Risk factors for treatment discontinuation caused by adverse events when using telaprevir, peginterferon, and ribavirin to treat chronic hepatitis C: A real-world retrospective cohort study.
In conclusion, this study not only revealed the risk factors for treatment discontinuation but also showed that patients with multiple risk factors are more likely to discontinue treatment due to adverse events compared to patients with fewer risk factors.
PMID: 28216512 [PubMed - as supplied by publisher] (Source: Biological and Pharmaceutical Bulletin)
Source: Biological and Pharmaceutical Bulletin - February 16, 2017 Category: Drugs & Pharmacology Authors: Ide K, Kawasaki Y, Iketani R, Masaki N Tags: Biol Pharm Bull Source Type: research
Response to: Cryoglobulinemic vasculitis in the era of direct-acting antiviral drug
We thank Moiseev et al for their interest in our work regarding sofosbuvir and ribavirin in hepatitis C virus (HCV)-associated mixed cryoglobulinemia vasculitis (VASCUVALDIC study)1 and to bring new elements for discussion. Moiseev et al emphasise that treatment with immunomodulatory or immunosuppressive therapy (including rituximab) may have contributed to the impressive results of the VASCUVALDIC study. We have to stress that with the advent of new direct-acting antiviral (DAA) drugs (ie, sofosbuvir plus ribavirin), up to 87.5% of patients achieved complete clinical remission while only 17% of patients required the use o...
Source: Annals of the Rheumatic Diseases - February 16, 2017 Category: Rheumatology Authors: Saadoun, D., Cacoub, P. Tags: Immunology (including allergy), Renal medicine, Degenerative joint disease, Musculoskeletal syndromes, Vascularitis Correspondence response Source Type: research
The safety profile of telaprevir-based triple therapy in clinical practice: a retrospective cohort study.
This study was designed to evaluate the safety profile of adding telaprevir to therapy using pegylated interferon-alfa-2b and ribavirin (PR) using real world patient data obtained from a nationwide Japanese interferon database. This retrospective cohort study compared telaprevir-based triple therapy (T/PR) with PR therapy. The study population comprised patients with genotype 1 chronic hepatitis C represented in the database between December 2009 and August 2015. The primary endpoint was dropout from treatment due to adverse events during the relevant standard treatment duration based on guidelines from the Japan Society o...
Source: Biological and Pharmaceutical Bulletin - February 8, 2017 Category: Drugs & Pharmacology Authors: Iketani R, Ide K, Yamada H, Kawasaki Y, Masaki N Tags: Biol Pharm Bull Source Type: research
Results of interferon-based treatments in Alaska Native and American Indian population with chronic hepatitis C.
Conclusions We had success with pegylated interferon-based treatment of AN/AI people with genotypes 2 and 3. However, there were low SVR and high discontinuation rates for those with genotype 1.
PMID: 28156405 [PubMed - in process] (Source: International Journal of Circumpolar Health)
Source: International Journal of Circumpolar Health - February 7, 2017 Category: Global & Universal Tags: Int J Circumpolar Health Source Type: research
Shift in disparities in Hepatitis C treatment from interferon to DAA era: A population ‐based cohort study
In conclusion, there is a shift in prescription of new HCV treatments to previously excluded groups (e.g., HIV‐co‐infected), though gaps remain for the socioeconomically marginalized populations.
