Treatment of chronic hepatitis C infection with direct acting antivirals: effects on liver fibrosis and patient reported outcomes

Chronic infection with hepatitis C virus (HCV) is a worldwide health problem.
Approximately 170 million people have chronic HCV infection worldwide.1 The
goal of antiviral treatment is to prevent development of fibrosis, cirrhosis
and hepatocellular carcinoma.2
Hepatitis C therapy is currently undergoing a revolution. Until recently,
pegylated interferon-alfa and ribavirin were the backbone of HCV treatment.
However, this regimen was associated with serious systemic side effects and
moderate response rates. At present there is a tendency towards treatment with
all-oral, interferon-free combinations of direct acting antivirals (DAA*s).
DAA*s target the HCV lifecycle at specific sites. With a combination of the
different DAA*s with or without ribavirin, an interferon-free treatment is now
available for all genotypes. Phase III clinical trials demonstrate that these
combinations can be expected to cure more than 90% of infections and are
generally well tolerated.3
In the Netherlands two drugs from different classes of DAA*s will be available
for reimbursement from the 1st of January 2015: sofosbuvir and simeprevir.
Reimbursement of other DAA*s (daclatasvir, ledipasvir, paritaprevir + dasabuvir
+ ombitasvir) is expected in the course of 2015. The major disadvantage of
these regimens is the high cost. Therefore in the Netherlands DAA treatment is
initially restricted to patients with severe fibrosis or cirrhosis (METAVIR
score F3-F4), in liver transplant setting and with severe extra hepatic disease.
Clinical trials with interferon-free DAA combinations included only a limited
amount of
cirrhotic patients whom all had compensated liver disease. Therefore it might
be that results from these trials cannot be replicated in clinical practice.4
Treatment of patients with cirrhosis remains a challenge.5 This is an
investigator-initiated study to examine the effect of DAA treatment on liver
fibrosis and patient reported outcomes in the Erasmus MC University Medical
Center (EMC). In addition we will examine efficacy and safety of DAA treatment.

• To study whether the degree of fibrosis/cirrhosis measured by non-invasive
markers diminishes after SVR.
• To study whether parameters of clinically significant important portal
hypertension change after SVR.
• To study patient reported outcomes during and after antiviral therapy in
order to investigate the effect of DAA treatment on quality of life.

Single-center, prospective observational study.
100 patients with Hepatitis C will be included.

There is no extra risk for the patient