DOCSLIB.ORG

Hepatitis C Agents

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Hepatitis C Agents Hepatitis C Agents Therapeutic Class Review (TCR) August 14, 2020 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage or retrieval system without the express written consent of Magellan Rx Management. All requests for permission should be mailed to: Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to [email protected]. Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2020 Magellan Rx Management. All Rights Reserved. FDA-APPROVED INDICATIONS Drug Mfr FDA-Approved Indications Interferons peginterferon alfa-2a Genentech Chronic hepatitis C (CHC) 1 (Pegasys®) . Treatment of adults with CHC as part of a combination regimen with other hepatitis C virus antiviral drugs in patients ≥ 5 years old with compensated liver disease . Monotherapy is not recommended unless a patient has a contraindication to, or significant intolerance of, other HCV antiviral drugs Chronic hepatitis B . Treatment of HBeAg-positive and HBeAg-negative chronic hepatitis B in adults with compensated liver disease and evidence of viral replication and liver inflammation peginterferon alfa-2b Merck Sharp Chronic hepatitis C 2 (PEGIntron®) & Dohme . For patients with compensated liver disease in combination with ribavirin and an approved Hepatitis C Virus (HCV) NS3/4A protease inhibitor in adult patients (≥ 18 years old) with HCV genotype 1 infection . For patients with compensated liver disease in combination with ribavirin in patients with genotypes other than genotype 1, pediatric patients (3 to 17 years of age), or in patients with genotype 1 infection where the use of an HCV NS3/4A protease inhibitor is not warranted based on tolerability, contraindications, or other clinical factors Monotherapy should only be used in the treatment of CHC in patients with compensated liver disease if there are contraindications to, or significant intolerance of, ribavirin and is indicated for use only in previously untreated adult patients; Combination therapy provides substantially better response rates than monotherapy Ribavirin ribavirin capsule*3 generic Chronic hepatitis C . In combination with interferon alfa-2b (pegylated [PEG-Intron] or non- pegylated [Intron-A®]) in patients (≥ 3 years of age) with compensated liver disease Ribavirin must not be used as monotherapy; Combination therapy with ribavirin/peginterferon alfa-2b is preferred over ribavirin/interferon alfa-2b as this combination provides substantially better response rates; Patients with the following characteristics are less likely to benefit from retreatment after failing a course of therapy: previous nonresponse, previous peginterferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection; No safety and efficacy data are available for treatment of longer than 1 year Hepatitis C Agents Review – August 2020 Page 2 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2020 Magellan Rx Management. All Rights Reserved. FDA-Approved Indications (continued) Drug Mfr FDA-Approved Indications Ribavirin (continued) ribavirin tablet†4 generic Chronic hepatitis C . In combination with peginterferon alfa-2a (Pegasys) in patients ≥ 5 years of age with compensated liver disease and have not been previously treated with interferon alfa . Includes patients with histological evidence of cirrhosis (Child-Pugh A) . Includes adult patients with clinically stable human immunodeficiency virus (HIV) disease and CD4 count > 100 cells/mm2 Ribavirin must not be used as monotherapy; Safety and efficacy have not been demonstrated with treatment longer than 48 weeks; Safety and efficacy have not been established in liver or other organ transplant recipients, patients with decompensated liver disease, or previous non-responders to interferon therapy ribavirin tablet generic Chronic hepatitis C (Ribasphere®, Capsules Ribasphere . 5,6,7 In combination with interferon alfa 2b (pegylated and non-pegylated) in RibaPak®) patients ≥ 3 years of age with compensated liver disease Ribasphere must not be used as monotherapy; Combination therapy with ribavirin/peginterferon alfa-2b is preferred over ribavirin/interferon alfa-2b as this combination provides substantially better response rates; Patients with the following characteristics are less likely to benefit from retreatment after failing a course of therapy: previous nonresponse, previous peginterferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection; No safety and efficacy data are available for treatment of longer than 1 year Tablets . In combination with peginterferon alfa-2a (Pegasys) in adults with compensated liver disease and adults who have not been previously treated with interferon alfa . Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh A) and patients with HIV disease that is clinically stable and CD4 count > 100 cells/mm2 Safety and efficacy data are not available for treatment longer than 48 weeks; The safety and efficacy of ribavirin and peginterferon alfa-2a therapy have not been established in liver or other organ transplant recipients, patients with decompensated liver disease, or previous non-responders to interferon; Safety and efficacy have not been demonstrated for treatment longer than 48 weeks Hepatitis C Agents Review – August 2020 Page 3 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2020 Magellan Rx Management. All Rights Reserved. FDA-Approved Indications (continued) Drug Mfr FDA-Approved Indications Oral NS5B Polymerase Inhibitors sofosbuvir Gilead Chronic hepatitis C genotype 1, 2, 3, or 4 in adults (Sovaldi®)8 . As a component of a combination antiviral treatment regimen . Without cirrhosis or with compensated cirrhosis Chronic hepatitis C genotypes 2 or 3 in pediatric patients (≥ 3 years of age) . In combination with ribavirin . Without cirrhosis or with compensated cirrhosis Oral Combination Products elbasvir/grazoprevir Merck Chronic hepatitis C genotype 1 or 4 in adults 9 (Zepatier™) . Co-formulated fixed-dose tablet of elbasvir (an NS5A inhibitor) and grazoprevir (an NS3/4A protease inhibitor) . Indicated for use with or without ribavirin . Testing for NS5A resistance-associated polymorphisms needed for genotype 1a . Without cirrhosis or with compensated cirrhosis glecaprevir/ Abbvie Chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6 infection in adults and pediatric pibrentasvir patients (≥ 12 years of age or weighing ≥ 45 kg) 10 (Mavyret™) . Mavyret includes a combination of glecaprevir (an NS3/4A protease inhibitor) and pibrentasvir (an NS5A inhibitor) . Indicated for use without ribavirin . Without cirrhosis or with compensated cirrhosis Indicated for use in treatment-experienced genotype 1 patients with prior regimen containing either an HCV NS5A inhibitor or an HCV NS3/4A PI, but not both ledipasvir/sofosbuvir generic‡, Chronic hepatitis C genotype 1, 4, 5, or 6 in adults and pediatric patients (≥ 3 years (Harvoni®)11 Gilead of age) . Without cirrhosis or with compensated cirrhosis . Co-formulated fixed-dose tablet of ledipasvir (an NS5A inhibitor) and sofosbuvir (an NS5B Inhibitor) . Indicated for use without ribavirin Chronic hepatitis C genotype 1 in adults and pediatric patients (≥ 3 years of age) . With decompensated cirrhosis, in combination with ribavirin Chronic hepatitis C genotypes 1 or 4 in adults and pediatric patients (≥ 3 years of age) Liver transplant recipients without cirrhosis or compensated cirrhosis, in combination with ribavirin ombitasvir/ Abbvie Chronic hepatitis C genotype 1 in adults paritaprevir/ritonavir + . Viekira Pak includes the combination of ombitasvir (an NS5A inhibitor), dasabuvir 12 paritaprevir (a protease inhibitor), ritonavir (a potent CYP3A inhibitor to (Viekira Pak®) pharmacologically boost paritaprevir), and dasabuvir (an NS5B polymerase inhibitor) Indicated for use with or without ribavirin, including in those with compensated cirrhosis Hepatitis C Agents Review – August 2020 Page 4 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2020 Magellan Rx Management. All Rights Reserved. FDA-Approved Indications (continued) Drug Mfr FDA-Approved Indications Oral
Load more

Recommended publications
  • Avis De La Commission De La Transparence
    COMMISSION DE LA TRANSPARENCE Avis 6 décembre 2017 Date d’examen par la Commission : 22 novembre 2017 glécaprévir / pibrentasvir MAVIRET 100 mg/40 mg, comprimé pelliculé B/ 84 (CIP 34009 301 087 6 5) Laboratoire ABBVIE Code ATC Code ATC non encore attribué (association d’antiviraux à action directe) Motif de l’examen Inscription Sécurité Sociale (CSS L.162-17) Listes concernées Collectivités (CSP L.5123-2) Indications « Traitement de l’infection chronique par le virus de l’hépatite C (VHC) de concernées génotypes 1 à 6 chez les adultes » HAS - Direction de l'Evaluation Médicale, Economique et de Santé Publique 1/28 Avis 2 SMR Important Compte tenu de : - son efficacité virologique pangénotypique importante (>90%), avec une durée de