The Clinton Health Access Initiative Inc (CHAI) and AmeriCares, with the aid of a multi-year product-donation from Bristol-Myers Squibb, have initiated a first-of-its-kind programme in Africa and Asia aimed at curing hepatitis C (HCV) among patients co-infected with HCV and human immunodeficiency virus (HIV). Bristol-Myers Squibb has agreed to immediately begin providing enough of the HCV medicine Daklinza (daclatasvir) to treat 10,000 patients. A separate agreement made recently between Bristol-Myers Squibb and the Medicines Patent Pool will allow generic firms to develop daclatasvir under royalty-free license for sale in 112 developing countries.
Globally, 2.75m people are estimated to be co-infected with HIV and HCV, most of them in the African and Asian regions. Historically, these patients’ condition has been particularly challenging to manage due to the therapeutic complexities of the overlapping regimens used to treat each disease. Studies of Daklinza have shown it can be administered concurrently with HIV medicines without a need to adjust or alter the HIV medicines, which sometimes is necessary with other hepatitis C treatments.
The countries where CHAI is launching its Quick-Start initiative to support governments to increase access to HCV treatment include Ethiopia, Indonesia, Myanmar, Nigeria, Rwanda, and Vietnam, which together have as many as 30m people who are antibody-positive for hepatitis C. Along with infrastructure challenges and lack of diagnostics, one barrier to treatment of HCV in these countries has been the availability of effective, safe and simple medication regimens.
“Daklinza, used in combination with sofosbuvir, has been shown in clinical trials to be able to cure almost all hepatitis C cases, and it is a critical part of the treatment algorithm for HIV and hepatitis C co-infection,” said Dr David Ripin, executive vice president of Access to Medicines and Malaria, and chief science officer at CHAI. “We already are moving forward with our committed partner countries to launch this treatment effort, and we applaud Bristol-Myers Squibb for its donation and AmeriCares for its work in advancing hepatitis C treatment for patients in these countries.”
“Patients in under-resourced countries co-infected with hepatitis C and HIV often face very serious complications including liver failure and an increased risk of death,” said AmeriCares president and CEO Michael J Nyenhuis. “This pioneering new programme will expand access to a highly effective hepatitis C therapy, saving lives and building healthier futures for thousands of patients who would otherwise go without treatment.”
The Bristol-Myers Squibb donation of Daklinza will be jointly managed by AmeriCares and CHAI, with AmeriCares providing logistical support for the donation and CHAI providing technical assistance to government ministries of health for implementing treatment programmes. CHAI is helping partner governments to secure low-cost, quality-assured supply of sofosbuvir.
CHAI has partnered with experts in viral hepatitis at Duke University to provide guidance on the development of clinical protocols. Drs Susanna Naggie and Andrew Muir, subspecialists in infectious diseases and hepatology, are leading training efforts with ministries of health and healthcare providers on liver disease, hepatitis B and C, and use of direct-acting antivirals.
“This regimen is highly efficacious in clinical trials and real-world experience in HIV/HCV co-infected patients” said Naggie. “This is the only direct-acting antiviral combination regimen for which drug interactions with antiretrovirals can be managed by changing the dose of the daclatasvir, thus significantly expanding the number of HIV/HCV co-infected patients who can access the regimen and a chance for cure.”AmeriCares material