hepVoice Vol 30 November 2018 | Page 6

The Medicines Patent Pool signs licence with AbbVie to expand access to key hepatitis C treatment The Medicines Patent Pool (MPP) has announced a new, royalty-free licence agreement with AbbVie for glecaprevir/pibrentasvir (G/P) – a World Health Organization (WHO) recommended treatment for people living with chronic hepatitis C (HCV). The licence will enable quality-assured manufacturers to develop and sell generic medicines containing G/P in 95 low- and middle-income countries (LMICs) and territories at affordable prices, enabling access to and treatment scale-up with the most effective pan-genotypic regimens. The agreement was launched at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2018 in San Francisco. “G/P is a priority therapy for licensing for the MPP, so this agreement with AbbVie is very good news for public health,” said Dr Marie-Paule Kieny, Chair of the MPP Governance Board. “It is a really important new option for a significant proportion of HCV patients throughout the world. As with previous MPP licences, we look forward to facilitating access to generic versions of this product as quickly as possible in as many territories as possible.” Globally, 71 million people are currently living with chronic HCV, many of them in LMICs. By the end of 2015, only 20 percent had been diagnosed and a mere seven percent of them had received treatment. In February 2017, the MPP issued its annual report on priority medicines for in-licensing. Given its favourable clinical profile and high potential in LMICs, G/P was listed as a key priority treatment. G/P is an all-oral, once-daily, pan- genotypic combination regimen and was originally approved in 2017. It has achieved high cure (SVR12) rates of 98 per cent in treatment-naïve non-cirrhotic patients across all six genotypes of the virus. It is recommended by the WHO as a first-line treatment for eight weeks in treatment- naïve non-cirrhotic patients. Treatment- naïve patients with compensated liver cirrhosis require a 12-week treatment course. Further, the regimen is also indicated for use in HCV patients with any degree of renal impairment, including patients on dialysis. Globally between five and ten percent of all people living with chronic HCV infection are estimated to be living with kidney disease and this treatment will be very helpful for them. There are 95 countries and four territories included in the MPP/AbbVie licence for G/P at this point. The countires are Afghanistan, Angola, Antigua and Barbuda, Bangladesh, Belize, Benin, Bhutan, Bolivia, Botswana, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Cook Island, Côte d’Ivoire, Democratic Republic of the Congo, Djibouti, Dominica, Egypt, Equatorial Guinea, Eritrea, Ethiopia, Fiji, Gabon, Gambia, Georgia, Ghana, Grenada, Guadeloupe, Guinea, Guinea-Bissau, Guyana, Haiti, Indonesia, Jordan, Kenya, Kiribati, Laos, Lesotho, Liberia, Libya, Madagascar, Malawi, Maldives, Mali, Marshall Islands, Mauritania, Mauritius, Micronesia, Morocco, Mozambique, Myanmar, Namibia, Nauru, Nepal, Niger, Nigeria, Niue, Pakistan, Palau, Papua New Guinea, Philippines, Rep., Reunion Islands, Rwanda, Saba, Saint Eustatius, Saint Kitts and Nevis, Saint Lucia, Saint Vincent & the Grenadines, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, Suriname, Swaziland, Tanzania, Timor-Leste, Togo, Tunisia, Turkmenistan, Tuvalu, Uganda, Vanuatu, Vietnam, West Bank & Gaza, Yemen, Zambia, Zimbabwe. World Hepatitis Alliance 2019 Elections nominate candidates from their countries for the board elections to be held in January 2019. 2019 is an election year for the World Hepatitis Alliance Board. All members are also able to nominate candidates for the position of President-Elect who will be selected by the newly elected Board from the candidates’ members put forward. The President-Elect selection will take place at the WHA board meeting in March 2019. The selected candidate will be learning the role of WHA President for a year before being endorsed as President The time has come for members to have a say about who is representing them at both a regional and global level. Nominations are now open for new Board members for the EURO, SEARO and PAHO regions. Members from those regions are able to by the Board at the end of their term as President-Elect. WHA members have been sent details of the nomination process. If you are a member and have not received the relevant documents to make your nomination then please email us on [email protected] The deadline for nominations is Friday 30th November. WHA at the World Health Summit In October, WHA CEO, Raquel Peck attended the World Health Summit in Berlin, an annual event bringing together global leaders including heads of state, development agencies, researchers, physicians as well as representatives from industry and NGO. At the event the World Health Organization released the Global Action Plan for healthy lives and well-being for all. A report to leverage the experience and expertise of the global health community to accelerate progress towards SDG3 “Claiming over one million lives each year, viral hepatitis is one of the world’s major public health challenges and disproportionately affects people living in LMICs. Therefore access to safe, quality-assured treatments, affordable for all, has to be the fundamental aim of the public health community. This is a big step in that direction. The next step is to see more territories included in the agreement. Each step makes the dream of hepatitis C elimination more real.” Raquel Peck, CEO, World Hepatitis Alliance 6 hep Voice November 2018 hep Voice November 2018 7