traitement de 8 à 12 semaines pour la majorité des patients sans cirrhose ou avec cirrhose compensée (Child-Pugh A uniquement), - la démonstration d’une efficacité importante dans des populations particulières telles que les patients insuffisants rénaux ou hémodialysés pour lesquelles les alternatives sont limitées, - son profil de tolérance et de résistance satisfaisant mais avec un ASMR potentiel d’interactions médicamenteuses important, - l’existence d’alternatives qui permettent également un traitement court (8 à 12 semaines) sans adjonction de ribavirine, la Commission considère que la spécialité, apporte, au même titre que les autres combinaisons d’antiviraux d’action directe disponibles (EPCLUSA, HARVONI, VIEKIRAX, EXVIERA, ZEPATIER), une amélioration du service médicale rendue mineure (ASMR IV) dans
    [Show full text]
  • Hepatitis-C-Virus-Induced Micrornas Dampen Interferon-Mediated
    LETTERS Hepatitis-C-virus-induced microRNAs dampen interferon-mediated antiviral signaling Abigail Jarret1, Adelle P McFarland1,6,7, Stacy M Horner1,6,7, Alison Kell1, Johannes Schwerk1, MeeAe Hong1, Samantha Badil1, Rochelle C Joslyn1, Darren P Baker2,6, Mary Carrington3,4, Curt H Hagedorn5, Michael Gale Jr1 & Ram Savan1 Hepatitis C virus (HCV) infects 200 million people globally, currently in clinical trials6,10. More recently, interferon-free com- and 60–80% of cases persist as a chronic infection that will binations of HCV protease and RNA polymerase inhibitors, some- progress to cirrhosis and liver cancer in 2–10% of patients1–3. times with ribavirin, have produced dramatic results in a subset of We recently demonstrated that HCV induces aberrant expression patients10. However, the emergence of resistant HCV variants and of two host microRNAs (miRNAs), miR-208b and miR-499a-5p, the high cost of DAA treatments might limit the availability of these encoded by myosin genes in infected hepatocytes4. These therapies worldwide11–13. The usefulness of DAA-based therapies for miRNAs, along with AU-rich-element-mediated decay, suppress some patients—such as those with advanced infection, who are at IFNL2 and IFNL3, members of the type III interferon (IFN) the highest risk for hepatic decompensation, liver failure, hepato- gene family, to support viral persistence. In this study, we cellular carcinoma and/or death—also remains to be fully proven13. show that miR-208b and miR-499a-5p also dampen type I Hence, it is critical to identify the mechanisms that HCV employs IFN signaling in HCV-infected hepatocytes by directly which lead to the failure of type I IFN therapy.
    [Show full text]
  • KALETRA (Lopinavir/Ritonavir)
    HIGHLIGHTS OF PRESCRIBING INFORMATION CONTRAINDICATIONS These highlights do not include all the information needed to use • Hypersensitivity to KALETRA (e.g., toxic epidermal necrolysis, Stevens- KALETRA safely and effectively. See full prescribing information for Johnson syndrome, erythema multiforme, urticaria, angioedema) or any of KALETRA. its ingredients, including ritonavir. (4) • Co-administration with drugs highly dependent on CYP3A for clearance KALETRA (lopinavir and ritonavir) tablet, for oral use and for which elevated plasma levels may result in serious and/or life- KALETRA (lopinavir and ritonavir) oral solution threatening events. (4) Initial U.S. Approval: 2000 • Co-administration with potent CYP3A inducers where significantly reduced lopinavir plasma concentrations may be associated with the potential for RECENT MAJOR CHANGES loss of virologic response and possible resistance and cross resistance. (4) Contraindications (4) 12/2019 WARNINGS AND PRECAUTIONS The following have been observed in patients receiving KALETRA: INDICATIONS AND USAGE • The concomitant use of KALETRA and certain other drugs may result in KALETRA is an HIV-1 protease inhibitor indicated in combination with other known or potentially significant drug interactions. Consult the full antiretroviral agents for the treatment of HIV-1 infection in adults and prescribing information prior to and during treatment for potential drug pediatric patients (14 days and older). (1) interactions. (5.1, 7.3) • Toxicity in preterm neonates: KALETRA oral solution should not be used DOSAGE AND ADMINISTRATION in preterm neonates in the immediate postnatal period because of possible Tablets: May be taken with or without food, swallowed whole and not toxicities. A safe and effective dose of KALETRA oral solution in this chewed, broken, or crushed.
