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Chronic Hepatitis C Treatment Guidelines

Hepatitis C In Children

Hepatitis C Treatment Update

HCV infection seems to progress more slowly to fibrosis and cirrhosis in childhood-acquired disease than in adult-acquired disease . Standard IFN 3 MU/m2 three times a week with ribavirin 15 mg/kg/day for 48 weeks yielded an SVR of 40% to 60% overall, and 70% to 100% in genotype 2 or 3 infection . PEG IFN-alpha-2a or -2b and ribavirin have been used in small numbers of HCV-infected children with SVR rates of 43% to 59% . Whether EVR can be used, as in adults, to stop therapy early in patients destined to be nonresponders is not clear. The tolerability and side effect profile in children and adults appears similar except for transient growth inhibition in children.

There is insufficient information to make any specific recommendations about treating children with hepatitis C.

Management Of Competing Interests

Members of the guideline panel have financial relationships with pharmaceutical companies related to HCV therapeutics. All members signed a commitment and competing interest statement at the outset of guideline development. Individuals with relevant disclosures were not excluded from voting on recommendations. However, in order to manage competing interests, the final guideline was vetted by the Canadian Association for the Study of the Liver membership, and specifically by the associations executive, to evaluate the presence of commercial bias. No funding, direct or in kind, was provided to the guideline panel for this work.

Recommended Daa Treatment Regimens

Reviewed and updated: David E. Bernstein, MD, with the HCV Guideline Committee October 6, 2022

RECOMMENDATIONS
Recommended DAA Treatment Regimens
  • Clinicians and patients should choose an anti-HCV regimen based on the pretreatment assessment and any previous HCV treatment.
  • If a regimen that includes weight-based RBV is prescribed, clinicians should dose as follows :
  • < 75 kg: RBV 400 mg once daily plus 600 mg once daily
  • 75 kg: RBV 600 mg twice daily
  • In patients with genotype 3 HCV and compensated cirrhosis, clinicians should perform NS5A RAS testing before initiating therapy.
  • Clinicians new to HCV treatment should consult a specialist in treatment of liver disease or viral hepatitis when retreating patients in whom any prior DAA treatment has failed. Failure is defined as detectable HCV RNA 12 weeks after the conclusion of HCV treatment.
  • Abbreviations: DAA, direct-acting antiviral HCV, hepatitis C virus PEG-IFN, pegylated interferon RAS, resistance-associated substitution RBV, ribavirin.

    All regimens listed in this guideline were available as of October 2022.

    HIV/HCV coinfection: Recommendations for treatment of chronic HCV infection in patients with HIV are the same as those for patients who do not have HIV, but attention to potential drug-drug interactions between DAAs and antiretrovirals is needed . Clinicians are encouraged to consult a specialist in the treatment of liver disease or viral hepatitis and an experienced HIV care provider as needed.

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    Standard Treatment Of Hepatitis C

    Standard and modified treatment algorithms are shown in Figures 2 and and33.

    Algorithm for the management of patients with hepatitis C virus genotype 1 infection on therapy with pegylated interferon and ribavirin. The dotted arrows and shaded boxes represent new treatment algorithms based on viral kinetics. The solid arrows and clear boxes represent the standard algorithms. *Advanced fibrosis, high viral load, high body mass index, older age, African American race, HIV coinfection or immunosuppression. EVC Early virological clearance EVR Early virological response PVR Partial virological response RVR Rapid virological response SVR Sustained virological response

    Algorithm for the management of patients with hepatitis C virus , genotype 2 or 3, on therapy with pegylated interferon and ribavirin. The dotted arrows and shaded boxes represent new treatment algorithms based on viral kinetics. The solid arrows and clear boxes represent the standard algorithms. ? Consider 36 to 48 weeks of therapy, but the evidence is weak. RVR Rapid virological response SVR Sustained virological response

    Recommendation 11: Therapy is given for 48 weeks for genotypes 1, 4, 5 and 6. In patients who do not achieve an early virological response or are still viremic after 24 weeks, therapy should be discontinued because the likelihood of SVR is negligible .

    Recommendation 13: The standard duration of therapy for patients with genotype 2 or 3 infection is 24 weeks .