This article is protected by copyright. All rights reserved. (Source: Journal of Viral Hepatitis)
Source: Journal of Viral Hepatitis - January 28, 2017 Category: Infectious Diseases Authors: Naveed Z. Janjua, Nazrul Islam, Jason Wong, Eric M. Yoshida, Alnoor Ramji, Hasina Samji, Zahid A. Butt, Mei Chong, Darrel Cook, Maria Alvarez, Maryam Darvishian, Mark Tyndall, Mel Krajden Tags: Original Paper Source Type: research
Clinical Significance of Two Real-Time PCR Assays for Chronic Hepatitis C Patients Receiving Protease Inhibitor-Based Therapy
In conclusion, although CAP/CTM and ART detected HCV RNA wi th comparable analytical sensitivity, CAP/CTM might be preferable for predicting the clinical outcomes of patients receiving protease inhibitor-based therapy. (Source: PLoS One)
Source: PLoS One - January 23, 2017 Category: Biomedical Science Authors: Takako Inoue Source Type: research
US FDA Perspective on Elbasvir/Grazoprevir Treatment for Patients with Chronic Hepatitis C Virus Genotype 1 or 4 Infection
This article describes FDA’s rationale for labeling determinations in situations where limited data made these decisions challenging. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - January 18, 2017 Category: Drugs & Pharmacology Source Type: research
Hepatitis C Treatment From “Response‐guided” to “Resource‐guided” therapy in the transition era from IFN‐containing to IFN‐free regimens
Abstract
Peginterferon/ribavirin has been the standard‐of‐care for chronic hepatitis C virus (HCV) infections: 48‐week for genotype 1 or 4 (HCV‐1/4) and 24‐week for HCV‐2/3. Response‐guided therapy recommended shorter 24‐week and 16‐week regimens for HCV‐1 with lower baseline viral loads (LVL, <400,000‐800,000 IU/ml) and rapid virological response (RVR, undetectable HCV RNA at week 4) and HCV‐2/3 with RVR, respectively; and extending to 72 and 48 weeks for HCV‐1 slower responders and HCV‐2 non‐RVR patients, respectively, to improve the efficacy.
The progress of directly‐acting‐antiv...
Source: Journal of Gastroenterology and Hepatology - December 31, 2016 Category: Gastroenterology Authors: Ming ‐Lung Yu Tags: Review Article Source Type: research
Genotypic analysis of HCV 1a by sequencing of the NS3 proteasic region in simeprevir therapy candidates.
Authors: Liberti A, Raddi A, Cuomo N
Abstract
Each phase of the HCV replication cycle can represent a therapy target. In fact, SIMEPREVIR (SMV) acts as NS3/4A protease inhibitor (PI); its efficacy is, however, reduced in HCV1a patients characterized by NS3Q80K polymorphism. The aim of this work was to design a genotypic analysis of NS3 protease in order to characterize viral quasispecies in HCV 1a patients before starting the SMV therapy. In all, 38 peripheral blood-EDTA samples were collected from patients infected with HCV 1a (RNA > 10,000 cp/ml). The samples were sequenced in a region of 543 nucleoti...
Source: Infezioni in Medicina - December 26, 2016 Category: Infectious Diseases Tags: Infez Med Source Type: research
Post-treatment resistance analysis of hepatitis C virus from phase II and III clinical trials of ledipasvir/sofosbuvir
In recent years, direct-acting antiviral drugs (DAAs) developed for the treatment of hepatitis C virus (HCV) have replaced the previous standard of care of pegylated interferon and ribavirin. Inhibitors targeting the viral NS3/4A protease (telaprevir, boceprevir, simeprevir, paritaprevir and grazoprevir), NS5B polymerase (the nucleotide inhibitor sofosbuvir and the non-nucleoside inhibitor dasabuvir), and NS5A protein (ledipasvir, daclatasvir, ombitasvir and elbasvir) have been approved by the USA FDA, with more in late-phase clinical trials. (Source: Journal of Hepatology)
Source: Journal of Hepatology - December 2, 2016 Category: Gastroenterology Authors: David Wyles, Hadas Dvory-Sobol, Evguenia S. Svarovskaia, Brian P. Doehle, Ross Martin, Nezam H. Afdhal, Kris V. Kowdley, Eric Lawitz, Diana M. Brainard, Michael D. Miller, Hongmei Mo, Edward J. Gane Tags: Research Article Source Type: research
Post-Treatment Resistance Analysis of Hepatitis C Virus from Phase 2 and 3 Clinical Trials of Ledipasvir/ Sofosbuvir
In recent years, direct acting antiviral drugs (DAAs) developed for the treatment of hepatitis C virus (HCV) have replaced the previous standard of care of pegylated interferon and ribavirin. Inhibitors targeting the viral NS3/4A protease (telaprevir, boceprevir, simeprevir, paritaprevir and grazoprevir), NS5B polymerase (the nucleotide inhibitor sofosbuvir and the nonnucleoside inhibitor dasabuvir), and NS5A protein (ledipasvir, daclatasvir, ombitasvir and elbasvir) have been approved by the US FDA, with more in late-phase clinical trials. (Source: Journal of Hepatology)
Source: Journal of Hepatology - December 2, 2016 Category: Gastroenterology Authors: David Wyles, Hadas Dvory-Sobol, Evguenia S. Brian Svarovskaia Doehle, Ross Martin, Nezam H. Afdhal, Kris V. Kowdley, Eric Lawitz, Diana M Brainard, Michael D. Miller, Hongmei Mo, Edward J. Gane Source Type: research
Twice-Daily Telaprevir for Posttransplant Genotype 1 Hepatitis C Virus: A Prospective Safety, Efficacy, and Pharmacokinetics Study.
