Background
There were 1.3 million new HIV acquisitions worldwide in 2023, far over UNAIDS target of <370,000 by 2025. Novel injectable pre-exposure prophylaxis (PrEP), lenacapavir (LEN), has superior efficacy to oral TDF/FTC. Gilead are drafting a voluntary license (VL) for LEN. We analysed the rate of HIV epidemic growth for countries inside and outside of the existing Gilead VL for tenofovir alafenamide (TAF). This VL excludes middle-income countries (MICs) in North Africa, the Middle East, South America, and Asia. Countries excluded from VLs pay higher prices for drugs, restricting access. LEN is priced at $40,000 per person per year (pppy) in the US, versus predicted costs of production of $40-$100 per person-year.
Methods
Epidemiological data were collected from the UNAIDS AIDSinfo 2023 database, which analyses country-level data using the Spectrum model. We extracted epidemic size, HIV acquisitions, change in acquisition rate, incidence in key risk populations including men who have sex with men (MSM) and people who inject drugs (PWID) and MTCT, for countries inside and outside the Gilead VL for TAF. Results were supplemented by PUBMED/EMBASE searches and national reports with most recent estimates for Russia and China (2021).
Results
The TAF VL covered 29,615,800 people living with HIV (PLHIV) and 808,900 new HIV acquisitions in 2023. Excluded MICs constitute 4,497,600 PLHIV and 288,189 new HIV acquisitions. Change in new acquisitions from 2010 to 2023 was +55.3% in excluded MICs vs -17.0% included. Excluded high incidence nations include Mexico, Peru, Brazil, Egypt, Bulgaria, Iran, Russia, and China. Annual HIV epidemic growth (incidence: prevalence ratio) was +6.7% for excluded countries vs +4.6% for included countries. High incidence rates are concentrated in key risk populations including MSM (incidence 9.2-16.5% in Mexico, Peru, Brazil, and China) and PWID (3.5-8.1% in Mexico, Bulgaria, Iran, Russia, and China). Average cost of TAF containing products in excluded countries was $7206 pppy versus $189 included.
Conclusions
The HIV epidemic is growing faster in countries excluded from the Gilead VL for TAF (+6.7%/year) versus those included (+4.6%/year). Rate of HIV acquisition has risen 55.3% in countries excluded since 2010, while falling 17% for included countries. If the imminent LEN VL includes all LMICs, this would cover 85% of the world’s population, where 95% of new HIV acquisitions are diagnosed, facilitating affordable pricing of LEN as seen in LMICs included in the TAF VL.
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