    [Show full text]
  • Hepatitis C Agents Therapeutic Class Review
    Hepatitis C Agents Therapeutic Class Review (TCR) November 2, 2018 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage or retrieval system without the express written consent of Magellan Rx Management. All requests for permission should be mailed to: Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to [email protected]. Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2018 Magellan Rx Management. All Rights Reserved. FDA-APPROVED INDICATIONS Drug Mfr FDA-Approved Indications Interferons peginterferon alfa-2a Genentech Chronic hepatitis C (CHC) 1 (Pegasys®) .
    [Show full text]
  • Acid Reducing Agent Treatment Selector
    www.hep-druginteractions.org Acid Reducing Agent Treatment Selector Charts produced April 2018. Full information available at www.hep-druginteractions.org For personal use only. Not for distribution. For personal use only. Not for distribution. For personal use only. Not for distribution. For personal use only. Not for distribution. DCV EBR/GZR GLP/PIB LED/SOF OBV/PTV/r OBV/PTV/r +DSV SMV SOF SOF/VEL SOF/VEL/VOX Aluminium hydroxide ↔ ↔ ↔ a ↔ ↔ ↔ ↔ b a a Antacids ↔ ↔ ↔ a ↔ ↔ ↔ ↔ b a a d d d Cimetidine ↔ ↔ ↔ ↔ ↔ Famotidine 18% c e ↔ ↔ ↔ ↔ f ↔ g H2 RA Ranitidine ↔ ↔ d ↔ ↔ ↔ ↔ d d Esomeprazole ↔ ↔ i k ↓ ↓ ↔ ↔ m o Lansoprazole ↔ ↔ i k ↓ ↓ ↔ ↔ m o Omeprazole 16% ↔ j l ↓ 54% ↓ 38% ↑ 21% ↔ n p PPI Pantoprazole ↔ h i k ↓ ↓ ↔ ↔ m o Rabeprazole ↔ ↔ i k ↓ ↓ ↔ ↔ m p Colour Legend No clinically significant interaction expected. These drugs should not be coadministered. Potential interaction which may require a dosage adjustment or close monitoring. Potential interaction predicted to be of weak intensity. Text Legend ↑ Potential increased exposure of the acid reducing agent Potential increased exposure of HCV DAA ↓ Potential decreased exposure of the acid reducing agent Potential decreased exposure of HCV DAA ↔ No significant effect Numbers refer to increased or decreased AUC as observed in drug-drug interaction studies. H2 RA H2 receptor antagonists PPI Proton pump inhibitors a It is recommended to separate administration of the acid reducing agent and the DAA by 4 hours. b Consider separating administration of the acid reducing agent and sofosbuvir by 2 hours. c Elbasvir AUC increased by 5%; grazoprevir AUC increased by 10%. d H2 receptor antagonists at a dose that does not exceed doses comparable to famotidine 40 mg twice daily can be given simultaneously with or 12 hours apart from the DAA.
