A long-lasting HIV preventive drug could be a game changer.

Injectable drugs that protect people at high risk of HIV infection are recommended for use by the World Health Organization (WHO). Cabotgravir (also known as CAB-LA), given every two months, was first approved by the U.S. Food and Drug Administration in December 2021.

Cabotegravir is currently manufactured by ViiV Healthcare, a UK-based company jointly owned by GSK in London, Pfizer in New York City and Shionogi in Osaka, Japan. On July 28, ViiV announced a voluntary license agreement, WHO issued a recommendation. This will allow up to three other companies to manufacture and supply generic versions of the drug. They are intended for use in the world’s 90 lowest-income countries, where the majority of new HIV cases occur.

A spokesperson for ViiV Healthcare said, “We believe that expanding access to cabotegravir has the potential to transform the HIV prevention landscape and make a significant contribution to the goal of ending the HIV epidemic.” says. However, many fear the drug is too expensive to be effective. The campaign group says the drug’s price tag – which he estimates at US$3,700 per vial in the US – is out of reach for the poorest countries. Medical charity Doctors Without Borders called the license “limited and disappointing”.

ViiV has pledged to provide the drug at “non-commercial prices” for public programs in low-income countries.It has not disclosed how much this price will be, but it has been revealed Nature It will be more than $10 per serving, which is the price the campaign group is claiming.

Infection prevention

According to the latest data, about 1.5 million people (between 1.1 and 2 million) were infected with HIV in 2021. update It was also announced last week by the Joint United Nations Program on HIV/AIDS (UNAIDS). The majority of new infections and deaths occur in Africa. According to UNAIDS updates, in 2021, 510,000 to her 860,000 will die from HIV.

Cabotgravir is the latest WHO recommended drug to prevent HIV infection. In January 2021, authorities approved the use of vaginal rings coated with the anti-HIV drug dapivirine. And in 2015, WHO recommended tenofovir disoproxil (TDF), an oral tablet. It is also available in popular form and is used in about 80 countries.

An uninfected person can use the pill individually, not during sex. This trait can be particularly important for young women and adolescent girls, he said, UNAIDS. However, according to research, Women and girls may be reluctant to take Because of the stigma associated with the disease and fear of violence if discovered.

Investigation¹ A study published in April showed that cabotegravir is more effective in preventing HIV than TDF. In addition, there is a potential for privacy, as vaccinations do not need to be given as frequently and the vaccine can be administered at the clinic.

Led by Sinead Delany-Moretiwe, Director of Research at the Wits HIV and Health Research Institute in Johannesburg, the study reports results from a Phase III clinical trial conducted in South Africa between 2017 and 2020. Injections and half oral tablets. Forty HIV infections were reported during the study period. 4 in the cabotegravir group and 36 in the oral group. “Her access to cabotegravir should be prioritized as an additional option,” Delaney-Moretlwe said at the 24th International AIDS Conference in Montreal, Canada.

who pays?

The WHO’s cabotegravir announcement — and ViiV’s licensing agreement — drew both praise and criticism from many after attending and conducting conferences that ended on August 2. His Iskandar Azwa, an infectious disease specialist at the University of Malaya in Kuala Lumpur, Malaysia, said at the conference:

According to the preprint² A paper published in March by Lise Jamieson, a biostatistician at the University of the Witwatersrand in Johannesburg, and her colleagues found that to be at least as cost-effective as an oral drug, price each injection from $9 to $14. Must be in dollars. According to an analysis by the Clinton Health Access Initiative, a philanthropic health organization based in Boston, Massachusetts, Presented at the workshop in February Generic drug makers have suggested that cabotegravir could be manufactured for about $20 per person per year.

For now, additional international funding for HIV/AIDS medicines will be a daunting task, the conference heard. In fact, official aid from many of the largest bilateral donors outside the United States has plummeted by 57% over the past decade. Overall, according to UNAIDS, international resources available for HIV in 2021 are 6% lower than they were in 2010. Based on this, researchers and advocates argue that expensive new drugs will not be affordable.

and open letter To ViiV CEO Deborah Waterhouse, a group of more than 70 politicians, civil society activists, researchers and philanthropic leaders have pushed the price of cabotegravir to match the price of existing HIV prevention drugs. He urged the company to “get as close as possible.” According to them, this is about $60 per person per year for him, which equates to $10 per dose of cabotegravir.

A ViiV spokesperson said in an email: Nature Because cabotegravir is more complex, it is more expensive than the “plain white pill”, so the $10 price tag is not realistic. In addition, low prices may discourage the entry of generic drug makers. “It is important now not to stifle public interest in development and manufacturing through the voluntary licensing agreements we have just finalized by setting unrealistic expectations on prices.”

A spokesperson said all manufacturers are welcome to apply to make generic copies of the drug, and three licenses will be awarded initially. “If the demand signal is supportive and we see a need, we can increase the number of sublicensees in the future,” the spokesperson added.