Tuesday, May 7, 2013

CDC - Half of People With Hepatitis C Never Complete Needed Tests


Study suggests only half of Americans with hepatitis C receive complete testing for the virus

CDC reinforces need for appropriate follow-up testing for current infection

Only half of Americans identified as ever having had hepatitis C received follow-up testing showing that they were still infected, according to a Centers for Disease Control and Prevention analysis of data from a multi-area study published today in the CDC report Vital Signs.

“Many people who test positive on an initial hepatitis C test are not receiving the necessary follow-up test to know if their body has cleared the virus or if they are still infected,” said CDC Director Tom Frieden, M.D., M.P.H. “Complete testing is critical to ensure that those who are infected receive the care and treatment for hepatitis C that they need in order to prevent liver cancer and other serious and potentially deadly health consequences.”

Testing for hepatitis C includes a blood test, called an antibody test, to determine if an individual has ever been infected with the virus. For people with a positive antibody test result, a follow-up test – called an RNA test – should be given to determine whether they are still infected so they can get needed care and treatment.

A small number of people with antibody-positive tests will have cleared the infection on their own, but most people with hepatitis C (about 80 percent) remain infected and can go on to develop significant health problems.

For the Vital Signs study, researchers looked at data from eight areas across the nation funded by CDC to conduct enhanced surveillance for hepatitis C virus infection. Of the hepatitis C cases reported in these areas (i.e., those cases with antibody-positive results), only 51 percent of the cases also included a follow-up (RNA) test result that identified current infection. Without follow-up testing, the other half are likely unaware if they are currently infected and therefore cannot get appropriate medical care.

Data included in this analysis also underscore the severe impact of hepatitis C among baby boomers. In the eight areas studied, 67 percent of all reported cases of current infection were among those born from 1945 through 1965. Deaths among people with hepatitis C also were more common among those born during these years (accounting for 72 percent of all reported deaths).

“Hepatitis C has few noticeable symptoms, and left undiagnosed it threatens the health of far too many Americans – especially baby boomers,” said John Ward, M.D., director of CDC’s Division of Viral Hepatitis. “Identifying those who are currently infected is important because new effective treatments can cure the infection better than ever before, as well as eliminate the risk of transmission to others.”

Overall, approximately 3 million Americans are infected with hepatitis C and up to 3 out of 4 do not know they are infected. The vast majority of those affected are baby boomers, or those born from 1945 through 1965. Left untreated, hepatitis C can cause serious liver damage, including liver cancer. Hepatitis C is a leading cause of liver cancer and the most common indication for liver transplants. In fact, liver cancer is the fastest-rising cause of cancer-related death in the United States. Deaths from hepatitis C have nearly doubled over the past decade, now accounting for more than 15,000 deaths each year.

In light of increasing evidence that many patients are not receiving the follow-up test, as well as recent changes in testing technologies and the availability of new effective treatments for hepatitis C, CDC is issuing updated guidance for health care providers on hepatitis C testing. These guidelines reinforce the recommended process for hepatitis C testing and underscore the importance of providers conducting follow-up RNA testing for all patients with a positive antibody test result in order to help ensure people infected with hepatitis C are properly tested and identified.

CDC recommends that everyone in the United States born from 1945 through 1965 be tested for hepatitis C. CDC also recommends that other populations at increased risk for hepatitis C get tested, including those who received blood transfusions or organ transplants before widespread screening of the blood supply began in 1992, or those who have ever injected drugs.

This Vital Signs coincides with Hepatitis Awareness Month and National Hepatitis Testing Day on May 19.

More information is available at www.cdc.gov/nchhstp/newsroom.

Long-term Outcome of Chronic Hepatitis C After Sustained Virological Response to Interferon-based Therapy


Long-term Outcome of Chronic Hepatitis C After Sustained Virological Response to Interferon-based Therapy

C. Koh, T. Heller, V. Haynes-Williams, K. Hara, X. Zhao, J. J. Feld, D. E. Kleiner, Y. Rotman, M. G. Ghany, T. J. Liang, J. H. Hoofnagle

Aliment Pharmacol Ther. 2013;37(9):887-894.

