DOCSLIB.ORG

S Sofosbuvir (Sovaldi )

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
S Sofosbuvir (Sovaldi ) Sofosbuvir (Sovaldi ™) UTILIZATION MANAGEMENT CRITERIA DRUG CLASS: Nucleotide Analog NS5B Polymerase Inhibitor BRAND (generic) NAME: Sovaldi (sofosbuvir ) 400 mg strength tablet FDA -APPROVED INDICATIONS Sovaldi is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. • Sovaldi efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV -1 co-infection. COVERAGE AUTHORIZATION CRITE RIA Sofosbuvir (Sovaldi) is cover ed for the following condition and situations: • Diagnosis of chronic hepatitis C (CHC) infection with c onfirmed genotype 1, 2, 3, or 4, OR • CHC infection with hepatocellular carcinoma awaiting liver transplant, AND • Sofosbuvir is prescribed in combination with ribavirin and pegylated interferon alfa for genotypes 1 and 4, OR • Sofosbuvir is prescribed in combination with ribavirin for p atients with genotype 1 who are peginterferon-ineligible* (medical record documentation of ineligibility for peginterferon therapy must be submitted for review), OR • Sofosbuvir is prescribed in combination with simeprevir, with or without ribavirin, for 12 weeks duration of therapy, for patients with genotype 1 that have advanced fi brosis (METAVIR score 2, 3, 4, OR cirrhosis secondary to Hepatitis C ), and are peginterferon - ineligible* (medical record documentation of ineligibility for peginterferon therapy m ust be submitted for review). In addition, the patient may either be treatment naïve, OR patient may have tried and failed previous treatment with peginterferon and ribavirin, OR • Sofosbuvir is prescribed in combination with ribavirin for genotypes 2 and 3 and/or in CHC patients with hepatocellular carcinoma awaiting liver transplant , AND • Sofosbuvir is prescribed by or in consultation with a physician with expertise and experience in the management of infectious hepatitis, AND • Not covered in pregnant women and men whose female partners are pregnant ( for combination therapy regimens that include ribavirin). *Peginterferon-ineligible, defined as one or more of the below: • Autoimmune hepatitis • Other autoimmune disorders, such as, myositis, thrombotic thrombocytopenic purpura, 1 Last Revision Date: August 2014 idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis, interstitial nephritis, thyroiditis, and systemic lupus erythematosus • Hypersensitivity to peginterferon or any of its components • Decompensated cirrhosis • History of depression, or clinical features consistent with depression or other neuropsychiatric conditions which would preclude safe use of peginterferon-based therapy • History of preexisting cardiac disease • Bone marrow suppression o Baseline neutrophil count below 1500/ µL o Baseline platelet count below 90,000/ µL o Baseline hemoglobin below 10 g/dL Duration of Approval Patients with genotype 1 or 4 CHC Sovaldi + peginteferon alfa + ribavirin 12 weeks Patients with genotype 1 who Sovaldi + simeprevir 12 weeks have advanced fibrosis (METAVIR (with or without ribavirin) score 2, 3, 4 OR cirrhosis secondary to Hepatitis C) and are peginterferon-ineligible* Patients with genotype 1 who are Sovaldi + ribavirin 24 weeks peginterferon-ineligible* Patients with genotype 2 CHC Sovaldi + ribavirin 12 weeks Patients with genotype 3 CHC Sovaldi + ribavirin 24 weeks CHC patients with hepatocellular Sovaldi + ribavirin 48 weeks carcinoma awaiting liver transplant DOSAGE AND ADMINISTRATION The recommended dose of Sovaldi is one 400 mg tablet, taken orally, once daily with or without food. Sovaldi should be used in combination with ribavirin or in combination with pegylated interferon alfa and ribavirin for the treatment of CHC in adults. The recommended regimen and treatment duration for Sovaldi combination therapy is provided in Table 1. Table 1: Recommended Regimens and Treatment Duration for Sovaldi Combination Therapy in HCV Mono-infected and HCV/HIV-1 Co-Infected Patients Patients with genotype 1 or 4 Sovaldi + peginterferon alfa + 12 weeks CHC ribavirin Patients with genotype 2 Sovaldi + ribavirin 12 weeks CHC Patients with genotype 3 Sovaldi + ribavirin 24 weeks CHC Per Sovaldi package labeling; r efer to peginterferon alfa and ribavirin prescribing information for dosing. 