Treatment-Naive Genotype 1a Without Cirrhosis Recommended Regimens Glecaprevir/Pibrentasvir The daily fixed-dose combination of glecaprevir (300 mg)/pibrentasvir (120 mg) is administered as three 100 mg/40 mg fixed-dose combination pills.
Full Answer
What is the treatment for hepatitis C genotype 1a 1b?
Treatment/medication for hepatitis c genotype 1a, 1b infection: • Sofosbuvir/Ledipasvir (generic Harvoni): Available popular Indian generic brands are Hepcinat LP by Natco pharma and Ledifos by Hetero Labs. • Sofosbuvir/Velpatasvir: Popular generics are Velpanat and Velasof.
How to treat genotype 1b without cirrhosis?
Treatment-Naive Genotype 1b Without Cirrhosis RECOMMENDED DURATION RATING Daily fixed-dose combination of elbasvir ... 12 weeks a I, A Daily fixed-dose combination of glecapre ... 8 weeks I, A Daily fixed-dose combination of ledipasv ... 12 weeks I, A 4 more rows ...
How is fibrosis treated in patients with genotype 1a?
Participants were randomized to receive 8 weeks or 12 weeks of the daily fixed-dose combination of glecaprevir (300 mg)/pibrentasvir (120 mg) administered as three 100 mg/40 mg fixed-dose combination pills ( Zeuzem, 2016 ). Of those enrolled, 43% had genotype 1a, 85% had fibrosis stage 0 or 1, and 62% were treatment naive.
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. ...
How long does it take to treat HCV genotype 1A?
What is the treatment for genotype 1?
What are the factors that affect the choice of treatment for HCV genotype 1?
What are the factors that influence the choice of treatment for HCV?
What is genotype 1?
What is the ION-1 trial?
What is the phase 3 trial of glecaprevir?
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About this website
What is the treatment for Hep C genotype 1a?
For initial therapy of HCV genotype 1a infection in adults who have compensated cirrhosis, three 12-week regimens with similar efficacy are recommended: elbasvir-grazoprevir (if no key resistance-associated substitutions are detected on pretreatment NS5A testing); ledipasvir-sofosbuvir; or sofosbuvir-velpatasvir.
Which medication 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 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.
What is the treatment plan for hepatitis?
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.
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)
What is the best medicine for hepatitis B?
Several antiviral medications — including entecavir (Baraclude), tenofovir (Viread), lamivudine (Epivir), adefovir (Hepsera) and telbivudine (Tyzeka) — can help fight the virus and slow its ability to damage your liver. These drugs are taken by mouth. Talk to your doctor about which medication might be right for you.
What does genotype 1a mean?
Background. Hepatitis C virus (HCV) genotype 1 is the most prevalent worldwide. Subtype 1a, compared with 1b, shows lower response rates and higher propensity to select for drug resistance to NS3 and selected NS5A and nonnucleoside NS5B inhibitors. Two distinct clades of subtype 1a have been described.
Is chronic hep C curable?
Today, chronic HCV is usually curable with oral medications taken every day for two to six months. Still, about half of people with HCV don't know they're infected, mainly because they have no symptoms, which can take decades to appear.
Do you treat asymptomatic hep C?
Acute HCV infections are usually asymptomatic and most do not lead to a life-threatening disease. Around 30% (15–45%) of infected persons spontaneously clear the virus within 6 months of infection without any treatment.
What is the best treatment for hepatitis A?
No specific treatment exists for hepatitis A. Your body will clear the hepatitis A virus on its own. In most cases of hepatitis A, the liver heals within six months with no lasting damage.
What is the latest treatment for hepatitis B?
Peginterferon alfa-2a. If your liver is working fairly well, the first treatment offered is usually a medicine called peginterferon alfa 2-a. This stimulates the immune system to attack the hepatitis B virus and regain control over it. It's usually given by injection once a week for 48 weeks.
What is the best treatment for liver cirrhosis?
If cirrhosis progresses and your liver is severely damaged, a liver transplant may be the only treatment option. This is a major operation that involves removing your diseased liver and replacing it with a healthy liver from a donor.
