Page 5 - EASL Recommendations on Treatment of Hepatitis C 2015 - Summary
P. 5
5. Indications for treatment: who should be protease inhibitor, boosted or not by ritonavir, is not
treated? recommended in HIV-infected patients receiving
simeprevir (A1)
• All treatment-naïve and treatment-experienced patients
with compensated or decompensated chronic liver • The daily daclatasvir dose should be adjusted to 30
disease due to HCV should be considered for therapy mg daily in HIV-infected patients receiving atazanavir/
(A1) ritonavir and to 90 mg daily in those receiving efavirenz
(B2)
• Treatment should be prioritized for patients with
significant fibrosis or cirrhosis (METAVIR score F3 to • No drug-drug interaction has been reported between
F4) (A1) sofosbuvir and antiretroviral drugs (A2).
• Patients with decompensated cirrhosis (Child-Pugh • The fixed-dose combination of sofosbuvir and ledipasvir
B and C) should be urgently treated with an IFN-free can be used with all antiretrovirals. However, this
regimen (A1) regimen should not be used with the combination
of tenofovir/emtricitabine with atazanavir/ritonavir,
• Treatment should be prioritized regardless of the darunavir/ritonavir, lopinavir/ritonavir or elvitegravir/
fibrosis stage in patients with HIV or HBV coinfection, cobicistat when possible, or used with caution with
patients in the pre- or post-liver transplant setting, frequent renal monitoring (B1)
patients with clinically significant extra-hepatic
manifestations (e.g. symptomatic vasculitis associated • The combination of ritonavir-boosted paritaprevir,
with HCV-related mixed cryoglobulinaemia, HCV ombitasvir and dasabuvir should not be used with
immune complex-related nephropathy and non-Hodgkin efavirenz, etravirine or nevirapine, and rilpivirine
B cell lymphoma), and patients with debilitating fatigue should be used cautiously with repeat ECG monitoring.
(A1) Atazanavir and darunavir should be taken without
ritonavir and other protease inhibitors are contra-
• Treatment should be prioritized regardless of the indicated with this combination. Elvitegravir/cobicistat
fibrosis stage for individuals at risk of transmitting should not be used with this regimen because of the
HCV, including active injection drug users, men who additional boosting effect (B1)
have sex with men with high-risk sexual practices,
women of childbearing age who wish to get pregnant, 7. Treatment of chronic hepatitis C,
haemodialysis patients, and incarcerated individuals including patients without cirrhosis and
(B1) patients with compensated (Child-Pugh A)
cirrhosis
• Treatment is justified in patients with moderate fibrosis
(METAVIR score F2) (A2) • Indications for HCV treatment in HCV/HIV coinfected
persons are identical to those in patients with HCV-
• In patients with no or mild disease (METAVIR score monoinfection (A1)
F0-F1) and none of the above-mentioned extra-hepatic
manifestations, the indication for and timing of therapy • Notwithstanding the respective costs of these options,
can be individualized (B1) IFN-free regimens are the best options when available
in HCV-monoinfected and in HIV-coinfected patients
• Treatment is not recommended in patients with limited without cirrhosis or with compensated (Child-Pugh A) or
life expectancy due to non-liver-related comorbidities decompensated (Child-Pugh B or C) cirrhosis, because
(B1) of their virological efficacy, ease of use and tolerability
(A1)
6. Drug-drug interactions
• The same IFN-free treatment regimens can be used
in HIV-coinfected patients as in patients without HIV
infection, as the virological results of therapy are
identical (A1)
• Numerous and complex drug-drug interactions are Treatment of HCV genotype 1 infection
possible with the HCV DAAs, especially when they
are used in IFN-free combinations. Strict rules should Six treatment options are available in 2015 for patients
thus be applied. As the data accumulate, guidance for infected with HCV genotype 1, including 2 IFN-containing
contra-indications and dose adjustments can be found regimens and 4 IFN-free regimens. The combination of
in Tables 4A to 4F of these Recommendations and at sofosbuvir and ribavirin should not be used in patients
www.hep-druginteractions.org where they are regularly infected with HCV genotype 1. In settings where none of
updated (B1) the proposed options is available, the double combination
of PegIFN-α and ribavirin, or the triple combination of
• The use of cobicistat-based regimens, efavirenz, PegIFN-α, ribavirin and either telaprevir or boceprevir,
etravirine, nevirapine, ritonavir, and any HIV remain acceptable for selected patients likely to respond
protease inhibitor, boosted or not by ritonavir, is not to these regimens until new DAAs become available and
recommended in HIV-infected patients receiving affordable; see prior EASL Clinical Practice Guidelines.
simeprevir (A1)
• The daily daclatasvir dose should be adjusted to 30
mg daily in HIV-infected patients receiving atazanavir/
ritonavir and to 90 mg daily in those receiving efavirenz
(B2)
4
• No drug-drug interaction has been reported between
sofosbuvir and antiretroviral drugs (A2).
treated? recommended in HIV-infected patients receiving
simeprevir (A1)
• All treatment-naïve and treatment-experienced patients
with compensated or decompensated chronic liver • The daily daclatasvir dose should be adjusted to 30
disease due to HCV should be considered for therapy mg daily in HIV-infected patients receiving atazanavir/
(A1) ritonavir and to 90 mg daily in those receiving efavirenz
(B2)
• Treatment should be prioritized for patients with
significant fibrosis or cirrhosis (METAVIR score F3 to • No drug-drug interaction has been reported between
F4) (A1) sofosbuvir and antiretroviral drugs (A2).