    Simplified Treatment Guidelines For Hepatitis C Infection: Myanmar

    Chronic Hepatitis
    Guidelines – Released in 2017

    Myanmar GI and Liver Society developed guidelines for the treatment of chronic hepatitis C infection in 2009. With the establishment of National Hepatitis Program, this guideline has been revised as the Simplified Treatment Guidelines for Hepatitis C Infection to include the recently developed direct-acting antiviral drugs and with simple procedure of Viral Load testing and clinical monitoring.

    This simplified guideline is essential for providing guidance on the use of oral, low cost, DAAs, with the aim to reduce the disease burden of Hepatitis C in the community. This guideline provides a clear guidance to all medical doctors for precise and quick clinical decisions with simplified clinical monitoring methods. We also aim for this guideline to be able to provide updated knowledge about the treatment and laboratory monitoring of HCV infection.

    • Ministry of Health and Sports – Myanmar

    Data Dashboard

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    Recommended Monitoring For Pregnancy

    RECOMMENDED RATING Women of childbearing potential and their partners should not receive ribavirin during or for at least 6 months prior to pregnancy. I, C Women of childbearing potential should be counseled not to become pregnant while receiving a ribavirin-containing antiviral regimen, and for at least 6 months after stopping the regimen. I, C Male partners of women of childbearing potential should be cautioned to prevent pregnancy while they are receiving a ribavirin-containing antiviral regimen, and for up to 6 months after stopping the regimen. I, C Serum pregnancy testing is recommended for women of childbearing potential prior to beginning treatment with a regimen that includes ribavirin. I, C Assessment of contraceptive use and of possible pregnancy is recommended at appropriate intervals during ribavirin treatment for women of childbearing potential, and for female partners of men who receive ribavirin treatment. I, C

    Ribavirin causes hemolysis. Patients receiving ribavirin should have hemoglobin levels checked during treatment, often after 2 weeks, and the ribavirin dose reduced if the patient develops significant anemia, often defined as hemoglobin < 10 g/dL.

    Recommended Treatment Regimens For Treatment

    Recommended regimens: The recommendations are organized by whether or not the patient has compensated cirrhosis. All drugs in the recommended regimens listed below are oral medications.

    Treatment interruption and adherence: Before initiating treatment with a DAA regimen, it is essential to develop an adherence plan with the patient, address potential barriers, and make support available if it is needed. Clinicians are advised to consult an HCV treatment specialist if a patients DAA treatment is interrupted.

    Drug names: A / between 2 drug names indicates a co-formulated tablet.

    Rating of regimens: All regimen choices listed below are rated A1 except where indicated.

    Table 2: Preferred Regimens for HCV Treatment-Naive Patients

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    Pregnancy And Hepatitis C

    The new hepatitis C medicines have not been tested in pregnancy.

    You should not become pregnant while taking treatment as it could be harmful to unborn babies.

    If you’re pregnant, you must delay treatment until after your baby is born.

    Speak to your doctor before starting hepatitis C treatment if you’re planning to become pregnant in the near future.

    You’ll need to wait several weeks after treatment has ended before trying to get pregnant.

    Women taking ribavirin should use contraception during treatment and for another 4 months after the end of treatment.

    If you become pregnant during treatment, speak to your doctor as soon as possible to discuss your treatment options.

    Interview Survey Of A Small Group Of Caregivers

    Hepatitis C Boot Camp 1: Pathogenesis, Epidemiology, and Treatment Guidelines – Jamie Morano, MD

    At first, to clarify psychology of caregivers of HCV-infected children, we conducted an interview survey of five parents whose children were visiting the Pediatrics department of the Osaka General Medical Center. With the parents consent recordings also were taken at the time of the interview to secure accuracy. The 10 items to be interviewed are as follows: baseline characteristics of parents , baseline characteristics of the child , knowledge of HCV infection and mother-to-child transmission , explanation from the doctor in charge , disliked or troubled experiences, related to HCV infection for the guardians, ask for keywords related to feelings of guilt, current anxiety and troubles, future anxiety , anxiety about recurrence, good and bad treatment, changes in feelings, etc. , others.

    The interview narratives of the five mothers were summarized to clarify the psychological burden of parents and the needs and significance of curative treatment in childhood.

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    Initial Treatment Of Adults With Hcv Infection

    Initial treatment of HCV infection includes patients with chronic hepatitis C who have not been previously treated with interferon, peginterferon, ribavirin, or any HCV direct-acting antiviral agent, whether investigational, or US Food and Drug Administration approved.