2 Last Revision Date: August 2014 Sovaldi in combination with ribavirin for 24 weeks can be considered as a therapeutic option for CHC patients with genotype 1 infection who are ineligible to receive a peginterferon-based regimen. Treatment decision should be guided by an assessment of the potential benefits and risks for the individual patient. Sovaldi in combination with ribavirin is recommended for up to 48 weeks or until the time of liver transplantation, whichever occurs first, to prevent post-transplant HCV reinfection. CONTRAINDICATIONS Sovaldi combination treatment with ribavirin or peginterferon alfa/ribavirin is contraindicated in women who are pregnant or may become pregnant and men whose female partners are pregnant because of the risks for birth defects and fetal death associated with ribavirin. DRUG-DRUG INTERACTIONS Drugs that are potent P-gp inducers in the intestine (e.g., rifampin, St. John’s wort) may significantly decrease sofosbuvir plasma concentrations and may lead to a reduced therapeutic effect of Sovaldi. Rifampin and St. John’s wort should not be used with Sovaldi. Table 2: Potentially Significant Drug Interactions Drug Class Drugs Within Class Clinical Comments Anticonvulsants Carbamazepine, oxcarbazepine, Decrease concentration of sofosbuvir leading to phenobarbital, phenytoin reduced therapeutic effect; coadministration is not recommended. Antimycobacterials Rifampin, rifabutin, rifapentine Decrease concentration of sofosbuvir with rifabutin or rifapentine, leading to reduced therapeutic effect; coadministration is not recommended. Sofosbuvir should not be used with rifampin, a potent intestinal P-gp inducer. Herbal St. John’s wort Sofosbuvir should not be used with St. John’s wort, a Supplements potent intestinal P-gp inducer. HIV protease Tipranavir/ritonavir Decrease concentration of sofosbuvir leading to inhibitors reduced therapeutic effect; coadministration is not recommended. REFERENCES Sovaldi (sofosbuvir) product labeling. Gilead Sciences, Inc. Foster City, CA. December 2013. Pegasys (peginterferon alfa-2a) product labeling. Genentech USA, Inc., A Member of the Roche Group, South San Francisco, CA. February 2013. Recommendations for Testing, Managing, and Treating Hepatitis C: Initial treatment of HCV infection in patients starting treatment. http://www.hcvguidelines.org/full-report/initial-treatment- hcv-infection-patients-starting-treatment. Retrieved on 4/1/14 and 6/1/14. 3 Last Revision Date: August 2014 4 Last Revision Date: August 2014 .
Load more

Recommended publications
  • Sofosbuvir for the Treatment of Genotype 1 Hepatitis C in Subjects Aged 65 Years Or Older
    AMERICAN ASSOCIATION FOR THE STUDY OFLIVERD I S E ASES HEPATOLOGY, VOL. 63, NO. 4, 2016 Safety and Efficacy of Ledipasvir/ Sofosbuvir for the Treatment of Genotype 1 Hepatitis C in Subjects Aged 65 Years or Older Sammy Saab,1 Sarah H. Park,1 Masashi Mizokami,2 Masao Omata,3 Alessandra Mangia,4 Ed Eggleton,5 Yanni Zhu,5 Steven J. Knox,5 Phil Pang,5 Mani Subramanian,5 Kris Kowdley,6 and Nezam H. Afdhal7 Elderly subjects have been historically underrepresented in clinical trials involving antiviral hepatitis C therapies. The aim of this analysis was to retrospectively evaluate the safety and efficacy of ledipasvir/sofosbuvir (LDV/SOF) by age groups of <65 years versus 65 years among subjects enrolled in phase 3 trials. Four open-label phase 3 clinical trials evaluated the safety and efficacy of LDV/SOF with or without ribavirin (RBV) for the treatment of genotype 1 chronic hepatitis C virus. Sustained virological response at 12 weeks, treatment-emergent adverse events (AEs), and graded laboratory abnor- malities were analyzed according to age group. Of the 2293 subjects enrolled in four phase 3 trials, 264 (12%) were 65 years of age, of whom 24 were aged 75 years. Sustained virological response at 12 weeks was achieved by 97% (1965/ 2029) of subjects aged <65 years and 98% (258/264) of subjects aged 65 years. The most common AEs in both LDV/ SOF groups that occurred in 10% of subjects were headache and fatigue. The rate of study discontinuation due to AEs was similar in the two age cohorts.
