The fight to control HIV has been a towering triumph for the pharmaceutical industry. An untreatable and terminal disease has been wrestled down to chronic status with the hint of an elusive cure. An epidemic with no medication and a terrifying death toll is now manageable thanks to the efforts of scientists, pharmacologists and a roll call of dedicated campaigners.
The progress, in human and medical terms, has been profound and the 22nd International AIDS conference held in the Netherlands in July and attended by 15,000 global policy makers, researchers and advocates, had a very different mood to its first, when times and prospects were far gloomier. Hope has been replaced by expectation and the 2018 programme proudly showcased ‘important advances in HIV preventions science’ and ‘future prevention’.
For Gilead, a leading light in the step-changes that have saved millions of lives, their discovery, R&D and roll-out of a franchise of drugs that generated $14bn in revenue last year is linked to and influenced by the HIV community.
Gilead’s HIV work continues apace as does that of rivals GSK, Sanofi, Janssen and others in a global HIV drug market expected to reach a value of $26,458bn in 2022, while WHO figures put the number of people diagnosed with HIV/AIDS at 36.7 million in 2015.
GSK’s majority-owned ViiV Healthcare is the strongest challenger to Gilead’s 52% market share. That means companies are vying to generate new therapies that will provide hope for patients.
“We have been working in HIV for a long time and a lot has changed over those years,” said Mike Elliott, VP Medical Affairs Gilead Sciences EMEA. “We have had good therapies available over the last five to ten years, which have helped people with HIV to keep the disease under control, and there has been good education both in the community with HIV and in the general population and health system. We are in a stable situation, which is a good time to reflect on what can be done better or what is missing.
Researching the right questions
“There is more work to do to optimise therapy and move towards a cure, if that’s possible. We have always been connected with the community. Feedback in the early days was strident and could have been considered negative against the industry, but we’ve always tried to work with that feedback.
“We didn’t always get it right but we strived to get it right. The campaigns we support today are a reflection of that journey and how we have listened to the community about how they want to live with their HIV, what medical care they want and what they believe our responsibility is. We want to know how they want to be empowered so that HIV is something they live with, but the condition does not stop them living the lives they want to live.
“From the research side, we try to make sure we are researching the right questions and that is about what people with HIV want, not what we think they want and need.”
The company’s annual R&D budget is $3.3bn which helps fund a global research programme, including its new class of antiretroviral drug – HIV capsid inhibitors – that are designed to provide long-acting treatment suppression.
Gilead has also raised hopes after its candidate GS-9620, which aims to expel the virus from hidden reservoirs, made it through phase 1.
Another company working on a similar candidate is French biotech Abivax. It recently presented new data for its drug candidate ABX464 that suggest it may suppress latent HIV in reservoirs, creating real competition in the race to achieve long-term remission from the infection.
Re-set the viral load
Elliott, who has been with the company for six years, is optimistic: “An HIV cure is a tough one but the good news is that there are a lot of people around the world working on it and a lot of money being invested by governments and companies like ours supporting research,” he added.
“There is a good collaborative approach and our labs are partnered with others around the world to push research forward.
“We have good antiretrovirals but we need to drive the virus out of reservoirs. The first data published in humans showed we could achieve that and then, using the antiretrovirals, reset the viral load in the blood at a much lower level. Now, that is not a cure because the virus is still there, but you could perhaps envisage someone being off therapy for prolonged periods and the virus having a lesser impact.
“These are early days but the hope is that it could take the burden off people who have other conditions and reduce the impact of virus.
“I would like to see phase II trials so hundreds, rather than tens, of patients could get to a much lower viral load and be able to come off therapy for a prolonged period of time – say six to 12 months – and if we had that in a good number of patients, at least you might have a prototype for ‘curing’ the HIV virus or achieving prolonged suppression.”
Cost is not the issue
HIV research is swirling with new candidates, molecules and potent combination drugs in feverish competition for the market. But Elliott insists that the striving and market positioning need to synchronise with the needs of people living with HIV for new treatments to have a transformative impact in the Western world and emerging nations.
“Most of our medicines in Europe are available at the same time, at generic prices, in Africa – in hepatitis C, the drugs are available earlier in Africa than Europe because of the reimbursement processes. In HIV, it is around plus maybe a month,” he added. “As soon as we know how to manufacture our pills, we hand it over to the generic manufacturer, so we are doing it as fast as we are in developing countries. Sure, it might be easier to work in the UK, France or Germany but that doesn’t mean we don’t work at the same speed for other countries.
“Cost is not the issue; it’s the education and infrastructure that is needed to make sure the health system has the treatments that patients need, and that individuals understand the need to get tested and be treated if found to be HIV positive. And then it is about getting the medicines to the clinics that are in remote areas. We fully support the education and local logistics in a number of community programmes.”
Gilead runs a Test and Treatment scheme in Tanzania in collaboration with The Vatican, whose locally-based nurses are trusted to deliver the HIV healthcare and education which is making a difference. But getting a template to work across the mosaic of Africa and Asia countries and cultures is a huge challenge.
“Globally, we want to make sure our medicines are used in the right way and we are providing what the patients want – as there is no point in researching something and bringing it to market if it is totally uninteresting and of no need to patients,” said Elliott.
“We check in continuously with the community. We hold ourselves to account and that is appreciated by the community.”
Danny Buckland is a health journalist