Recommended follow-up for people not on treatment.
Review every 6 to 12 months and monitor for signs and symptoms of liver disease e.g. palmar erythema, spider naevi, jaundice, ascites, encephalopathy, hepato-splenomegaly, pruritis, weight loss and/or lethargy.
Monitor FBC, ALT, INR, albumin and bilirubin every 6 to 12 months.
Screening for hepatocellular carcinoma: Ultrasound and AFP every 6 months for those with cirrhosis.
Fatigue: advise planning rest periods during the day and the addition of light to moderate exercise into their routine to reduce fatigue.
Important: Provide immunisation and advice on how to reduce transmission.
Recommended follow-up for people on treatment or post-treatment
Monitoring of patients receiving antiviral therapy for hepatitis C virus (HCV) infection: (A) on-treatment and post-treatment monitoring for virological response; and (B) monitoring after SVR.
|A. On-treatment and post-treatment monitoring for virological response
|Routine monitoring for a 12 week treatment regimen:
- FBE, urea and electrolytes, LFTs, INR, HCV RNA level (quantitative)
- FBE, LFTs, HCV PCR (qualitative)
At each treatment visit, assess for:
- medications adherence
- treatment adverse effects
- drug-drug interactions.
|Week 12 after EOT (SVR)
- FBE, LFTs, HCV PRC (qualitative)
- Routine on-treatment HCV RNA testing is not mandated but may be considered where there is a clinical concern about non-adherence to treatment, especially in people with cirrhosis.
- The need for increased frequency of review should be individualised.
- Patients taking ribavirin may require FBE at Week 2 and Week 4 and then every 4 weeks.
- Patients with cirrhosis require monitoring every 4 weeks, including FBE, LFTs and assessment for hepatic decompensation. Measurement of quantitative HCV RNA level is recommended at Weeks 4, 12 ± 24 on-treatment in patients with cirrhosis.
- Patients with decompensated liver disease require close monitoring, with review every 2–4 weeks.
- Patients taking hepatitis C treatment need monitoring for drug-drug interations (external site).
|B. Monitoring after SVR
SVR, no cirrhosis and normal LFT results (males, ALT < 30 U/L; females, ALT < 19 U/L):
- Patients who are cured do not require clinical follow-up for HCV
SVR and abnormal LFT results (males, ALT ≥ 30 U/L; females, ALT ≥ 19 U/L):
- Patients with persistently abnormal LFT results require evaluation for other liver diseases and should be referred for gastroenterology review. Investigations to consider include: fasting glucose level, fasting lipid levels, iron studies, ANA, ASMA, anti-LKM antibodies, total IgG and IgM, AMA, coeliac serology, copper level, caeruloplasmin level and α-1-antitrypsin level
- Patients with cirrhosis require long-term monitoring and should be enrolled in screening programs for:
- hepatocellular carcinoma — liver ultrasound ± serum α-fetoprotein level
- oesophageal varices — gastroscopy
EOT = end of treatment. SVR = sustained virological response at least 12 weeks after treatment (cure). FBE = full blood examination. LFT = liver function test. INR = international normalised ratio. PCR = polymerase chain reaction. ALT = alanine aminotransferase. ANA = anti- nuclear antibodies. ASMA = anti-smooth muscle antibodies. LKM = liver–kidney microsome. AMA = anti-mitochondrial antibody.
Source: Gastroenterological Society of Australia (GESA) (external site) – see Table 6.
Refer to a PBS approved specialist for the following (see metro and regional list of approved specialists):
1. If the patient is suspected of having cirrhosis or the hepascore is >0.8;
2. If the ALT following treatment remains elevated;
3. All people with decompensated cirrhosis should urgently be referred.
Hepatitis C and HIV infection
Refer to specialist for treatment.
Hepatitis C in pregnancy and breastfeeding
There are no safety data for the use of any DAA regimen during pregnancy, with all PBS-listed DAA regimens classed as Category B (sofosbuvir, B1; ledipasvir, B1; daclatasvir, B3; PrOD, B3) for their risk in pregnancy. Treatment of pregnant women with DAA therapy is therefore not recommended.
Hepatitis C in children
Children under the age of 18 years are not currently eligible for treatment with the new HCV medications under the PBS.
People under the age of 18 years should be referred to a paediatrician who is experienced in the treatment of HCV for discussion about therapy.