There are two fronts in the global fright against HIV and AIDS.  Obviously, treating those infected is one.  But equally important is preventing new infections.  Since the early part of the last decade we have had the “preventative” drug regimen known as PrEP or “pre-exposure prophylaxis.”  PrEP refers to medication used by an HIV-negative person to reduce the risk of contracting HIV, and to date, the US Food and Drug Administration has approved four forms of PrEP:  Truvada and Descovy are daily pills, while Apretude is a shot given every two months.

The fourth is Lenacapavir which the FDA approved under the brand name Sunlenca in 2022 to treat certain people with HIV.  It is the first capsid inhibitor.  Capsid inhibitors are a class of antiviral drugs that target the HIV capsid, a protein shell that protects the virus’ genetic material – they work by preventing the capsid from disassembling and releasing the viral RNA into the host cell, thus inhibiting HIV replication.

It is a good option for teens and young adults, who often struggle with consistent adherence to daily prevention pills, and for those in places where the stigma (and in some cases the criminalization) surrounding HIV means people want, or need, to hide the fact they are taking something to prevent it.

But the miracle of Lenacapavir comes at a very high price – literally.  It was launched in the US with a list price of $28,218 a year.  That price tag puts it out of reach in places where it is needed most:  the countries with the highest rates of HIV.  It is one thing for the World Health Organization to recommend it as a preventive drug last July, WHO director general, Dr. Tedros Adhanom Ghebreyesus, describing it as “the next best thing” to an HIV vaccine, but quite another to deliver it at those prices.

Until now.

Cheap supplies of Lenacapavir will be available in many poorer countries within two years thanks to Gilead, which originally brought the drug to market, granting voluntary licenses to six generic manufacturers, including Dr. Reddy’s and Hetero Labs, to supply the drug through national HIV programs and organizations such as Unitaid, the Clinton Health Access Initiative (CHAI), and the Johannesburg-based Wits RHI who have entered into partnership with Dr. Reddy’s Laboratories, and the Gates Foundation which has an agreement with Hetero Labs.

Last year there were 1.3 million new HIV infections globally and experts have said that Lenacapavir could have a dramatic effect on lowering that figure.  The drug almost completely prevented new cases of HIV:  two clinical trials were conducted for it, with the first involving more than 2,000 women in sub-Saharan Africa, resulting in a 100% reduction in infections and demonstrating superior efficacy over the daily oral preventative pill Truvada; in the second trial, involving over 2,000 men and gender-diverse individuals, only two infections were recorded – a 99.9% prevention rate, again surpassing Truvada.

There have been efforts to increase access to Lenacapavir in the period before generics become available, with PEPFAR – the US President’s Emergency Plan for AIDS Relief, the Global Fund, and the Children’s Investment Fund Foundation promising funding; Gilead has said it will provide them with the drug at no profit.  However, the Trump administration, for ideological reasons, has suggested its PEPFAR funding should only apply to pregnant and breastfeeding women, which would exclude other high-risk groups such as men who have sex with men, sex workers, drug users, and prisoners.  Ideology has no place in healthcare, or in ending a global pandemic.  Period.

Still, securing a $40 price tag for generic Lenacapavir to be used as PrEP is historic and a turning point in the now decades-long effort to end HIV/AIDS as a global health crisis and should be heralded and celebrated as such.