Discussion Only

View Full Text @ Medscape

Links
Abstract and Introduction
Materials and Methods
Results
Discussion

References

The initial 5 of 10 patients treated with antiviral therapy in 1986 at the NIH for chronic HCV achieved an SVR and had both biochemical and histological evidence of improvement in the year following treatment.[26] These five patients have now been followed up for more than 20 years and remain HCV RNA-negative and have normal or near-normal serum enzyme levels.[28] Liver biopsies on these patients 10 years after initial therapy showed resolution of the disease activity and regression of fibrosis in some.[35] After this initial study, patients at the NIH were enrolled in various therapeutic trials for chronic hepatitis C. As of 2003, a total of 103 patients had achieved an SVR, all in response to interferon-based therapy. The duration of subsequent follow-up in these 103 patients varied from a few months to as long as 23 years. In this cohort, three patients relapsed, and the remaining 100 patients had markedly improved liver tests at the time of follow-up evaluation and none had clinical evidence of advanced cirrhosis, hepatic decompensation or end-stage liver disease. These findings indicate that an SVR from interferon-based therapies for chronic HCV is usually durable and associated with improvement in biomarkers of disease, a favourable long-term prognosis and lack of evidence of progression of liver disease.

Similar findings after SVR in chronic HCV have been published in other cohorts.[15–20, 36–39] However, the current analysis extends this experience to more than 20 years after therapy. Importantly, while patients who achieved an SVR did not develop progressive liver disease, at least one case of HCC still occurred. In this cohort, one patient who had cirrhosis before treatment developed HCC despite having had an SVR 12 years previously. The occurrence of HCC after SVR has been reported in several cohorts, although the rate of liver cancer appears to be far less than occurs among untreated patients with advanced fibrosis or cirrhosis due to chronic hepatitis C.[19, 20, 36, 37] Such findings suggest that patients with an SVR should continue to have regular surveillance for HCC if they had histological evidence of cirrhosis before treatment.

A shortcoming of this study is the lack of a control group of patients with chronic hepatitis C who were not treated or a comparison group of patients who were treated but did not achieve an SVR. However, it was not feasible or considered ethical to randomise patients to therapy vs. no therapy and follow them for an indefinite period. In early controlled trials of interferon for hepatitis C, some patients were not treated for the initial 1–2 years after randomisation.[27] However, the controls from those studies were subsequently offered therapy on an open-label basis and some achieved an SVR and are a part of this analysis. Since 1992 and the approval of interferon as therapy of hepatitis C, all large 'controlled' trials of treatment have compared one interferon-based regimen to another and patients were not given placebo or randomised to no therapy.

Another approach to assessment of the possible benefit of an SVR is to compare patients who achieve an SVR to those who relapse or do not respond. However, multiple studies have shown that patients who have an SVR have a durable loss of HCV RNA and are less likely to have advanced fibrosis or cirrhosis.[5–7, 27] For these reasons, such comparisons require careful balancing of risk factors. Among the 262 patients treated in at this centre, the majority of the non responders were retreated at one time or another, with differing regimens and often at different institutions.

Use of transient elastography, a non-invasive marker for hepatic fibrosis, suggested that 41% of the cohort had residual evidence of fibrosis at the time of last follow-up 3–23 years after SVR. The elevated elastography scores were not associated with residual abnormalities of serum aminotransferase levels but were more likely to be abnormal in patients who had advanced fibrosis or cirrhosis before treatment. This suggests that some degree of fibrosis persists despite the resolution of disease activity as assessed by serum enzymes. Slight decreases in platelet counts at the time of final follow-up also correlated with the initial liver histology. Elastography scores were not available from before treatment, but improvements in other markers of advanced disease (platelet count, direct bilirubin, immunoglobulin levels) suggest that SVR may be associated with subsequent improvement in portal hypertension and perhaps partial regression of fibrosis. These findings suggest that the greatest benefit from successful eradication of HCV may be in non-cirrhotic patients, but that even patients with advanced disease, gain a benefit from treatment.

