NCCVH Guidelines for the Management
of Adult Patients with HCV Infection
August 2020
Inclusion criteria
- Positive HCV RNA within the past 6 months. If the patient has received HCV therapy during that period, a new test should be performed.
Exclusion criteria
- Child C cirrhosis.
- Manifest liver decompensation: uncontrolled ascites, history of hepatic encephalopathy, hepatorenal syndrome.
- Serum albumin less than 2.8 g/dl, total bilirubin more than 3 mg/dl and INR 1.7 or more.
- Platelets count less than 50,000/mm3.
- HCC, except 6 months after concluding an intervention aiming at cure with no evidence of activity by dynamic CT or MRI.
- Extra-hepatic malignancy except after two years of disease-free interval. In lymphomas and chronic lymphatic leukaemia, treatment can be initiated immediately after remission based on the treating oncologist’s report.
- Pregnancy or inability to use effective contraception.
Precautions before starting treatment
- Check HCV treatment history.
- Ladies in the childbearing period should have a recent negative pregnancy test and should be counselled for effective contraception especially with the use of ribavirin.
- Check medications received by the patient especially cardiovascular disease therapy (particularly amiodarone), antipsychotic therapy and statins.
- Family counselling for the risk of transmission and prevention of infection.
Management of HCV treatment-naïve patients
Patients are categorized into “easy” or “not easy” to treat groups according to pre-treatment tests:
Criteria |
Easy to treat
● Total serum bilirubin ≤ 1.2 mg/dl ● Serum albumin ≥ 3.5 g/dl ● INR ≤ 1.2 ● Platelets count ≥ 150,000/mm3
|
Not easy to treat group
●Total serum bilirubin > 1.2 mg/dl ● Serum albumin < 3.5 g/dl ● INR > 1.2 ● Platelets count < 150,000/mm3
|
Treatment regimen |
SOF + DCV for 12 weeks
|
● SOF + DCV + RBV* for 12 weeks ● SOF + DCV for 24 weeks if cases of RBV ineligibility or intolerance
|
*Ribavirin cannot be given if the patient’s hemoglobin is less than 10 g/dl, in case of depression, or cardiac
dysfunction. A drop of hemoglobin of 2 g, or less than 10 g/dl necessitates intervention either by dose
reduction, possible use of erythropoietin or possible discontinuation. Ribavirin dose starts by 600 mg/day and
is raised gradually to 1,000 mg/day according to tolerance.
DCV, daclatasvir; LDV, ledipasvir; RBV, ribavirin; SOF, sofosbuvir.
Management of HCV treatment-experienced patients
Previous Regimen |
Child-Pugh class A |
Child-Pugh class B |
●IFN + RBV ● INF+ SOF + RBV ● SOF + RBV ● SOF + SIM ± RBV ● OBV/ PTV/r + RBV
● SOF + DCV for 12 weeks
● OBV/ PTV/r + SOF ± RBV for 12/24 weeks ● SOF + SIM +DCV ± RBV for 12 weeks
|
SOF + DCV + RBV for 24 weeks
SOF/VEL/VOX for 12 weeks
SOF/VEL/VOX for 12 weeks
|
SOF + DCV + RBV for 24 weeks
SOF/VEL + RBV (initial dose 600 mg daily) for 24 weeks (Treatment in special centers)
|
● SOF/VEL/VOX for 12 weeks
● SOF/VEL + RBV for 24 weeks
|
SOF/VEL/VOX + RBV for 24 weeks
|
|
DCV, daclatasvir; IFN, interferon; LDV, ledipasvir; OBV, ombitasvir; PTV, paritaprevir; r, ritonavir; RBV,
ribavirin; SIM, simeprevir; SOF, sofosbuvir; VEL, velpatasvir; VOX, voxilaprevir.
Patients with chronic kidney disease
- As described above for HCV treatment-naïve and experienced patients.
- Sofosbuvir-containing regimens could be used without dose adjustment in patients with renal disease, including those with an eGFR ≤30 ml/min and those on dialysis.
- RBV dose adjusted according to eGFR and hemoglobin level:
- eGFR > 50: 600-1,200 mg daily as tolerated
- eGFR 30-50: 400 mg alternating with 200 mg
- eGFR < 30, not on dialysis: 200 mg daily to be reduced if not tolerated to 200 mg, 3 times weekly
- eGFR < 30, on dialysis: 200 mg, every other day given on dialysis day, 4 hours before dialysis.
- Should be discontinued if hemoglobin level declines by more than 2 g/dl despite the use of erythropoietin.
Patients post-liver transplantation (Treatment in special centers)
- As described above for HCV treatment-naïve and experienced patients.
- Voxilaprevir is not recommended in patients receiving cyclosporine.
Dual HBV and HCV infection
- HCV therapy should be started immediately, following the same rules as in patients with HCV mono-infection.
- HBsAg positive patients are treated if the treatment requirements are present, as in patients with HBV mono-infection. In case these criteria are not met (like an inactive carrier state), the following 2 options are available:
- Initiate prophylaxis, to be continued until 12 weeks after end of treatment.
- Monitor HBV DNA levels every 4 weeks, during and immediately after end of treatment for HCV. Nucleos(t)ide therapy is initiated if HBV DNA rises by 10-fold (one log), or if HBV DNA exceeds 1,000 IU/ml if it was previously undetectable.
Combined HCV/HIV Infection and HCV/HBV/HIV (Treatment in special centers)
According to the special protocol for these co-infections.
Precautions after the end of treatment
- Confirmatory PCR test for the sustained virologic response should be performed 12 weeks after the end of treatment.
- Patients with advanced liver fibrosis (FIB4 ≥ 3.25) should be enrolled in the HCC surveillance program using AFP and abdominal ultrasonography every 4 months.
- HBV vaccination should be initiated if not already received