    [Show full text]
  • Sofosbuvir-Velpatasvir (Epclusa)
    © Hepatitis C Online PDF created September 29, 2021, 4:07 am Sofosbuvir-Velpatasvir (Epclusa) Table of Contents Sofosbuvir-Velpatasvir Epclusa Summary Drug Summary Adverse Effects Class and Mechanism Manufacturer for United States Indications Contraindications Dosing Clinical Use Cost and Medication Access Resistance Key Drug Interactions Full Prescribing Information Figures Drug Summary Sofosbuvir-velpatasvir is a pangenotypic NS5A-NS5B inhibitor single-pill combination regimen that has potent activity against hepatitis C virus (HCV) genotypes 1, 2, 3, 4, 5, and 6. It provides a much-needed option for patients with HCV genotype 3 infection, including those with compensated cirrhosis. Notably, an abbreviated duration of 8 weeks has not been studied with sofosbuvir-velpatasvir for any of the genotypes, except in conjunction with a third agent (voxilaprevir). Sofosbuvir-velpatasvir, like ledipasvir-sofosbuvir, may have have levels significantly reduced with acid-reducing agents, particularly proton-pump inhibitors. Adverse Effects The most common adverse effects, observed in at least 10% of phase 3 trial participants, were headache and fatigue. Class and Mechanism Sofosbuvir-Velpatasvir is an oral fixed-dose combination of sofosbuvir, a nucleotide analog NS5B polymerase inhibitor and velapatasvir, an NS5A replication complex inhibitor. Sofosbuvir is currently approved in the Page 1/4 United States for the treatment of genotype 1, 2, 3 and 4 HCV infection with different regimens and durations dependent on the HCV genotype. Velpatasvir (formerly GS-5816) is a novel NS5A inhibitor that has potent in vitro anti-HCV activity across all genotypes at the picomolar level. The combination of sofosbuvir-velpatasvir is the first once-daily single-tablet regimen with pangenotypic activity.
    [Show full text]
  • Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) Information Packet
    Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) Information Packet Liver Disease & Hepatitis Program Providers: Brian McMahon, MD; Youssef Barbour, MD; Lisa Townshend-Bulson, FNP-C; Annette Hewitt, FNP-C; Stephen Livingston, MD; Ellen Provost, DO; Timothy Thomas, MD Family Medicine Provider: _____________________________________________ If you are considering hepatitis C treatment, please read this treatment agreement carefully and be sure to ask any questions you may have before you begin treatment. The FDA approved sofosbuvir combined with velpatasvir and voxilaprevir in one tablet (Vosevi®) for the re-treatment of hepatitis C genotypes 1-6. PREGNANCY & BREASTFEEDING WARNING It is not known if Vosevi® will harm an unborn or breastfeeding baby, so it is recommended that women do not get pregnant or breastfeed while taking this medicine. PLEASE NOTE: You must let medical, mental health, dental providers, and pharmacist(s) know that you are taking Vosevi ® before starting any new medications. You must let Liver Clinic providers know about any new medications you are prescribed before starting them. This includes vitamins and other supplements. If you have ever had hepatitis B infection, the virus could become active again during or after taking Vosevi®. You will have blood tests to check for hepatitis B infection before starting treatment (HBsAg, HBcAb). If you have hepatitis B or are HBcAb or HBsAg positive you will have HBV DNA levels checked before and while on treatment. HOW THE TREATMENT PROCESS WORKS You will have an appointment monthly while you are taking the medication. At each visit blood will be collected. A monthly pregnancy test will be done for female patients of childbearing potential.
    [Show full text]
  • Hepatitis C Treatment
    Hepatitis C Treatment The goal of treatment for hepatitis C virus (HCV) is to cure the virus, which can be done with a combination of drugs. The specific meds used and the duration of treatment depend on a number of factors, including HCV genotype (genetic structure of the virus), viral load, past treatment experience, degree of liver damage, ability to tolerate the prescribed treatment, and whether the person is waiting for a liver transplant or is a transplant recipient. In some cases, HCV treatment may be limited by your health insurance plan or drug formulary. Here’s information about each type, or class, of approved HCV treatment along with drugs in the late stages of development: Multi-Class Combination Drugs Brand Name Generic Name Status Pharmaceutical Company Epclusa* sofosbuvir + velpatasvir Approved Gilead Sciences Harvoni* ledipasvir + sofosbuvir Approved Gilead Sciences Mavyret glecaprevir + pibrentasvir Approved AbbVie Vosevi sofosbuvir/velpatasvir/ Approved Gilead Sciences voxilaprevir Zepatier elbasvir + grazoprevir Approved Merck n/a daclatasvir + asunaprevir + Phase III Bristol-Myers Squibb beclabuvir *generic available What are they? Multi-class combination drugs are a combination of drugs formulated into a single pill or package of pills. For instance, the drug Harvoni combines two drugs, ledipasvir and sofosbuvir. Ledipasvir is an NS5A inhibitor and is only sold as part of Harvoni; sofosbuvir may be prescribed separately under the brand name of Sovaldi. Pegylated Interferon Alfa Brand Name Generic Name Status Pharmaceutical Company Pegasys peginterferon alfa-2a Approved Genentech What are they? Interferon is a protein made by the immune system, named because it interferes with viral reproduction. In addition, interferon signals the immune system to recognize and respond to microorganisms, including viral and bacterial infections.