In summary, with continued follow-up of patients with chronic hepatitis C for up to 23 years after achieving sustained clearance of HCV RNA, progressive liver disease was not seen. Among patients who had advanced fibrosis and cirrhosis before being treated, evidence from platelet counts and transient elastography suggested the persistence of some degree of hepatic fibrosis and a low but continued risk for HCC.

Of Interest

Clin Infect Dis. doi: 10.1093/cid/cit234

A risk for hepatocellular carcinoma still persists long-term after sustained virological response in patients with hepatitis C associated liver cirrhosis
                 
+ Author Affiliations
  1. 1Department of Gastroenterology and Hepatology
  2. 2Department of Infectious Diseases, Karolinska Institutet
  3. 3Department of Medicine, Skåne University Hospital
  4. 4Department of Infectious Diseases, Skåne University Hospital
  5. 5Department of Clinical Epidemiology, Karolinska University Hospital, Sweden
  1. Correspondence to: Soo Aleman, Department of Gastroenterology and Hepatology, and Infectious Diseases, Karolinska University Hospital, at Karolinska Institute, 171 76 Stockholm, Sweden, Phone: +46 8 517 72741, Fax: +46 8 517 700 00, E-mail: soo.aleman@ki.se
  1. Alternate corresponding author: Rolf Hultcrantz, Department of Gastroenterology and Hepatology, Karolinska University Hospital, 171 76 Stockholm, Sweden, Phone: +46 8 517 00 00, E-mail: rolf.hultcrantz@ki.se 
Abstract
Background.
The long-term effect of sustained virological response (SVR) to antiviral therapy on the risk to develop hepatocellular cancer (HCC), liver complications, liver-related deaths and overall death in hepatitis C (HCV) infected patients with liver cirrhosis is not fully known.
 
Methods. 
These risks were evaluated during long-term follow-up in in 351 patients with HCV related cirrhosis. 110 with SVR, 193 with non-SVR and 48 untreated patients were included in a multi-center cohort which was initiated 2001 and prospectively followed-up for a mean 5.3 ±SD 2.8 years. Complementary follow-up data from national registries were used to minimize the loss of patients during follow-up.
                 
Results.
Six patients with SVR developed HCC at 0.04, 0.64, 2.4, 7.4, 7.4 and 7.6 years after achieving SVR. The incidence of HCC, any liver complication, liver-related and overall death per 100 person-years was significantly lower in SVR time with 1.0, 0.9, 0.7, 1.9, compared to 2.3, 3.2, 3.0, 4.1 and 4.0, 4.9, 4.5, 5.1 in non-SVR and untreated time, respectively. The long-term consequences did not decline significantly after more than 3-year versus during the first 3-year of follow-up.
                 
Conclusions.
The risk for HCC, liver decompensation, and death in patients with liver cirrhosis related to HCV was markedly reduced after SVR, but a long-term risk to develop HCC remains for up to 8 years. Cirrhotic patients with HCV who achieve SVR should therefore maintain long-term surveillance for HCC. Future studies aimed to better identify those with remaining long-term risk for HCC are needed.

http://cid.oxfordjournals.org/content/early/2013/04/23/cid.cit234.abstract

Early HCV Response More Likely With Peg-Interferon Alpha-2a Than -2b

Pegasys (Peginterferon alfa-2a )..Peg-Intron (Peginterferon alfa-2b)
Reuters Health Information
 
Early HCV Response More Likely With Peg-Interferon Alpha-2a Than -2b
May 03, 2013
By Will Boggs, MD

NEW YORK (Reuters Health) May 03 - Patients with hepatitis C virus (HCV) are more likely to have an early response to pegylated interferon alpha-2a than alpha-2b, a new meta-analysis has found.

