Showing posts with label SVR24-SVR12-SVR4. Show all posts
Showing posts with label SVR24-SVR12-SVR4. Show all posts

Wednesday, March 29, 2017

Care of Patients Who Have Achieved a Sustained Virologic Response (SVR) Following Antiviral Therapy for Chronic Hepatitis C Infection

AGA Institute releases practice update for managing patients cured of HCV infection
The American Gastroenterological Association (AGA) Institute released a practice update on managing patients with chronic hepatitis C virus (HCV) infection who have attained a sustained virologic response (SVR) after antiviral treatment. The clinical practice update was published in Gastroenterology.

Direct-acting antiviral (DAA) regimens for chronic HCV infection achieve high rates of SVR and have replaced interferon (IFN) in many countries. The current definition of SVR is undetectability of HCV RNA at 12 weeks after treatment (SVR12). Patients who achieve an SVR have a less than 1% risk of relapse and are considered cured.

Patients cured of HCV may experience reductions in the risk for death and hepatocellular carcinoma (HCC), as well as regression of liver changes including fibrosis or cirrhosis, but may still have higher rates of HCV-related complications than the general population. Patients who have already developed liver damage at the time of achieving SVR may be particularly at risk for future complications.
Continue reading.....

Updated
May 2017
Full Text Online
Expert Review
American Gastroenterological Association Institute Clinical Practice Update—Expert Review: Care of Patients Who Have Achieved a Sustained Virologic Response After Antiviral Therapy for Chronic Hepatitis C Infection

Online

Gastroenterology
Articles in Press

AGA Institute Clinical Practice Update: Care of Patients Who Have Achieved a Sustained Virologic Response (SVR) Following Antiviral Therapy for Chronic Hepatitis C Infection
Ira M. Jacobson M.D., Joseph K. Lim, M.D., and Michael W. Fried, M.D.

ACCEPTED MANUSCRIPT
DOI: http://dx.doi.org/10.1053/j.gastro.2017.03.018

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Abstract
Chronic hepatitis C virus (HCV) infection is well-recognized as a common blood borne infection with global public health impact, affecting 3 to 5 million persons in the U.S. and over 170 million persons worldwide. Chronic HCV infection is associated with significant morbidity and mortality due to complications of liver cirrhosis and hepatocellular carcinoma (HCC). Current therapies with all-oral directly acting antiviral agents (DAAs) are associated with high rates of sustained virologic response (SVR), generally exceeding 90%. SVR is associated with a reduced risk of liver cirrhosis, hepatic decompensation, need for liver transplantation, and both liver-related and all-cause mortality. However, a subset of patients who achieve SVR will remain at long-term risk for progression to cirrhosis, liver failure, HCC, and liver-related mortality. Limited evidence is available to guide clinicians on which post-SVR patients should be monitored versus discharged, how to monitor and with which tests, how frequently should monitoring occur, and for how long. In this clinical practice update, available evidence and expert opinion are used to generate best practice recommendations on the care of patients with chronic HCV who have achieved SVR.

Index
Assessment of HCV RNA after SVR12 has been attained
With the initiation of trials of DAA regimens, initially in combination with interferon and later
without it, the attainment of SVR 12 weeks after completion of treatment replaced SVR24 as
the primary endpoint, defined as undetectable HCV RNA on a highly sensitive PCR assay (lower
limit of detection <12 IU/mL).  This transition was based upon the rarity of relapse after follow
up week 12, and it helped move the field ahead by shortening the intervals between successive
trials in development programs (22). It has become apparent that late relapse beyond this time
point is no more common, and perhaps less so, than it was after interferon-based therapy

Ongoing surveillance for hepatocellular carcinoma after SVR
Is HCC risk after SVR exclusive to patients with advanced fibrosis and cirrhosis?
Can HCC surveillance ever be discontinued?
How should screening for, and management of, varices be affected by SVR?
Should patients be routinely monitored for regression of advanced fibrosis or
cirrhosis?

Recurrent HCC After SVR
Reinfection
Lifestyle Measures
Conclusions
Continue reading...

Full Text Articles
I highly suggest you follow Henry E. Chang on Twitter if you are interested in reading full text articles about the treatment and management of hepatitis C.
A link to the above full text PDF article was tweeted today.