    [Show full text]
  • Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) Reference Number: HIM.PA.SP63 Effective Date: 08.01.20 Last Review Date: 08.20 Line of Business: HIM* Revision Log
    Clinical Policy: Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) Reference Number: HIM.PA.SP63 Effective Date: 08.01.20 Last Review Date: 08.20 Line of Business: HIM* Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Sofosbuvir/velpatasvir/voxilaprevir (Vosevi®) is a fixed-dose combination oral tablet. Sofosbuvir is a nucleotide analog hepatitis C virus (HCV) NS5B polymerase inhibitor, velpatasvir is an NS5A inhibitor, and voxilaprevir is an NS3/4A protease inhibitor. ____________ *This criteria does NOT apply to California Commercial Exchange Plans. FDA Approved Indication(s) Vosevi is indicated for the treatment of adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have: Genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor*; Genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor**. o Additional benefit of Vosevi over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an NS5A inhibitor. _____________ * In clinical trials, prior NS5A inhibitor experience included daclatasvir, elbasvir, ledipasvir, ombitasvir, or velpatasvir. ** In clinical trials, prior treatment experience included sofosbuvir with or without any of the following: peginterferon alfa/ribavirin, ribavirin, HCV NS3/4A protease inhibitor (boceprevir, simeprevir or telaprevir). Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation® that Vosevi is medically necessary when the following criteria are met: I.
    [Show full text]
  • Real-Life Effectiveness and Safety of Glecaprevir/Pibrentasvir for Korean Patients with Chronic Hepatitis C at a Single Institution
    Gut and Liver https://doi.org/10.5009/gnl19393 pISSN 1976-2283 eISSN 2005-1212 Original Article Real-Life Effectiveness and Safety of Glecaprevir/Pibrentasvir for Korean Patients with Chronic Hepatitis C at a Single Institution Young Joo Park1,2, Hyun Young Woo1,2, Jeong Heo1,2, Sang Gyu Park3, Young Mi Hong1,4, Ki Tae Yoon1,4, Dong Uk Kim1,2, Gwang Ha Kim1,2, Hyung Hoi Kim2,5, Geun Am Song1,2, and Mong Cho1,4 1Department of Internal Medicine, College of Medicine, Pusan National University, 2Biomedical Research Institute, Pusan National University Hospital, 3Department of Internal Medicine, Good Samsun Hospital, Busan, 4Liver Center, Pusan National University Yangsan Hospital, Yangsan, and 5Department of Laboratory Medicine, College of Medicine, Pusan National University, Busan, Korea Article Info Background/Aims: Glecaprevir/pibrentasvir (G/P) is a combination of direct-acting antiviral Received November 21, 2019 agents that is an approved treatment for chronic infections by all six hepatitis C virus (HCV) geno- Revised June 3, 2020 types. However, there are limited data on the effect of G/P in Korean patients in actual real-world Accepted June 21, 2020 settings. We evaluated the real-life effectiveness and safety of G/P at a single institution in Korea. Published online August 26, 2020 Methods: This retrospective, observational, cohort study used sustained virologic response at 12 weeks after treatment completion (SVR12) as the primary effectiveness endpoint. Safety and Corresponding Author tolerability were also determined. Jeong Heo Results: We examined 267 individuals who received G/P for chronic HCV infections. There were ORCID https://orcid.org/0000-0003-0961-7851 148 females (55.4%), and the overall median age was 63.0 years (range, 25 to 87 years).
