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