    [Show full text]
  • Effectiveness and Safety of Sofosbuvir Plus Ribavirin for the Treatment of HCV Genotype 2 Infection
    Hepatology ORIGINAL ARTICLE Effectiveness and safety of sofosbuvir plus ribavirin Gut: first published as 10.1136/gutjnl-2016-311609 on 13 July 2016. Downloaded from for the treatment of HCV genotype 2 infection: results of the real-world, clinical practice HCV-TARGET study Tania M Welzel,1 David R Nelson,2 Giuseppe Morelli,2 Adrian Di Bisceglie,3 Rajender K Reddy,4 Alexander Kuo,5 Joseph K Lim,6 Jama Darling,7 Paul Pockros,8 Joseph S Galati,9 Lynn M Frazier,10 Saleh Alqahtani,11 Mark S Sulkowski,11 Monika Vainorius,7 Lucy Akushevich,7 Michael W Fried,7 Stefan Zeuzem,1 for the HCV-TARGET Study Group ► Additional material is ABSTRACT published online only. To view Objective Due to a high efficacy in clinical trials, Significance of this study please visit the journal online sofosbuvir (SOF) and ribavirin (RBV) for 12 or 16 weeks (http://dx.doi.org/10.1136/ gutjnl-2016-311609). is recommended for treatment of patients with HCV genotype (GT) 2 infection. We investigated safety and What is already known on this subject? For numbered affiliations see effectiveness of these regimens for GT2 in HCV-TARGET ▸ fi end of article. Due to a high ef cacy in clinical trials, the participants. all-oral combination of sofosbuvir (SOF) and Correspondence to Design HCV-TARGET, an international, prospective ribavirin (RBV) for 12 weeks is currently Dr Tania Mara Welzel, JW observational study evaluates clinical practice data on considered standard of care in patients with Goethe University Hospital, novel antiviral therapies at 44 academic and 17 HCV genotype 2 (GT2) infection.
    [Show full text]
  • SOVALDI® (Sofosbuvir)
    HIGHLIGHTS OF PRESCRIBING INFORMATION --------------------------------CONTRAINDICATIONS-----------------------------­ These highlights do not include all the information needed to use • When used in combination with peginterferon alfa/ribavirin or SOVALDI safely and effectively. See full prescribing information ribavirin alone, all contraindications to peginterferon alfa and/or for SOVALDI. ribavirin also apply to SOVALDI combination therapy. (4) ® SOVALDI (sofosbuvir) tablets, for oral use -------------------------WARNINGS AND PRECAUTIONS---------------------­ Initial U.S. Approval: 2013 • Bradycardia with amiodarone coadministration: Serious symptomatic bradycardia may occur in patients taking ------------------------------RECENT MAJOR CHANGES-----------------------­ amiodarone and SOVALDI in combination with another direct Indications and Usage (1) 08/2015 acting antiviral (DAA), particularly in patients also receiving beta Dosage and Administration (2.1, 2.2) 08/2015 blockers, or those with underlying cardiac comorbidities and/or Contraindications (4) 08/2015 advanced liver disease. Coadministration of amiodarone with Warnings and Precautions (5.1) 03/2015 SOVALDI in combination with another DAA is not recommended. Warnings and Precautions (5.2, 5.3, 5.4) 08/2015 In patients without alternative, viable treatment options, cardiac -------------------------------INDICATIONS AND USAGE------------------------­ monitoring is recommended. (5.1, 6.2,7.1) SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B • Use with other drugs containing
    [Show full text]
  • 2015 Hepatitis C Second Generation Antivirals (Harvoni [Ledipasvir/Sofosbuvir], and Viekira Pak [Ombitasvir/Paritaprevir/Ritonavir
