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Sofosbuvir-Based Treatment Offers High SVR Rates in Hard-to-Treat HCV Genotype 3 Patients

AUG 18, 2017 | GAIL CONNOR ROCHE
Patients with chronic hepatitis C virus (HCV) genotype 3 infections and advanced liver disease are becoming increasingly harder to treat.

A new study, conducted in the real-life setting of Scandinavia, sought to assess the treatment outcome of a therapy based on the direct-acting antiviral (DAA) drug sofosbuvir. The researchers found that HCV patients with hard-to-treat genotype 3 showed sustained virologic response (SVR) of greater than 90%.

Previous studies have found that HCV genotype 3 has been linked to an increased risk of developing cirrhosis and hepatocellular carcinoma (HCC) compared with other versions of the virus.

“Chronic hepatitis C virus (HCV) genotype 3 infection with advanced liver disease has emerged as the most challenging to treat,” researchers — led by Olav Dalgard, MD, PhD, at Akershus University Hospital in Oslo, Norway — noted in their study.

The research team from Norway, Denmark, Finland, and Sweden chose patients from those four countries for the retrospective cohort study. About 100,00 individuals in Scandinavia are infected with HCV – and half of them have genotype 3, according to the paper. 

“Genotype 3 is common all over Scandinavia and in the UK,” Dr. Dalgard told MD Magazine ® in email correspondence. “We don’t know why, but genotype 3 has its origin in South Asia and both the UK and Norway and Denmark have large immigrant populations from Pakistan.”

Only a few studies have reported the effect of sofosbuvir-based treatment in genotype 3 patients with advanced liver disease in a real-life setting, the authors note.

“Our paper is important globally because it shows that very good SVR rates can be achieved with available drugs even in patients with decompensated cirrhosis and genotype 3 infection,” Dr. Dalgard said.

The team chose patients for the study who were 18 years of age or older and had received at least one dose of sofosbuvir. Those who’d had an organ transplant or were co-infected with hepatitis B (HBV) or human immunodeficiency virus (HIV) were excluded. In total, 316 patients were selected and 311 were included in the modified intention to treat (miTT) population.

The group was given sofosbuvir in various combinations with other drugs. The combinations included sofosbuvir with ribavirin, daclatasvir (Daklinza, Bristol-Myers Squibb), ledipasvir (Harvoni, Gilead) or pegylated interferon alpha (peg-IFN-α). The treatment administered depended on national guidelines and availability.

The researchers found that the rates of SVR at 12 weeks were similar across all treatment regimens. Men had a lower cure rate (89%) than women (97%.) Patients with cirrhosis fared worse than those who did not have liver scarring, 90% compared with 96% respectively. Those with decompensated cirrhosis had lower SVR12 rates than individuals with compensated liver disease, at 82% compared with 94%. Similarly, increasing liver stiffness was associated with a decreased chance of attaining SVR, the authors wrote.

The results must be interpreted with caution, however, because there was no external monitoring of the data, according to the paper. Even so, data obtained in a real-world setting complement the information derived from randomized clinical trials, the researchers said. 

Real-life studies also provide important outcome data in a broader range of patients, including those with more advanced liver disease, the authors note. Such individuals are often excluded from clinical trials.
 
Dr. Dalgard reported receiving research grants and conducting paid lectures involving Gilead, AbbVie Inc. and Merck & Co. Other team members also reported competing interests.

 
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