Research: Hepatitis C Trial Shows Strong Results in Rwanda

Posted on Jul 26, 2019

Alphonsine Imanishimwe, coordinator of the 2017 hepatitis C trial in Rwanda, counsels a new patient
Alphonsine Imanishimwe, coordinator of the 2017 hepatitis C trial at Rwanda Military Hospital in Kigali, counsels a new patient through her first dose of medication. Neil Gupta/PIH

A recently published study showed strong success for treating hepatitis C with new antiviral medicine in Rwanda, potentially creating a model for broader treatment plans across the region.

Several of the study’s co-authors are affiliated with Partners In Health, which is locally known as Inshuti Mu Buzima and has worked in Rwanda since 2005. The 2017, PIH-led study tracked 300 patients who had 12 weeks of treatment at Rwanda Military Hospital in the nation’s capital, Kigali, and resulted in successful treatment for 87 percent of them. Co-authors found no previous large-scale, antiviral hepatitis C treatment studies in sub-Saharan Africa, where limited treatment data is available and where new treatments for the virus only have been introduced in recent years.

“This is the first large-scale prospective study reporting direct-acting antiviral outcomes in sub-Saharan Africa,” the study states. “The high adherence and treatment success without intensive support measures…support the feasibility of (hepatitis C) treatment decentralization and scale-up in sub-Saharan Africa.”

The successful trial and evidence of effective antiviral treatment among Rwandan patients was followed by the Rwandan government's December 2018 launch of its plan to eliminate hepatitis C in the country by 2024—significantly sooner than the World Health Organization’s target of 2030.

“This research allowed us to provide evidence that hepatitis C treatment is effective and safe, and can be used in Rwanda, and hence, in comparable settings in sub-Saharan Africa,” said Fredrick Kateera, chief medical officer for PIH in Rwanda and a co-author of the study.

The government’s roadmap plans to screen more than 4 million Rwandans and treat about 112,000 people living with hepatitis C—an often-overlooked, highly treatable liver disease. With a projected budget of $113 million, officials aim to treat 90 percent of all infections, expand the health workforce, provide medications, develop monitoring tools, and launch vertical micro-elimination along with wider, community-based awareness and treatment campaigns.

Co-authors shared results of the antiviral drug trial in a report titled, “Treatment of Chronic Hepatitis C Virus Infection in Rwanda with Ledipasvir–Sofosbuvir,” which appeared in the December 2018 issue of the Lancet Gastroenterology & Hepatology Journal. Co-authors also presented their findings at the 2018 International Liver Congress in Paris.

PIH’s research helped the Rwandan government successfully negotiate a lower cost for the medication, prompting the progressive elimination plan described in a recent editorial. That editorial, “Rwanda Launches a Five-Year National Hepatitis C Elimination Plan: A Landmark in Sub-Saharan Africa,” appeared in the April 2019 Journal of Hepatology.

“We sought to test the drug in an African population to characterize its impact,” said Kateera, who worked on the trial alongside Dr. Neil Gupta, formerly chief medical officer for PIH in Rwanda. “Through ongoing negotiations, the price of direct-acting antiviral drugs in Rwanda is expected to continue to decrease substantially.”

The work highlights how antiviral medication could effectively cure people with hepatitis C and reduce the number of Rwandans living with the virus, currently estimated at 3 to 4 percent of the adult population. More broadly, the plan contributes to a goal of essentially eradicating the viral liver infection in sub-Saharan Africa. 

Globally, 71 million people live with chronic hepatitis C. The often asymptomatic—and therefore undiagnosed—blood-borne virus commonly is transmitted through contaminated injections or transfusions. The virus currently has no effective vaccine and can cause serious scarring of the liver, known as cirrhosis, or liver cancer.

Personal stories emerged from the study.

A 30-year-old Rwandan man, for example, faced severe virus-related symptoms before joining the PIH-led trial, a year after he was diagnosed with chronic hepatitis C. He couldn’t afford antiviral medication, and had dropped to an unhealthy weight after being put on a strict diet to avoid liver damage. Upon enrollment into the study, he began taking medication. With proper nutritional counseling, he gradually returned to a healthy weight. Three months after completing the treatment, there was no trace of the virus in his system.

A Rwandan woman, meanwhile, was planning her wedding when she found out she had contracted the virus a few weeks earlier, while donating blood. She postponed her wedding to undergo treatment.

“The virus was undetectable after this patient completed the treatment as part of the trial. She was so thankful that she invited the study team to her wedding,” said Dr. Fabienne Shumbusho, a Rwandan clinician who co-authored the study.

Researchers leading the trial conducted assessments and evaluations before, during, and after treatment. They also found that the medication does not require extensive follow-up care, making treatment even more accessible.

Those successfully treated in the trial saw a significant improvement in physical and mental quality of life, including reduced symptoms of depression and higher success rates at work. Patients were excluded from the study if they had other advanced ailments, such as uncontrolled HIV. Globally, 25 percent of hepatitis C patients have HIV, according to the Centers for Disease Control.

Some of the patients in the study were less likely to be cured by the medication tested, because they have a unique genotype for hepatitis C that is more common in Africa than other parts of the world. In August 2019, PIH in Rwanda is launching a new study to explore potential treatment across genotypes.  

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