All-Oral Direct-Acting Antiviral Treatments Improve Survival In Patients With HCV-Related Hepatocellular Carcinoma

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BOSTON – Data from a new study presented this week at The Liver Meeting® – held by the American Association for the Study of Liver Diseases – found that hepatitis C virus-related hepatocellular carcinoma (HCC) patients who achieved sustained virologic response (SVR) – denoting an undetectable level of HCV virus - with any oral direct-acting antiviral (DAA) had over 60-70 percent improvement in five-year survival. This improvement was found in both all-cause and liver-related cancers and was compared to patients with untreated hepatitis C virus (HCV). The study’s findings suggest that anyone with HCV-related HCC who is a candidate for HCC therapy should also be considered for DAA therapy.

There is limited data on survival outcomes for patients with HCV-related HCC following an HCV cure with DAAs. To address this lack of data, a multinational study was conducted by researchers in the U.S., Korea, Japan and Taiwan in order to compare survival rates in patients who achieved SVR with patients whose HCV was untreated.

"Patients with HCC have such dismal prognosis, especially those who are not candidates for curative treatment, and unfortunately, these are the majority of the HCC population. Systemic palliative therapies for HCC generally have increased median survival of treated patients by a few months, and many of these treatments are poorly tolerated," says Mindie H. Nguyen, MD, MAS, professor of medicine at Stanford University in California. "I have observed significant improvement in survival for hepatitis B-related HCC patients who received antiviral treatment for hepatitis B, even in patients with advanced tumor and/or liver disease stages. So, I wanted to see if antiviral treatment with DAA for HCV-related HCC patients can yield similar or even better results, since DAA therapies are very well tolerated even in patients with very advanced liver disease and HCC. Prior studies have also shown that cure rates with DAAs for HCV-related HCC are similar to rates in patients without HCC (about 95 percent). Patients with untreated or only partially treated HCC have a lower cure rate at 85 percent, though this is still fairly high and should not exclude these patients from HCV treatment."

The study’s participants included 1,676 mono-infected HCV-related HCC patients: 614 were seen at two U.S. medical centers, and 1,062 at six medical centers in Korea, Japan and Taiwan from 2005-2017. Patients were put into two groups: those untreated for HCV and those treated for HCV with DAAs who achieved SVR. There were 1,239 patients in the untreated group and 437 in the SVR group. The researchers matched and balanced the two groups based on a number of demographics, liver function and HCC characteristics, and they evaluated survival rates taking into consideration when patients began treatment.

After patient matching, the researchers ended up with 321 pairs of patients (321 untreated and 321 SVR, all treated for HCC). After time-varying adjustment for the HCV treatment start time, SVR patients had significantly higher five-year overall survival rates compared to those untreated for HCV (87.78 percent compared to 66.05 percent). The SVR group also had higher liver-related survival compared to untreated patients (90.90 percent compared to 68.76 percent). SVR was independently associated with a 63 percent lower risk of all-cause mortality and a 76 percent lower risk of liver-related mortality, according to multivariate regression analysis. Further analysis at 90, 180 and 360 days also showed that achieving SVR with DAAs was independently associated with a lower risk of death compared to no HCV treatment.

"SVR patients following treatment with very safe and well-tolerated DAAs could increase their survival rates by a median of 18 months, [which is] considerable progress compared to other currently available systemic therapies for HCC. I believe the next important step is to study the current DAA utilization among HCC patients and how to optimize its use," says Dr. Nguyen.

"Our results clearly showed that SVR by DAA therapy is associated with improved overall survival, which is the most important endpoint for patients with a cancer," says co-author of the study, Hidenori Toyoda, MD, PhD, director of hepatology in the Department of Gastroenterology at Ogaki Municipal Hospital in Japan. "Next, we should elucidate how SVR by DAA contributes to improved survival of patients with HCC, whether through the improvement of liver function which, in turn, provides patients with more hepatic reserve more opportunities to get HCC treatment, through both initial and repeat treatment, or through more direct effects that suppress the recurrence and/or progression of HCC."

Drs. Nguyen and Toyoda will present these findings at AASLD’s press conference in Room 210 at the Hynes Convention Center in Boston on Saturday, Nov. 9 from 4 – 5:30 PM. The study entitled “HCV Cure by All Oral DAA Improves 5-Year Overall and Liver-Related Survival in HCV-Related HCC Patients: A Real-World, Propensity Score-Matched Study From Both East and West” will be presented on Sunday, Nov. 10 at 8:30 AM in Room 304/306. The corresponding abstract (number 0040) can be found in the journal, HEPATOLOGY.