    Simplification of the treatment regimen may expand the number of healthcare professionals who prescribe antiviral therapy and increase the number of persons treated. This would align with the National Academies of Science, Engineering, and Medicine strategy to reduce cases of chronic HCV infection by 90% by 2030 .

    Recommended and alternative regimens are listed by pan-genotypic activity and in order of level of evidence. When several regimens are at the same recommendation level, they are listed in alphabetical order. Regimen choice should be determined based on patient-specific data, including drug-drug interactions. Patients receiving antiviral therapy require careful pretreatment assessment for comorbidities that may influence treatment response or regimen selection. All patients should have access to an HCV care provider during treatment, although preset clinic visits and/or blood tests depend on the treatment regimen and may not be required for all regimens/patients. Patients receiving ribavirin require additional monitoring for anemia during treatment .

    The Need For Guidelines

    Hepatitis C virus is a major health care concern in the UK affecting some 200 000 to 400 000 individuals. The majority of these patients will have chronic HCV infection and many will develop chronic liver disease with the risk of developing cirrhosis and hepatocellular carcinoma . Successful treatment will arrest the progression of liver disease and so prevent the serious complications of chronic HCV infection. In addition, treatment will reduce the numbers of HCV infected individuals.

    The relatively high cost of treatment enforces the need for a systematic approach for this condition so that resources are used most effectively. The development of clinical guidelines is important, as these will assist purchasing authorities, providers, clinicians, primary care groups, and patients in making decisions about appropriate treatment.

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    Switch Trial Design: 401816

    The efficacy and safety of switching from TDF 300 mg once daily to VEMLIDY 25 mg once daily in virologically suppressed adults with CHB infection were evaluated in a randomized, double-blind, active-controlled trial: Trial 4018 .

    Patients must have been taking TDF 300 mg once daily for 12 months, with HBV DNA less than the Lower Limit of Quantitation by local laboratory assessment 12 weeks prior to screening and HBV DNA < 20 IU/mL at screening. Patients were randomized in a 1:1 ratio to either switch to VEMLIDY or stay on TDF . At baseline, the median duration of exposure to TDF prior to the trial was similar in both treatment groups .

    The primary endpoint was the proportion of patients with plasma HBV DNA 20 IU/mL at Week 48.

    Additional efficacy endpoints included:

    • Proportion of patients with HBV DNA < 20 IU/mL
    • ALT normal and normalization, HBsAg loss and seroconversion
    • HBeAg loss and seroconversion

    At Week 48, all patients who were randomized to TDF for the controlled portion of the trial were switched to VEMLIDY for the open-label extension through Week 96.

    Recommended Monitoring For Patients In Whom Treatment Failed To Achieve A Sustained Virologic Response

    Current Standards in the Treatment of Chronic Hepatitis C (11.05.2012)

    RECOMMENDED For patients with cirrhosis, endoscopic surveillance for varices should be performed in accordance with the AASLD guidance on portal hypertension bleeding in cirrhosis. Guidanceb a For, please refer to the appropriate section.b Unlike the AASLD/IDSA HCV guidance, the AASLD guidelines use the GRADE system to rate recommendations please see that document for further information about this rating system.

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    Who Guidelines For The Care And Treatment Of Persons Diagnosed With Chronic Hepatitic C Virus Infection

    WHO estimates that in 2015, 71 million persons were living with chronic hepatitis C virus infection worldwide and that 399 000 died from cirrhosis or hepatocellular carcinoma caused by HCV infection. In May 2016, the World Health Assembly endorsed the Global Health Sector Strategy on viral hepatitis, which proposes to eliminate viral hepatitis as a public health threat by 2030 . Elimination of viral hepatitis as a public health threat requires 90% of those infected to be diagnosed and 80% of those diagnosed to be treated.

    Since the last update to the Guidelines was issued in 2016, three key developments have prompted changes in terms of when to treat and what treatments to use. First, the use of safe and highly effective direct-acting antiviral regimens for all persons improves the balance of benefits and harms of treating persons with little or no fibrosis, supporting a strategy of treating all persons with chronic HCV infection, rather than reserving treatment for persons with more advanced disease. Second, since 2016, several new, pangenotypic DAA medicines have been approved by at least one stringent regulatory authority, reducing the need for genotyping to guide treatment decisions. Third, the continued substantial reduction in the price of DAAs has enabled treatment to be rolled out rapidly in a number of low- and middle- income countries.

