A new HIV vaccine? Not really, but lenacapavir (Yeztugo) is the biggest breakthrough in prevention in decades. Two injections a year can prevent HIV infection.
Lenacapavir, what's the drug?
Lenacapavir, sold under the name Yeztugo, is the first HIV medicine approved by the FDA (American Food and Drug Administration) to be taken only twice a year to effectively protect itself from HIV infection. It works completely different from the previous therapies, blocks the virus in several stages of its life cycle, not just on one, like most currently available drugs.
Efficacy confirmed by studies
In two pivotal clinical studies (Purpose 1 and 2) Lenacapavir achieved results that were hard to imagine a few years ago:
- Purpose 1: Among women in Sub-Saharan Africa and Uganda – 100% Effectiveness, zero infections in the drug group
- Purpose 2: Among men, transgenders and non-binar people in the USA, South America, Africa and Asia – Efficacy 99.9%, only two infections on over 2100 subjects
These results are better than the daily PrEP tablets (e.g. Truvada) that can only be effective in the real world if the patient does not forget the daily dose.
Two injections a year, comfort and revolution
The biggest advantage of Yeztugo is convenience, instead of a daily tablet, only two injections per year are enough. This may be a breakthrough for people who have problems with regularity, live in difficult conditions or just don't want to remember about drugs every day.
The price is now the biggest problem
That's where the catch comes in. The annual Yeztugo catalogue price in the US is over $28,000. Meanwhile, experts have calculated that the cost of producing the drug is only $26-40 a year. This gap gives rise to great emotions – both among patient organisations and the UN.
Gilead, the drug manufacturer, has licensed six generic companies to produce cheap versions for the 120 poorest countries, but countries with medium incomes (e.g. Brazil, where HIV is a serious problem) are beyond this agreement. By the time the generics appeared, Gilead undertook to deliver 2 million doses at production costs.
Who is most concerned with HIV?
Almost 40 million people live with HIV, with 1.3 million new infections per year. In the United States, 700 new cases are reported every week, and the epidemic is the strongest hit by black, Latin, homosexual and transgender men, prostitutes and sex workers. In these groups, access to HIV protection often limits financial, insurance and social barriers.
How will the new drug affect prostitutes and sex business?
The introduction of lenacapavir may particularly change the lives of sex business workers who have been at the highest risk of HIV infection for years. For many of them, daily intake of PrEP tablets was a challenge – due to irregular lifestyle, stigmatisation and sometimes simply lack of access to healthcare. Two injections a year are a huge comfort and a chance for real protection, even when it is difficult to fully control working conditions or negotiate security with customers. Studies show that 40% coverage in this group can significantly reduce the number of new infections – and with wider access the effect would be even greater. However, as always, the price and availability will be crucial – because the revolution in HIV prevention cannot bypass those who need it most.
Yeztugo is the biggest breakthrough in HIV prevention in years – a simple scheme, almost 100% effectiveness and a chance of a real reduction of the epidemic. However, without solving the problem of price and access, the revolution can bypass those who need it most.
Source:
https://www.unaids.org/en/resources/fact-sheet
https://www.webmd.com/hiv-aids/hiv-aids-in-blacks-alarming-crisis
