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Hepatology Xagena

EASL Recommendations on treatment of hepatitis C - Indications for treatment: who should be treated ?


All treatment-naïve and –experienced patients with compensated or decompensated chronic liver disease related to ( hepatitis C virus ) HCV, who are willing to be treated and who have no contra-indications to treatment, should be considered for therapy.
Because not every HCV-infected patient can be treated within the next year or so, prioritization is necessary. The panel acknowledges that priorities may be modulated according to local and/or societal considerations.

Treatment priority should be based on fibrosis stage, risk of progression towards more advanced disease, presence of extrahepatic manifestations of HCV infection and risk of HCV transmission.

Treatment should be prioritized in patients with advanced fibrosis ( METAVIR score F3 to F4 ), including patients with decompensated cirrhosis who have a contra-indication to the use of Interferon-alpha ( IFN-a ) but can be safely treated with IFN-free regimens.
Indeed, data from clinical trials and real-life cohorts indicate that these patients could benefit more from a cure of HCV infection in the short-term, because substantial decreases in Child-Pugh and MELD scores and reductions in the incidence of clinical events have been observed.
However, evidence for an improved outlook is still limited in patients with Child-Pugh scores above 12 and MELD scores higher than 20.

IFN-free treatment in patients with decompensated disease should only be attempted in experienced centres until further safety and efficacy data have accumulated.

High priority groups also include patients with HIV or HBV coinfection, patients in the pre- or post-liver transplant setting, patients with clinically significant extra-hepatic manifestations ( e.g. symptomatic vasculitis associated with HCV-related mixed cryoglobulinaemia, HCV immune complex-related nephropathy and non-Hodgkin B cell lymphoma ), and patients with debilitating fatigue, regardless of their liver fibrosis stage.

Treatment should also be prioritized regardless of the fibrosis stage or extra-hepatic manifestations in individuals at risk of transmitting HCV, including active injection drug users, men who have sex with men with high-risk sexual practices, women of childbearing age who wish to get pregnant, haemodialysis patients, and incarcerated individuals.
Injection drug users and men who have sex with men with high-risk sexual practices should be made aware of the risk of reinfection and should apply preventative measures after successful treatment.

Treatment is justified in patients with moderate fibrosis ( METAVIR score F2 ). The timing and nature of therapy for patients with minimal or no fibrosis ( METAVIR score F0–F1 ) and no severe extra-hepatic manifestations is debatable, and informed deferral can be considered.

The decision to defer treatment for a specific patient should consider the patient’s preference and priorities, the natural history and risk of progression, the presence of comorbidities, and the patient’s age.
Patients who have treatment deferred should be assessed on a regular basis for evidence of progression, to reconsider the indication for treatment, and to discuss new therapies as they emerge or become available and affordable.

Treatment is not recommended in patients with limited life expectancy due to non–liver-related comorbidities.

Recommendations

• All treatment-naïve and treatment-experienced patients with compensated or decompensated chronic liver disease due to HCV should be considered for therapy ( A1 );

• Treatment should be prioritized for patients with significant fibrosis or cirrhosis ( METAVIR score F3 to F4 ) ( A1 );

• Patients with decompensated cirrhosis ( Child-Pugh B and C ) should be urgently treated with an IFN-free regimen ( A1 );

• Treatment should be prioritized regardless of the fibrosis stage in patients with HIV or HBV coinfection, patients in the pre- or post-liver transplant setting, patients with clinically significant extra-hepatic manifestations ( e.g. symptomatic vasculitis associated with HCV-related mixed cryoglobulinaemia, HCV immune complex-related nephropathy and non-Hodgkin B cell lymphoma ), and patients with debilitating fatigue ( A1 );

• Treatment should be prioritized regardless of the fibrosis stage for individuals at risk of transmitting HCV, including active injection drug users, men who have sex with men with high-risk sexual practices, women of childbearing age who wish to get pregnant, haemodialysis patients, and incarcerated individuals ( B1 );

• Treatment is justified in patients with moderate fibrosis ( METAVIR score F2 ) ( A2 );

• In patients with no or mild disease ( METAVIR score F0-F1 ) and none of the above-mentioned extra-hepatic manifestations, the indication for and timing of therapy can be individualized ( B1 );

• Treatment is not recommended in patients with limited life expectancy due to non-liver-related comorbidities ( B1 ). ( Xagena )

Source: Journal of Hepatology, 2015

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