Selecting HCV Treatment Caveats Focus on treatment selection for genotypes 1, 2, and 3. Majority of US population infected with GT 1, 2, or 3 GT 4 treatment closely reflects GT 1 treatment GT 5 and 6 are rare and treatment has relatively little clinical data Focus on treatment naïve and PEG-IFN/RBV treatment experienced patients.
Full Answer
What is the initial treatment of hepatitis C virus (HCV) infection?
Initial Treatment of 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 (DAA) agent, whether experimental, investigational, or US Food and Drug Administration...
What is the best treatment for HCV genotype 1?
Studies of Initial Treatment of Adults with HCV Genotype 1 1 Elbasvir-Grazoprevir. The study enrollment included 288 patients with genotype 1 infection. ... 2 Glecaprevir-Pibrentasvir. Among those enrolled, 33 were coinfected with HIV. ... 3 Ledipasvir-Sofosbuvir. ... 4 Sofosbuvir-Velpatasvir-Voxilaprevir. ...
What if initial HCV treatment fails to achieve cure (SVR)?
Patients in whom initial HCV treatment fails to achieve cure (SVR) should be evaluated for retreatment by a specialist, in accordance with AASLD/IDSA guidance.
How does the baseline HCV RNA level influence treatment choice and duration?
The baseline HCV RNA level generally does not influence the treatment choice or duration, except in treatment-naïve noncirrhotic patients in whom 8 or 12 weeks of ledipasvir-sofosbuvir is being considered. [ 13]
How do you decide on the most effective treatment for hepatitis?
Your doctor determines the specific medication or medications that are likely to be most effective for you based on which genotype of hepatitis C you have, whether there is scarring of the liver, and whether you have taken antiviral medication previously.
Which HCV is better response for treatment?
Hepatitis C virus (HCV) genotype 2a has a better virologic response to antiviral therapy than HCV genotype 1b - PMC. The . gov means it's official.
What are the factors that need to be considered before the specific HCV treatment?
Pre-treatment assessment.Perform a virological evaluation.Evaluate for the presence of cirrhosis.Consider whether there is HBV or HIV coinfection or coexisting liver disease present.Consider concomitant medications for risk of drug–drug interactions.Adherence to treatment.Consensus recommendations.
What is recommended treatment for a patient who is treatment naïve and does not have cirrhosis?
Treatment-Naive Genotype 1a Patients Without Cirrhosis Dosing is 3 coformulated tablets (glecaprevir [100 mg]/pibrentasvir [40 mg]) taken once daily.
When do you recheck Hep C after treatment?
However, because relapses beyond SVR12 have rarely been reported, treatment guidelines recommend confirming cure by testing for HCV RNA at 24 to 48 weeks after the end of treatment (SVR24 or SVR48). Late relapse, when it occurs, typically happens between 12 and 24 weeks posttreatment.
Do you still test positive for hep C after treatment?
Other things to know: After a successful course of treatment for hepatitis C, the hepatitis C antibody remains detectable, but the hepatitis C RNA will be undetectable. If you plan to donate blood, you will be tested for the hepatitis C antibody and will be turned away even if you do not have an active infection.
What is the most commonly recommended treatment protocol for HCV?
Hepatitis C is treated using direct-acting antiviral (DAA) tablets. DAA tablets are the safest and most effective medicines for treating hepatitis C. They're highly effective at clearing the infection in more than 90% of people. The tablets are taken for 8 to 12 weeks.
What are the first steps that you would take in planning an HCV intervention?
The first step in the HCV cascade of care is screening and diagnosis. Historically, hepatitis C screening was recommended for those with specific risk behaviors, risk exposures, or specific medical conditions.
What are the goals of treatment for chronic HCV infection?
The primary goal in the treatment of HCV infection is to reduce the mortality by preventing liver-related deaths associated with the development of hepatocellular carcinoma and decompensated cirrhosis. Pegylated interferons together with ribavirin are currently the standard of care for patients with chronic hepatitis.
What are treatment naive patients?
A person is considered to be "treatment-naive" if they have never undergone treatment for a particular illness. 1 In the world of sexually transmitted infections (STIs), the term is most often used to refer to people who are HIV-positive and who have never taken any antiretroviral therapy for their infection.
Which HCV genotype is easiest to treat?
In the United States, hepatitis C genotype 3 is less commonly contracted than genotype 1, but genotype 3 is also harder to treat....Genotype 3 has been found to respond better to newer drug combinations, including:glecaprevir-pibrentasvir (Mavyret)sofosbuvir-velpatasvir (Epclusa)daclatasvir-sofosbuvir (Sovaldi)
Which of the following medications is only approved for genotype 1 treatment of HCV?
Ledipasvir/sofosbuvir (400 mg sofosbuvir/90 mg ledipasvir co-formulated in a single tablet) was approved by the FDA in October 2014 for the treatment of genotype 1 infection.
What is the first treatment for HCV?
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 (DAA) agent, whether investigational, or US Food and Drug Administration (FDA) approved .
How are recommended and alternative regimens listed?
Recommended and alternative regimens are listed 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.
What is recommended regimen?
Recommended regimens are those that are favored for most patients in a given group, based on optimal efficacy, favorable tolerability and toxicity profiles, and treatment duration.
What is an alternative regimen?
Alternative regimens are those that are effective but, relative to recommended regimens, have potential disadvantages, limitations for use in certain patient populations, or less supporting data than recommended regimens.
What are the factors that influence the choice of treatment for HCV?