    2015 Hepatitis C Second Generation Antivirals (Harvoni [ledipasvir/sofosbuvir], and Viekira Pak [ombitasvir/paritaprevir/ritonavir + dasabuvir ]) Prior Authorization – Through Preferred Agents Program Summary 2015 Hepatitis C Second Generation Antivirals (Harvoni [ledipasvir/sofosbuvir], and Viekira Pak [ombitasvir/paritaprevir/ritonavir + dasabuvir]) Prior Authorization – Through Preferred Oral Agent(s) The Hepatitis C First Generation, Hepatitis C Second Generation and Sovaldi Prior Authorization Programs must be implemented together. OBJECTIVE The intent of the Hepatitis C second generation antiviral Prior Authorization (PA) program is to appropriately select patients for therapy according to the Food and Drug Administration (FDA) approved product labeling and/or clinical guidelines and/or clinical studies. The PA process will evaluate the use of these agents when there is supporting clinical evidence of Class IIa, Level C or better for their use. Patients requesting Harvoni that are treatment naïve, non-cirrhotic and with an initial viral load < 6 M IU/mL will be approved for 8 weeks assuming all other criteria are met. This criteria does not include the use of Sovaldi (sofosbuvir), and requests for Sovaldi (sofosbuvir) in combination with Olysio (simeprevir) which will not be approved. For the use of Sovaldi (sofosbuvir) see Sovaldi specific criteria. For the use of Olysio in combination with peginterferon and ribavirin, see Hepatitis C First Generation criteria. For hepatocellular carcinoma patients, see Sovaldi (sofosbuvir) specific criteria. TARGET DRUGS Preferred Agent(s) Harvoni® (ledipasvir/sofosbuvir) Nonpreferred Agent(s) Viekira Pak (ombitasvir/paritaprevir/ritonavir + dasabuvir) PRIOR AUTHORIZATION CRITERIA FOR APPROVAL Harvoni (ledipasvir/sofosbuvir) will be approved when the following criteria are met: 1. The patient has a diagnosis of chronic hepatitis C confirmed by serological markers AND 2.
    [Show full text]
  • Interplay Between Hepatitis D Virus and the Interferon Response
    viruses Review Interplay between Hepatitis D Virus and the Interferon Response Zhenfeng Zhang 1 and Stephan Urban 1,2,* 1 Department of Infectious Diseases, Molecular Virology, University Hospital Heidelberg, 69120 Heidelberg, Germany; [email protected] 2 German Centre for Infection Research (DZIF), Partner Site Heidelberg, 69120 Heidelberg, Germany * Correspondence: [email protected]; Tel.: +49-6221-564-902 Received: 27 October 2020; Accepted: 18 November 2020; Published: 20 November 2020 Abstract: Chronic hepatitis D (CHD) is the most severe form of viral hepatitis, with rapid progression of liver-related diseases and high rates of development of hepatocellular carcinoma. The causative agent, hepatitis D virus (HDV), contains a small (approximately 1.7 kb) highly self-pairing single-strand circular RNA genome that assembles with the HDV antigen to form a ribonucleoprotein (RNP) complex. HDV depends on hepatitis B virus (HBV) envelope proteins for envelopment and de novo hepatocyte entry; however, its intracellular RNA replication is autonomous. In addition, HDV can amplify HBV independently through cell division. Cellular innate immune responses, mainly interferon (IFN) response, are crucial for controlling invading viruses, while viruses counteract these responses to favor their propagation. In contrast to HBV, HDV activates profound IFN response through the melanoma differentiation antigen 5 (MDA5) pathway. This cellular response efficiently suppresses cell-division-mediated HDV spread and, to some extent, early stages of HDV de novo infection, but only marginally impairs RNA replication in resting hepatocytes. In this review, we summarize the current knowledge on HDV structure, replication, and persistence and subsequently focus on the interplay between HDV and IFN response, including IFN activation, sensing, antiviral effects, and viral countermeasures.