    Hematopoietic Growth Factor Support In The Management Of Hepatitis C

    Maximizing response rates to HCV therapy requires full treatment adherence to both PEG IFN and ribavirin. However, anemia due to ribavirin-induced hemolysis is often a limiting factor. Treatment-associated anemia requiring a reduction in the ribavirin dose occurs in 25% of patients, often in the first one to two months of therapy , and negatively impacts the SVR. Ribavirin-induced anemia is more frequent with the higher doses of ribavirin used to treat nongenotypes 2 and 3 infection. The use of erythropoietin to stimulate red cell production has been investigated. The data clearly show that erythropoietin stimulates a rise in hemoglobin and allows a higher overall ribavirin dose to be given . These studies were recently extended and showed that the use of erythropoietin allowed higher ribavirin dosing and, thereby, improved SVR compared with a group in which erythropoietin was not used .

    Although erythropoietin can be useful, there are insufficient data to recommend its routine use in all patients.

    Although the package inserts for both PEG IFNs suggest dose reductions if the platelet count falls below 75×109/L and recommend discontinuation if the platelet count falls below 50×109/L, experts suggest that dose reductions are not necessary until the platelet count falls below 30×109/L, with discontinuation if the platelet count falls below 20×109/L.

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    The Following Monitoring Is Not Recommended During Or After Therapy

    NOT RECOMMENDED RATING Monitoring for HCV drug resistance-associated substitutions during or after therapy is not recommended unless retreatment will be performed. RAS testing is recommended in advance of retreatment therapy. See the Retreatment section for recommendations regarding RAS testing prior to retreatment. Additional information about RAS testing can be found in the HCV Resistance Primer. IIb, C

    Patients who do not achieve SVR retain the possibility of continued liver injury, progression of hepatic fibrosis, and the potential to transmit HCV infection to others. Such patients should be considered for retreatment per the Retreatment of Persons in Whom Prior Therapy Has Failed section.

    Ifn Monotherapy In Acute Hepatitis C

    KDIGO-ISN Webinar on the KDIGO Hepatitis C Guideline Update

    Although the short courses of standard IFN monotherapy introduced in the 1980s by Hoofnagle et al, Davis et al, and Di Bisceglie et al led to sustained improvement in liver disease and loss of virus in less than 10% of patients, these therapies were the first to cure chronic viral hepatitis.

    Jaeckel et al reported that treatment with IFN alfa-2b prevented chronic infection in 98% of a group of 44 German patients with acute hepatitis C. In this study, patients received 5 million U/day of IFN alfa-2b subcutaneously for 4 weeks and then three times per week for another 20 weeks the IFN alfa-2b was well tolerated in all patients but one.

    Because it has the poorest safety profile of all the HCV antiviral agents, with few exceptions PEG-IFN is no longer recommended in combination regimens. Spontaneous resolution of acute HCV infection may occur in 15% to 50% of patients. Monitoring for spontaneous clearance for a minimum of 6 months before initiating any treatment is therefore recommended.

    References
  • World Health Organization. Hepatitis C: fact sheet. Available at . Updated: October 2017 Accessed: January 23, 2018.

  • Frank C, Mohamed MK, Strickland GT, et al. The role of parenteral antischistosomal therapy in the spread of hepatitis C virus in Egypt. Lancet. 2000 Mar 11. 355:887-91. .

  • Kim A. Hepatitis C virus. Ann Intern Med. 2016 Sep 6. 165 :ITC33-ITC48. .

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    E Treatment Of Hepatitis C

    The primary goal of HCV therapy is to achieve a SVR, defined as an undetectable HCV RNA 6 months after stopping antiviral therapy. Secondary goals of antiviral therapy include improvements in histology, quality of life and prevention of hepatocellular carcinoma. Antiviral therapy is approved by the Food and Drug Administration for patients with persistently abnormal liver enzymes, detectable HCV RNA and an abnormal liver biopsy. Recent data have shown that patients with normal liver enzymes, detectable HCV RNA and an abnormal liver biopsy respond to therapy at similar rates as those with abnormal liver enzymes.55

    The efficacy of HCV treatment has improved over the past decade. Initial treatment consisting of interferon alpha has been replaced by pegylated interferon and now by combination therapy using pegylated interferon and ribavirin. Efficacy varies depending on multiple factors especially viral genotype, but achieving sustained viral suppression in 50% of patients can be expected .

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