AsianScientist (Apr. 19, 2016) – The Drugs for Neglected Diseases initiative (DNDi) and the Egyptian drug manufacturer Pharco Pharmaceuticals have signed agreements covering the clinical testing and scale-up of a hepatitis C treatment regimen at a price of just under US$300.
“An affordable cure for this deadly disease that treats all strains, or genotypes, of the disease, is essential to tackling the worldwide hepatitis C epidemic,” said Dr. Bernard Pécoul, executive director of DNDi.
As soon as the necessary approvals are received, DNDi will be launching clinical trials to test a combination treatment of the drug candidate ravidasvir and the registered hepatitis C drug sofosbuvir in pan-genotypic patient populations in Malaysia and Thailand. Ravidasvir is an NS5A inhibitor, one of a new generation of direct-acting antivirals (DAAs) that are revolutionizing the treatment of hepatitis C.
Before DAAs became available, hepatitis C treatment consisted of multiple injections over a period of up to one year and frequently caused severe side effects; treatment was only successful 40-80 percent of the time.
DAAs have transformed treatment options for patients and clinicians, but multiple barriers to access for patients exist—in particular, price. As with the introduction and scale-up of antiretroviral therapy for HIV/AIDS over the past 15 years, new and innovative public health approaches to HCV treatment will require affordable access to DAAs.
In a Phase III clinical trial in Egypt, conducted by Pharco, ravidasvir showed cure rates of up to 100 percent in patients with genotype 4 when used in combination with sofosbuvir, which also is a DAA.
“Because of the high prices of new hepatitis C medicines, it has been almost impossible for governments to provide access to treatment at the necessary scale,” said YB Datuk Seri Dr. S. Subramaniam, the Minister of Health in Malaysia.
“We are pleased to support this project and hope data from these studies will support our efforts to introduce this combination as soon as possible and scale up to reach all patients in need.”
DNDi’s Phase II/III studies in Malaysia and Thailand will be conducted with the full cooperation of both governments and will compare sofosbuvir plus ravidasvir with a current standard of care, sofosbuvir plus daclatasvir. These studies will enroll approximately 1,000 participants and will evaluate the efficacy, safety, and pharmacokinetics of the sofosbuvir plus ravidasvir combination in patients with various levels of liver fibrosis, various genotypes, and with or without HIV co-infection.
Of the up to 150 million people infected with chronic hepatitis C globally, approximately 75 percent live in middle-income countries.
“Once these trials have been successfully completed and the safety and efficacy data of this combination assessed, we will encourage governments to design their national health strategies to use all options at their disposal to gain access to life-saving DAAs, including price negotiation, voluntary licensing, or the use of TRIPS flexibilities such as patent oppositions and compulsory licensing,” added Pécoul.
Source: Drugs for Neglected Diseases initiative.
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