Laurent Castera and Jean-Michel Pawlotsky present the 2016 EASL treatment guidelines. Photo by Liz Highleyman, hivandhepatitis.com
The European Association for the Study of the Liver (EASL) released its latest recommendations on treatment of hepatitis C at a special meeting last Thursday in Paris. The updated guidelines now include highly effective interferon-free options for all hepatitis C virus (HCV) genotypes and for people who are the most challenging to treat.
EASL usually releases revised recommendations at its International Liver Congress in the spring, but this year the guidelines panel decided to hold off the release to wait for European approval of two newer direct-acting antiviral (DAA) regimens, grazoprevir/elbasvir (Zepatier) and sofosbuvir/velpatasvir (Epclusa).
The new 2016 guidelines call for universal access to hepatitis C treatment, stating that "All treatment-naive and treatment-experienced patients with compensated or decompensated chronic liver disease due to HCV must be considered for therapy."
Acknowledging that treatment may not be immediately available to all due to cost and other factors, the recommendations stress that some people should be treated without delay, including those with significant liver fibrosis or cirrhosis (Metavir stage F2 or higher), those with clinically significant extra-hepatic manifestations and those with HCV recurrence after a liver transplant. This is broader than the 2015 recommendations, which prioritised people at stage F3 or higher.
The new guidelines also call for prioritisation of individuals at risk for transmitting HCV, including people who inject drugs, gay and bisexual men with high-risk sexual practices, women who wish to get pregnant, kidney dialysis patients and people in prison.
All recommended regimens now include at least two DAAs. For the first time no interferon-containing regimens are listed among the recommended options, although the guidelines say these should still be considered if they are the only agents available in a given country.
Ribavirin still plays a role in helping prevent relapse in people who are difficult to treat such as those with genotype 3, prior treatment failure, cirrhosis or high viral load.
Presenting the guidelines, Prof. Jean-Michel Pawlotsky recommended ribavirin for people who are likely to experience treatment failure. "It's very important with DAAs that patients respond immediately," he said. "We can't just try the simplest regimen and retreat if needed."
Notable changes from the 2015 recommendations include the addition of grazoprevir/elbasvir (Zepatier) and sofosbuvir/velpatasvir (Epclusa), omission of sofosbuvir (Sovaldi) plus ribavirin alone for genotypes 2 and 3, removal of sofosbuvir (Sovaldi) plus simeprevir (Olysio) for genotype 1, and removal of sofosbuvir (Sovaldi) or simeprevir (Olysio) plus pegylated interferon and ribavirin for any genotype.
The approval of sofosbuvir/velpatasvir (Epclusa) now offers a single-tablet option for genotype 3, which remains a bit more difficult to treat. However, the panel decided that all treatment-experienced people with genotype 3 should use it with ribavirin (differing from US recommendations, which only recommend ribavirin for treatment-experienced people with cirrhosis).
The new guidelines also contain specific recommendations, summarised in the Infohep report on the guidelines, for the treatment of the following groups of people or situations:
- People with HIV/HCV co-infection
- People with HCV/hepatitis B virus co-infection
- People who inject drugs
- People previously treated with DAAs
- Decompensated cirrhosis
- Post-transplant recurrence of HCV
- Acute HCV infection.
Viral monitoring is not necessary during treatment, as DAA therapy has high response rates and does not rely on response-guided treatment adjustments. Monitoring can be simplified by measuring HCV RNA or HCV core antigen only before starting treatment and at 12 or 24 weeks after completing therapy.
However, people who are at ongoing risk for hepatitis C – including people who inject drugs and men who have sex with men – should be tested at least annually for reinfection. Individuals who continue to inject drugs "should not be excluded from treatment on the basis of perceived risk of reinfection," the guidelines state.
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