What you should know about GSK, ViiV Healthcare and DTG
- GSK is a science-led global healthcare company with a purpose: to help people do more, feel better, and live longer. This includes a commitment to improve global health impact through research and development (R&D) for infectious diseases affecting children and adolescents in the developing world, with a focus on malaria, TB and HIV.
- ViiV Healthcare is a global specialist HIV company with GSK as its majority shareholder, dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV
- ViiV Healthcare’s current portfolio of 13 HIV treatments includes dolutegavir (DTG), an innovative antiretroviral indicated in combination with other medicine for the treatment of HIV’.
- In the developing world, more than one billion doses of DTG and DTG-based medicines had been delivered across 61 countries by the end of 2018.
Q1). What has been key in navigating the challenges and opportunities of bringing a new medicine to market?
Understanding the shortfalls of other anti-retroviral (ARV) medicines in treating adults and children living with HIV has been an important consideration in our approach. Informed by World Health Organisation (WHO) and community priorities, we were able to design DTG as a broad use medicine (i.e. a medicine that can treat naïve patients who have not received treatment through to people running out of options), which has led to breadth of access. From the outset, heavy investment in R&D of DTG has been central to our approach. The outcome of being able to complete such a breadth of studies enabled clarity of intent and better understanding as to where the medicine could bring the most value, looking at many different sub-populations affected by HIV.
Q2). To facilitate access to markets, who else needed to be in the room?
For ViiV Healthcare, it was really important to partner with organisations and businesses that understood and aligned around our mission to deliver affordable and accessible HIV medicine, and we needed a collaborative model that leveraged the expertise of different partners in delivering healthcare. While WHO played an important role in terms of giving us greater visibility to see gaps from a public health perspective, we also involved other stakeholders including the President’s Emergency Plan for AIDS Relief (PEPFAR) and the broader HIV community from the early planning stage of clinical trials, as they are positioned to influence programmes around HIV treatment. Establishing voluntary license agreements that allow generic manufacturers to produce and supply versions of patented medicines, with the generic manufacturer Aurobindo and the UN-backed Medicines Patent Pool (MPP), meant we had a relationship and mechanism to support the sustainable delivery of DTG at affordable prices across the developing world. Our partnership with the Clinton Health Access Initiative (CHAI) funded by Unitaid helped us plan ahead for rapid product introduction in developing countries.
Q3. What has been your main learning from the experience?
When working in global health no company on their own is going to be able to overcome the challenges without working in partnerships. So the key is how do you establish the right kind of partnership? For ViiV Healthcare, this meant having open conversations with our partners to establish intent and ensure transparency and alignment around our respective individual and shared goals. This has been essential for setting up the foundations for productive partnering.
Q4. What have been the biggest benefits to adopting this approach to partnership?
The best example would be our work in paediatric HIV. Around 2 million children are infected with HIV, compared to about 36 million adults meaning this is an issue area that is often neglected. We recognised this was a key and fertile space for partnership, but to find the sweet spot the approach had to work for all parties. ViiV Healthcare gave a voluntary licence for DTG for children at the same time as adults in a move to increase interest. However, due to uncertainties at the time around dosing in children as well as the limited market opportunity in paediatric ARVs, there was inertia. The challenge, therefore, was to find out how to make the proposition attractive to generic manufacturers.
With CHAI and Unitaid in 2018, ViiV Healthcare built an incentive programme offering technology transfer – giving two generic manufacturers the know-how to develop the child-friendly formulation of our medicine, as well as providing regulatory support. Alongside this, a financial incentive from Unitaid was offered against milestones for the generic manufacturers to prioritise delivering DTG formulations for children. Combined, the business model became a sustainable proposition, and the programme should meet the collective goals of all stakeholders involved:
Q5. Do you think you can truly scale an impact business?
While we’re still learning, the big question is whether everything is happening fast enough and at the right level of magnitude to stem the HIV epidemic in developing countries. There is a Global Action Plan, backed by the Vatican, to improve the paediatric HIV response by engaging leaders across all sectors. This points towards huge intent and momentum; but at the country level, the transition over to new medicines remains a slow process. To expedite it, we urgently require more multi-stakeholder collaboration and advance planning.
We also need to step up our prevention efforts as treatment alone will not see the end of the HIV/AIDS epidemic. As an example, we are currently working in partnership with the Bill and Melinda Gates Foundation alongside other prevention product manufacturers to understand what the challenges look like and how to plan processes to bring new products to market as they become available.