Wednesday, January 4, 2017

Late Relapse After Hepatitis C Virus Treatment Is Rare


Article Summary Source - NEJM Journal Watch

Late Relapse After Hepatitis C Virus Treatment Is Rare

January 3, 2017
Neil M. Ampel, MD reviewing Sarrazin C et al. Clin Infect Dis 2017 Jan 1.
Few patients treated with a sofosbuvir-containing regimen for hepatitis C virus infection had late recurrent viremia, and most occurrences appeared to be reinfections.

Neil M. Ampel, MD
Use of direct antiviral agents (DAAs) for the treatment of hepatitis C virus (HCV) infection has been associated with sustained viral suppression by 12 weeks after therapy (SVR12) in >90% of patients. Because HCV infection does not confer full protective immunity, it is important to determine the frequency of recurrences after SVR12 is achieved and to distinguish between posttreatment relapse and reinfection.

To explore these issues, researchers in Germany, Russia, France, and the U.S. conducted an industry-supported study, examining samples from 11 phase III trials that used the NS5B inhibitor sofosbuvir, alone or in combination. To distinguish late relapse from reinfection, they conducted NS5B deep sequencing analysis, short-fragment NS5B population sequencing, and phylogenetic analyses.

Among 3004 patients, only 12 (0.4%) were found to have detectable HCV RNA by 24 weeks after SVR12. Deep genetic sequencing and phylogenetic analyses revealed that 5 of these 12 patients had HCV with minimal genetic changes in the NS5B sequence, suggesting that the recurrence was due to relapse. In the other 7, the sequences prior to and after DAA therapy were significantly unrelated, indicating reinfection.

Comment
This well-performed study indicates that absence of detectable HCV RNA by 12 weeks after DAA therapy is a good measure of SVR. It also demonstrates that most cases of recurrence are due to reinfection. Unfortunately, the tools needed to distinguish reinfection from relapse are not generally available to clinicians, suggesting the need for longer follow-up of patients after DAA therapy and better strategies to prevent reinfection.

Late Relapse Versus Hepatitis C Virus Reinfection in Patients With Sustained Virologic Response After Sofosbuvir-Based Therapies

Tuesday, November 29, 2016

Three anti-HCV regimens “highly effective” in achieving SVR

Three anti-HCV regimens “highly effective” in achieving SVR

A comparison of three different anti-HCV regimens concluded that all of them appeared highly effective in achieving sustained virologic response (SVR).

A study at the University of Southern California compared the SVR rates achieved 12 weeks post-treatment in 11,464 patients treated with three such agents by the Veterans Health Administration.

Without controlling for other risk factors, a SVR at least 12 weeks post treatment was achieved in 92% of ledipasvir/ sofosbuvir, 86% of ombitasvir/paritaprevir/ritonavir/dasabuvir, and 83% of simeprevir/sofosbuvir patients.

After adjusting for patient characteristics, simeprevir/sofosbuvir (93.3%) and ledipasvir/sofosbuvir (96.2%) patients were statistically more likely than ombitasvir/paritaprevir/ritonavir/dasabuvir (91.8%) patients to demonstrate a SVR.

HIV, HBV, diabetes, obesity, previous treatment history and augmentation therapy using ribavirin did not impact the SVR rates. Sustained SVR rates were lower for patients under age 65, with cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, indications of fibrosis or a non-genotype 1 infection. Women and Caucasian patients were more likely to achieve a SVR.

Reference
Comparative treatment effectiveness of direct acting antiviral regimens for hepatitis C: data from the Veterans Administration. Fox DS, McGinnis JJ, Tonnu-Mihara I et al. J Gastroenterol Hepatol. 2016 Nov 21 [Epub ahead of print]


Tuesday, November 22, 2016

(Epclusa) Sofosbuvir plus velpatasvir “best options” for HCV G3

Related
Epclusa for Hep C: What Pharmacists Should Know
JANUARY 04, 2017
Hepatitis C is an infection of the liver caused by the hepatitis C virus (HCV). It is one of the leading causes of chronic liver disease in the United States with the CDC estimating that between 2.7 and 3.9 million people in the United States are infected with chronic HCV.1 Over the past several years, a number of direct acting antivirals have been approved to treat the infection.

In June 2016, the FDA approved Epclusa, a fixed-dose combination product containing sofosbuvir, an HCV NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor, for treatment of chronic hepatitis C genotypes 1, 2, 3, 4, 5, or 6. With its approval, Epclusa became the first antiviral indicated for all 6 major forms of HCV.

