Key HIV Treatment To Be Rolled Out Among More Children & Adults In Low- And Middle-Income Countries Hepatitis & Sexually Transmitted Infections 01/12/2020 • J Hacker Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Around 1.7 million children are living with HIV around the world, but high costs mean the number who receive treatment is only half that. A new agreement could see the drugs reduced from $400 to $36 per child. Two groundbreaking agreements with pharma companies that should greatly expand access to WHO-recommended HIV drugs for children and adults in low- and middle-income countries (LMICs) have been announced by the Geneva-based Unitaid and Medicines Patent Pool (MPP). The announcements, coinciding with World AIDS Day, celebrated on Tuesday 1 December, both involve cheaper versions or new formulations of the WHO-approved antiviral dolutegravir-based (DTG) treatments for HIV. The initiatives aim to reduce the 12.6 million people around the world who lack access to effective ARVs – many of them living in middle- and upper-middle-income countries. One agreement, between the Medicines Patent Pool (MPP) and ViiV Healthcare – is designed to improve access to DTG HIV treatment to adults, while still prioritising investment in drug innovation. The agreement clears the way for the generic production of the ViiV Healthcare formulation by generic manufacturers at a much reduced price in several upper-middle-income countries, including Azerbaijan, Belarus, Kazakhstan and Malaysia. A second agreement, facilitated by Unitaid, would also open the way for generic production and sales of a dispersible paediatric formulation of DTG for a price of just US$ 120 per child as compared to US$ 480. The long-awaited agreement on production and sale of an HIV treatment designed specifically for children is thanks to a landmark agreement between Unitaid and the Clinton Health Access Initiative (CHAI) on support for the product. 75% Cost Reduction for Children’s HIV Treatment in LMICs Around 1.7 million children are living with HIV around the world, but the number who receive treatment is only half that, due in part to a lack of or limited accessibility to effective drugs, properly adapted for children. HIV drugs for children are often incorrectly dosed or bitter tasting, which makes it harder for children to adhere to their treatment. A new dispersible formulation of DTG treatment – WHO’s foremost recommendation for treating people living with HIV – will be launched at a cost of $36 per child, following an agreement between generic manufacturers Viatris and Macleods which saw the price reduced from $400. Philippe Duneton, Unitaid’s executive director, said: “Children in LMICs often wait years to access the same medications as adults, hindering their quality of life, or even resulting in preventable deaths.” Incorrectly dosed treatments and bitter tastes mean that many children living with HIV respond poorly to antiretroviral treatment and, despite WHO having recommended DTG for children for nearly 2 years, there are no affordable drugs for small children (under 20kg). The new 10mg DTG tablet, produced ViiV Healthcare, under the plan supported by Unitaid and CHAI, has been given a strawberry flavour, to ensure children’s adherence to the medication, and preventing some of the 100,000 child deaths annually from HIV. The new product will be made available initially in Benin, Kenya, Malawi, Nigeria, Uganda and Zimbabwe in the first half of 2021. “Today we can finally guarantee that countries have rapid access to the appropriate formulations needed to fully implement WHO guidelines; so that no child is left behind,” said Dr Meg Doherty, Director of Global HIV, Hepatitis and STI Programmes at WHO. “Congratulations to all the partners involved for showing how quickly we can bring new formulations to market when we work together – clear proof that solidarity delivers results.” “This groundbreaking agreement will bring quality assured dispersible DTG to children at a record pace,” Duneton added. “Ensuring access to this treatment will transform the lives of children living with HIV, helping them to remain on treatment and saving thousands of lives.” The agreement is expected to save global health budgets an estimated US$60-260 million over 5 years. MPP agreement – New Adult DTG Formation For Azerbaijan, Belarus, Kazakhstan and Malaysia For adults, a milestone licensing agreement will enable greater access to WHO approved antiretroviral DTG treatments for HIV, in several upper-middle-income countries, including Azerbaijan, Belarus, Kazakhstan and Malaysia. The four countries were excluded from a 2014 MPP licensing deal that covered dozens of other lower and middle income countries, because they were considered upper middle-income by World Bank definitions. Under the terms of the new agreement reached between the Geneva-based Medicines Patent Pool (MPP) and the pharma manufacturer ViiV Healthcare – generic manufacturers will be able to supply DTG regimens at a much-reduced prices, enabling greater access to HIV treatment in each country, MPP said. Charles Gore, MPP Executive Director said in a statement: “Increasing access to life-saving medicines for low- and middle-income countries is at the core of our mission and we have been able to achieve that over the last 10 years through strong partnerships that span industry, generics manufacturers, governments and civil society. This new and first-of-its-kind agreement with ViiV