    [Show full text]
  • Estimating the Long-Term Clinical and Economic Outcomes of Daclatasvir
    VALUE IN HEALTH REGIONAL ISSUES ] ( ]]]]) ]]]– ]]] Available online at www.sciencedirect.com journal homepage: www.elsevier.com/locate/vhri Estimating the Long-Term Clinical and Economic Outcomes of Daclatasvir Plus Asunaprevir in Difficult-to-Treat Japanese Patients Chronically Infected with Hepatitis C Genotype 1b Phil McEwan, PhD1,2, Thomas Ward, MSc1,*, Samantha Webster, BSc1, Yong Yuan, PhD3, Anupama Kalsekar, MS3, Kristine Broglio, MS4, Isao Kamae, PhD5, Melanie Quintana, PhD4, Scott M. Berry, PhD4, Masahiro Kobayashi, MD6, Sachie Inoue, PhD7, Ann Tang, PhD8, Hiromitsu Kumada, MD6 1Health Economics and Outcomes Research Ltd., Monmouth, UK; 2Centre for Health Economics, Swansea University, Swansea, UK; 3Global Health Economics and Outcomes Research, Princeton, NJ, USA; 4Berry Consultants, LLC, Austin, TX, USA; 5Graduate School of Public Policy, University of Tokyo, Tokyo, Japan; 6Department of Hepatology, Toranomon Hospital, Tokyo, Japan; 7CRECON Research and Consulting, Inc., Tokyo, Japan; 8Health Economics and Outcomes Research, Bristol-Myers K.K., Tokyo, Japan ABSTRACT Objectives: Japan has one of the highest endemic rates of hepatitis C treated with TVR þ pegIFN-α/RBV. Results: Initiating DCV þ ASV virus (HCV) infection. Treatments in Japan are currently limited to treatment in patients in the chronic hepatitis C disease stage resulted interferon-alfa–based regimens, which are associated with tolerability in quality-adjusted life-year gains of 0.96 and 0.77 over TVR þ pegIFN- and efficacy issues. A novel regimen combining two oral HCV α/RBV for NRs and PRs, respectively, and a gain of 2.61 in interferon- therapies, daclatasvir and asunaprevir (DCV þ ASV), has shown alfa–ineligible/intolerant patients over no treatment.
    [Show full text]
  • HARVONI® (Ledipasvir and Sofosbuvir) Tablets, for Oral Use Weight
    HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use • Recommended dosage in pediatric patients 3 years and older: HARVONI® safely and effectively. See full prescribing information Recommended dosage of HARVONI in pediatric patients 3 years of for HARVONI. age and older is based on weight. Refer to Table 2 of the full prescribing information for specific dosing guidelines based on body HARVONI® (ledipasvir and sofosbuvir) tablets, for oral use weight. (2.4) HARVONI® (ledipasvir and sofosbuvir) oral pellets • Instructions for Use should be followed for preparation and Initial U.S. Approval: 2014 administration of HARVONI oral pellets. (2.5) WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN • HCV/HIV-1 coinfection: For adult and pediatric patients with PATIENTS COINFECTED WITH HCV AND HBV HCV/HIV-1 coinfection, follow the dosage recommendations in the tables in the full prescribing information. (2.3, 2.4) See full prescribing information for complete boxed warning. • If used in combination with ribavirin, follow the recommendations for ribavirin dosing and dosage modifications. (2.3, 2.4) Hepatitis B virus (HBV) reactivation has been reported, in some • For patients with any degree of renal impairment, including end cases resulting in fulminant hepatitis, hepatic failure, and death. stage renal disease on dialysis, no HARVONI dosage adjustment is (5.1) recommended. (2.6) ------------------------------RECENT MAJOR CHANGES ----------------------- -----------------------DOSAGE FORMS AND STRENGTHS-------------------- Indications and Usage (1) 8/2019 • Tablets: 90 mg of ledipasvir and 400 mg of sofosbuvir; 45 mg of Dosage and Administration ledipasvir and 200 mg of sofosbuvir. (3) Recommended Treatment Regimen and Duration in Patients 3 Years of Age and Older with Genotype 1, 4, 5, • Oral Pellets: 45 mg of ledipasvir and 200 mg of sofosbuvir; 33.75 mg or 6 HCV (2.2) 8/2019 of ledipasvir and 150 mg of sofosbuvir.