This article highlights several key therapeutics areas with Epclusa that every pharmacist should know


Sofosbuvir plus velpatasvir “best options” for HCV G3

An analysis of published studies on direct acting antivirals (DAAs) found that regimens containing sofosbuvir and velpatasvir were the best option for patients with HCV genotype three (G3).

The analysis indicated that ribavirin significantly increased rates of SVR and should be considered if tolerated.

Researchers at Radboud University Medical Centre in the Netherlands performed a Bayesian network meta-analysis using a random effects model to indirectly compare DAA regimens in HCV G3 patients with and without cirrhosis. They found 27 appropriate studies involving 3,415 patients.

Among patients without cirrhosis, the greatest rates of SVR were estimated for those receiving sofosbuvir + velpatasvir with ribavirin (99%) and without ribavirin (97%), for sofosbuvir + daclatasvir + ribavirin (96%), and for sofosbuvir + peginterferon + ribavirin (95%), all for 12 weeks.

Among patients with cirrhosis, the highest rates of SVR were estimated for those receiving sofosbuvir + velpatasvir for 24 weeks (96%), for sofosbuvir + daclatasvir + ribavirin for 24 weeks (94%), and for sofosbuvir + velpatasvir + ribavirin for 12 weeks (94%).

Ribavirin increases efficacy in patients with and without cirrhosis (odds ratios 2.6 and 4.5).

Reference
Identification of the best direct-acting antiviral regimen for patients with hepatitis C virus genotype 3 infection: a systematic review and network meta-analysis. Berden FA, Aaldering BR, Groenewoud H et al. Clin Gastroenterol Hepatol. 2016 Nov 10 [Epub ahead of print]

Nov 21, 2016
Sofosbuvir/velpatasvir improved patient-reported outcomes, knocked out HCV genotypes 1-6
– When given with ribavirin, a fixed-dose combination of sofosbuvir/velpatasvir (Epclusa) achieved a sustained viral response at 12 weeks (SVR-12) in 94% of decompensated cirrhotic patients with hepatitis C virus (HCV) genotypes 1-6 infection, according to Zobair M. Younossi, MD.

Patients with and without cirrhosis also reported meaningful improvements across a variety of outcome measures after successfully completing treatment with Epclusa or sofosbuvir (Harvoni), said Dr. Younossi of Inova Fairfax Hospital in Falls Church, Va. “Although on-treatment patient-reported outcomes improved more with ribavirin-free regimens, post-SVR improvements were similar,” regardless of whether patients had received ribavirin, he reported at the annual meeting of the American Association for the Study of Liver Diseases.
Continue reading..

Of Interest
Nov 17, 2016
AbbVie Pangenotypic Combination Cures Hard-to-Treat People with HCV Genotype 3


October 2016
Short-duration Treatment With Elbasvir/Grazoprevir and Sofosbuvir - HCV GT1 or GT3 with or without cirrhosis

Vol 4, Supplement 1 (October 2016): Annals of Translational Medicine
           

Thursday, July 30, 2015

HCV Next: HCV In MSM: An Epidemic with a 'Shocking" Lack of Education

HCV In MSM: An Epidemic with a 'Shocking" Lack of Education

The following articles appeared in the July 2015 print edition of "HCV Next" published online at "Healio."

"HCV Next" offers information on a range of topics, which include diagnosis, new combination therapies, side effects, drug/drug interaction, guidelines, fatty liver disease and more.

Table of Contents
5 QUESTIONS
A Conversation with Catherine T. Frenette, MD


MEETING NEWS COVERAGE

TREND WATCH

Sunday, January 25, 2015

Sofosbuvir-based regimens for HCV: SVR12 Is Equivalent to SVR24 in Assessing New HCV Regimens

Related Video Podcast: Jan 16 2015
AASLD Video Podcast: Concordance of Sustained Virological Response With Sofosbuvir-containing Regimens for HCV

Full text available; Concordance of sustained virological response 4, 12, and 24 weeks post-treatment with sofosbuvir-containing regimens for hepatitis C virus 

NEJM Journal Watch 
January 23, 2015

SVR12 Is Equivalent to SVR24 in Assessing New HCV Regimens

Atif Zaman, MD, MPH reviewing Yoshida EM et al. Hepatology 2015 Jan.