• Patients with decompensated cirrhosis (Child-Pugh • The fixed-dose combination of sofosbuvir and ledipasvir
B and C) should be urgently treated with an IFN-free can be used with all antiretrovirals. However, this
regimen (A1) regimen should not be used with the combination
of tenofovir/emtricitabine with atazanavir/ritonavir,
• Treatment should be prioritized regardless of the darunavir/ritonavir, lopinavir/ritonavir or elvitegravir/
fibrosis stage in patients with HIV or HBV coinfection, cobicistat when possible, or used with caution with
patients in the pre- or post-liver transplant setting, frequent renal monitoring (B1)
patients with clinically significant extra-hepatic
manifestations (e.g. symptomatic vasculitis associated • The combination of ritonavir-boosted paritaprevir,
with HCV-related mixed cryoglobulinaemia, HCV ombitasvir and dasabuvir should not be used with
immune complex-related nephropathy and non-Hodgkin efavirenz, etravirine or nevirapine, and rilpivirine
B cell lymphoma), and patients with debilitating fatigue should be used cautiously with repeat ECG monitoring.
(A1) Atazanavir and darunavir should be taken without
ritonavir and other protease inhibitors are contra-
• Treatment should be prioritized regardless of the indicated with this combination. Elvitegravir/cobicistat
fibrosis stage for individuals at risk of transmitting should not be used with this regimen because of the
HCV, including active injection drug users, men who additional boosting effect (B1)
have sex with men with high-risk sexual practices,
women of childbearing age who wish to get pregnant, 7. Treatment of chronic hepatitis C,
haemodialysis patients, and incarcerated individuals including patients without cirrhosis and
(B1) patients with compensated (Child-Pugh A)
cirrhosis
• Treatment is justified in patients with moderate fibrosis
(METAVIR score F2) (A2) • Indications for HCV treatment in HCV/HIV coinfected
persons are identical to those in patients with HCV-
• In patients with no or mild disease (METAVIR score monoinfection (A1)
F0-F1) and none of the above-mentioned extra-hepatic
manifestations, the indication for and timing of therapy • Notwithstanding the respective costs of these options,
can be individualized (B1) IFN-free regimens are the best options when available
in HCV-monoinfected and in HIV-coinfected patients
• Treatment is not recommended in patients with limited without cirrhosis or with compensated (Child-Pugh A) or
life expectancy due to non-liver-related comorbidities decompensated (Child-Pugh B or C) cirrhosis, because
(B1) of their virological efficacy, ease of use and tolerability
(A1)
6. Drug-drug interactions
• The same IFN-free treatment regimens can be used
in HIV-coinfected patients as in patients without HIV
infection, as the virological results of therapy are
identical (A1)
• Numerous and complex drug-drug interactions are Treatment of HCV genotype 1 infection
possible with the HCV DAAs, especially when they
are used in IFN-free combinations. Strict rules should Six treatment options are available in 2015 for patients
thus be applied. As the data accumulate, guidance for infected with HCV genotype 1, including 2 IFN-containing
contra-indications and dose adjustments can be found regimens and 4 IFN-free regimens. The combination of
in Tables 4A to 4F of these Recommendations and at sofosbuvir and ribavirin should not be used in patients
www.hep-druginteractions.org where they are regularly infected with HCV genotype 1. In settings where none of
updated (B1) the proposed options is available, the double combination
of PegIFN-α and ribavirin, or the triple combination of
• The use of cobicistat-based regimens, efavirenz, PegIFN-α, ribavirin and either telaprevir or boceprevir,
etravirine, nevirapine, ritonavir, and any HIV remain acceptable for selected patients likely to respond
protease inhibitor, boosted or not by ritonavir, is not to these regimens until new DAAs become available and
recommended in HIV-infected patients receiving affordable; see prior EASL Clinical Practice Guidelines.
simeprevir (A1)
• The daily daclatasvir dose should be adjusted to 30
mg daily in HIV-infected patients receiving atazanavir/
ritonavir and to 90 mg daily in those receiving efavirenz
(B2)
4
• No drug-drug interaction has been reported between
sofosbuvir and antiretroviral drugs (A2).
