Page 10 - EASL Recommendations on Treatment of Hepatitis C 2015 - Summary
P. 10
8. Treatment monitoring • The patients receiving PegIFN-α and ribavirin should
be assessed for clinical side effects at each visit, while
Monitoring of treatment efficacy the haematological side effects should be assessed at
weeks 2 and 4 of therapy and at 4 to 8 week intervals
• A real-time PCR-based assay with a lower limit of thereafter (A1)
detection of ≤15 IU/ml should be used to monitor HCV
RNA levels during and after therapy (A1) • Renal function should be checked regularly in patients
receiving sofosbuvir (B1)
• In patients treated with the triple combination of
PegIFN-α, ribavirin and sofosbuvir for 12 weeks, HCV • Rashes and indirect bilirubin elevations without ALT
RNA should be measured at baseline and at weeks 4, elevations may be seen with simeprevir (A1)
12 (end of treatment), and 12 or 24 weeks after the end
of therapy (A2) • Indirect bilirubin increases are rarely observed with the
combination of ritonavir-boosted paritaprevir, ombitasvir
• In patients treated with the triple combination of and dasabuvir (A1)
PegIFN-α, ribavirin and simeprevir (12 weeks plus 12 or
36 weeks of PegIFN-α and ribavirin alone), HCV RNA • No dose adjustment of simeprevir, sofosbuvir and
should be measured at baseline, week 4, week 12, ledispavir or daclatasvir is required in patients with mild,
week 24 (end of treatment in treatment-naïve patients moderate or severe renal impairment. The appropriate
and prior relapsers), week 48 (end of treatment in prior dose of sofosbuvir for patients with eGFR <30 ml/
partial and null responders), and 12 or 24 weeks after min/1.73 m2 is not yet established (B2)
the end of therapy (A2)
• No dose adjustment of sofosbuvir plus ledipasvir or
• In patients treated with an IFN-free regimen, HCV RNA daclatasvir is required for patients with mild, moderate
should be measured at baseline, week 2 (assessment or severe (Child-Pugh C) hepatic impairment (B2)
of adherence), week 4, week 12 or 24 (end of treatment
in patients treated 12 or 24 weeks, respectively), and 12 • Higher exposures have been observed with the
or 24 weeks after the end of therapy (A2) combination of ritonavir-boosted paritaprevir, ombitasvir
and dasabuvir in patients with severe hepatic
Stopping (futility) rules impairment and their safety in this group requires further
study (B2)
• With the triple combination of PegIFN-α, ribavirin and
simeprevir, treatment should be stopped if HCV RNA Monitoring drug-drug interactions
level is ≥25 IU/ml at treatment week 4, week 12 or week
24 (A2) • The efficacy and toxicity of concurrent drugs given
for comorbidities and potential drug-drug interactions
• An immediate switch to another IFN-containing DAA- should be monitored during treatment (A1)
containing or to an IFN-free regimen without a protease
inhibitor should be considered (B1) • When possible, an interacting co-medication should
be stopped for the duration of HCV treatment or the
• No futility rules have been defined for other treatment interacting co-medication should be switched to an
regimens (A1) alternative drug with less interaction potential (B1)
9. Measures to improve treatment adherence
Monitoring treatment safety • HCV treatment should be delivered within a
multidisciplinary team setting, with experience in HCV
• Women of childbearing potential and/or their male assessment and therapy (A1)
partners must use an effective form of contraception
during ribavirin-containing treatment and for a period of • HCV-infected patients should be counselled on the
6 months after the treatment has concluded (A1) importance of adherence for attaining an SVR (A1)
9 • In patients with socioeconomic disadvantages and
in migrants, social support services should be a
component of HCV clinical management (B2)
• In persons who actively inject drugs, access to harm
reduction programs is mandatory (A1)
• Peer-based support should be evaluated as a means to
improve HCV clinical management (B2)
• Patients should be counselled to abstain from alcohol
be assessed for clinical side effects at each visit, while
Monitoring of treatment efficacy the haematological side effects should be assessed at
weeks 2 and 4 of therapy and at 4 to 8 week intervals
• A real-time PCR-based assay with a lower limit of thereafter (A1)
detection of ≤15 IU/ml should be used to monitor HCV
RNA levels during and after therapy (A1) • Renal function should be checked regularly in patients
receiving sofosbuvir (B1)
• In patients treated with the triple combination of
PegIFN-α, ribavirin and sofosbuvir for 12 weeks, HCV • Rashes and indirect bilirubin elevations without ALT
RNA should be measured at baseline and at weeks 4, elevations may be seen with simeprevir (A1)
12 (end of treatment), and 12 or 24 weeks after the end
of therapy (A2) • Indirect bilirubin increases are rarely observed with the
combination of ritonavir-boosted paritaprevir, ombitasvir
• In patients treated with the triple combination of and dasabuvir (A1)
PegIFN-α, ribavirin and simeprevir (12 weeks plus 12 or
36 weeks of PegIFN-α and ribavirin alone), HCV RNA • No dose adjustment of simeprevir, sofosbuvir and
should be measured at baseline, week 4, week 12, ledispavir or daclatasvir is required in patients with mild,
week 24 (end of treatment in treatment-naïve patients moderate or severe renal impairment. The appropriate
and prior relapsers), week 48 (end of treatment in prior dose of sofosbuvir for patients with eGFR <30 ml/
partial and null responders), and 12 or 24 weeks after min/1.73 m2 is not yet established (B2)
the end of therapy (A2)
• No dose adjustment of sofosbuvir plus ledipasvir or
• In patients treated with an IFN-free regimen, HCV RNA daclatasvir is required for patients with mild, moderate
should be measured at baseline, week 2 (assessment or severe (Child-Pugh C) hepatic impairment (B2)
of adherence), week 4, week 12 or 24 (end of treatment
in patients treated 12 or 24 weeks, respectively), and 12 • Higher exposures have been observed with the
or 24 weeks after the end of therapy (A2) combination of ritonavir-boosted paritaprevir, ombitasvir
and dasabuvir in patients with severe hepatic
Stopping (futility) rules impairment and their safety in this group requires further
study (B2)
• With the triple combination of PegIFN-α, ribavirin and
simeprevir, treatment should be stopped if HCV RNA Monitoring drug-drug interactions
level is ≥25 IU/ml at treatment week 4, week 12 or week
24 (A2) • The efficacy and toxicity of concurrent drugs given
for comorbidities and potential drug-drug interactions
• An immediate switch to another IFN-containing DAA- should be monitored during treatment (A1)
containing or to an IFN-free regimen without a protease
inhibitor should be considered (B1) • When possible, an interacting co-medication should
be stopped for the duration of HCV treatment or the
• No futility rules have been defined for other treatment interacting co-medication should be switched to an
regimens (A1) alternative drug with less interaction potential (B1)
9. Measures to improve treatment adherence
Monitoring treatment safety • HCV treatment should be delivered within a
multidisciplinary team setting, with experience in HCV
• Women of childbearing potential and/or their male assessment and therapy (A1)
partners must use an effective form of contraception
during ribavirin-containing treatment and for a period of • HCV-infected patients should be counselled on the
6 months after the treatment has concluded (A1) importance of adherence for attaining an SVR (A1)
9 • In patients with socioeconomic disadvantages and
in migrants, social support services should be a
component of HCV clinical management (B2)
• In persons who actively inject drugs, access to harm
reduction programs is mandatory (A1)
• Peer-based support should be evaluated as a means to
improve HCV clinical management (B2)
• Patients should be counselled to abstain from alcohol