The two efficacy endpoints were highly concordant in data from phase III trials of sofosbuvir-based regimens.

Eradication of hepatitis C virus (HCV) is typically defined as an undetectable level of HCV RNA 24 weeks after completing treatment (i.e., sustained virologic response at week 24, or SVR24). The FDA recently determined that sustained virologic response at 12 weeks posttreatment (SVR12) is as valid as SVR24 as an efficacy endpoint due to its high rate of concordance with SVR24. However, this concordance has not been extensively studied since the advent of direct-acting antiviral–based regimens.

In a retrospective analysis of data from five phase III trials of sofosbuvir-containing regimens (with and without peginterferon) in 863 patients with HCV infection (genotypes, 1–6), investigators assessed the concordance between SVR at 4 weeks (SVR4) and SVR12, concordance between SVR12 and SVR24, and positive-predictive and negative-predictive values (PPV and NPV).

Rates of SVR4, SVR12, and SVR24 were 92%, 91%, and 91%, respectively, in patients with HCV genotype 1 or 4 through 6; 94%, 92%, and 92% for genotype 2; and 87%, 85%, and 84% for genotype 3. The concordance of SVR4 and SVR12 was 98% (PPV, 98%; NPV, 100%). The concordance of SVR12 and SVR24 was >99% (PPV, >99%; NPV, 100%). Over three fourths (78%) of patients who relapsed post-therapy did so within the first 4 weeks.

COMMENT
This analysis of data from phase III trials of sofosbuvir-based regimens for HCV infection confirms that SVR12 is equivalent to SVR24 as an efficacy endpoint. This is true for direct-acting antiviral regimens that include interferon and for interferon-free regimens. In clinical practice, SVR12 can routinely be used as a marker for treatment success among HCV monoinfected patients with compensated liver disease. Further analysis should be forthcoming regarding special subpopulations such as patients who are coinfected or have decompensated liver disease.

EDITOR DISCLOSURES AT TIME OF PUBLICATION
Disclosures for Atif Zaman, MD, MPH at time of publicationNothing to disclose

CITATION(S):
Yoshida EM et al. Concordance of sustained virological response 4, 12, and 24 weeks post-treatment with sofosbuvir-containing regimens for hepatitis C virus. Hepatology 2015 Jan; 61:41. (http://dx.doi.org/10.1002/hep.27366)
PubMed abstract (Free)


Thursday, May 29, 2014

How Long Should HCV Treatment Last? Study Suggests Answers Are Complex

How Long Should HCV Treatment Last? Study Suggests Answers Are Complex

Translational researchers tracked in real-time how virus replicates and how drug clears HCV from liver, plasma
Released: 5/28/2014 1:00 PM EDT
Source Newsroom: University at Buffalo

Newswise — BUFFALO, N.Y. – As new treatments for hepatitis C virus (HCV) are approved, biomedical scientists are exploring their mechanisms and what they reveal about the virus. An online publication this month in Hepatology is the first to report real-time tracking of viral decay in the liver and blood in 15 patients with HCV.

Led by Andrew H. Talal, MD, University at Buffalo professor of medicine in the Division of Gastroenterology, Hepatology and Nutrition and corresponding author, the study is the first to trace in real-time how the drug telaprevir inhibits viral replication in the liver and how it clears HCV from infected cells and plasma of infected patients.
The study was sponsored by Vertex Pharmaceuticals, which makes telaprevir, an HCV protease inhibitor.

“Our findings begin to define for how long patients may need to be treated in order to achieve viral eradication,” explained Talal.

“There has been no precise definition of the duration of treatment based upon serial measurements of the virus in the liver,” said Talal. “This is the first time that serial measurements in the liver have been performed during antiviral therapy.”

In previous studies, a more invasive procedure – core needle biopsy – was used to sample the liver in HCV infection. In the current study, fine needle aspiration was used; this method is better tolerated by patients and allows for repeated sampling at more time points than core needle biopsy.
“Fine needle aspiration enables us to sample the liver repeatedly during the course of treatment, to better understand what’s happening with the virus, how these drugs work and how to tailor therapy to the patient,” Talal explained.

In the study, conducted at Weill Cornell Medical College in New York City, 15 patients with chronic HCV infection were treated with telaprevir-based triple therapy (consisting of telaprevir/pegylated interferon alfa/ribavirin), an HCV treatment regimen that was approved by the Food and Drug Administration in 2011.

