Previously Unforeseen Risk Tarnishes Hep C Wonder Drugs

The improvement in Hepatitis C treatment success marks a dramatic change in the prognosis for most Hepatitis C diagnoses. New direct-acting antiviral drugs boast viral eradication rates in the high 90th percentile, rendering hope that the Hepatitis C virus can be eradicated. Until recently, the only major obstacle surrounding these Hepatitis C medications has been their outrageously high cost. However, a large-scale prospective study has revealed a surprising caveat – revealing that the direct-acting antiviral drugs for Hepatitis C may not be the panacea the medical community had been hoping for.

Side Effects

Like all potent medications, the drugs used to eliminate Hepatitis C are likely to have side effects. Prior to 2014 when direct-acting antiviral drugs started getting approved by the U.S. Food and Drug Administration, the drugs used to treat chronic Hepatitis C had many severe side effects. Thankfully, the newer Hepatitis C treatments have fewer and milder side effects.

The most common adverse reactions to direct-acting antiviral medications for Hepatitis C include:

• Fatigue
• Diarrhea
• Headache
• Nausea
• Insomnia
• Skin Rash/Itching

Liver Cancer

Although none of the side effects listed above are pleasant, they are certainly minimal when evaluating their potential benefit of eradicating Hepatitis C. That was true until an Italian researcher presented results of his study at the American Association for the Study of Liver Diseases (AASLD) annual 2016 Liver Meeting in Boston, MA.

According to lead investigator Alfredo Alberti, MD, professor of gastroenterology at the University of Padova in Italy, direct-acting antiviral drugs could worsen liver cancer. If future investigations into this association support Alberti’s results, direct-acting antiviral drugs may present more hazard than benefit to our health. Some details from Alberti’s study include:

• Dr. Alberti and colleagues followed over 3,000 patients with Hepatitis C infection for an average of 300 days after beginning direct-acting antiviral therapy.
• Direct-acting antiviral drugs do not appear to increase liver cancer risk for people with Hepatitis C and cirrhosis.
• Direct-acting antiviral drugs appear to make previously undetected cancers worse and harder to treat.
• 50 percent of those studied who developed a tumor early during Hepatitis C treatment or just after stopping treatment developed a more aggressive type of tumor than what is typically seen.
• The severity of hepatocellular carcinoma (primary liver cancer) seemed to correlate with the antiviral therapy over a 540-day follow-up period.
• The incidence rates of liver cancer were no different in those who received direct-acting antiviral therapy and those who did not receive the therapy.
• Alberti and his colleagues hypothesized that when viral replication is halted, dramatic changes in the immunologic and molecular microenvironment occur in the liver, which impact tumor suppression mechanisms. This change allows or promotes the growth of previously undetected liver cancer cells.

Conclusion

In putting Alberti’s conclusion into a larger perspective, valuable information in the battle against Hepatitis C is gleaned. Just like the need for physical therapy to help someone recover from orthoscopic knee surgery, a rehab for liver health may be necessary following Hepatitis C viral eradication.

After the presentation of this large-scale study, more investigation into the risk of liver cancer growth acceleration from direct-acting antiviral medications for treating Hepatitis C is warranted. Until a definitive conclusion is drawn, Alberti’s work sends two clear signals.

1. One, patients with Hepatitis C who receive treatment with direct-acting antiviral medications must be monitored for hepatocellular carcinoma.
2. Two, even if the Hepatitis C virus has been eliminated, liver monitoring and care must persist.

Eliminating the virus has been the goal of Hepatitis C treatment since the infectious agent was first identified. However – Alberti’s study brings a larger picture into focus – the overall health of the liver. Viral eradication without severe side effects may only be step one of treating Hepatitis C. The second step may be finding ways to return the liver to a healthy microenvironment.