What is the difference between interferon and peginterferon?
Overview. Pegylated interferon, usually called peginterferon, is a chemically modified form of the standard interferon that treats hepatitis C and rarely hepatitis B. The difference between interferon and peginterferon is the PEG, which stands for a molecule called polyethylene glycol.
Which antiviral C combination can be applied to all genotypes?
Sofosbuvir/velpatasvir is one of the simplified treatment options that can be prescribed without genotyping for short-course treatment of hepatitis C with a low risk of adverse events.
What is HCV genotyping?
A genotype is a way to put the hepatitis C virus (HCV) into categories based on similar genes. It's important to know and understand HCV genotypes because different genotypes respond differently to medicines that treat and cure HCV. HCV has six genotypes, labeled 1 through 6.
What is the antiviral drug ribavirin?
Producing a broad-spectrum activity against several RNA and DNA viruses, Ribavirin is a synthetic guanosine nucleoside and antiviral agent that interferes with the synthesis of viral mRNA. It is primarily indicated for use in treating hepatitis C and viral hemorrhagic fevers.
Treatment of HCV Genotype 1 - Treatment of Chronic Hepatitis C ...
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Treatment-Naive Genotype 1a Without Cirrhosis | HCV Guidance
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for patients who are HIV-uninfected and whose HCV RNA level is <6 million IU/mL
How long does it take to treat HCV genotype 1A?
For initial therapy of HCV genotype 1a infection in adults who have compensated cirrhosis, three 12-week regimens with similar efficacy are recommended: elbasvir-grazoprevir (if no key resistance-associated substitutions are detected on pretreatment NS5A testing); ledipasvir-sofosbuvir; or sofosbuvir-velpatasvir. One 8-week regimen is also recommended: glecaprevir-pibrentasvir.
What is the treatment for genotype 1?
From 1998-2013, therapy evolved from interferon monotherapy, to peginterferon monotherapy, to peginterferon plus ribavirin, to triple therapy with peginterferon plus ribavirin plus an NS3/4A protease inhibitor ( boceprevir or telaprevir ). [ 6, 7, 8, 9] Since 2014, the standard of care for HCV genotype 1 has consisted of all-oral therapy with a combination of DAAs. As of 2017, there have been multiple safe, convenient, and highly effective all-oral regimens recommended for the treatment of HCV genotype 1, most of which do not require ribavirin.
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 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 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) ...
What is the ION-1 trial?
ION-1: This phase 3 trial examined the fixed-dose combination of ledipasvir-sofosbuvir, given with or without ribavirin, in treatment-naïve adults with HCV genotype 1 , including those with compensated cirrhosis. [ 25] All treatment arms had SVR12 rates greater than 95%; no differences were observed with respect to receipt of ribavirin, or whether patients received 12 or 24 weeks of treatment.
What is the phase 3 trial of glecaprevir?
EXPEDITION-1: This phase 3, single-arm, open-label trial evaluated the safety and efficacy of 12 weeks of glecaprevir-pibrentasvir in 146 adults with compensated cirrhosis and HCV genotype 1, 2, 4, 5, or 6. [ 22] Among all participants enrolled, 60% had HCV genotype 1 infection and 75% were treatment naïve, with the other 25% having failed an interferon-based regimen with or without sofosbuvir. For the participants with HCV genotype 1 infection, 99% (89 of 90) achieved an SRV12. One person with genotype 1a experienced a viral relapse at week 8 post-treatment; this individual had a Y93N resistance-associated substitution detected at baseline and at the time of virologic failure.
What is the best treatment for hep C?
Now for preventing the occurrence of Hep C virus, all kinds of oral and Direct Acting Antivirals (DAAs) medication can be used and administered. Interferon-free treatments are available that offer shorter treatment duration and higher cure rates.
What is the genotype 1 of hepatitis C?
However, at present, a large number of people are known to be infected with hepatitis c genotype 1. In fact, genotype 1 is the most prevalent among all the types of the Hepatitis C genotypes virus.