Fine needle aspiration of the liver was performed before treatment on all 15 patients and at these intervals following treatment: ten hours, on days 4 and 15, and at week eight. Viral kinetics, resistance patterns, drug concentrations and host transcription profiles were measured.
Of particular interest were the study’s findings regarding the rate of decay for viral ribonucleic acid (RNA), an indicator of how quickly the virus is being eradicated.

“We found that HCV RNA decay in the liver lagged behind that in the peripheral blood, which has implications for how long the virus may persist in the body and the possible duration of treatment needed,” said Talal.

They also found higher levels of the drug in blood than in the liver.

“These findings can affect the duration of therapy,” said Talal, adding that they can also help to identify when drug-resistant variants of the virus emerge in blood and in the liver.

The findings also may have relevance to the development of other methods of treating HCV, such as vaccines that could be used to control the infection, he added.

Talal conducts research on HCV in the Clinical and Translational Research Center in the School of Medicine and Biomedical Sciences and he sees patients as a physician with UBMD, the physician practice plan of the UB medical school. Talal has had additional research projects funded by Vertex Pharmaceuticals.

In addition to Talal, who has an adjunct appointment at Weill Cornell, co-authors of the paper are: Rositsa B. Dimova, PhD, research assistant professor in the departments of medicine and biostatistics at UB; Marija Zeremski, PhD, senior research associate at Weill Cornell and research assistant professor of medicine at UB; Christine M. Cervini, RN, staff associate in medicine and Ira M. Jacobson, MD, chief of the division of gastroenterology and hepatology, both of Weill Cornell; Eileen Z. Zhang, Min Jiang, Marina S. Penney, James C. Sullivan, Martyn C. Botfield, Ananthsrinivas Chakilam and Rishikesh Sawant, all of Vertex Pharmaceuticals and Ann D. Kwong, of InnovaTID Pharmaceuticals, formerly of Vertex Pharmaceuticals. Jacobson has served as a paid consultant to Vertex.

Monday, June 17, 2013

Hepatitis C - Is SVR12 As Good As SVR24?

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In patients with chronic Hepatitis C virus (HCV) infection, a sustained viral response to treatment regimens 12 weeks after therapy (SVR12) is a good indicator that the response will be maintained until week 24 (SVR 24), based on an analysis of pooled clinical trial data published in the June issue of Gastroenterology. Therefore SVR12 can be used instead of SVR24 as a primary end point for registration trials.

A SVR24 (undetectable levels of HCV RNA in serum 24 weeks after completion of therapy) is considered to indicate successful treatment—most patients who achieve SVR24 maintain their serum-negative status and have reduced complications from liver disease and increased survival times. It is therefore the primary endpoint of HCV therapy trials for regulatory approval—efficacies of all HCV therapies approved by the US Food and Drug Administration have been based on the proportion of patients attaining SVR24. However, earlier time points could increase efficiency of drug development.

Jianmeng Chen et al. assessed data from 15 phase 2 and 3 trials, 3 pediatric studies, and 5 drug-development programs to determine the concordance between SVR24 and SVR12, and even SVR4. They analyzed data from groups of subjects who received various combinations and regimens with interferon, ribavirin, and direct-acting antiviral agents.

Of the 13,599 adult subjects in the database analyzed, 50.6% achieved SVR24 and 51.8% achieved SVR12. These appeared to be mostly the same patients—the positive predictive value of SVR12 for SVR24 was 98% and the negative predictive value was 99% among subjects with genotype 1 HCV infection. A similar level of concordance was observed in subjects with HCV genotype 2 or 3 infections, as well as in pediatric studies.

The positive predictive value of SVR4 for SVR24 was 91% and the negative predictive value was 98% in subjects with genotype 1 HCV infection. Chen et al. observed similar values regardless of subjects’ race, sex, treatment experience, genotype 1a vs 1b, or presence of cirrhosis.

Why is there such a high level of agreement between SVR12 and SVR24, and to a lesser extent SVR4 and SVR24? Chen et al. explained that 65% of subjects who relapsed had detectable viral load by week 4 after treatment and 95% had detectable viral load by week 12. So if the virus is going to reappear, in generally does so within 12 weeks after the treatment ends.

The authors conclude that individual patients should be followed for 24 weeks or longer after treatment to confirm their responses. But SVR12, which is currently used as supportive information for registration trial design, can also be appropriate for regulatory approval of treatment regimens.