"The Cochrane meta-analysis about sustained virological response and our meta-analysis taking into account rapid virological response and early virological response (show that) the efficacy of peg-a-2a is superior to peg-a-2b and thus it is the first choice in the management of hepatitis C," Dr. Manuel Romero-Gomez from Valme University Hospital in Seville, Spain, told Reuters Health by email.

Dr. Romero-Gomez and colleagues pooled data from eight randomized trials that compared peginterferon alpha-2a and alpha-2b in 4,566 patients.

A complete early virological response (EVR) was achieved by 53.3% of patients treated with peginterferon alpha-2a and 43.8% of those treated with alpha-2b (p=0.0028), the authors reported April 14 online in Alimentary Pharmacology & Therapeutics.

Results were similar in a sub-analysis of patients infected with HCV genotypes 1 and 4, but the difference fell short of statistical significance.

Crude rates of rapid virological response (RVR) were higher for peginterferon alpha-2a than alpha 2-b (25.0% vs 16.8%; p=0.0056), and results were also significantly better for alpha-2a in a sub-analysis of patients infected with HCV genotypes 1 and 4 (p=0.0048).

"RVR and EVR are crucial in the management of therapy in hepatitis C because they allow us to make decision about futility rules, saving cost and adverse events," Dr. Romero-Gomez said. "Using peg-a-2a we can treat more patients with double therapy if they reach RVR or add boceprevir/telaprevir in patients without RVR."

"We need more data to define which patients have to be treated with peg-a-2a or peg-a-2b," Dr. Romero-Gomez cautioned. "According to baseline characteristics, pega-a-2a seems to be better in very difficult-to-cure patients (genotype 1 with advanced fibrosis and metabolic derangements), but this point needs to be confirmed in further studies."

SOURCE: http://bit.ly/11lmZED

Aliment Pharmacol Ther 2013

TACE, sorafenib improve survival among patients with infiltrative HCC



TACE, sorafenib improve survival among patients with infiltrative HCC
May 7, 2013
Patients with infiltrative hepatocellular carcinoma experienced prolonged survival when treated with transarterial chemoembolization or sorafenib in a recent retrospective cohort study.
Researchers evaluated data from 155 patients with infiltrative hepatocellular carcinoma (iHCC) seen at the University of California, San Francisco Medical Center between 2002 and 2010. Participants had a median age of 60 years, MELD score of 13, maximum tumor diameter of 11.3 cm and alpha-fetoprotein level of 347 ng/mL.
Full Story »

Boceprevir/peginterferon/ribavirin effective, safe in chronic HCV patients with compensated cirrhosis
May 6, 2013
Patients with chronic hepatitis C and compensated cirrhosis experienced higher rates of sustained virologic response with the addition of boceprevir to therapy with pegylated interferon and ribavirin in a study presented at the International Liver Congress in Amsterdam.
Full Story »

Monday, May 6, 2013

Alcohol and Chronic Hepatitis C


Clinical Liver Disease
Special Issue: Alcoholic Liver Disease
Volume 2, Issue 2, pages 72–75, April 2013

Watch a video presentation of this article
Watch the interview with the author

View full text here, below is an excerpt on alcohol and HCV.

Alcohol and Chronic Hepatitis C
Chronic HCV infection is the leading cause of advanced liver disease in the United States; an estimated 3.2 million people have active chronic HCV infection.7 Alcohol consumption is a common comorbidity in these patients, and multiple studies have shown that it may result in synergistic injury, with accelerated rates of fibrosis and the development of cirrhosis and liver cancer.8–11 Various mechanisms have been proposed, including: alcohol's effect on HCV viral replication, HCV-related cytotoxicity, hepatic oxidative stress, and immune modulation.
 
