BOSTON, MA—An ongoing registry study has found that sustained virologic response (SVR) rates were well-maintained in patients with chronic hepatitis C virus (HCV) infection with cirrhosis after treatment with a sofosbuvir (SOF)-based regimen, according to a long-term registry study presented at The Liver Meeting® 2016.
“Preliminary data from this ongoing observational study of SOF-treated patients with cirrhosis who have achieved SVR show SVR maintained in >99% of patients with a median follow-up of 21 months from the end of treatment,” reported Andrew J. Muir, MD, of Duke University in Durham, NC.
De novo hepatocellular carcinoma (HCC) incidence rates were lower for patients with compensated cirrhosis than has been reported elsewhere for interferon-treated, SVR-achieving patients with cirrhosis, he noted. Among patients with decompensated cirrhosis, the incidence rate of new HCC was higher.
Most patients with decompensated cirrhosis and Model for End-stage Liver Disease (MELD) scores of ≥15 at pre-treatment saw maintained MELD scores drop to below 15 for up to 42 months after their treatment started.
“The majority of patients maintained or improved their CPT (Child-Pugh-Turcotte) category relative to pre-treatment through up to 36 (CPT C) or 42 (CPT B) months, relative to treatment start,” he added.
While SVR rates may now be achieved in most patients, data on long-term virologic and clinical outcomes with SOF-based regimens are needed. For example, a recent report has suggested that incidence of hepatocellular carcinoma (HCC) may not be reduced after successful direct-acting antiviral therapy, Dr. Muir noted.
In order to evaluate long-term outcomes in patients with compensated or decompensated cirrhosis who achieve an SVR following treatment with a sofosbuvir-based regimen, the research team enrolled 1,087 patients with chronic HCV infection who had achieved SVR following treatment with a SOF-based regimen. A secondary goal of the study was to determine whether or not HCV RNA recurrence indicated late relapse or reinfection.
Average age of participants was 59 years (range, 33–83); 67% were male and 86% were white.
Every 6 months, HCV RNA and labs were taken and CPT and MELD criteria scored. Elastography was undertaken at baseline and then annually; endoscopy at baseline and Week 240. An optional liver biopsy as undertaken at the end of study participation. After discontinuations and withdrawals, deaths, and protocol violations, a total of 1,030 patients remained enrolled in the study at a median follow-up of 85 months.
For the registry, patients may enroll within 60 weeks of completing a treatment study or transferring from another SVR registry study, or within 2 years of achieving SVR following treatment in a clinical practice setting, Dr. Muir stated. Patients return for visits every 24 weeks for 5 years and are followed for durability of SVR and clinical outcomes—decompensation, HCC, transplantation, and liver-related death—and laboratory parameters relating to disease progression and regression.
The ongoing study will provide information on whether achieving SVR following treatment with a direct-acting antiviral regimen “will improve longer-term liver function and reduce the rate of liver-related complications, including HCC,” they noted.