A new HIV prevention drug described as “the closest we have ever been to an HIV vaccine” may become available for $40 a year for each patient, a thousand times decrease from the current price, new research revealed. 

UNAids said the drug could “herald a breakthrough for HIV prevention” if it was available “rapidly and affordably”.

Sold as Sunlenca by Gilead, Lenacapavir is currently priced at $42,250 for the first year. The biopharmaceutical company is being urged to globally reduce the drug's cost by a thousand times.

Lenacapavir is administered through injection, preventing infections and suppressing HIV in infected people. However, the drug currently has a license for treatment, not prevention, despite Gilead releasing results last month showing its 100% protection rate during a trial of over 5,000 South African and Ugandan women.

A time and cost-effective alternative

The 25th International Aids conference was held in Munich on Tuesday, where a study was presented regarding Lenacapavir's pricing, production, and effectiveness. 

The research determined that, factoring ingredients and manufacturing expenses, and a 30% profit margin, the lowest feasible cost to produce a generic alternative of Lenacapavir would be $40 per year. This conclusion is based on the assumption that 10 million people would use the drug annually.

Experts said they anticipate that around 60 million people would require the drug for preventative reasons to significantly reduce HIV levels in the long run. 

“You’ve got an injection somebody could have every six months and not get HIV," lead research Dr Andrew Hill of Liverpool University said, highlighting "That’s as close as we’ve ever been to an HIV vaccine.”

The current HIV prevention methods rely on daily pills and barrier measures, such as condoms.

Generic licensing and accessibility

Advocates have urged Gilead to enable generic licensing of the drug under the UN-backed Medicines Patent Pool in all low-and-middle-income countries (LMICs), which comprise 95% of HIV cases. Similar approaches have occurred in the HIV treatment market where the drugs are priced higher in wealthy countries than in poorer ones. 

Hill said that if the company does not allow generic licensing, countries should issue compulsory licenses for generic manufacturing amid public health emergencies. However, Gilead stated it was "too early" to price Lenacapavir as a prevention drug since it awaiting clinical trial results and possible regulation filings, but pledging "a strategy to enable broad, sustainable access globally."

The pharmaceutical company added that this process would include supplying "countries where the need is greatest until voluntary licensing partners are able to supply high-quality, low-cost versions of Lenacapavir” and establishing a voluntary licensing program for “high-incidence, resource-limited countries." However, Gilead said choosing those countries is ongoing.

In contrast, advocates urged for access to the low-cost general forms of Lenacapavir, stressing it is pivotal for all LMICs.

Hill highlighted that trials conducted in LMICs reinforced the support for universal access, referring to the Helsinki Declaration on medical ethics, which stipulates that trials should only be tested on populations likely to benefit from the results.

Senior programs officer at Y+ Global, Joyce Oyma, said that a bi-annual injection would be "transformative for young people like me living with or at risk of HIV."

Gene-editing unlocks hope for HIV cure

Researchers asserted in March that they've wiped out HIV from infected cells through CRISPR gene-editing, and were honored with the Nobel Prize. CRISPR functions akin to molecular scissors, excising DNA to eliminate or render harmless problematic segments.

The objective is total virus eradication from the body, yet further investigation is essential to ensure safety and efficacy. While existing HIV therapies can curb the virus, they fall short of complete elimination.

Presenting their initial findings at a medical conference, the University of Amsterdam team underscored that their research is still in its infancy and not a definitive HIV cure.