patients

R&D MODEL & PORTFOLIO
HEPATITIS C
DEVELOPMENT
Sofosbuvir/Ravidasvir treatments
PROJECT START: Clinical trial to start 2016
OVERALL OBJECTIVE: Conduct Phase II/III clinical trials to test the
efficacy of a combination of sofosbuvir + ravidasvir
OBJECTIVE 2015: Exploratory work
More than 1 million people are estimated to be chronically
infected with HCV in Thailand and 400,000 in Malaysia (genotypes
1, 3, and 6). Both countries have been excluded from all
global voluntary licensing agreements with drug companies
that have developed effective treatments for HCV that include
low and some middle income countries. In the short term, DNDi
will focus on combining SOF – already registered for hepatitis
C – and RDV – a drug candidate developed by Presidio and
licensed to Pharco – to evaluate pan-genotypic activity in Thai
and Malaysian populations. The study will assess, in real-world
settings, the efficacy, safety, tolerability, pharmacokinetics, and
acceptability of a 12-week regimen containing SOF plus RDV in
participants infected with HCV, regardless of the HCV genotype,
source of transmission (including intravenous drug use), or
HIV co-infection, and also in patients with compensated liver
disease with or without cirrhosis. For participants with compensated
liver cirrhosis, treatment duration will be 24 weeks.
A total of 750 subjects will be enrolled, including up to 30%
with compensated cirrhosis and up to 20% people who inject
drugs, providing data on efficacy and safety of the SOF-RDV
combination as well as on treatment compliance.
In 2015 the HCV project was undertaking exploratory work on
assessing patient needs and project opportunities, recruitment
of patients, and fund-raising.
MAIN PARTNERS: Pharco Pharmaceuticals, Inc., Egypt; Presidio
Pharmaceuticals, Inc., USA; Clinical Research Malaysia (CRM),
Ministry of Health, Malaysia
50 › DNDi Annual Report 2015