CATIE’s HepCInfo Update 5.4

New and Noteworthy

European Medicines Agency advises on compassionate use of sofosbuvir (Sovaldi) and ledipasvir
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the compassionate use of sofosbuvir (Sovaldi) and ledipasvir for people with hepatitis C who are at high risk of liver failure or death within 12 months.

In mid-stage trials, high cure rates have been shown for the combination of sofosbuvir (Sovaldi) and ledipasvir, with or without ribavirin, in people with advanced liver disease.

Compassionate use programs are intended to give people with life-threatening illnesses access to medications that are still in clinical development. CHMP provides opinions to member states of the European Union on compassionate use programs.

CHMP will release a report on the compassionate use of sofosbuvir (Sovaldi) and ledipasvir with or without ribavirin on the European Medicines Agency website in the near future. (, February 2014, in English)


High cure rate with daclatasvir and asunaprevir for people with genotype 1b and considered ”hard to treat”
A mid-stage trial of daclatasvir and asunaprevir showed high cure rates for people with genotype 1b, reported researchers in the Journal of Hepatology. The participants in this study were considered “hard-to treat”.  They were people who had not responded to previous treatment (null responders) and the majority carried a gene that is associated with a poor response to interferon (IL28B CT or TT).

Participants were treated with daclatasvir and asunaprevir once or twice daily with some treatment arms also taking peg-interferon and ribavirin. All participants were treated for 24 weeks.  Side effects included headache, diarrhea and asthenia (weakness), but none were considered serious.

Participants with genotype 1a were also included in this study but they did not have high cure rates with the treatment regimen of daclatasvir and asunaprevir.  However, these participants did have high cure rates with the quad therapy of daclatasvir, asunaprevir, peg-interferon and ribavirin.

Given the differences in response by genotype subgroups, the researchers recommended that, “interferon-free regimens including daclatasvir and twice-daily asunaprevir for genotype 1 null responders should be tailored to subtype.” (, March 2014, in English)


Current treatments may not benefit some groups of older people with hepatitis C
Curing Hep C appears to provide little benefit to older people with minimal liver damage, according to a modeling study published in the Journal of Hepatology.

The researchers created a model to simulate the lifetime course of hepatitis C related liver disease according to two scenarios: the person who is cured as a result of Hep C treatment and the person who is not cured either because he or she does not want treatment or does not respond to treatment. The course of liver disease was compared for different model subjects. Treatment in the model was peg-interferon, ribavirin and a direct-acting anti-viral medication. The benefit of a cure was defined as the likelihood of gaining additional life-years and “healthy” life-years spent avoiding liver failure.

Results indicated that the benefit of a cure varied widely. For example, the probability that a 60-year-old person with mild liver damage would gain life-years as a result of being cured was low (1.6%).  In comparison, the likelihood of a 30-year-old person with severe liver damage gaining life-years was high (between 57.9% and 67.1%).

According to the researchers, “in the short term, this work will inform the contemporary patient dilemma of immediate treatment with existing interferon-centered therapies, versus holding out for future regimens that promise higher SVR rates and improved tolerability,” (, February 2014, in English)