What’s New, Updates and Changes to the Guidance

This version of the guidance has been updated to reflect several important developments in the identification and management of chronic hepatitis C. Sections of the guidance where key updates occurred are listed below:

HCV Testing and Linkage to Care

  • Recommendations for one-time, routine and opt out testing included based on recent releases from CDC and USPSTF. Supporting text updated.

Monitoring Patients Who Are Starting HCV Treatment, Are on Treatment, or Have Completed Therapy

  • New recommendation added stating that ribavirin should not be used during (or for 6 months before) pregnancy. The guidance implied this recommendation previously, but this version of the Monitoring section states it explicitly.

Initial Treatment of Adults with HCV Infection

  • Introduction has been reorganized placing emphasis on the fact that although guidance is provided by genotype, most patients will fall into one of two simplified treatment algorithms.
  • New real-world data on mixed infections included
  • End Stage renal disease removed as a contraindication in the simplified treatment section for patients without cirrhosis.
  • Real world data to support the use of glecaprevir (300mg)/pibrentasivr (120mg) for 8 weeks in cirrhotic patients added
  • Daily fixed-dose combination of elbasvir (50 mg)/grazoprevir (100 mg) recommendation changed from IB to IA and supporting data included
  • New integrated analysis for GT5/6 included

Patients With HIV/HCV Coinfection

  • Pharmacology and drug interaction data updated

Patients With Decompensated Cirrhosis

  • Data from TARGET long term study included
  • Sentence added clearly stating that protease inhibitor-containing regimens are not recommended

Patients Who Develop Recurrent HCV Infection Post Liver Transplantation

  • Removed RBV from the box for ledipasvir/sofosbuvir in those with compensated liver disease (with or without cirrhosis). Summary of multicenter ANRS CO23 CUPILT study added to support this.

Treatment of HCV-Uninfected Transplant Recipients Receiving Organs From HCV-Viremic Donors

  • New study included regarding immediate administration of antiviral therapy after transplantation of hepatitis C‐infected solid organs (livers excluded) into uninfected recipients
  • Recommendation tables updated
  • New study included regarding short term duration

Renal Impairment

  • Updated final results of C-SURFER study (elbasvir/grazoprevir for renal insufficiency), VA study on elbasvir/grazoprevir in renal failure (real-world), EXPEDITION 5 (G/P for renal insufficiency), and use of sofosbuvir for renal insufficiency.
  • Potential for colchicine toxicity in patients receiving G/P or LDV/SOF

HCV in Pregnancy

  • Recommendation for Universal Hepatitis C Screening in Pregnancy has been updated following USPSTF and CDC updated screening recommendations

HCV in Children

  • Recommendations updated to include FDA approval of (sofosbuvir/velpatasvir) for Children Ages 6 and Older or Weighing at Least 17 kg
  • Regimens reordered based on age rather than level of evidence. This arrangement will make it easier for the reader to determine which regimen is for what age group. Weight-based dosing tables rearranged accordingly.


Updated references have been provided throughout the guidance where appropriate.

Thursday, August 27, 2020