CONCLUSIONS: Telaprevir combination therapy for posttransplant hepatitis C virus infection yielded superior efficacy than historical controls. Adverse events were similar to, but exceeded, those in immunocompetent patients. Calcineurin inhibitor dosing levels were substantially reduced with telaprevir.
PMID: 27855589 [PubMed - as supplied by publisher] (Source: Experimental and Clinical Transplantation : official journal of the Middle East Society for Organ Transplantation)
Source: Experimental and Clinical Transplantation : official journal of the Middle East Society for Organ Transplantation - November 17, 2016 Category: Transplant Surgery Authors: Rubin RA, Russo MW, Brown KA, Fontana RJ, Levitsky J, Vargas H, Yoshida EM, Brown RS Tags: Exp Clin Transplant Source Type: research
Anti-rods/rings autoantibody seropositivity does not affect response to telaprevir treatment for chronic hepatitis C infection
ConclusionsOverall, the data suggest that anti-RR seropositivity is not associated with resistance to TPV treatment in this patient cohort, but monitoring anti-RR-positive patients for relapse within the first 6 months after treatment may be useful. (Source: Autoimmunity Highlights)
Source: Autoimmunity Highlights - November 13, 2016 Category: Allergy & Immunology Source Type: research
Spending on Hepatitis C Antivirals in the United States, 2009 –2015
ConclusionNew HCV antivirals are driving the increased expenditures for this class. Decreased expenditures in 2013 may have been secondary to delaying HCV treatment until new therapies received approval from the U.S. Food and Drug Administration (termed “warehousing”). With continued drug development and approval of HCV therapies, expenditures are expected to continue to increase, barring actions by payers that may impede this trend. Medication policies guiding HCV treatment should focus on safety and efficacy while balancing the long‐term costs of HCV.This article is protected by copyright. All rights reserved. (Sou...
Source: Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy - November 8, 2016 Category: Drugs & Pharmacology Authors: Katie J. Suda, Drew J. Halbur, Robert J. Hunkler, Linda M. Matusiak, Glen T. Schumock Tags: Special Issue on Drug Costs Source Type: research
Prevention of allograft HCV recurrence with peri ‐transplant human monoclonal antibody MBL‐HCV1 combined with a single oral direct‐acting antiviral: A proof‐of‐concept study
Summary
Patients with active hepatitis C virus (HCV) infection at transplantation experience rapid allograft infection, increased risk of graft failure and accelerated fibrosis. MBL‐HCV1, a neutralizing human monoclonal antibody (mAb) targeting the HCV envelope, was combined with a licensed oral direct‐acting antiviral (DAA) to prevent HCV recurrence post‐transplant in an open‐label exploratory efficacy trial. Eight subjects received MBL‐HCV1 beginning on the day of transplant with telaprevir initiated between days 3 and 7 post‐transplantation. Following FDA approval of sofosbuvir, two subjects received MBL‐H...
Source: Journal of Viral Hepatitis - October 31, 2016 Category: Infectious Diseases Authors: H. L. Smith, R. T. Chung, P. Mantry, W. Chapman, M. P. Curry, T. D. Schiano, E. Boucher, P. Cheslock, Y. Wang, D. C. Molrine Tags: Original Article Source Type: research
