The 17th National Conference on Viral Hepatitis and Liver Diseases of the Chinese Medical Association and the 2015 Annual Meeting of the Infectious Diseases Branch of the Chinese Medical Association and the Annual Meeting of the Hepatology Branch of the Chinese Medical Association were held at the China National Convention Center in Beijing, with experts and scholars in the field of hepatology holding a two-day seminar on the theme of “Hepatology in Rapid Development”. Experts and scholars in the field of hepatology held a two-day symposium, showing the latest achievements and development trends in the field of hepatology in all aspects.
As the biggest highlight of the conference, the guidelines conference held in the afternoon of the 25th officially launched the 2015 edition of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B and the Guidelines for the Prevention and Treatment of Hepatitis C. The key points of the updates regarding the 2015 edition of the Guidelines for the Prevention and Treatment of Hepatitis C are as follows.
Non-invasive diagnosis of liver fibrosis
Recommendation 1: Non-invasive diagnostic methods such as serology and/or imaging such as transient elastography can be used to help determine the presence of hepatitis C cirrhosis or fibrosis. Current noninvasive methods have better diagnostic efficacy for cirrhosis than for significant liver fibrosis. (A1)
Recommendation 2: The combination of serology and noninvasive indicators of imaging such as transient elastography can improve the diagnostic accuracy of significant liver fibrosis. When the two results are inconsistent, liver biopsy is recommended to clarify the diagnosis. (A1)
Indications for antiviral therapy
Recommendation 3: All HCV
RNA-positive patients should receive antiviral therapy as long as they are willing to be treated and have no contraindications to treatment.
Recommendation 4: PR regimen is the main regimen of antiviral therapy for patients with current HCV infection in China, and can be applied to patients with all genotypes of HCV infection and no contraindications to treatment.
Recommendation 5: DAA-based antiviral regimens include DAA in combination with PR, DAA in combination with ribavirin, and different DAAs in combination or compound, and the three regimens can cover almost all types of HCV-infected patients. Even if medical resources are limited, the decision to prioritize patients for antiviral therapy should be based on patient preference, disease and drug accessibility.
PEGylated interferon alpha in combination with ribavirin for primary care patients and monitoring
Recommendation 6: Once the diagnosis of chronic hepatitis C is confirmed and HCV is detected in the blood
RNA is detected in the blood, standardized antiviral therapy should be administered. Pre-treatment should be based on a comprehensive assessment of viral load, genotyping, stage of liver fibrosis and the presence of contraindications to antiviral therapy. (A1)
Recommendation 7: Prior to the marketing of DAA, PEG
IFNα combined with ribavirin remains the main antiviral treatment regimen for chronic hepatitis C in China at present. (A1)
Recommendation 8: Before receiving PEG
IFNα in combination with ribavirin should be individualized during treatment according to the on-treatment viral response. HCV should be monitored before treatment, at 4 weeks, 12 weeks, and 24 weeks of treatment using highly sensitive methods
RNA to assess viral response to guide therapy. (B1)
Recommendation 9: Regardless of genotype, if HCV at 12 weeks of treatment
RNA decreases <2log at 12 weeks of treatment or remains detectable at 24 weeks, then consider discontinuing the drug. （b1)
Recommendation 10: Hematology, biochemistry and HCV should be monitored regularly during treatment
RNA and adverse effects. (B1)
PEGylated interferon alpha in combination with ribavirin in patients who have not achieved a sustained virologic response with treatment
Recommendation 11: DAAs should be considered first in patients who have relapsed or failed to respond to prior PR therapy. (A1)
Recommendation 12: Patients who have not been treated with Peg-IFN-α in combination with ribavirin in previous therapy, or who have been treated with insufficient dose or duration of therapy leading to relapse, may be given Peg-IFN-α in combination with ribavirin again for 48 weeks, with the same treatment monitoring and discontinuation principles as in patients on initial therapy. (B2)
Recommendation 13: Patients who have relapsed on prior therapy and do not have an urgent need for treatment, such as the absence of the following conditions: significant liver fibrosis or cirrhosis (F3-F4), HIV or HBV co-infection, etc., awaiting liver transplantation, recurrence of HCV after liver transplantation, significant extrahepatic manifestations, individuals at high risk of transmitting HCV, etc., may choose to wait to obtain accessible and suitable drugs for retreatment. (A2)
Recommendation 14: Patients who have not been treated with Peg-IFN-α in combination with ribavirin in previous therapy, or who have been treated with insufficient dose or duration of therapy without response, may be given Peg-IFN-α in combination with ribavirin again with an extended course of therapy up to 72 weeks, with the same principles of treatment monitoring and discontinuation as in patients with primary therapy. (B2)
Recommendation 15: Patients who do not respond to previous standardized therapy can wait to obtain accessible and suitable drugs for retreatment, but patients with urgent treatment needs should be treated with direct antiviral drugs as soon as possible. (A2)
Antiviral therapy for special populations
Pediatric patients
Recommendation 16: Peg-IFN-α-2a 104μg/M2 body surface area, Peg-IFN-α-2b
60μg/M2 body surface area, once weekly subcutaneous injection, combined with RBV
15mg/kg/d for the same duration of treatment as in adults.
Patients with renal insufficiency
Recommendation 17: Simeprevir, daclatasvir, and ritonavir
boosted paritaprevir, ombitasvir, and dasabuvir are metabolized in the liver and can be used in patients with combined renal insufficiency and eGFR <30
There is currently no evidence for the use of Sofosbuvir in patients with ml/min/1.73m2 and end-stage renal disease.DAAs regimens are available for 12 weeks in patients without cirrhosis and 24 weeks in patients with cirrhosis.PEG-IFNα in combination with RBV should be dose adjusted according to eGFR.
