On-treatment monitoring

In contrast to IFN-based treatment regimens, intense monitoring of people undergoing DAA therapy is usually unnecessary. This simplification recognises the high efficacy of these regimens, the lack of a role for response-guided therapy and the considerably improved side effect profile. During treatment, follow-up intervals need to be established on a case-by-case basis to optimise adherence, assess adverse events and potential drug–drug interactions and monitor blood test results necessary for patient safety (Table 4). All patients should be provided with contact details for a clinician to contact if problems arise in between appointments. For many people, no assessment will be required during treatment, and review at 12 weeks after completion of therapy can be organised to document SVR.

More intensive monitoring may be required in certain populations. On-treatment and end-of-treatment virological assessments may be considered if there are concerns about adherence to therapy, particularly if there are risk factors for reinfection. Low levels of plasma HCV RNA can be detected in up to 20% of people using sensitive PCR assays at Week 4 of treatment, but this does not predict treatment failure, nor does it require treatment extension. The product information for the regimen of elbasvir plus grazoprevir recommends that liver function tests be performed at Week 8 for people treated for 12 weeks’ duration, and at Week 8 and Week 12 for those receiving 16 weeks of treatment.49

Patients treated with ribavirin require monitoring of haemoglobin levels. People with advanced liver disease (portal hypertension or hepatic decompensation) require more intensive monitoring. In this setting, more frequent liver function tests are advisable to monitor for medication adherence and early evidence of hepatic decompensation related to drug reaction. Calculation of MELD and Child–Pugh scores, as well as measurement of body weight, is useful for detecting deteriorating liver function or ascites in people with cirrhosis.

Screening for HCC is recommended at baseline for all people living with cirrhosis. We recommend ongoing surveillance with liver ultrasound every 6 months. The impact of DAA treatment on HCC risk is not yet clear (see Direct-acting antiviral therapy and risk of hepatocellular carcinoma in people with cirrhosis). HCV treatment should not suspend HCC screening programs. We recommend a liver ultrasound be performed before starting DAA treatment (within 1 month before starting treatment) for all patients with cirrhosis to ensure that HCC screening remains up to date during the treatment and follow-up period.

People with HCV–HBV coinfection are at risk of HBV reactivation during DAA therapy for HCV (see Treatment of HCV in the setting of HBV coinfection). Specific monitoring for HBV reactivation is required. It is recommended that these people be treated by a specialist with experience in treating HCV and HBV infection.