Page 35 - EASL Recommendations on Treatment of Hepatitis C 2015 - Full version
P. 35
Clinical Practice Guidelines hepatitis C. High SVR rates (>90%) have been reported with
Over 100 liver transplants have been carried out in haemophi- PegIFN-a monotherapy, regardless of the HCV genotype. Lower
lic patients worldwide. Factor VIII/IX concentrate is administered
immediately before the surgery, either by bolus injection or con- SVR rates have been reported with this regimen in patients with
tinuous infusion, and for the immediate post-operative period for HIV coinfection. Combination therapy with ribavirin does not
12–48 h, after which no further concentrate is required. increase the SVR rate in HCV-monoinfected patients, but used
Coinfection with HIV/HCV is not a contra-indication to liver to be considered during treatment in patients with slow
transplantation in haemophilia. The indications for liver trans- response, HIV coinfection and other negative predictors of treat-
plantation in humans with haemophilia are the same as non-hae- ment response [122–130]. A study reported higher SVR rates
mophilic individuals, but the procedure has the major advantage
of producing a phenotypic cure of the haemophilia as a result of after the addition of telaprevir to PegIFN-a and ribavirin in
factor VIII production by the transplanted liver.
HIV-coinfected patients infected with genotype 1 [131]. No data
Recommendations are available on the use of new IFN-free treatment regimens in
patients with acute hepatitis C.
• The indications for HCV therapy are the same in
patients with and without bleeding disorders (A1) The ideal time point for starting therapy has not been firmly
established. Some investigators estimate that the onset of ALT
• Potential drug-drug interactions in HCV-HIV coinfected elevation, with or without clinical symptoms, may be the ideal
patients receiving antiretroviral agents requires careful time point for treatment [132–135]. It has also been suggested
selection of agents (A1) that patients should be followed with 4-weekly HCV RNA quan-
tification and that only those who remain HCV RNA positive at
Follow-up of untreated patients and of patients with treatment 12 weeks from onset should be treated [136].
failure
Recommendations for treatment of patients with acute hep-
Untreated patients with chronic hepatitis C and those who failed atitis C can only be inferred from results obtained in a priori more
to respond to previous treatment should be regularly followed. difficult-to-cure chronically infected patients. There is currently
The reason(s) for non-treatment and treatment failure should no indication for antiviral therapy as post-exposure prophylaxis
be clearly documented. Untreated patients should be assessed in the absence of documented HCV transmission.
every 1 to 2 years with a non-invasive method. Patients with cir-
rhosis should undergo specific surveillance for HCC every Recommendations
6 months.
• Based on existing data, PegIFN-α monotherapy
Recommendations (PegIFN-α2a, 180 µg/week or PegIFN-α2b, 1.5 µg/kg/
week) for 12 weeks can be used in patients with acute
• Untreated patients with chronic hepatitis C and those hepatitis C, who will achieve SVR in as many as 90% of
who failed prior treatment should be regularly followed cases (A1)
(A1)
• PegIFN-α (PegIFN-α2a, 180 µg/week or PegIFN-α2b,
• Non-invasive methods for staging fibrosis are best 1.5 µg/kg/week) should be combined with daily weight-
suited for follow-up assessment at intervals (A1) based ribavirin (1000 or 1200 mg in patients <75 kg or
≥75 kg, respectively) for 24 weeks in patients with acute
• HCC surveillance must be continued indefinitely in hepatitis C who are HIV-coinfected (B1)
patients with cirrhosis (A1)
• Although no data is available yet, IFN-free regimens
Treatment of acute hepatitis C can be used in these patients as they are expected to
achieve high SVR rates. The same doses and durations
Most patients with acute hepatitis C are asymptomatic, but a as for patients with chronic hepatitis C can be used,
high rate of chronicity is expected without treatment (50–90%). without ribavirin, until new data indicate whether shorter
Symptomatic disease with jaundice, female gender, a young and/or less intensive treatment is sufficient to achieve
age, and genetic polymorphisms in the region upstream of the high infection cure rates (B1)
IL28B gene have been associated with spontaneous viral clear-
ance, but none of these parameters accurately predicts sponta- • There is no indication for antiviral therapy as post-
neous resolution at the individual level. exposure prophylaxis in the absence of documented
HCV transmission (B1)
Patients with acute hepatitis C should be considered for
antiviral therapy in order to prevent progression to chronic Perspective of new treatments
34 Other treatment regimens are at the clinical developmental stage
and could reach the market within the next few years. They
include nucleotide analogue-based regimens; nucleotide-free tri-
ple combinations of three drugs, each with a low barrier to resis-
tance, which collectively achieve a high barrier to resistance; and
nucleotide-free double combinations of two drugs that include at
Over 100 liver transplants have been carried out in haemophi- PegIFN-a monotherapy, regardless of the HCV genotype. Lower
lic patients worldwide. Factor VIII/IX concentrate is administered
immediately before the surgery, either by bolus injection or con- SVR rates have been reported with this regimen in patients with
tinuous infusion, and for the immediate post-operative period for HIV coinfection. Combination therapy with ribavirin does not
12–48 h, after which no further concentrate is required. increase the SVR rate in HCV-monoinfected patients, but used
Coinfection with HIV/HCV is not a contra-indication to liver to be considered during treatment in patients with slow
transplantation in haemophilia. The indications for liver trans- response, HIV coinfection and other negative predictors of treat-
plantation in humans with haemophilia are the same as non-hae- ment response [122–130]. A study reported higher SVR rates
mophilic individuals, but the procedure has the major advantage
of producing a phenotypic cure of the haemophilia as a result of after the addition of telaprevir to PegIFN-a and ribavirin in
factor VIII production by the transplanted liver.