There is evidence that HCV RNA levels increase in concert with a more pronounced alcohol intake (Fig. 1a).12 Conversely, it has been shown that serum HCV RNA decreases with a reduction in alcohol intake (Fig. 1b).2


Alcohol consumption is also associated with HCV progression, and there is extensive evidence showing that chronic alcohol consumption leads to disease progression (Table 1) - see below.

Even small doses of alcohol intake (below 30 g/day) can promote liver fibrogenesis.13 Thus, it appears that there is no “safe alcohol consumption” among patients with HCV infection.

Chronic alcohol consumption in HCV-infected patients stimulates not only fibrogenesis but also hepatocarcinogenesis.

Patients with chronic HCV infection who actively consume alcohol have a higher relative risk of hepatocellular carcinoma (HCC) compared with abstainers (54 versus 19, respectively).14 This risk also appears to be dose-dependent. In one study, alcohol consumption >80 g/day increased the risk for HCC significantly by a factor of 7.3 when compared with <40 g/day.11

Finally, there are data showing that alcoholics have inferior rates of response to HCV therapy.15 However, the question about a possible inhibitory effect of alcohol on therapy rather than patient noncompliance requires further research.

Table 1. Effect of Alcohol Consumption in the Progression of HCV Infection
 
StudyAlcohol Intake EvaluationNo. of PatientsResults
Roudot-Thoraval et al.33Excessive alcohol intake defined as >5 drinks/day for women and 6 drinks/day for men for >1 year6,664Excessive alcohol intake was also associated with a higher risk of cirrhosis (34.9% versus 18.2%; P < 0.001).
Poynard et al.34Abstinent/Moderate, <50 g/day; high, ≥50 g/day2,235Fibrosis rate progression increased from 0.125 to 0.167 in patients with consumption ≥50 g/day
Pessione et al.12Weekly self-reported alcohol consumption233Significant correlation between self-reported alcohol consumption and serum HCV RNA levels (r = 0.26; P = 0.001)
Corrao et al.35Lifetime daily alcohol intake702Alcohol intake + HCV infection multiplies the alcohol-associated risk of cirrhosis (odds ratio: 9.0 for 50 g/day, 26.1 for 100 g/day, 133 for >125 g/day)
Harris et al.36Heavy drinking defined as >80 g/day836Heavy drinking exacerbates the risk for cirrhosis among patients with HCV infection (odds ratio: 7.8 versus 31.1 in HCV and HCV heavy drinkers, respectively)

Additional Topics:
Alcohol and Chronic Hepatitis B
Alcohol and NAFLD
Alcohol Consumption and Hereditary Hemochromatosis
Alcohol, Drug Interactions and Autoimmune Liver Diseases
View full text
 

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


Related:
AbbVie gains inside 'breakthrough' track at FDA for hot hep C combo
The company says that the FDA has picked its antiviral combo--with and without ribavirin-- as a new breakthrough therapy worthy of a swift review and perhaps a shortened clinical trial process ahead of a regulatory decision. 

Breakthrough Therapy Designation from the U.S. Food and Drug Administration Granted to Investigational HCV Regimen Containing Protease Inhibitor ABT-450

WATERTOWN, Mass.--(BUSINESS WIRE)--
Enanta Pharmaceuticals, Inc., (ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, today announced that AbbVie’s investigational direct-acting antiviral (DAA) combination regimen with and without ribavirin for the treatment of genotype 1 (GT1) hepatitis C virus (HCV) infection has been designated as a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA). ABT-450, Enanta’s lead HCV protease inhibitor identified in its ongoing collaboration with AbbVie, is one of three DAAs in the regimen.
   
The all-oral, triple-DAA combination regimen is currently being studied in Phase 3 clinical trials that are being conducted by AbbVie. The Phase 3 program includes more than 2,000 patients with genotype 1 HCV infection, with trial sites in 29 countries. The DAAs in the trials include ABT-450/r (protease inhibitor and ritonavir) combined with two of AbbVie’s proprietary investigational DAAs, ABT-267 (NS5A inhibitor) and ABT-333 (non-nucleoside polymerase inhibitor), and are being dosed with and without ribavirin.
   