Why are genotypes important for treatment?
A patient suffering from Hepatitis C should first need to know about Hepatitis C genotype through a blood test so that the doctor can start the hep c treatment accordingly.
How much does a genotype test cost for hep C?
The genotype test can cost around $200 to $300.
What is the difference between genotype 1 and 1b?
However, genotypes 1 and 1b have very close relations. The only difference between them is that 1a is difficult to treat than the 1b type. Europe has a slightly bigger number of people who are infected by hepatitis c genotype 1b. which in most cases leads to higher risk of liver cancer or cirrhosis.
Does Sofosbuvir require genotype test?
Please note, latest treatment (Sofosbuvir+Velpatasvir) doesn’t require genotype test because this medicine is helpful for the treatment of all HCV genotypes between 1 to 6.
Is Harvoni a direct acting antiviral?
Generic versions of Direct-Acting Antivirals such as Sofosbuvir + Ledipasvir, Velpatasvir, Daclatasvir, generic harvoni which are quite effective for treatment of Hepatitis C genotype 1 are easily available on the Indian market. They are as effective and safe as many of the other branded drugs.
How long does it take to take sofosbuvir?
Sofosbuvir/Velpatasvir. The fixed-dose combination of 12 weeks of sofosbuvir (400 mg)/velpatasvir (100 mg) was approved by the FDA for the treatment of genotype 1 infection in treatment-naive patients based on ASTRAL-1.
Does NS5A resistance affect genotype 1b?
In contrast to genotype 1a, the presence of baseline substitutions associated with NS5A resistance did not appear to affect genotype 1b response to elbasvir/grazoprevir. Thus, current data do not support extending the treatment duration or adding ribavirin in genotype 1b patients with NS5A RASs.
Initial Treatment Of Hcv Infection
This section addresses treatment of patients with chronic hepatitis C who are naive to any type of therapy.
Factors Associated With The Two Distinct Subtype 1a Clades
Table summarizes the analysis of the association of some demographic, epidemiological, and virological factors with segregation of European HCV 1a into clade I or II.
Evolutionary Rate Estimates Time
Bayes factor analysis showed that the relaxed clock fitted the data significantly better than the strict clock . Under the relaxed clock, the BF analysis showed that the constant model was better than the other models .
Medications Used To Treat Hcv Genotype 1
The HCV Medications section on this website provides detailed information for each of the Food and Drug Administration -approved medications listed in the treatment recommendations, including links to the full prescribing information and to patient assistance programs. The DAAs exert their action at specific steps in the HCV life cycle.
How Is Genotype Determined
A simple blood test can be used to determine your hepatitis C genotype. The test doesnt have to be repeated because once someone has been infected with HCV, the genotype remains the same. It is possible to be infected by more than one HCV genotype. However, this occurs rarely.
First Combination Tablet For Chronic Hepatitis C Genotype 1 Infection
On October 10, 2014, the FDA approved the fixed-dose combination capsule of ledipasvir plus sofosbuvir for the treatment of patients with chronic HCV genotype 1 infection., Ledipasvir plus sofosbuvir is the first combination tablet approved for the treatment of patients with chronic HCV genotype 1 infection, as well as the first approved regimen that does not require the use of interferon or ribavirin.
Why Do Genotypes Matter For Treatment
Knowing your HCV genotype is important information that can help patients and doctors find the most effective treatment.
How many genotypes of hepatitis C are there?
The hepatitis C genotype is a type or "strain" of hepatitis C virus. There are 6 genotypes of hepatitis C around the world. In the United States, 3 genotypes are common:
Does genotype 2a change over time?
Genotype 2a or 2b or 2c. Genotype 3a or 3b. A person's hepatitis C genotype does not change over time. It needs to be tested only once. If you are treated for hepatitis C, your genotype will determine your treatment plan, such as which medications are prescribed and how long the treatment will be. < Previous.
What is the purpose of genotypes in HCV?
Genotypes are used to identify particular strains of HCV. They’re based on differences in particular regions of the viral genome. There are additional branching subcategories within a genotype.
