The new direct-acting antiviral drugs have enabled viral eradication rates in the high 90th percentile; this gave new hope that the Hepatitis C virus can be eradicated. Until recently, the only major difficulty with these Hepatitis C medications has been their very high cost, although now we have proof that the much cheaper generic versions of these drugs are just as effective as brand name drugs.

Reactivation of hepatitis B infection

New drugs that cure hepatitis C (called direct acting anti-viral drugs) can reactivate the hepatitis B virus in people who have had previous infections with hepatitis B virus or who are currently infected with hepatitis B virus. Thus, it is vital to test all patients who are about to start drugs for hepatitis C to be tested for previous infection with the hepatitis B virus. During treatment for hepatitis C, patients must be tested for flare ups of hepatitis B during and after treatment.

Between November 2013 and July 2016, the FDA became aware of 24 cases of reactivation of the hepatitis B virus in patients being treated with drugs for hepatitis C infection. Two of these cases were fatal and one patient required a liver transplant.

Reactivation of the hepatitis B virus can cause severe liver damage, and usually occurs within 4 to 8 weeks of starting the drugs for hepatitis C. Patients commencing drug treatment for hepatitis C should be advised to see a doctor urgently if they get symptoms of hepatitis such as nausea, vomiting and jaundice. It is also thought that liver cancer recurrence can be stimulated by taking direct anti-viral drugs for hepatitis C in patients co-infected with hepatitis B.

The direct anti-viral drugs linked to reactivation of the hepatitis B virus are –

  • Daclatasvir
  • Ledipasvir,
  • Sofosbuvir
  • Simeprevir
  • Dasabuvir
  • Ombitasvir
  • Paritaprevir
  • Ritonavir
  • Elbasvir
  • Grazoprevir

Liver Cancer Risk

At the American Association for the Study of Liver Diseases (AASLD) annual 2016 liver meeting in Boston, MA, an Italian researcher presented results of his study on direct acting anti-viral drugs for hepatitis C.

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 research into this link, support Alberti’s results, direct-acting antiviral drugs may present more hazard than benefit for long term liver health. 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.

Some results from Alberti’s study include:

  • 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 tumor than average.
  • 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 hypothesized that when viral replication is halted by the anti-viral drugs, 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.

Alberti’s conclusion provides valuable information in the long-term battle against Hepatitis C. Similar to the need for physiotherapy to help someone recover from joint surgery, a rehabilitation program for liver health may be necessary following Hepatitis C viral eradication.

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

  1. Patients with Hepatitis C who receive treatment with direct-acting antiviral medications must be monitored for liver cancer (hepatocellular carcinoma).
  2. Even if the Hepatitis C virus has been eliminated, liver monitoring and care must persist.

Eliminating the hepatitis C virus has been the holy grail of Hepatitis C treatment since the virus was first identified in the 1980s. However – Alberti’s study brings a larger picture into focus – the overall long-term health of the liver and immune system. 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 state so that it can be repaired and protected long term.

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