From the Guidelines
Laboratory monitoring for Epclusa treatment for hepatitis C should include baseline testing, monitoring during treatment, and assessment of sustained virologic response (SVR) 12 weeks after treatment completion. The most recent and highest quality study 1 recommends using a real-time PCR-based assay with a lower limit of detection of ≤15 IU/ml to monitor HCV RNA levels during and after therapy.
Key Monitoring Points
- Before initiating Epclusa, patients should have: + Complete blood count (CBC) + Comprehensive metabolic panel (including liver function tests) + HCV viral load + HCV genotype determination + Assessment of hepatic fibrosis + Hepatitis B serology + Pregnancy testing for women of childbearing potential
- During the standard 12-week treatment course: + Liver function tests should be checked at weeks 4 and 8 + Monitoring for side effects + HCV viral load should be measured at week 4 to confirm response, though this is optional as most patients respond well
- After completing treatment: + HCV RNA viral load should be checked at 12 weeks post-treatment to confirm SVR, which indicates cure ### Special Considerations
- More frequent monitoring may be necessary for patients with cirrhosis, renal impairment, or those taking medications with potential interactions
- The monitoring schedule helps ensure treatment effectiveness, detects potential hepatotoxicity early, and confirms viral clearance, which is achieved in over 95% of patients treated with Epclusa across all genotypes of hepatitis C, as supported by 1.
From the Research
Laboratory Monitoring for Epclusa Treatment for Hepatitis C
- The treatment of hepatitis C with Epclusa (sofosbuvir/velpatasvir) typically involves a 12-week course of therapy, with or without ribavirin, depending on the patient's condition 2, 3.
- Laboratory monitoring during Epclusa treatment may include: + Hepatitis C virus (HCV) RNA testing to assess viral load and response to treatment 2, 3. + Liver function tests, such as alanine aminotransferase (ALT) and aspartate aminotransferase (AST), to monitor for potential liver injury 4, 5. + Complete blood counts and platelet counts to monitor for potential hematologic adverse effects 4, 5.
- The frequency and type of laboratory monitoring may vary depending on the patient's individual needs and medical history 6, 3.
- Patients with severe renal impairment may require more frequent monitoring of liver function and other laboratory parameters due to the potential for increased risk of adverse effects 4.
- Patients with decompensated cirrhosis may require more intensive monitoring, including regular assessments of liver function and coagulation parameters 2, 3.
Special Considerations
- Patients with HIV coinfection or other comorbidities may require more frequent laboratory monitoring and closer clinical follow-up 2, 3.
- Patients who have previously failed direct-acting antiviral therapy may require more intensive monitoring and potentially longer treatment durations 5.
- The use of ribavirin in combination with Epclusa may require more frequent monitoring of hemoglobin and other laboratory parameters due to the potential for increased risk of anemia 5, 3.