What are hepatitis C genotypes?
A variable for those with chronic hepatitis C virus (HCV) is the “genotype,” or the strain of the virus when they contracted an infection. The genotype is determined by a blood test.
What is the current research into genotypes and treatments for each type?
The most widely used anti-HCV therapy, PEG/ribavirin, doesn’t target the virus itself. This treatment regimen primarily affects the person’s immune system. Its goal is to rally the immune system to recognize and eliminate cells infected with HCV.
How many different genotypes of HCV are there?
According to the Centers for Disease Control and Prevention (CDC), at least seven distinct HCV genotypes, and more than 67 subtypes, have been identified.
What happens after hepatitis C diagnosis?
After you receive a diagnosis of hepatitis C, your doctor will work to identify the type you have so you’ll get the best treatment.
Why is the human genetic code not proofread?
The human genetic code goes through strict proofreading during the process of DNA replication. Random changes (mutations) to the human genetic code occur at a low rate. That’s because most mistakes of DNA replication are recognized and corrected. In contrast, HCV’s genetic code isn’t proofread when it’s replicated.
Which agent is least likely to be affected by virus genotype?
The effectiveness of those agents that bind most directly to the protein’s active site is least likely to be affected by virus genotype.
What is the genotype 1b of hepatitis C?
Hepatitis C virus genotype 1b as a major risk factor associated with hepatocellular carcinoma in patients with cirrhosis: a seventeen-year prospective cohort study.
How often is HCC detected?
HCC occurrence was detected by ultrasound surveillance every 6 months.
What is the most common cause of death in patients with hepatitis C?
Hepatocellular carcinoma (HCC) is the most frequent cause of death in patients with hepatitis C virus (HCV)-induced cirrhosis. Despite a number of studies in different populations worldwide suggesting an association between HCV genotype 1 and the risk of HCC, no consensus has emerged yet on this matter, which is still controversial.
How long does it take to treat HCV genotype 1A?
For initial therapy of HCV genotype 1a infection in adults who have compensated cirrhosis, three 12-week regimens with similar efficacy are recommended: elbasvir-grazoprevir (if no key resistance-associated substitutions are detected on pretreatment NS5A testing); ledipasvir-sofosbuvir; or sofosbuvir-velpatasvir. One 8-week regimen is also recommended: glecaprevir-pibrentasvir.
What is the treatment for genotype 1?
From 1998-2013, therapy evolved from interferon monotherapy, to peginterferon monotherapy, to peginterferon plus ribavirin, to triple therapy with peginterferon plus ribavirin plus an NS3/4A protease inhibitor ( boceprevir or telaprevir ). [ 6, 7, 8, 9] Since 2014, the standard of care for HCV genotype 1 has consisted of all-oral therapy with a combination of DAAs. As of 2017, there have been multiple safe, convenient, and highly effective all-oral regimens recommended for the treatment of HCV genotype 1, most of which do not require ribavirin.
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 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 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) ...
What is the ION-1 trial?
ION-1: This phase 3 trial examined the fixed-dose combination of ledipasvir-sofosbuvir, given with or without ribavirin, in treatment-naïve adults with HCV genotype 1 , including those with compensated cirrhosis. [ 25] All treatment arms had SVR12 rates greater than 95%; no differences were observed with respect to receipt of ribavirin, or whether patients received 12 or 24 weeks of treatment.
What is the phase 3 trial of glecaprevir?
EXPEDITION-1: This phase 3, single-arm, open-label trial evaluated the safety and efficacy of 12 weeks of glecaprevir-pibrentasvir in 146 adults with compensated cirrhosis and HCV genotype 1, 2, 4, 5, or 6. [ 22] Among all participants enrolled, 60% had HCV genotype 1 infection and 75% were treatment naïve, with the other 25% having failed an interferon-based regimen with or without sofosbuvir. For the participants with HCV genotype 1 infection, 99% (89 of 90) achieved an SRV12. One person with genotype 1a experienced a viral relapse at week 8 post-treatment; this individual had a Y93N resistance-associated substitution detected at baseline and at the time of virologic failure.