Liver transplant patients
Recommendation 18: Antiviral therapy should be initiated at least 30 days prior to liver transplantation to prevent HCV reinfection after transplantation. sofosbuvir+RBV (genotype 2), sofosbuvir+ledipasvir (genotypes 1, 4, 5, 6) or sofosbuvir+
daclatasvir+RBV (all genotypes).
Recommendation 19: Sofosbuvir+ RBV or sofosbuvir+ ledipasvir or sofosbuvir+ daclatasvir+ RBV for 12 weeks is preferred in patients with recurrence or reinfection after liver transplantation. Patients who have had liver transplantation for more than 3 months can also have Peg-IFN-α+RBV for 24-48 weeks or Peg-IFN-α+sofosbuvir+RBV for 12 weeks.
Patients with cirrhosis
Recommendation 20: compensated cirrhosis (Child-Pugh
Grade A), apply standard dose Peg-IFN-α combined with RBV for 48-72 weeks depending on the genotype, Peg-IFN-α + sofosbuvir + RBV for 12-24 weeks, sofosbuvir + daclatasvir for 12-24 weeks, and preferentially recommend IFN-free regimens.
Recommendation 21: In decompensated cirrhosis (Child-Pugh
B/C grade), choose IFN-free and RBV-free regimens with sofosbuvir+daclatasvir combination for 24 weeks for all genotypes. Choose sofosbuvir + ledipasvir for genotypes 1/4/5/6: 24 weeks of therapy and genotype 2/3: 16-20 weeks of therapy, IFN-based therapy is contraindicated and none of the DAAs require dose adjustment.
Recommendation 22: Liver ultrasound is still required every 6 months to monitor HCC in all patients with cirrhosis after obtaining SVR.
Patients with drug use
Recommendation 23: New IFN-free or PEG-IFN-based “triple” regimens are preferred but need to be evaluated for safety and efficacy. After obtaining SVR, HCV
RNA testing is still needed to monitor reinfection and drug use.
Patients with hemophilia/thalassemia and other blood disorders
Recommendation 24.
Patients with coagulation disorders such as hemophilia who are co-infected with HCV should be treated with the same regimen for HCV as for patients without co-infection with hemophilia (B2).
Recommendation 25: In patients with thalassemia and sickle cell anemia combined with HCV infection, the anti-HCV treatment regimen is the same as that for non-anemic patients, but a combination treatment regimen of DAAs without interferon and ribavirin is recommended.
Patients with psychiatric disorders
Recommendation 26: HCV patients with a history of psychiatric disorders may be considered for anti-HCV treatment with DAAs without interferon (B2) if conditions warrant. Mental status should be assessed prior to anti-HCV treatment, monitored during treatment, and treated with antipsychotic medications if necessary (C2). When treating with antipsychotics and anti-HCV drugs, be aware of drug-drug interactions (B2).
Patients with HBV co-infection
Recommendation 27: When co-infected with HBV, treatment for HCV is the same as that for HCV infection alone (B1).
Recommendation 28: Pay attention to the monitoring of HBV DNA while anti-HCV therapy, and if HBV
nucleoside analogue anti-HBV therapy may be given if HBV DNA is significantly active (B1).
HIV co-infected patients
Recommendation 29: In co-infection with HIV, treatment for HCV is the same as that for HCV infection alone (B1).
Recommendation 30: In HIV co-infection, if HIV is inactive and HCV is acquired, extended courses of pegylated interferon alpha may be considered for patients with genotype 2 or 3 HCV, even if the early response to interferon is poor (B1).
Recommendation 31: In co-infected HIV, consider ledipasvir/sofosbuvir treatment in patients with HCV genotype 1 (A1).
Patients with acute hepatitis C
Recommendation 32: In patients with acute HCV infection, treatment with pegylated interferon alpha alone (A1) is recommended.
Recommendation 33: Consider treatment with pegylated interferon alfa in combination with ribavirin for 24 weeks in HIV patients with co-infection with acute HCV (B1).
Monitoring and follow-up
Recommendation 34: Review and evaluate the progression of liver fibrosis once a year in a non-invasive diagnostic manner in patients who are untreated or have failed treatment.
Recommendation 35: In patients with underlying cirrhosis, review abdominal ultrasound and AFP every 6 months, regardless of whether SVR is obtained.
Questions to be addressed
1. The study of biological markers with early warning role in the progression of chronic hepatitis C to cirrhosis, cirrhosis loss and HCC process.
2.The exploration of new protocols for DAA treatment of hepatitis C, especially the study of standard protocols suitable for the whole genotype.
3, pharmacoeconomic evaluation of DAA and PR treatment strategies.
4.Long-term effectiveness and safety issues after obtaining SVR for DAA treatment of chronic hepatitis C.
5.DAA treatment for hepatitis C cirrhosis and its decompensated patients to improve disease complications and prognosis after obtaining SVR.
6.Long-term effects of DAA therapy on prevention of cirrhosis and its complications and HCC.
7, DAA drug resistance and drug interactions, especially the need to focus on DAA and Chinese herbal drug interactions.
8, further in-depth study of DAA in special populations: pregnancy, children, co-infection with HIV, renal dysfunction and renal failure, liver transplantation and other patients with hepatitis C effectiveness and safety of five issues.
9, to carry out health economics research, explore effective ways to reduce drug prices and improve treatment accessibility.