Hepatitis C affects hundreds of millions of people worldwide and remains one of the leading causes of liver cirrhosis, liver failure, and liver transplant need globally. A new clinical trial published in the Journal of the American Medical Association evaluated an investigational three drug combination from Bristol-Myers Squibb and found that a 12 week course cleared the hepatitis C virus in 93 percent of previously untreated patients with liver cirrhosis, a population historically associated with lower treatment response rates.
Why Hepatitis C Treatment for Cirrhosis Patients Is So Critical
Patients with hepatitis C related cirrhosis face a narrowing treatment window. Cirrhosis represents advanced liver scarring that, without effective viral clearance, can progress to liver failure requiring transplantation. The urgency of achieving high response rates in this population is therefore not simply a clinical benchmark but a matter of preventing irreversible organ damage.
Historically, hepatitis C treatment response rates in cirrhotic patients have lagged behind those in patients without advanced liver disease, making the 93 percent sustained virologic response seen in this trial particularly meaningful. Lead author Andrew Muir, MD, chief of the division of gastroenterology at Duke Medicine, emphasized that seeing response rates above 90 percent in cirrhotic patients represents exactly the kind of outcome this population needs to stop disease progression before it reaches the point of transplant necessity.
What the Hepatitis C Drug Combination Trial Involved
The trial was conducted between December 2013 and September 2014 at nearly 50 sites across the United States, Canada, France, and Australia. It enrolled patients with hepatitis C related cirrhosis, 112 of whom had not previously been treated and 90 who had received prior therapies that were unsuccessful. All patients were infected with genotype 1 hepatitis C, the most common genotype globally, estimated to affect approximately 84 million people.
The three drug investigational regimen consisted of daclatasvir, an inhibitor of the viral protein NS5A, combined with asunaprevir and beclabuvir, all developed by Bristol-Myers Squibb. None of the three had received FDA approval at the time of publication, though daclatasvir was under active FDA review for use in combination with sofosbuvir for hepatitis C genotype 3 treatment.
Hepatitis C Response Rates Across Treatment Naive and Experienced Patients
Among patients who had not previously received hepatitis C treatment, the three drug combination achieved a 93 percent viral clearance rate over the 12 week course. For patients who had failed prior therapies, the three drug regimen performed somewhat less effectively, clearing the virus in 87 percent. When a fourth drug, ribavirin, was added for previously treated patients, response rates in that group rose to 93 percent, matching those seen in treatment naive patients.
The drugs were well tolerated overall. Nine patients experienced serious complications, three of which were considered potentially related to the treatment. The minimal side effect profile is significant given that older hepatitis C regimens based on interferon were notorious for causing substantial toxicity and were poorly tolerated by many patients.
The Competitive Landscape and What This Means for Hepatitis C Treatment
The Bristol-Myers Squibb trial entered a highly competitive market. Gilead Sciences had already achieved dominant market position with its hepatitis C drugs Sovaldi and Harvoni, which generated approximately 4.45 billion dollars in revenue in just the first three months of the year the trial was published. AbbVie’s competing product Viekira Pak had also secured exclusive coverage through Express Scripts, the largest pharmacy benefits manager in the United States.
The emergence of multiple interferon free hepatitis C treatment options has fundamentally changed the standard of care. As Dr. Muir noted, these drugs are highly effective and well tolerated across all stages of liver disease, a departure from the treatment era in which many patients could not complete therapy due to side effects.
The study’s limitations included the absence of a placebo control group and a significant lack of racial diversity, with 88 percent of participants being white, a gap that underscores the ongoing need for broader inclusion in hepatitis C clinical trials to ensure findings are generalizable across all affected populations.
To read more about infectious disease and liver disease research, visit the FOMAT blog. FOMAT conducts infectious disease clinical trials at sites across the United States. To learn more about active studies, visit FOMAT’s patient studies page.
For the full source, see the original article at DDDmag.com.