Elation and dismay over Gilead’s HIV drug

There is elation and public outpouring of joy, and there is also anxiety and gnawing worry. Both reactions are related to new studies of a drug, already in the market, which show that it suppresses and provides protection against HIV at all stages. The exhilaration is understandable because the drug, lenacapavir, discovered by US pharma giant Gilead Sciences, is the closest thing to an HIV vaccine the world has now; it offers hope of ending HIV-AIDS transmission. The gloom is on account of Gilead’s pricing of the game-changing drug. It costs as much as US $44,819 per patient per year in some developed countries, for two shots of the injection taken at a six-monthly interval. That puts it out of reach of most patients and even governments.

First, let’s understand why the drug, which is in use as treatment for HIV, will be a game changer. Studies conducted among multiple groups across continents are showing dramatic results. Lenacapavir demonstrated 100 per cent efficacy and safety in the investigational PURPOSE 1 use of HIV prevention in cisgender women in sub Saharan Africa, said Gilead in July. That is why many of those attending the International AIDS Conference in Munich wept for joy when the results were presented in detail. A blog post published by the New England Journal of Medicine explains that there was a standing ovation for the scientists who presented the findings. And on September 12, Gilead announced that its PURPOSE 2 trial had shown 99.9 per cent efficacy. This trial included cisgender men, transgender men, transgender women, and gender non-binary individuals in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the US who have sex with male partners. That was stunning.

It has been a long wait for a long-acting HIV prevention and treatment formulation—no one is calling it a vaccine yet—to fight the HIV scourge that has no known cure. The statistics are pretty grim. HIV has claimed an estimated 42.3 million lives so far and continues to be transmitted in all countries. UNAIDS estimates there were 39.9 million people living with HIV at the end of 2023, of whom the huge majority are in the World Health Organization (WHO) African Region. Last year, an estimated 1.3 million people acquired HIV while 630,000 people are reported to have died from HIV-related causes. Around 76,000 of these fatalities were among children.

The world urgently needs to prevent the spread of HIV if it is to meet the target of ending the HIV epidemic by 2030 under the UN Sustainable Development Goals (SDGs). Should we begrudge Gilead its patents and resultant profits, when it is offering the best hope of fighting the scourge? There is a moral issue here. The price is not just unaffordable but apparently immoral, too, given how little it would cost to produce the drug. A global group of scientists have shown that it can be produced for $100 for the two injections needed in a year, a cost that could be pared to $40 per patient per year. This garnered as much attention at the Munich conference as Gilead’s trial results did.

The scientists from Europe and the US presented a study which put the cost of producing a generic version of Gilead’s drug (marketed as Sunlenca) at just $40 even after allowing for a 30 per cent profit margin, assuming the demand to be 10 million injections a year. They argue that such a low price for generic lenacapavir is vital for a mass prevention campaign that would target communities facing the highest risk of HIV infection.

To ensure this, says Andrew Hill of Liverpool University who led the expert study, Gilead should sign voluntary licences (VLs) with the major generic manufacturers as soon as possible to kick off mass production at the earliest, instead of waiting for further results from other randomised trials. A VL covering all low- and middle-income countries would allow the use of lenacapavir in 83 per cent of the world’s population, where 95 per cent of HIV infections are seen. Humanitarian health organisation Médecins Sans Frontières is also campaigning for VLs to make lenacapavir more widely available in all low and middle-income countries through the UN’s medicines patent pool. This would enable the production and supply of generic versions in low- and middle-income countries.

Is this likely? Gilead says it is "executing an access strategy that prioritises speed and enables the most efficient paths for the regulatory review and approval of lenacapavir in regions around the world." The focus would be on high-incidence, low-resource countries, which of course are primarily low- and lower-middle-income countries. It would, therefore, be expediting such measures, including VLs, to supply high-quality, low-cost versions of lenacapavir. However, public health activists are sceptical because they say Gilead’s track record is none too good in this regard. Its past VL deals have tended to exclude middle-income countries.

In India, the focus is to ensure that patents are not awarded to Gilead for lenacapavir. The battle is more direct with community health organisations and patient groups once again filing patent oppositions to lenacapavir, just as TB (tuberculosis) patients did with Johnson & Johnson’s patents on bedaquiline. These include the Sankalp Rehabilitation Trust that works with vulnerable populations and the Delhi Network of People Living with HIV. The struggle to democratise medicine availability for HIV patients has been launched elsewhere, too, with other HIV networks questioning the validity of Gilead’s patent claims. But the key outcome will be in India, which has the largest generics industry outside the US. Sankalp’s contention is that some of Gilead’s applications are not tenable since lenacapavir is a known compound and India’s patent laws debar the patenting of derivatives such as salts and esters of a known compound. So claims by drugmakers to extend the patent life on products through incremental changes do not stand the test unless these are proven to be more efficacious.

The generic drug industry, which is scenting lucrative VL deals from Gilead, is studiously avoiding any confrontation with the company that is a tried and tested business partner. Health activists may have chafe about the unfair nature of the VLs, but generics companies that stand to benefit hugely from the handout of VLs are no longer troubled by such concerns. They are clearly a different breed of companies from those which took on drug giants to reach antiretroviral drugs to HIV patients in Africa two decades ago. Now they can sit pretty. If the patent opposition succeeds they benefit; if it does not, they will in any case get VLs from Gilead. On the other hand, what India’s patent office decides could be a matter of life and death for people living with HIV/AIDS worldwide.

This was first published in the 1-15 October, 2024 Print edition of Down To Earth