    [Show full text]
  • Pegasys®) Peginterferon Alfa-2B (Peg-Intron®
    Peginterferon alfa-2a (Pegasys®) Peginterferon alfa-2b (Peg-Intron®) UTILIZATION MANAGEMENT CRITERIA DRUG CLASS: Pegylated Interferons BRAND (generic) NAME: Pegasys (peginterferon alfa-2a) Single-use vial 180 mcg/1.0 mL; Prefilled syringe 180 mcg/0.5 mL Peg-Intron (peginterferon alfa-2b) Single-use vial (with 1.25 mL diluent) and REDIPEN®: 50 mcg, 80 mcg, 120 mcg, 150 mcg per 0.5 mL. FDA-APPROVED INDICATIONS PEG-Intron (peginterferon alfa-2b): Combination therapy with ribavirin: • Chronic Hepatitis C (CHC) in patients 3 years of age and older with compensated liver disease. • Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection. Monotherapy: CHC in patients (18 years of age and older) with compensated liver disease previously untreated with interferon alpha. Pegasys (Peginterferon alfa-2a): • Treatment of Chronic Hepatitis C (CHC) in adults with compensated liver disease not previously treated with interferon alpha, in patients with histological evidence of cirrhosis and compensated liver disease, and in adults with CHC/HIV coinfection and CD4 count > 100 cells/mm3. o Combination therapy with ribavirin is recommended unless patient has contraindication to or significant intolerance to ribavirin. Pegasys monotherapy is indicated for: • Treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B who have compensated
    [Show full text]
  • Combination of Entecavir Or Tenofovir with Pegylated Interferon
    International Journal of Molecular Sciences Review Combination of Entecavir or Tenofovir with Pegylated Interferon-α for Long-Term Reduction in Hepatitis B Surface Antigen Levels: Simultaneous, Sequential, or Add-on Combination Therapy Kanako Yoshida 1, Masaru Enomoto 1,*, Akihiro Tamori 1 , Shuhei Nishiguchi 2,3 and Norifumi Kawada 1 1 Department of Hepatology, Graduate School of Medicine, Osaka City University, Osaka 545-8585, Japan; [email protected] (K.Y.); [email protected] (A.T.); [email protected] (N.K.) 2 Division of Medical Science of Regional Cooperation for Liver Diseases, Graduate School of Medicine, Osaka City University, Osaka 545-8585, Japan; [email protected] 3 Department of Internal Medicine, Kano General Hospital, Osaka 531-0041, Japan * Correspondence: [email protected]; Tel.: +81-666-453-811 Abstract: Seroclearance of hepatitis B surface antigen (HBsAg) (“functional cure”) is the optimal endpoint of antiviral therapy for chronic hepatitis B virus (HBV) infection. Currently available anti-HBV therapy includes nucleoside/nucleotide analogs (NAs) and peginterferon-α (Peg-IFNα). Combination of NAs and Peg-IFNα, each with different mechanisms of action, is an attractive approach for treating chronic HBV infection. In earlier studies, compared with monotherapy using IFNα, combination therapy showed greater on-treatment HBV DNA suppression but no difference in the sustained response. However, responses to the combination of non-pegylated IFNα with Citation: Yoshida, K.; Enomoto, M.; lamivudine or adefovir were not assessed based on HBsAg quantification but were defined by Tamori, A.; Nishiguchi, S.; Kawada, normal alanine aminotransferase levels, testing negative for hepatitis B e-antigen, and low HBV DNA N.
    [Show full text]
  • Nucleic Acid Polymers: Much-Needed Hope for Hepatitis D?
