The agreement has seen expanded access to HIV treatment dolutegravir for millions in low- and middle-income countries

Geneva – Ten years ago the Medicines Patent Pool (MPP) and ViiV Healthcare signed a voluntary licence agreement to establish greater access to dolutegravir (DTG) in low- and middle-income countries (LMICs). Once the licence for DTG was signed in 2014, selected generic pharmaceutical manufacturers could develop, produce and supply the medicine in selected countries.

With well over one billion packs of generic DTG now distributed and  24 million peoples taking DTG regimens daily in LMICs, the result has not only been a spectacular success, but has also demonstrated that MPP’s voluntary licensing model could be expanded to encompass many different disease areas.

Frank experiences about transformative medicine
A 45-minute documentary produced by MPP tells the story of some of those living in LMICs whose lives have been transformed by this agreement and the work of many partners. Featuring personal accounts from Cameroon, India, Kenya, Senegal and South Africa, The dolutegravir story: A Decade of Access lets people living with HIV speak frankly, and in their own words, about their experiences. (link to the story page https://medicinespatentpool.org/partners/stories/i-am-part-of-the-dtg-story)

A Decade of Access was first shown to a selected audience of stakeholders on 28 May 2024, at the sidelines of the World Health Assembly. Following the screening, Ben Plumley, host of internationally renowned health podcast ‘A Shot in the Arm’, chaired a panel discussion on the impact of DTG on the lives of people living with HIV.

Several important themes emerged from the discussion. Dr Lucia Rizka Andalucia, the Director General of Pharmaceutical and Medical Devices at Indonesia’s Ministry of Health, with whom MPP had just signed a Memorandum of Understanding, congratulating MPP and Unitaid on the ten years of successful access to DTG, she stressed that with “the number of HIV cases in Indonesia increasing to over 500,000 in 2022” access to DTG is as vital to Indonesia as it ever has been. “DTG is one of our priority drugs provided by the Ministry of Health, available in 10mg tablets for children and 50mg tablets for adults. I hope we can continue the collaboration between Indonesia and MPP.”

Strong and trusting partnerships are key
Deborah Waterhouse, the current CEO of ViiV Healthcare emphasised that nothing can be achieved “without partnership. That was how we were able to negotiate the licences for DTG for adults. MPP is critical because they’ve issued the sub-licences, and then the amazing partners in the field make sure that the product is flowing into the places where it’s most going to have an impact.”

Her points were echoed by Dominique Limet, former ViiV CEO when the agreement was signed in 2014. He stressed the value of WHO’s role in the process, as “with their fantastic prequalification treatment guidelines, everything went very quickly. Thanks to MPP, we were able to travel more quickly. That’s also a key success factor, because by going fast, you create access to more volumes, and by creating higher volumes, you decrease prices.”

Siobhan Crowley, head of HIV at the Global Fund, was also adamant that authentic partnership is a crucial ingredient for success: “It is hard to move a very, very big machine, to do things absolutely properly. The transitions have tested us, but they are really worth it. The power of partnership, that bold ambition of aggressive tenacity of saying ‘we can and we must’, is really important”.

Affordability need not equate with poor quality
Another key element of the discussion was a recognition that there is no necessary clash between affordability and access to the best medicines. This point was made most acutely by Professor Matthew Kavanagh, a senior adviser to Winnie Byanyima, the Executive Director of UNAIDS.

Professor Kavanagh hailed the ten year achievement as “remarkable”, stressing that the cost of “$40 per patient per year is a number to be celebrated. Because what that shows us is that when the world says we have to choose between affordability and great medicines, that is a false dichotomy.”

Safety must always come first
Mrs Uchennna Elmuwa, the Director of Pharmacovigilance at NAFDAC, Nigeria’s regulatory agency, outlined the importance of putting safety first. Recounting that DTG-based treatment for HIV began in 2017 in her country, she stressed that “we insist we have an active monitoring system in place. Because in the midst of its wonders, there is always an identified risk. So the need for continuous monitoring is very critical”.

Health teams in Nigeria have therefore closely monitored the effectiveness and tolerability of DTG, establishing a national database of cases. As there is some skepticism about its use in women of childbearing age, Ms Elmuwa did not pretend that everyone was convinced by DTG, but also pointed out that several studies demonstrate that the benefits outweigh the risks.

Stunning success of paediatric DTG
Mrs Elmuwa was also clear about the positive impact of pDTG. “A lot of children who were transitioned into the new paediatric dose, were actually doing very, very great. One of the children in the study – and this really drove the story home – was a small child of three years, almost at the point of death. But when she was transitioned to the paediatric dose, she really picked up and started doing very well.”

Her words were echoed by Meg Doherty, the director of the HIV department at WHO. She reminded the audience that “more than 76 percent of people living with HIV are now on antiretroviral therapy, with the majority of those on DTG based regimens. The viral load suppression is at 93 percent. It’s creeping up and getting much better for children, but with previous medicines viral suppression was very low.”

Vital role of affected communities
Another reason for the stunning success of DTG is that affected communities have never been ignored. This point was stressed by Robert Matiru, Unitaid’s Director of Programme Management.

“No story is complete if you have missing chapters and no story is complete if it doesn’t include all the people it’s supposed to be about. The voices of those people are really key.”

Maurine Murenga, founder of Lean on Me, Kenya spoke movingly about the negative effects of the HIV medication that came before DTG. “We were the ones who used to sleep in meetings, and our kids used to sleep in classes because they couldn’t keep up with the effects of the medication,” she said.

Looking to a challenging future with CAB-LA
Meg Doherty reminded the audience that whilst DTG “is one of my favourite success stories, we need to do it for CAB-LA  for prevention of HIV – we can’t forget what we’ve done so well in the case of DTG.”

Robert Matiru also offered a few words of caution. “CAB-LA is going to be an even harder story to develop and prepare,” he said. “DTG is a daily, oral, fixed-dose combination, but CAB-LA is an injection every two months and for people who aren’t even sick. We have to write this story to be as successful as DTG, but it’s a different one.”

 
“At that point it became real”
Concluding the session, Esteban Burrone, MPP’s Director of Policy, Strategy and Market Access, reiterated that it had been a “very exciting journey over the last ten years.” He focused on three moments on that journey. The first was the signing of the original licence, which had been “a tough negotiation but that’s part of what it is to forge a good partnership”, he said.

Mr Burrone’s second critical milestone was in August 2017 when the fixed-dose combination first became available. His third highlight was when he saw a box containing DTG stamped with ‘Manufactured by licence from the Medicines Patent Pool’. “At that point it became real,” he said, “and that’s what this story is really about.”