More Information on HCV Infection
Read the article online.

 Chen J, Florian J, Carter W, et al. Earlier sustained virologic response end points for regulatory approval and dose selection of hepatitis c therapies. Gastroenterology 2013;144:1450–1455.e2.

Friday, January 18, 2013

HCV Weekly Rewind: IFN-free Trials, The Silent Pandemic and Veterans Affected By Buffalo VA Infection Risk

Good afternoon folks,

Another Friday is upon us and its time for a quick review of the top hepatitis C headlines for the week of January 7th, including today's news in this edition of HCV Weekly Rewind.


Interferon-Free

We begin with an interferon-free trial announced yesterday by Boehringer Ingelheim, the company is headquartered in Ingelheim, Germany and based in Ridgefield, CT.

Boehringer Ingelheim has begun enrolling patients in a pivotal late-stage hepatitis C study. The companies investigational IFN-free regimen combines the compounds faldaprevir (BI 201335), a protease inhibitor administered once-daily, and BI 207127, a non-nucleoside polymerase inhibitor administered twice-daily, plus ribavirin.

"Our investigational interferon-free regimen has shown particular promise in treating patients with HCV genotype-1b so we have decided to enroll these patients in our Phase 3 trial program. Our goal is for an interferon-free future and ensuring patients are treated with the most effective treatment for them individually," said Peter Piliero, M.D., vice president, clinical development and medical affairs.

Purpose

The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

U.S. Locations

U.S. clinical trial sites: Arkansas, California, Connecticut, Florida, Georgia, Illinois, Indiana, Louisiana, Michigan, Mississippi, Missouri, New Jersey, Ohio, Texas, Utah, and Virginia. International sites and additional information can be found at clinicaltrials.gov. Contact Boehringer Ingelheim at 1-800-243-0127.

January 17, 2013 Press Release
Boehringer Ingelheim Enrolls First Patients in Pivotal Phase 3 Interferon-Free Hepatitis C Trial Program

Previous Trials:

A quick summary-Faldaprevir (BI-201335) and BI-207127

Cirrhosis SOUND-C2

In November results of the interferon-free trial called SOUND-C2 using Boehringer Ingelheim’s faldaprevir (BI-201335) and BI-207127 with ribavirin were presented at the 63rd annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.

Results from SOUND-C2 Sub-analysis of Patients with Compensated Liver Cirrhosis due to HCV
 Data from the SOUND-C2 study are the first data for an IFN-free regimen in HCV patients with compensated liver cirrhosis. This sub-analysis included 33 patients (nine percent of the study population) with compensated liver cirrhosis, as confirmed by either biopsy or Fibroscan. Investigators noted that data from this analysis support the continued development of this investigational IFN-free treatment regimen in Phase 3 trials for patients with compensated liver cirrhosis.

SOUND-C2 Sub-Analysis in Patients with Compensated Liver Cirrhosis
1335 QD/7127 TID/RBV
16, 28 or 40 weeks
Pooled (n=21)
1335 QD/7127 BID/RBV
28 weeks (n=9)
1335 QD/7127 TID
28 weeks (n=3)
GT1a
(n=7)
GT1b
(n=14)
GT1a
(n=4)
GT1b
(n=5)
GT1a
(n=0)
GT1b
(n=3)
SVR12 / 24, n (%)3 (43%)8 (57%)2 (50%)4 (80%)N/A1 (33%)
DCs due to AEs,
n (%)
6 * (29%)1 (11%) 0
DCs due to rash,
n (%)
3 * (14%)00
DCs due to
photosensitivity,
n (%)
2 (10%) 00
DCs due to vomiting,
n (%)
1 (5%) 00
*No cases of erythema multiforme, Stevens-Johnson Syndrome (SJS), toxic epidermal necrosis, or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

Comparison of SVR4, SVR12 and SVR24 Results from SOUND-C2 A comparison of results from the SOUND-C2 study shows that almost all patients (98 percent) in the study who achieved SVR4 continued to maintain undetectable virus levels and achieve SVR24. All of the patients who achieved SVR12 in the SOUND-C2 study maintained their undetectable virus levels and achieved SVR24.

Of the patients with undetectable hepatitis C virus levels at the end of treatment (EOT), and who received the treatment per the pre-specified protocol, 15 experienced documented relapse (7 percent). Relapse occurred within 12 weeks post-treatment for 14/15 patients. One patient in the 16 week study arm relapsed between 24-48 weeks post-treatment.