According to the FDA, Breakthrough Therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy designation include preliminary clinical evidence demonstrating a drug may have substantial improvement on at least one clinically significant endpoint compared to available therapy. A Breakthrough Therapy designation conveys all of the fast track program features, as well as more intensive FDA guidance on an efficient drug development program.1

About Hepatitis C Virus (HCV)
Hepatitis C is a liver disease affecting over 170 million people worldwide. The virus is typically spread through direct contact with the blood of an infected person. Hepatitis C increases a person’s risk of developing chronic liver disease, cirrhosis, liver cancer and death. There is an acute need for new HCV therapies that are safer and more effective for many variants of the virus.
   
Collaboration with AbbVie (formerly the research-based pharmaceutical business of Abbott Laboratories
In December 2006, Enanta and Abbott announced a worldwide agreement to collaborate on the discovery, development and commercialization of HCV NS3 and NS3/4A protease inhibitors and HCV protease inhibitor-containing drug combinations. Under the agreement, AbbVie (as the successor to Abbott) is responsible for all development and commercialization activities for ABT-450. Enanta received a $57 million upfront payment upon signing the collaboration agreement, has received all clinical milestone payments, and is eligible to receive an additional $195 million in payments for regulatory milestones, as well as double-digit royalties worldwide on any revenue allocable to the collaboration’s protease inhibitors. Also, for any additional collaborative HCV protease inhibitor product candidate developed under the agreement, Enanta holds an option to modify the U.S. portion of it rights to receive milestone payments and worldwide royalties. With this option, Enanta can fund 40 percent of U.S. development costs and U.S. commercialization efforts (sales and promotion costs) in exchange for 40 percent of any U.S. profits ultimately achieved after regulatory approval instead of receiving payments for U.S. commercial regulatory approval milestones and royalties on U.S. sales.
   
About Enanta
Enanta Pharmaceuticals is a research and development-focused biotechnology company that uses its robust chemistry-driven approach and drug discovery capabilities to create small molecule drugs in the infectious disease field. Enanta is discovering and developing novel inhibitors designed for use against the hepatitis C virus (HCV). These inhibitors include members of the direct acting antiviral (DAA) inhibitor classes – protease (partnered with AbbVie), NS5A (partnered with Novartis) and nucleotide polymerase – as well as a class of host-targeted antiviral (HTA) inhibitors targeted against cyclophilin. Additionally, Enanta has created a new class of antibiotics, called Bicyclolides, for the treatment of multi-drug resistant bacteria, with a current focus on developing an intravenous and oral treatment for hospital and community MRSA (methicillin-resistant Staphylococcus aureus) infections.
   
Forward-Looking Statement Disclaimer
This press release contains forward-looking statements, including statements with respect to the Breakthrough Therapy designation that the FDA has given to AbbVie’s regimen containing ABT-450 for treatment of genotype 1 HCV infection and milestones and royalties that Enanta is eligible to receive on ABT-450 and any additional collaboration protease inhibitor products. Statements that are not historical facts are based on our management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our management’s beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors that may affect actual results include the development and commercialization efforts of AbbVie for HCV treatment regimens containing ABT-450 or any additional collaboration protease inhibitor product, regulatory actions affecting clinical development or treatment regimens containing ABT-450 or any additional collaboration protease inhibitor product, and clinical development of competitive product candidates. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.
   
1U.S. Food and Drug Administration. Frequently Asked Questions: Breakthrough Therapies. 2013.

Sunday, May 5, 2013

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

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

(Ref: ViewPoints Desk)
May 5th, 2013

New data from Gilead Sciences' LONESTAR study has not only strengthened the company's position in the race to develop an oral, interferon-sparing treatment for hepatitis C, but reinforced the strategic rationale for not pursuing a co-developed product with Bristol-Myers Squibb last year.

