News24 | Lenacapavir: What it would it take to get the 6-monthly anti-HIV jab to SA

Only Gilead, as the original developer of the product, can file for registration – and it would need to apply separately in each country, which can take years.

Gilead, however, plans to use faster ways, the company says, including World Health Organisation approval procedures and a system called the EU Medicines for All (EU-M4All), which runs at the same time as the European Medicine Agency’s approval process (to save time). This can help other countries speed up their own checks because they can rely on already scrutinised data.

Sahpra CEO Boitumelo Semete-Makokotlela says South Africa is a member of EU-M4All, but even with this process, she says, it still could still take up to 210 days – seven months – for a product to be approved and another 90 days for each country to finalise the process on a local level.

“But it does save time, and when a pharmaceutical company needs to fill out the dossier that we send them, the time this takes is reduced from months to weeks because they’re able to use the data they used for EU-M4All filing with only a few minor modifications,” she explains.

Gilead, however, says it will wait for the data of a second lenacapavir study, which will only be released by the end of the year or early next year, before it files for registration with the EMA.

The second study tests lenacapavir on gay and bisexual men as well as transgender people.

READ | HIV infections down 39% worldwide, but 1.7 million infected South Africans still not on treatment

Baetan says this will be a smoother process than filing for registration immediately because it will allow for approval of a broader population straight away.

However, Andrew Hill, a pharmacology expert who’s been working on the development of antiretrovirals for the past 30 years and who’s also the main author of the study on the cost of lenacapavir presented at the conference, says this doesn’t make sense.

“Rolling applications, which almost all regulators have, will allow Gilead to file now and then just add the new information later.”

Amid all these politics, about 43 000 young women in South Africa will get infected with HIV in 2024, figures from the Thembisa model show.

Yvette Raphael and her daughter, Yisha. (Supplied) 

And to mothers like Yvette Raphael, who attended the Munich conference, which is held every two years, that is devastating.

“I took my daughter, Yisha, who is 24, with me. She’s HIV-negative.

“I was 25 when I was diagnosed with HIV two decades ago. I don’t want Yisha to return to the next conference in 2026, or the one in 2028, and be HIV-positive. That’s why I’m fighting for this medication to be affordable and widely accessible.”