(RxWiki News) The hepatitis C virus (HCV) can cause serious liver disease which may require a liver transplant. And according to the authors of a new study, many cases of HCV in the US are among hard-to-treat patients with serious health issues — something not always represented in studies of this virus.
A new study led by researchers from the National Institutes of Health (NIH) focused on a combination treatment proven successful in earlier studies. However, in this new study, researchers included hard-to-treat patients, some with advanced liver problems.
The study found that the combination treatment of sofosbuvir and ribavirin was successful in this study population.
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"The HCV epidemic in the United States is centered in large urban areas among populations with a high prevalence of unfavorable traditional predictors of treatment response," the study authors noted. These unfavorable treatment predictors include high levels of the virus in the body, other health issues (like obesity) and advanced liver problems.
This study, led by Anuoluwapo Osinusi, MD, MPH, of NIH in Bethesda, Maryland, looked at a combination treatment using two medications, sofosbuvir and ribavirin (brand name Rebetol). Sofosbuvir is an experimental medication under review by the US Food and Drug Administration (FDA) and ribavirin is currently available to patients.
According to the study authors, these medications have proven successful in previous studies, but study populations have not included those with these unfavorable treatment predictors.
The researchers looked at 60 patients with chronic HCV who had never received treatment for the condition. Patients were enrolled between October 2011 and April 2012.
Most of the patients (83 percent) were black and 66 percent were men. Forty-eight percent had a body mass index (BMI, a proportion of weight and height used to determine healthy weight) over 30, which is generally considered obese. Advanced liver disease was seen in 23 percent of the patients.
The study was divided into two parts that each lasted 24 weeks. In the first part, 10 patients with early to moderate liver fibrosis (scarring of the liver) were given 400 milligrams of sofosbuvir daily and a dose of ribavirin based on their weight.
In the second part, 50 patients with all stages of liver fibrosis were randomly put into one of two groups. Both groups received 400 milligrams of sofosbuvir daily, and one group was given weight-based ribavirin while the other was given a low-dose of ribavirin (600 milligrams).
After the 24-week treatment period, Dr. Osinusi and team examined the patients to see if they could detect HCV in the patients' bodies. If they could not detect the virus (called an "undetectable HCV viral load"), then the patients were considered to have a "sustained virologic response of 24 weeks" or SVR24. This means that the treatment successfully managed the HCV in their bodies for the 24 weeks of the study.
In the first part of the study, nine out of the 10 (90 percent) early to moderate liver fibrosis patients achieved SVR24.
In the second part of the study, seven of the weight-based ribavirin patients (28 percent) and 10 of the low-dose group relapsed after treatment was over. SVR24 rates were found to be 68 percent in the weight-based group and 48 percent in the low-dose group.
The most common side effects seen were mild to moderate headache, anemia (low red blood cell count), fatigue and nausea. The researchers also observed seven more serious events, which included anemia and pancreatitis (inflammation of the pancreas). However, the study authors noted that no patients decided to stop treatment based on these events.
"In a population of patients with a high prevalence of unfavorable traditional predictors of treatment response, a 24-week regimen of sofosbuvir and weight-based or low-dose ribavirin resulted in SVR24 rates of 68 percent and 48 percent, respectively," the authors concluded.
This was a fairly small study and more research needs to be done to confirm the findings. Dr. Osinusi and team highlighted the need for future studies to look at these populations that are both more difficult to treat and make up the majority of HCV patients in the US.
The study was published August 27 in JAMA (Journal of the American Medical Association). The research was funded by NIH.
Several study authors noted their involvement with a variety of pharmaceutical companies. They reported serving as consultants, advisory board members, speakers or employees for a number of pharmaceutical companies, including Novartis, Gilead and Merck.