HIV prevention therapy likely to become cheaper but accessibility concerns remain

US pharma giant Gilead Sciences' partnership with domestic companies to produce generic versions of its groundbreaking HIV prevention therapy, lenacapavir , is expected to make treatment significantly more affordable, with prices likely to drop to a fraction of those charged in the US. However, despite this potential for reduced costs, concerns persist regarding accessibility in high-incidence developing countries and those experiencing rising HIV infections.

On Oct 2, Gilead announced it will allow generic manufacturers including Dr Reddy's, Emcure, Hetero and Mylan - to produce a generic version of the twice-yearly HIV injection in 120 low- and lower-middle-income countries. The pathbreaking AIDS therapy which costs around $44,000 for twice-yearly injections in the US, has garnered attention for its potential in HIV prevention globally. "Given the transformative potential of lenacapavir for prevention, our focus is on making it available as quickly and broadly as possible where the need is greatest," said Daniel O'Day, chairman and CEO of Gilead.

The entry of generics is projected to drastically reduce prices in India from the exorbitant $40,000 per patient per year to around $200-300 within next couple of years, following necessary regulatory approvals. A study by Liverpool University estimated that prices for generic lenacapavir could initially fall to $100 per person per year and eventually reach $40 per person per year as production volumes increase. "We are not able to comment on pricing at this point. However, the aim of this collaboration is to increase access so we will price it affordably," a Dr Reddy's spokesperson said.

Patent and public health experts argue that voluntary license (VL) granted by Gilead is "restrictive," limiting the ability of generics to significantly contribute to ending the decades-long HIV pandemic. "The VL appears good on paper. However, it seeks to control production of active pharmaceutical ingredient (API), key to production of affordable versions, while failing to fully utilise the capabilities of large API manufacturers like Natco, Lupin, Aurobindo and Laurus Labs. And for finished formulation - Lupin, Strides and Aurobindo. If overall supply of API is restricted, a reduction in the prices could take longer," Leena Menghaney, India Head of Medecins Sans Frontieres Access Campaign told TOI.

A faster regulatory approval for patients here hinges on waiver of local clinical trials, she added.

Gilead has filed patents widely on the drug, and the VL meant to overcome patent barriers will not make lenacapavir accessible in key countries, KM Gopa Kumar a senior researcher with Third World Network said.