countries ought to consider issuing compulsory licenses to allow generic production in the face of a public health emergency. Gilead responded by saying that it is still too early to determine the price for lenacapavir as a preventive measure, as they await clinical trial data and potential regulatory filings. However, the company has promised a strategy to ensure broad and sustainable global access to the drug, including voluntary licensing partnerships and Gilead supply in countries with the highest need.

It is crucial, according to campaigners, that all low- and middle-income countries, including "upper middle-income" nations like Brazil, have access to affordable generic forms of lenacapavir. They argue that previous selections have excluded countries with rapidly growing HIV epidemics, highlighting the importance of universal access to the drug.

Those directly affected by HIV also emphasize the significance of affordable options. Joyce Ouma, a senior programs officer at Y+ Global, a network of young people living with HIV, stated that a semi-annual injectable drug like lenacapavir would be transformative for individuals living with or at risk of HIV. Ouma stressed that Gilead's commitment to fair access in the global south is integral to achieving the goal of ending new HIV transmissions by 2030.

Winnie Byanyima, the executive director of UNAids, noted that lenacapavir's availability as a treatment option would be life-saving, especially for those who face stigma due to their HIV status or sexuality. With the potential for improved accessibility and affordability, lenacapavir could be a game-changer in combating the HIV epidemic on a global scale.