Hepatitis C

Specialty Pharmacy Times, Jan/Feb 2013, Volume 4, Issue 1

Achieving a sustained viral response in patients with hepatitis C is showed to reduce the risk of liver cancer.

Achieving a sustained viral response in patients with hepatitis C is showed to reduce the risk of liver cancer.

Suppressing HCV Decreases Risk of Liver Cancer

A study published online on October 23, 2012, in The Journal of Hepatology confirms that successful suppression of hepatitis C virus (HCV) with pegylated interferon and ribavirin reduces the risk that patients will develop hepatocellular carcinoma (HCC).

The study enrolled 1013 patients with chronic hepatitis C and treated them with the same 2 drugs. Virological responses were recorded, and it was found that 557 (55%) patients achieved a sustained virological response (SVR), 304 (30%) had transient virological responses (TVRs), and 152 (15%) had no virological response (NVR). SVR rates were higher with HCV genotype 2 than with genotype 1.

The researchers then calculated the 5-year cumulative incidence rate of HCC, and they found that the rate of HCC was significantly higher in the NVR group (18.8%) than in either the SVR group (3.1%, P <0.001) or the TVR group (5.8%, P <0.001). They saw this pattern to be even more dramatic in HCV patients who had cirrhosis: HCC rates were significantly lower in the SVR (18.9%) and TVR (20.8%) groups than in the NVR group (39.4%). In non-cirrhotic patients younger than 60 years, the results did not reach statistical significance. However, in older non-cirrhotic patients, HCC rates were significantly lower for patients who achieved an SVR.

The study confirms the best way to decrease the risk of HCC is to successfully treat patients with chronic HCV by achieving an SVR. The researchers also noted that because the risk for HCC exists even after an SVR is achieved, long-term follow-up is important.

Interferon-Free Regimens Associated with High HCV Sustaiend Response

The use of oral, interferon-free regimens is gaining traction among hepatitis C experts, and the successful results of trials with these oral drugs, presented at the American Association for the Study of Liver Diseases 63rd Annual Meeting in Boston, have only sparked enthusiasm even more.

The study was a phase 2b trial of 3 direct-acting antiviral drugs (DAAs), which included a boosted protease inhibitor, a nonnucleoside polymerase inhibitor with or without ribavirin, and an NS5a inhibitor. Patients who were enrolled in the study were between the ages of 18 and 70 years, had chronic HCV genotype 1a or 1b, were noncirrhotic, and were either treatment-naïve or had not responded to prior treatment with peginterferon and ribavirin and were not coinfected with HIV or hepatitis B virus.

The researchers found that regardless of treatment assignment, all patients reached very high rates of SVR after 12 weeks of therapy with excellent safety and tolerability. The lead author, Dr. Kris Kowdley, said that the 3-drug regimen will move into phase 3 as a co-formulated tablet of all 3 drugs.

While many experts are optimistic about these results—especially that SVR seems to be the same between genotypes 1a and 1b—some express concerns that 8-week therapy does not offer as frequent SVRs as 12-week therapy. Moreover, if the pill burden is not decreased from 5 pills a day (as in this study), then results in the real world might not be as promising. Once the tablets are reformulated into 1 tablet daily, however, proponents argue compliance will be simple.

Triple Therapy Superior in Treating HCV

In a review published online on November 26, 2012, in the Annals of Internal Medicine, Roger Chou, MD, and colleagues from the Oregon Health and Science University in Portland assessed the comparative clinical effectiveness of dual therapy with pegylated interferon combined with ribavirin and triple therapy with either boceprevir or telaprevir, the 2 new oral agents that were approved in 2011.

The researchers found that in 2 clinical trials, triple therapy was associated with a greater likelihood for SVR than dual therapy. They also found that a 24-week triple therapy regimen was associated with a greater likelihood of SVR than a 48-week dual therapy regimen.

The results provide further evidence that triple therapy may become the mainstay of treatment of chronic hepatitis C virus. The review, the researchers note, “has important implications for treatment as well as for screening, since screening benefits depend in part on the effectiveness of available treatments.”

About the Author

Michael C. Wisotsky, PharmD, RPh, practices in Shrewsbury, New Jersey.