Healthcare, that is specifically aimed at increasing access in these upper-middle-income countries, will mean that people living with HIV in Azerbaijan, Belarus, Kazakhstan and Malaysia will now have greater access to affordable and quality WHO-recommended dolutegravir-based treatment regimens.” Meg Doherty, WHO’s Director of Global HIV, Hepatitis and STI Programmes. In 2019, WHO recommended DTG as the preferred HIV treatment in all populations – including pregnant women – after two large clinical trials in the time since, however, have found that risks of birth complications are significantly lower than had been initially believed. With reference to the announcement, Dr Meg Doherty, Director of Global HIV, Hepatitis and STI Programmes at the World Health Organization said; “WHO recommends the use of dolutegravir (DTG) as part of the preferred first-line and second-line regimen for people living with HIV, including pregnant women and those of childbearing potential. WHO welcomes this licence and through our regional and country offices have worked alongside governments and MPP to ensure that this agreement responds to people’s HIV treatment needs in these countries.” Vinay Saldanha, Special Adviser to the UNAIDS Executive Director, said: “Voluntary licensing agreements have proven to be an important tool to improve affordability of newer ARV formulations and products in low- and middle-income countries (LMICs), through increasing generic competition. “Several upper-middle-income countries, however, have not been able to benefit from several access to medicines initiatives, with growing barriers to procure more affordable ARVs in the generic pharmaceutical market. We hope that the current agreement will be the first of many to come, opening the doors for countries in other regions, which are still paying higher prices for innovative health technologies that could advance treatment outcomes.” Medicines Access Advocates Criticize MPP Deal As Setting Unfavorable Precedent on Secrecy Medicines access advocates, however, criticized the MPP’s mediated licensing agreement, saying that the organization had allowed for the royalty provisions made between the countries and ViiV and (which is controlled by GSK, with a minority shared held by Pfizer) to remain secret. That, they said, runs contrary to MPP’s longstanding tradition of transparency in the agreements that it mediates between pharma companies holding patents or other production rights, governments and generic manufacturers. Brook Baker, a professor at Northeastern University School of Law, USA, and a senior policy analyst with Health GAP (Global Access Project), said in a blog post: “The MPP for the first time ever is acceding to industry demands to redact the royalty terms from its published licenses. The MPP has historically been committed to full transparency of its licenses. “Now upsetting that commendable principle … a key term in an MPP license will be hidden from public view. This is a major setback to the principles upon which the MPP was founded and it is also a dangerous precedent in the COVID-19 era, where companies are hiding behind claims of transparency to maximize profits and power. They are insisting that everything – their R&D contracts, clinical trial protocols, research data, pricing decisions, advance purchase agreements and option contracts are entitled to full confidentiality as ‘trade secrets’.” He also charged that the price to be charged could still wind up being five or six times higher than the US$75 paid by low-income countries under the 2014 agreement. “MPP also admits that generic licensees will in all likelihood price their generic versions substantially higher than the $75 per year secured through by the Clinton Health Access Initiative and others in 2014,” Baker said. “In fact, the MPP anticipates an eventual price in the range of $400-$500 per year, a sign of both inexcusably high tiered pricing by generic licensees and an excessive royalty charged by ViiV.” In response, an MPP spokesperson said a price for the product hadn’t yet been set, but said it would be half or more of what it currently is in the countries involved: “We don’t have a price yet. Following consultations with both governments and generic manufacturers, MPP is confident that affordable DTG and DTG-based combinations will have a price reduction of 50% to 70%. Estimates have been discussed with the governments of the countries during our consultations with them and this price is agreeable to them, and that this will enable a gradual transition to the WHO recommended regimen. As for the secrecy around the royalties, the spokesperson said: “The royalty rates of the agreement were redacted from the published licence because it was considered commercially sensitive information by ViiV Healthcare who requested its redaction. “MPP discussed with its independent Expert Advisory Group and Governance Board. In view of the importance of the agreement for access in the four countries and the requests from the four governments to facilitate access to these products as soon as possible, MPP exceptionally agreed to redact these clauses. The rest of the agreement is made public on the MPP website. MPP continues to be the global public health organisation with the highest level of transparency in its licensing agreements and commits to continued transparency in its licensing practices.” Image Credits: Paul Kamau/DNDi, NIAID, WHO. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.