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HCV New Drug Research: Broccoli and Joint Health

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2013 – Most popular post

Sexual transmission of HCV among monogamous heterosexual couples: The HCV partners study.

Listen: AASLD Podcast-Sexual Transmission of Hepatitis C

Hot Topics – August

Gilead’s Sofosbuvir and Ribavirin for Hepatitis C Genotype 1 shows promise in NIH trial

Investigational oral regimen for hepatitis C shows promise in NIH trial. Side effects minimized with combination therapy in hard-to-treat patients The new study also differs from many previous trials because it enrolled people with severe liver damage as well as those with mild or moderately scarred livers.

Medivir AnnouncesInterim Results from Cohort 2 of the COSMOS Study Evaluating Simeprevir and Sofosbuvir in HCV Patients with METAVIR Scores F3-F4

In Hepatitis C patients with advanced liver fibrosis or cirrhosis (METAVIR F3 or F4) 12 weeks all oral treatment with simeprevir and sofosbuvir with or without ribavirin led to SVR4 rates of 96% and 100%, respectively Once-dailysimeprevir and sofosbuvir with or without ribavirin was generally safe and well tolerated

Expect miracles: New drug for hepatitis C may put treatment in the hands of primary care

Treatment of hepatitis C infection is likely to shift from gastroenterology and hepatology clinics to primary care physicians’ offices, perhaps as early as next year. That’s the prediction of Dr. Gregory T. Everson, who cited rapid progress in developing interferon-free treatment regimens as the driving force behind what is anticipated to be a huge change in clinical practice, given that there are an estimated 5 million or more patients with hepatitis C virus (HCV) infection in the United States

Vertex’s VX-135 partial hold signals heightened FDA scrutiny toward HCV drugs

Other therapies developed to treat HCV that are similar to VX-135, a direct-acting antiviral (DAA) have been shown to trigger only transient elevations in liver enzymes, which are less of a concern

Review: A pill for HCV – myth or foreseeable future?

All-oral, IFN-free therapies are an evolutionary step for future anti- HCV therapies. Initial results of clinical studies conducted during the last year give hope for “a pill for HCV” at least in selected CHC populations. In 2013 several clinical trials of all- oral anti-HCV therapies had been completed, first all-oral combination submitted for registration and some conclusions could be drawn. However there is not yet a clear direction for IFN-free therapies in treatment naïve patients or more complex non responders.

2013: August Hepatitis Newsletters

A collection of monthly newsletters from over ten different websites written by devoted advocates and organizations working hard to improve the lives of people affected by viral hepatitis.

Hepatitis C: Interferon-Free Regimen Works in Over 50% of Patients

More than half (52% – 69%) of patients with hepatitis C virus (HCV) genotype 1 who received interferon-free treatment with faldaprevir combined with deleobuvir plus ribavirin had sustained virologic response 12 weeks after treatment completion, according to a phase 2b, randomized open-label trial of 362 patients.

While it is important to show that responses in the 50% to 60% range can be obtained without interferon, it is unlikely that these drugs will have much impact in the near future,” said Gary L. Davis, MD, director of general and transplant hepatology at Baylor University Medical Center, Baylor HealthCare System, Dallas, Texas, in an interview with Medscape Medical News.

Psychiatric Treatment Considerations With Direct Acting Antivirals in Hepatitis C

This paper provides a review of the neuropsychiatric adverse effects of DAAs (boceprevir/telaprevir) and drug-drug

interactions (DDIs) between DAAs and psychiatric medications.

Chronic hepatitis C: Treat or wait?

A collection of news articles and research weighing the risks and benefits of treating HCV now vs waiting for future therapies.

July

COMMENTARY ON: Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C

CDC- Hepatitis C Online Course

(TAG) 2013 Pipeline Report – 28 HCV interferon-free regimens in development

In the 2013 “HCV Treatment Pipeline,” Tracy Swan (TAG) notes that the “confluence of a robust HCV drug pipeline, shortened regimens, and [shorter] posttreatment follow-up are extraordinary. The new FDA breakthrough therapy designation may speed things up as well. By the end of 2014, [new HCV drugs] from four different classes and fixed-dose combinations (FDCs) are likely to be approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), offering the potential for off-label mixing and matching.” An impressive 26 new HCV drugs are being studied in phases II/III in at least 28 interferon-free regimens, which are bringing the potential of faster, all-oral HCV cures rapidly toward approval for the world’s 185 million people living with HCV.