HIV-coinfected patients infected with genotype 1 [131]. No data
Recommendations are available on the use of new IFN-free treatment regimens in
patients with acute hepatitis C.
• The indications for HCV therapy are the same in
patients with and without bleeding disorders (A1) The ideal time point for starting therapy has not been firmly
established. Some investigators estimate that the onset of ALT
• Potential drug-drug interactions in HCV-HIV coinfected elevation, with or without clinical symptoms, may be the ideal
patients receiving antiretroviral agents requires careful time point for treatment [132–135]. It has also been suggested
selection of agents (A1) that patients should be followed with 4-weekly HCV RNA quan-
tification and that only those who remain HCV RNA positive at
Follow-up of untreated patients and of patients with treatment 12 weeks from onset should be treated [136].
failure
Recommendations for treatment of patients with acute hep-
Untreated patients with chronic hepatitis C and those who failed atitis C can only be inferred from results obtained in a priori more
to respond to previous treatment should be regularly followed. difficult-to-cure chronically infected patients. There is currently
The reason(s) for non-treatment and treatment failure should no indication for antiviral therapy as post-exposure prophylaxis
be clearly documented. Untreated patients should be assessed in the absence of documented HCV transmission.
every 1 to 2 years with a non-invasive method. Patients with cir-
rhosis should undergo specific surveillance for HCC every Recommendations
6 months.
• Based on existing data, PegIFN-α monotherapy
Recommendations (PegIFN-α2a, 180 µg/week or PegIFN-α2b, 1.5 µg/kg/
week) for 12 weeks can be used in patients with acute
• Untreated patients with chronic hepatitis C and those hepatitis C, who will achieve SVR in as many as 90% of
who failed prior treatment should be regularly followed cases (A1)
(A1)
• PegIFN-α (PegIFN-α2a, 180 µg/week or PegIFN-α2b,
• Non-invasive methods for staging fibrosis are best 1.5 µg/kg/week) should be combined with daily weight-
suited for follow-up assessment at intervals (A1) based ribavirin (1000 or 1200 mg in patients <75 kg or
≥75 kg, respectively) for 24 weeks in patients with acute
• HCC surveillance must be continued indefinitely in hepatitis C who are HIV-coinfected (B1)
patients with cirrhosis (A1)
• Although no data is available yet, IFN-free regimens
Treatment of acute hepatitis C can be used in these patients as they are expected to
achieve high SVR rates. The same doses and durations
Most patients with acute hepatitis C are asymptomatic, but a as for patients with chronic hepatitis C can be used,
high rate of chronicity is expected without treatment (50–90%). without ribavirin, until new data indicate whether shorter
Symptomatic disease with jaundice, female gender, a young and/or less intensive treatment is sufficient to achieve
age, and genetic polymorphisms in the region upstream of the high infection cure rates (B1)
IL28B gene have been associated with spontaneous viral clear-
ance, but none of these parameters accurately predicts sponta- • There is no indication for antiviral therapy as post-
neous resolution at the individual level. exposure prophylaxis in the absence of documented
HCV transmission (B1)
Patients with acute hepatitis C should be considered for
antiviral therapy in order to prevent progression to chronic Perspective of new treatments
34 Other treatment regimens are at the clinical developmental stage
and could reach the market within the next few years. They
include nucleotide analogue-based regimens; nucleotide-free tri-
ple combinations of three drugs, each with a low barrier to resis-
tance, which collectively achieve a high barrier to resistance; and
nucleotide-free double combinations of two drugs that include at
