A new drug described as “the closest we’ve ever been to an HIV vaccine” could cost $40 (£31) a year for each patient, a thousand times less than the current price, new research suggests .
Lenacapavir, sold as Sunlenca by US pharmaceutical giant Gilead, currently costs $42,250 for the first year. The company is requested to make it available at a a thousand times less than that price worldwide.
UNAids said it could “herald a breakthrough for HIV prevention” if the drug was available “quickly and affordably”.
Lenacapavir, given by injection every six months, can prevent infection and suppress HIV in people who are already infected.
In a trial, the drug provided 100% protection to more than 5,000 women in South Africa and Uganda, according to results announced by Gilead last month.
Lenacapavir is currently licensed for treatment, not prevention.
In a study that on the 25th international AIDS conference up in Munich On Tuesday, experts calculated that the minimum price for mass production of a generic version, based on the cost of lenacapavir’s ingredients and manufacturing, and allowing for a 30% profit, was $40 a year, assuming 10 million people took it annually use. In the long term, 60 million people would likely need to take the drug prophylactically to significantly lower HIV levels, they said.
Dr Andrew Hill, from the University of Liverpool, who led the research, said: “You have an injection that someone can have every six months and not get HIV. This is as close as we’ve ever been to an HIV vaccine.”
Most HIV prevention currently relies on daily pills and barrier measures, such as condoms.
Campaigners want Gilead to allow generic licensing through the UN-backed Medicines Patent Pool in all low- and middle-income countries (LMICs), which account for 95% of HIV infections. Similar mechanisms have been in place for decades in the HIV treatment market, where rich countries pay higher prices than poorer countries.
If that doesn’t happen, Hill said, countries should consider issuing mandatory licenses that allow generic manufacturing in the face of a public health emergency.
Gilead said it was “too early” to praise lenacapavir for preventionas it awaited clinical trial data and potential regulatory submissions, but promised “a strategy to enable broad, sustainable access worldwide”.
This will include both “Gilead supply in the countries where the need is greatest until voluntary licensing partners are able to provide high-quality, low-cost versions of lenacapavir” and a voluntary licensing program for “high-incidence, resource-limited countries”. . Gilead said the selection of those countries is ongoing.
But campaigners said it was vital that all LMICs, including “upper middle income” nations such as Brazil, had access to low-cost generic forms of the drug.
Similar selections in the past have excluded countries where the HIV epidemic is growing the fastest, they said.
Trials in LMICs made the case for universal access even stronger, Hill said, and after the Declaration of Helsinki on medical ethics, which said that trials should only be conducted in populations that could benefit from the results.
Joyce Ouma, senior program officer at Y+ Global, a network of young people living with HIV, said a twice-yearly injection would be “transformative for young people like me who are living with or at risk of having HIV”. .
Ouma said: “It is not an exaggeration to say that achieving the 2030 goal of ending new HIV transmissions depends on Gilead ensuring that people in the global south have equitable access to lenacapavir.”
UNAids executive director Winnie Byanyima said treatment could be “lifesaving” by providing a more discreet option than daily tablets for people who face stigma because of their HIV status or sexuality.