Achillion Hepatitis C Drug Trial on Hold on Liver Concern

U.S. regulators put the hepatitis C drug trial on hold after some patients experienced elevated liver enzymes. The elevations were observed in healthy patients when Achillion’s sovaprevir was combined with two medicines used to treat HIV infections in order to test for possible drug interactions. The combination may have resulted in a drug interaction that produced higher-than-expected blood levels of the therapies.

June

Question about Obamacare? Here’s a number to call for help: 800-318-2596, is available 24/7 and can provide assistance in 150 languages. There is also a new live-chat feature on HealthCare.gov.

All Baby Boomers Should Be Screened

U.S. Preventive Services Task Force (USPSTF) recommendation on screening for and treatment of hepatitis C virus (HCV) infection in asymptomatic adults.

Full Text : Screening for Hepatitis C Virus Infection in Adults: U.S. Preventive Services Task Force Recommendation

(Source – Annals Of Internal Medicine)

Medicare/private insurers-Can get tested for HCV without copayment

Emerging Therapeutic Targets for Hepatitis C Virus Infection

IDX20963 – Idenix sees delay in hep c drug human trials as FDA seeks more data

Hepatitis C – Is SVR12 As Good As SVR24?

AbbVie Says It Can Be First With All-oral hepatitis C drugs

Both Simeprevir and Sofosbuvir Likely Approved by 2014-Clinical/Ethical/Pharmacoeconomic Dilemmas Loom

Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir for the Treatment of Hepatitis C

Hepatitis C: The Pace of Progress/Interferon-Free Treatment Still Searching

May

Interferon-free, treat-all approach cost effective, beneficial for chronic HCV

European Medicines Agency Validates Gilead’s Marketing Application for Sofosbuvir for the Treatment of Hepatitis C

(On April 08) Gilead Submitted New Drug Application to U.S. FDA for Sofosbuvir (GS-7977) for the Treatment of Hepatitis C

Current and Future Therapies for Hepatitis C Virus Infection

If the past is a harbinger of the future, therapy for HCV infection will probably continue to advance at a brisk pace. Many additional potent agents are in the clinical pipeline, and interferon-free regimens are likely to dominate the HCV therapeutic landscape within the next 5 years…..

Summary EASL 2013 – New HCV DAAs on their way soon: what do the phase III studies tell us?

At this year’s EASL in Amsterdam with over 9600 delegates the phase III study results for the two “second wave HCV protease inhibitors” faldaprevir and simeprevir each in combination with pegylated interferon (PEG-IFN) and ribavirin (RBV) for HCV genotype 1 patients were presented as well as the phase III findings for the polymerase inhibitor sofosbuvir again in combination with PEG-IFN/RBV for treatment of genotypes 1,4,5 and 6. In addition phase III results of the first interferon free combination of sofosbuvir with ribavirin for treatment of genotype 2 and 3 were presented….

EASL Webcast

HCV: Highlights from EASL 2013/Fred Poordad, MD

Best of the EASL 2013 on hepatitis C – webcast with Dr Andrew Muir

Hepatitis C in the United States Perspective

Care for hepatitis C is evolving rapidly, with increasingly effective and better-tolerated antiviral therapies being evaluated and approved for use. It’s clear, however, that not everyone who would qualify for therapy has been tested and identified, referred for appropriate care, and offered or given the best therapy available. Furthermore, currently used antiviral drugs – pegylated interferon and ribavirin “base” plus either telaprevir or boceprevir – can cost more than $70,000 for a full course of therapy. It is expected that the new oral antiviral agents will be just as expensive, at least in the short term.

Hepatitis C Therapy Update 2013-What About Interferon-free Regimens?

U.S. FDA grants priority review to Simeprevir (TMC435) for combination treatment of genotype 1 chronic hepatitis C

AbbVie’s ABT-450- Breakthrough Therapy Designation from the U.S. Food and Drug Administration Granted to Investigational HCV Regimen

Gilead Sofosbuvir and ledipasvir: Plans to initiate a third Phase 3 clinical trial with and without ribavirin

April

Cost will limit uptake of off-label Gilead/Bristol-Myers Squibb Hep C combo, despite best-in-class data

ViewPoints: New Hep C data validates Gilead’s solo approach

Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir (GS-7977) for the Treatment of Hepatitis C— Sofosbuvir Would Form Basis of First All-Oral Regimen for HCV Genotype 2 and 3 Patients, and Interferon-Sparing Regimen for Genotype 1 Patients —