Insight, Analysis & Opinion

Gilead may have attracted a raft of criticism for the decision not to develop its nucleotide NS5B inhibitor sofosbuvir with Bristol-Myers Squibb's NS5A inhibitor daclastasvir (see Spotlight On: Bristol-Myers Squibb and Gilead Sciences deliver stellar HCV results, decide to go separate ways?), but its rationale for not doing so has proven correct.

Just days after that combination delivered a second set of highly impressive data, Gilead's own combination – of sofosbuvir and ledipasvir – has demonstrated comparable efficacy in a Phase II study. Furthermore, this combination advances Gilead's opportunity to deliver the 'holy grail' of next-generation hepatitis C therapies – a single fixed dose, once-daily tablet.

In genotype 1 treatment-naive patients, the sofosbuvir/ledipasvir combination demonstrated an impressive SVR 8 rates of 95 percent (which increased to 100 percent when ribavirin was added to the regimen) after 8 weeks of treatment. In the same patient group the combination achieved an SVR 4 rate of 100 percent without ribavirin after 12 weeks of therapy. Both analysts at Lazard Capital and International Strategy & Investment suggested that the data will further enhance Gilead's leadership within the hepatitis C development space.

Perhaps most impressively – commented analysts at Barclays – was a 12 week SVR 4 rate of 95 percent in treatment-experienced genotype 1 patients, of whom half were cirrhotic. Barclays analyst Anthony Butler described the data in this patient cohort as "remarkable."

Such had been the clear best-in-class combination properties of sofosbuvir and daclastasvir, there has been considerable speculation that physicians may prescribe the two product off-label. While there is likely to be an element of this, noted key opinion leaders interviewed by FirstWord, cost – and the availability of cheaper fixed dose combinations – is a likely deterrent. Data from the LONESTAR study would appear to significantly enhance this point of view.

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

http://www.firstwordpharma.com/node/1081565?tsid=28&region_id=2

Saturday, May 4, 2013

Webcast - Update on hepatitis C: what it is, how you get it, and how you treat it.

When education-related information on hepatitis C becomes available this blog points the reader to the new learning activity. MedNet21recently launched a webcast on Hepatitis C discussing not only  FDA approved drugs to treat HCV, but also drugs currently in clinical trials. I have provided links and a few topics presented in the webcast below.

The video is a short introduction to the learning activity, the CME webcast can be viewed in its entirety here.



Step 1
A quick free registration is required, click here to register.

All webcasts are free to view. You must only pay if you wish to access the post test following the webcast, in order to earn CME credit.

Release Date - 04/19/2013

Objectives As a result of this educational activity, webcast participants will be able to: UNDERSTAND the CDC Baby Boomer Directive; IDENTIFY current Rx with the new DAAs; and DISCUSS current Hepatitis C statistics.

Step 2
After registering, scroll down to the bottom of the page, click on "View Webcast On Demand"

Step 3
Firefox and Internet Explore Pop-up Blocker may prevent the launch of the program. If you haven't disabled - Pop-up Blocker the information bar will display a message saying "Pop-up blocked click on options to allow." Either click options or press CTRL+ALT to open the website.

Step 4
Once this is accomplished the program will launch, as shown below, click on "Start Webcast."



Highlights
 
Percentage of blood transfusions causing hepatitis
Testing for hepatitis C
Hepatitis C viral load testing
Hepatitis C Virus (HCV)
Hepatitis C: A Global Health Problem
CDC
Modeling of Liver Fibrosis in Chronic Hepatitis C
Advances in HCV Therapy Average SVR
Treatment of Chronic HCV Type of Response
Virological Response Terms
Interferon Free Therapies
Summary: Current State of Play 2013 
Unanswered Questions
Final Q & A