    [Show full text]
  • Effectiveness and Safety of Sofosbuvir/Velpatasvir ± Ribavirin Vs
    Original research Eur J Hosp Pharm: first published as 10.1136/ejhpharm-2019-002060 on 7 February 2020. Downloaded from Effectiveness and safety of sofosbuvir/velpatasvir ± ribavirin vs glecaprevir/pibrentasvir in genotype 3 hepatitis C virus infected patients Luis Margusino- Framiñán,1,2 Purificación Cid- Silva,1,2 Sandra Rotea- Salvo,1 Álvaro Mena- de- Cea,2,3 Francisco Suárez- López,4 Pilar Vázquez- Rodríguez,2,3 Manuel Delgado- Blanco,2,4 Ana Isabel Sanclaudio- Luhia,5 Isabel Martín- Herranz,1 Ángeles Castro- Iglesias2,3 1Pharmacy Service, Universitary ABSTRact 1.1%, with a total affected population of 5.6 million Hospital of A Coruña, A Objectives Sofosbuvir/velpatasvir±ribavirin (SOF/ people.1 The prevalence of HCV genotypes varies Coruña, Spain 2 among regions, with genotype 3 (G3) being the Division of Clinical Virology, VEL±RBV) and glecaprevir/pibrentasvir (GLE/PIB) are Biomedical Research Institute the drug combinations of choice for treating individuals second most prevalent in Europe after genotype 1 of A Coruña (INIBIC), with genotype 3 hepatitis C virus (G3- HCV) infection. The (G1), accounting for approximately 25% of cases Universitary Hospital of A objective of this study was to evaluate the effectiveness of chronic hepatitis C (CHC).2 Compared with Coruña (CHUAC), Sergas, and safety of SOF/VEL±RBV compared with GLE/PIB for G1- HCV, G3- HCV chronic infection has a faster University of A Coruña (UDC), 3–6 A Coruña, Spain treating G3- HCV infection under routine clinical practice progression to liver cirrhosis and hepatocellular
    [Show full text]
  • Hepatitis C Viral RNA Genotype 1 NS5B Drug Resistance
    Test Summary TM Hepatitis C Viral RNA Genotype 1 NS5B Drug Resistance The Hepatitis C Viral RNA Genotype 1 NS5B Drug Resistance Test Code: 906679 assay determines the HCV genotype (1a, 1b, or 1) and detects mutations associated with resistance to sofosbuvir. The Specimen Requirements: 2 mL frozen plasma from an identication of specic mutations or polymorphisms may be EDTA lavender-top tube (0.6 mL minimum). useful to optimize treatment selection. INDIVIDUALS SUITABLE FOR TESTING CPT Code*: 87902 • Individuals with genotype 1 HCV infection who experience treatment failure with sofosbuvir CLINICAL USE METHOD • Identify resistance-associated mutation as potential • Reverse transcription polymerase chain reaction (PCR) cause of NS5B inhibitor (sofosbuvir) failure and DNA sequencing of NS5B codons 270 to 530 • Analytical sensitivity: >95% for viral loads ≥700 IU/mL CLINICAL BACKGROUND Results reported: HCV infection aects more than 3.5 million individuals in the • United States.1 Left untreated, it can lead to progressive liver – HCV genotype: 1a, 1b, 1, or not detected (genotypes injury, cirrhosis, hepatocellular carcinoma, and the need for other than 1 may not be detected) liver transplantation. Of the 6 major HCV genotypes, genotype – Sofosbuvir resistance: predicted or not predicted 1 (including subtypes 1a and 1b) is the most prevalent by far in the United States.2 Combination therapy with pegylated INTERPRETIVE INFORMATION interferon (PEG) plus ribavirin was the mainstay of treatment An interpretation of “resistance predicted” suggests that for all genotypes, but resulted in low sustained virologic treatment failure with sofosbuvir may be due to the presence response rates of approximately 40% to 50% in HCV genotype of an NS5B mutation (S282T).
    [Show full text]