2013 – Most popular post
Sexual transmission of HCV among monogamous heterosexual couples: The HCV partners study.
Hot Topics – August
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.
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
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
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
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.
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.
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.
This paper provides a review of the neuropsychiatric adverse effects of DAAs (boceprevir/telaprevir) and drug-drug
interactions (DDIs) between DAAs and psychiatric medications.
A collection of news articles and research weighing the risks and benefits of treating HCV now vs waiting for future therapies.
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.
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.
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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.
(Source – Annals Of Internal Medicine)
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…..
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….
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.
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 —
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.
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?
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
Clinical Trial Updates
HCV PipelineHCV Advocate – News & Pipeline Blog
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!