CATIE HepCinfo Update 4.22

New and Noteworthy

FDA advisory committee recommends the approval of simeprevir and sofosbuvir

The Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously recommended the approval of two direct-acting antivirals for hepatitis C, simeprevir and sofosbuvir. The newer direct-acting antiviral medications are more effective, easier to take and have significantly fewer side effects.

Simeprevir was recommended as a once-daily dose with peg-interferon and ribavirin for people with genotype 1 who have never been treated (treatment naïve) or who have previously not responded to treatment (prior non-responders) and people who have severe liver damage. Side effects may include rash and increased likelihood of sunburn (photosensitivity).

Sofosbuvir was recommended as a triple therapy with peg-interferon and ribavirin for people with genotype 1 and as an interferon-free treatment of sofosbuvir and ribavirin for genotypes 2 and 3. Side effects may include fatigue, headache and nausea.

Final decisions about U.S. approval of simeprevir and sofosbuvir are expected by the end of 2013. The FDA is not required to follow its advisory committees’ recommendations, but it usually does so. (, October 2013, in English)


Simeprevir triple therapy effective for people co-infected with Hep C and HIV

A late-stage trial of the direct-acting antiviral medication, simeprevir in combination with peg-interferon and ribavirin produced cure rates of 74% in participants with genotype 1 and co-infected with HIV, reported researchers at the European AIDS Conference in Brussels. Participants had well-controlled HIV and the majority of them were on HIV treatment. The participants took simeprevir once daily in addition to peg-interferon and ribavirin for 12 weeks. Participants with a good early response to treatment were eligible for shortened treatment that involved an additional 12 weeks of peg-interferon only.  All other participants stayed on treatment of peg-interferon and ribavirin for 36 additional weeks. People who had previously not responded well to Hep C treatment and those who had severe liver damage also remained on treatment. People who had previously tried treatment and had no response (prior null responders) had a high cure rate (57%) compared to previous studies of null responders co-infected with HIV (5%). The treatment was well tolerated with a similar side effect profile to trials of people with only hepatitis C.

Simeprevir once-daily plus pegylated interferon/ribavirin for 12 weeks “led to high rates of [sustained virological response] SVR12 in HCV genotype 1/HIV-1 patients regardless of prior HCV treatment response,” the researchers concluded. (, October 2013, in English)


High rates of Hep C reinfection among HIV-positive gay men in Europe

Almost 10% (55 out of 556) of HIV-positive gay men in a large European study who had previously cleared the Hep C virus became reinfected, reported researchers at the European AIDS Conference in Brussels. The study was a type of study that follows a group of people over time (called a prospective cohort study). Participants joined the study in 2002 and were from the U.K., Austria and Germany. Four (out of 55) participants had a third Hep C infection and one became reinfected a fourth time. Participants who became reinfected had well-controlled HIV (low or undetectable viral load and a high CD4 count).

Factors associated with Hep C transmission among HIV-positive gay men from other studies include anal sex, fisting, group sex, sexually transmitted infections and non-injection recreational drug use.

“This [research] highlights the need for further research to identify factors associated with acute hepatitis C (AHC) transmission as well as the need for subsequent adequate counselling by the health care provider,” recommended the researchers.  (, October 2013, in English)

See also: Sexual transmission of hepatitis C: Are HIV-positive gay and bisexual men at risk? (, Spring 2011, in English and French)


Straight to the source for new science

Continued low uptake of treatment for hepatitis C virus infection in a large community-based cohort of inner city residents, Liver International, October 2013, in English

Is the genotype 3 of the hepatitis C virus the new villain? Hepatology, October 2013, in English