Treatment
- For genotype 1a-infected, treatment-naive patients without cirrhosis, there are 4 recommended regimens with comparable efficacy. Four regimens are classified as alternative because, compared to the recommended regimens, they require a longer duration of treatment, involve greater prescribing complexity, are potentially less efficacious, and/or ther...
Clinical significance
- The presence of certain baseline NS5A RASs significantly reduces SVR12 rates with a 12-week course of elbasvir/grazoprevir in genotype 1a-infected patients (Zeuzem, 2017). Baseline NS5A RASs were identified in 12% (19/154) of genotype 1a-infected patients enrolled in the C-EDGE study, of which 58% (11/19) achieved SVR12 compared to an SVR12 rate of 99% (133/135) in pa…
Prevention
- Based on known inferior response in patients with baseline NS5A RASs, NS5A resistance testing is recommended in genotype 1a patients who are being considered for elbasvir/grazoprevir therapy. If baseline RASs are present (ie, substitutions at amino acid positions 28, 30, 31, or 93), treatment extension to 16 weeks with the addition of weight-based ribavirin (1000 mg [<75 kg] t…
Administration
- The daily fixed-dose combination of glecaprevir (300 mg)/pibrentasvir (120 mg) is administered as three 100 mg/40 mg fixed-dose combination pills. Based on favorable data for 8 weeks of treatment among noncirrhotic patients in the phase 2 SURVEYOR-1 study (33/34 patients with SVR and no virologic failures) (Kwo, 2017b), ENDURANCE-1 enrolled 703 noncirrhotic, genotype …
Research
- EXPEDITION-1 investigated the use of glecaprevir/pibrentasvir in DAA-naive (75%) or -experienced (interferon or peginterferon ± ribavirin, or sofosbuvir plus ribavirin ± peginterferon) patients with compensated cirrhosis. Of 146 patients with genotype 1, 2, 4, 5, or 6 given 12 weeks of glecaprevir/pibrentasvir, 145 (99%) achieved SVR12. The single relapse occurred in a genotype 1…
Analysis
- ION-3 excluded patients with cirrhosis and investigated shortening therapy from 12 weeks to 8 weeks (with or without ribavirin) (Kowdley, 2014). SVR12 rates were 93% to 95% across all study arms with no difference in SVR in the intention-to-treat analysis. However, relapse rates were higher in the 8-week arms (20/431)regardless of ribavirin usecompared with the 12-week arm (3/…
Contraindications
- Based on available data, shortening treatment to less than 12 weeks is not recommended for HIV/HCV-coinfected patients (see HIV/HCV Coinfection section) and black patients (Su, 2016); (Wilder, 2016); (O'Brien, 2014); (Ioannou, 2016). For others, it should be done at the discretion of the practitioner with consideration of other potential negative prognostic factors.
Pharmacology
- The fixed-dose combination of 12 weeks of sofosbuvir (400 mg)/velpatasvir (100 mg) was approved by the FDA for the treatment of genotype 1 infection in treatment-naive patients based on ASTRAL-1. This placebo-controlled trial involved a 12-week course of sofosbuvir/velpatasvir administered to 624 participants with genotype 1, 2, 4, 5, or 6 who were treatment naive (n=423) …
Medical uses
- The daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) plus twice-daily dosed dasabuvir (250 mg) and weight-based ribavirin was approved by the FDA for the treatment of genotype 1a infection in treatment-naive patients based on 3 registration trials: SAPPHIRE-I (322 treatment-naive patients with genotype 1a infection without cirrhosis); P…
Treatment
Results
Research
Analysis
- The following is a summary of the AASLD-IDSA HCV Guidance for adults with hepatitis C genotype 1a or 1b infection who are treatment experienced and failed prior therapy, including those without cirrhosis and those with compensated cirrhosis.[41,42,43,44,45,46,47] For individuals with cirrhosis, the AASLD-IDSA HCV Guidance defines compensated cirrho...
Contraindications
Pharmacology
Medical uses