Anemia Top Side Effect of HCV Antivirals

Hepatitis C Virus Infection: Looking for Interferon Free Regimens

Review: NS5A Inhibitors in the Treatment of Hepatitis

VX-135/daclatasvir: Vertex signs agreement with Bristol-Myers for all-oral midstage studies for hepatitis C treatments

March

Simeprevir (TMC435) – Janssen Submits New Drug Application to U.S. FDA

Miravirsen- Hepatitis C drug goes after patients’ RNA

Update on Phase 3 Study of Oral Fixed-Dose Combination of Sofosbuvir and Ledipasvir for Genotype 1 Hepatitis C Patients

Hepatitis C – Presidio Collaboration with Boehringer Ingelheim for interferon-free Phase IIa clinical trial

February

Gilead hepatitis C drug sofosbuvir (GS-7977) meets goal of fourth late-stage study

EASL-Burden of Liver Disease in Europe: Looks at leading causes of cirrhosis and primary liver cancer in Europe

Gilead Announces SVR Rates from Two Phase 3 Studies of Sofosbuvir (GS-7977) for Hepatitis C

Potential IFN-Free Regimens For HCV

IDX184 and IDX19368 – Idenix drops development of hepatitis C drugs

January

Interferon free regimens for the “difficult to treat”: are we there?

Current Prospects for Interferon-free Treatment of Hepatitis C in 2012

Numerous other DAAs are in clinical development, and phases 2 and 3 trials are evaluating interferon-free combination DAA therapy. Interferon-free sustained virologic responses have now been achieved with combinations of asunaprevir and daclatasvir; sofosbuvir and ribavirin; sofosbuvir and daclatasvir; faldaprevir and BI207127; ABT-450, ritonovir and ABT-333; ABT-450, ritonovir and ABT-072; miracitabine, danoprevir and ritonavir; and alisporivir and ribavirin. Some drugs are genotype-specific in their activity, whereas others are pan-genotypic, and differential responses for the genotype 1 subtypes 1a and 1b have emerged with many DAA combinations. Viral breakthrough and resistance are important considerations for future trial design. The prospect of interferon-free combination DAA therapy for hepatitis C virus is now finally becoming a reality.

2013-Guide to Clinical Trials for People with Hepatitis C

Bristol-Myers to Hold Talks On Settling Claims of Hepatitis C Patients

Treat Now or Wait?

The debate rather to treat HCV now or wait is ongoing, in the journal “Liver International” factors which affect the decision to treat now or delay therapy are discussed. You can view the article here: Patients with HCV and F1 and F2 fibrosis: treat now or wait?

Of Interest

Lucinda K. Porter, RN Shares A Personal Experience: Starting 12 weeks of sofosbuvir, GS-5885, and ribavirin

Coming in September 2013

A second book authored by Lucinda K. Porter, RN: Hepatitis C Treatment One Step at a Time: Inspirational Readings and Practical Tips for Successful Hepatitis C Treatment

First Book

FREE FROM HEPATITIS C

Clinical Trial Updates

ClinicalTrials.gov: updated in the last 30 days

HCV PipelineHCV Advocate – News & Pipeline Blog

Chronic Hepatitis C Infection: Treat Now or Wait?

2012

INCIVEK® (telaprevir)-Updates label after reports of a ‘small number of fatal skin reactions’

Vertex discloses Hep C drug deaths

HCV Transplant Studies GS-7977 Also Telaprevir & Boceprevir

Perspectives and challenges of interferon-free therapy for chronic hepatitis C

Hepatitis C–What Are Your Treatment Choices: New Webinar

Setbacks in HCV Drug Development Highlight Uncertainties in Treat or Wait Decisions

So You Think You’re a Hepatitis C Expert

Back in July Clinical Care Options released part one of a three part online quiz containing 35 questions on hepatitis C, answered by nine world-renowned hepatology experts. In October CCO released part two of the series which included case scenarios from 11 leading international experts on hepatitis C, and today part three was released!

Idenix: FDA Places IDX19368 Hepatitis C Treatment on Clinical Hold

IDX184-Idenix hepatitis C drug put on partial hold

BMS halts the development of BMS-986094 due to patient death

BMS-986094-Bristol-Myers Sued Over Heart Damage In Hepatitis C Drug Trial

hepatitis c

via hepatitis c http://hepatitiscweb.blogspot.com/2013/08/hcv-new-drug-research-broccoli-and.html

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