    Comment Nucleic acid polymers: much-needed hope for hepatitis D? In the Lancet Gastroenterology & Hepatology, results appear promising, a more thorough evaluation of Michel Bazinet and colleagues1 describe the results these molecules is warranted to validate their use. of a phase 2 clinical trial on the safety and efficacy of First, the results of this uncontrolled study must be combined treatment with the nucleic acid polymer confirmed by a randomised controlled trial that includes REP 2139 and pegylated interferon alfa-2a for treatment at least a pegylated interferon alfa-2a monotherapy arm. of patients with chronic hepatitis B virus (HBV) and Indeed, although all patients were reported to have had hepatitis D virus (HDV) co-infection. HDV infection for more than 1 year before treatment Chronic hepatitis D is considered the most severe and the decline of HDV RNA and HBsAg concentrations and most difficult form of chronic viral hepatitis to was faster than that expected during the natural course treat. Despite affecting an estimated 15–20 million of disease, data on IgM antibodies against hepatitis B Cavallini/Science Photo Library James people worldwide, often in impoverished settings, the core antigen were not provided. Thus, the possibility Published Online September 27, 2017 allocation of resources for the treatment of chronic that some enrolled patients had a protracted acute HDV http://dx.doi.org/10.1016/ hepatitis D is low compared with other chronic infection that spontaneously cleared cannot be excluded. S2468-1253(17)30292-3
    [Show full text]
  • Original Article Randomized Study of Asunaprevir Plus Pegylated Interferon-Α and Ribavirin for Previously Untreated Genotype 1 Chronic Hepatitis C
    Antiviral Therapy 2013; 18:885–893 (doi: 10.3851/IMP2660) Original article Randomized study of asunaprevir plus pegylated interferon-α and ribavirin for previously untreated genotype 1 chronic hepatitis C Jean-Pierre Bronowicki1*, Stanislas Pol2, Paul J Thuluvath3, Dominique Larrey4, Claudia T Martorell5, Vinod K Rustgi6, David W Morris7, Ziad Younes8, Michael W Fried9, Marc Bourlière10, Christophe Hézode11, K Rajender Reddy12, Omar Massoud13, Gary A Abrams14, Vlad Ratziu15, Bing He16, Timothy Eley16, Alaa Ahmad17, David Cohen18, Robert Hindes19, Fiona McPhee18, Bridget Reilly16, Patricia Mendez16, Eric Hughes16 1INSERM 954, Centre Hospitalier Universitaire de Nancy, Université de Lorraine, Vandoeuvre les Nancy, France 2Université Paris Descartes, INSERM U1610 and Liver Unit, Hôpital Cochin, Paris, France 3Mercy Medical Center, Baltimore, MD, USA 4Hôpital Saint Eloi, Service d’Hépato-Gastroentérologie et Transplantation, INSERM 1040-IRB, Montpellier, France 5The Research Institute, Springfield, MA, USA 6Metropolitan Research, Fairfax, VA, USA 7Healthcare Research Consultants, Tulsa, OK, USA 8Gastro One, Germantown, TN, USA 9Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, NC, USA 10Hôpital Saint Joseph, Service d’Hépato-Gastroentérologie, Marseille, France 11CHU Henri Mondor, Service d’Hépato-Gastroentérologie, Créteil, France 12Division of Gastroenterology, University of Pennsylvania, Philadelphia, PA, USA 13Division of Gastroenterology and Hepatology, University of Alabama at
    [Show full text]
  • DAKLINZA (Daclatasvir)
    HIGHLIGHTS OF PRESCRIBING INFORMATION ---------------------DOSAGE FORMS AND STRENGTHS---------------------­ These highlights do not include all the information needed to use • Tablets: 60 mg, 30 mg, and 90 mg (3) DAKLINZA safely and effectively. See full prescribing information for ------------------------------CONTRAINDICATIONS------------------------------­ DAKLINZA. • Strong inducers of CYP3A, including phenytoin, carbamazepine, rifampin, DAKLINZA (daclatasvir) tablets, for oral use and St. John’s wort. (4) Initial U.S. Approval: 2015 -----------------------WARNINGS AND PRECAUTIONS-----------------------­ WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN • Risk of Hepatitis B Virus Reactivation: Test all patients for evidence of PATIENTS COINFECTED WITH HCV AND HBV current or prior HBV infection before initiation of HCV treatment. Monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare See full prescribing information for complete boxed warning. during HCV treatment and post-treatment follow-up. Initiate appropriate Hepatitis B virus (HBV) reactivation has been reported, in some cases patient management for HBV infection as clinically indicated. (5.1) resulting in fulminant hepatitis, hepatic failure, and death. (5.1) • Bradycardia When Coadministered with Sofosbuvir and Amiodarone: ---------------------------RECENT MAJOR CHANGES--------------------------­ Serious symptomatic bradycardia may occur in patients taking amiodarone Boxed Warning 02/2017 with sofosbuvir in combination with another HCV direct-acting agent, Dosage and Administration, Testing Prior to the Initiation of including DAKLINZA, particularly in patients also receiving beta blockers Therapy (2.1) 02/2017 or those with underlying cardiac comorbidities and/or advanced liver Warnings and Precautions, Risk of Hepatitis B Virus Reactivation disease. Coadministration of amiodarone with DAKLINZA in combination in Patients Coinfected with HCV and HBV (5.1) 02/2017 with sofosbuvir is not recommended.
    [Show full text]