For treatment-naïve adults with chronic HCV genotype 1 infection, the main factors that influence the choice and duration of therapy are (1) presence or absence of cirrhosis, and (2) medication cost or insurance considerations. In the case of elbasvir-grazoprevir use, the HCV genotype 1 subtype (1a or 1b) is also important, as the presence of specific baseline NS5A RASs significantly reduces SVR12 rates in persons with HCV genotype 1a. [ 10, 11, 12] In cases where the genotype 1 subtype is not known, the individual should be treated as HCV genotype 1a. The baseline HCV RNA level generally does not influence the treatment choice or duration, except in treatment-naïve noncirrhotic patients in whom 8 or 12 weeks of ledipasvir-sofosbuvir is being considered. [ 13] Additional data from the HCV-TARGET registry and the Veterans Affairs National Healthcare System demonstrated comparable SVR rates of 94 to 98% for adults without cirrhosis treated with either 8 or 12 weeks of ledipasvir-sofosbuvir if the baseline HCV RNA levels were less than 6 million IU/mL. [ 14, 15, 16] In addition to the factors noted above, drug interactions may also influence the choice of therapy, particularly for individuals with HIV coinfection who are taking antiretroviral medications. Of note, individuals with HCV and HIV coinfection, depending on their specific antiretroviral therapy, are eligible for most of the same regimens for initial treatment of genotype 1 as for persons with HCV monoinfection, except that persons with HIV should not receive (1) any 8-week option of ledipasvir-sofosbuvir, or (2) the 8-week option of glecaprevir-pibrentasvir if cirrhosis is present. [ 11, 12, 17, 18]
What are the factors that affect the choice of treatment for HCV genotype 1?
For individuals with chronic HCV genotype 1 infection, the main factors that influence the choice and duration of therapy are cirrhosis status and prior treatment experience . With the use of certain regimens for persons with HCV genotype 1a, namely elbasvir-grazoprevir, the genotype 1 subtype (1a or 1b) also impacts the choice of therapy, as elbasvir-grazoprevir is only recommended for persons with HCV genotype 1a who do not have baseline NS5A resistance-associated substitutions (RASs). In addition, the HCV RNA level and the patient’s HIV status can impact the duration of ledipasvir-sofosbuvir, but does not affect the duration of other regimens. Finally, the cost of the regimen, insurance coverage, and provider preference can play a major role in the regimen choice. The following treatment recommendations are based on the AASLD-IDSA HCV Guidance for initial treatment of adults with HCV genotype 1 and for retreatment of adults in whom prior therapy failed, including those with HCV genotype 1. [ 4, 5]
What is the AASLD-IDSA HCV guidance?
The following is a summary of the AASLD-IDSA HCV Guidance for adults with HCV genotype 1 infection who are treatment experienced and failed prior DAA therapy , including those without cirrhosis and those with compensated cirrhosis. [ 5, 28, 29, 30] For individuals with cirrhosis, the AASLD-IDSA HCV Guidance defines compensated cirrhosis as Child-Turcotte-Pugh class A and decompensated cirrhosis as Child-Turcotte-Pugh class B or class C. The AASLD-IDSA HCV Guidance for retreatment is no longer genotype specific, but instead emphasizes a pangenotypic approach to retreatment based on the prior treatment regimen. In addition, the AASLD-IDSA HCV Guidance no longer includes recommendations for the retreatment of persons who experienced prior treatment failure with interferon-based therapy, including interferon plus first-generation protease inhibitors ( telaprevir, boceprevir ); these individuals have robust cure rates with modern DAA regimens similar to that observed with treatment-naïve persons. The recommended regimens in the tables below are based on prior regimen failure and listed by evidence level; when the evidence level is considered equivalent, the regimens are listed alphabetically.
What is genotype 1?
In the United States, genotype 1 hepatitis C virus (HCV) accounts for approximately 70 to 75% of all HCV infections. [ 1] . Accordingly, treatment of genotype 1 has the most extensive data and highest clinical relevance for hepatitis C treatment issues in the United States. In recent years, multiple studies using direct-acting antiviral (DAA) ...
How are recommended and alternative regimens listed?
Recommended and alternative regimens are listed 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 interactions.
What is recommended regimen?
Recommended regimens are those that are favored for most patients in that group based on optimal efficacy, favorable tolerability and toxicity profiles, complex ity, and shorter treatment duration .
Is DAA therapy a failure?
The success of initial DAA therapy has led to treatment of hundreds of thousands of patients in the US. With this massive scale-up, there will inevitably be failures. Even with a 2% to 3% failure rate, there will still be thousands who need retreatment. Since the last iteration of this section, additional published evidence has emerged to support recommendations for retreatment. To simplify and consolidate the guidance, this section no longer contains retreatment recommendations for interferon or interferon plus first generation protease inhibitor failures because the cure rates with modern DAA regimens in these populations were comparable to treatment naive patients. In addition, pangenotypic regimens without the addition of ribavirin have shown high efficacy for patients with prior failure across all genotypes except genotype 3. Therefore, recommendations are categorized by regimen failure.
Is liver biopsy required for hepatitis C?
Adults with chronic hepatitis C (any genotype) who have compensated cirrhosis (Child-Pugh A) and have not previously received hepatitis C treatment. Liver biopsy is not required. For the purpose of this guidance, a patient is presumed to have cirrhosis if they have a FIB-4 score >3.25 or any of the following findings from a previously performed ...
Should patients with HCV be tested for RNA?
Patients with ongoing risk for HCV infection (eg, intravenous drug use or MSM engaging in unprotected sex) should be counsel ed about risk re duction, and tested for HCV RNA annually and whenever they develop elevated ALT, AST, or bilirubin. Patients should abstain from alcohol to avoid progression of liver disease.