It should be noted that rare late relapses have been observed following both IFN-based and IFN-free treatment. It is unclear why these patients relapsed so late in the follow up period. These results emphasize the importance of monitoring patients for at least one year following the end of treatment regardless of whether they were treated with an IFN-based or IFN-free regimen.
Continue reading...


Slides available @ NATAP - EFFICACY AND SAFETY OF THE INTERFERON-FREE COMBINATION OF FALDAPREVIR (BI 201335) + BI 207127 ± RIBAVIRIN IN TREATMENT-NAIVE PATIENTS WITH HCV GT-1 AND COMPENSATED LIVER CIRRHOSIS: RESULTS FROM THE SOUND-C2 STUDY

What About SVR-4, SVR-12 and SVR-24 ?

Have you noticed at scientific meetings new terminology has evolved over the years, especially relating to sustained virologic response - SVR?  The once standardized term "SVR" was defined as being HCV RNA negative 6 months after finishing standard therapy. This endpoint used in clinical trials had low rates of relapse and has been interpreted by researchers as a 'cure'. However, now with new agents the definitions of viral responses using standard therapy or peginterferon and ribavirin have become somewhat insufficient.

That Was Then This Is Now

Tracy Swan from TAG (Treatment Action Group) recently wrote an update on the newer sustained virologic response terminology; SVR-4, SVR-12 and SVR-24, in the report SVR rates from HCV drugs currently under development are included using data from the 2012 liver meeting.

Swan warns of the importance of monitoring late relapse, using examples of late relapses in two interferon-free trials-one was SOUND-C2.

Excerpt:
The hunger for information about cure rates from interferon-free regimens has led to earlier reporting of results; SVR-4 (undetectable HCV RNA four weeks after finishing treatment) is now commonly used. But with interferon-free regimens, SVR-4 does not always predict SVR-12, and SVR-12 does not always predict SVR-24. In fact, there have been two late relapses, between 24 and 48 weeks after treatment with an interferon-free regimen: one in Abbott’s PILOT trial [1] and one in Boehringer Ingelheim’s SOUND-C2 trial [2]. In both cases, treatment consisted of an HCV protease inhibitor, a non-nucleoside polymerase inhibitor and ribavirin. Although SVR-12 and SVR-24 are primary outcomes for interferon-free trials, monitoring for late relapse will continue. 
Read the full report entitled: Cure rates with pipeline HCV drugs: reports from AASLD.

Gilead Sciences: Sofosbuvir (GS-7977)/GS-5885 and Ribavirin

Gilead Sciences is now recruiting at some locations in the U.S.

Study Title
Safety and Efficacy of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin for the Treatment of HCV

The purpose of this study is to evaluate the safety, tolerability and antiviral efficacy of sofosbuvir/GS-5885 (fixed dose combination) with or without RBV administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1 HCV infection.

More Information @ Clinicaltrials.gov
 
In Case You Missed It

Gilead Update January 7 - Press Release:

Gilead Update - 2nd Phase 3 Study of Sofosbuvir and GS-5885 to Begin Later this Month
-- Sustained Virologic Response Achieved with Oral Regimen of Sofosbuvir, GS-5885 and Ribavirin in 9/9 Null Responder Genotype 1 Hepatitis C Patients --
-- Second Phase 3 Study Evaluating Fixed-dose Combination of Sofosbuvir and GS-5885 to Begin Later this Month --
Continue Reading....

Bristol-Myers

As most of you know, last August Bristol-Myers Squibb discontinued a mid-stage study of the experimental nucleotide polymerase inhibitor BMS-986094 after heart failure was reported in one of the 30 patients enrolled in the study - several participants suffered serious complications.

On Wednesday  over at Fierce Biotech reported that Bristol-Myers will begin talks on settling claims from patients and families involved in the tragic trial, read the article here. 

Roche

CHMP post-authorisation summary of positive opinion for Pegasys  On 17 January 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product Pegasys. The marketing authorisation holder for this medicinal product is Roche Registration Ltd. They may request a re-examination of the CHMP opinion, provided that they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.

The extension adopted by the CHMP is to add a new strength (90 µg) to the existing product range.
The CHMP also adopted a new indication, as follows:

Paediatric patients 5 years of age and older:
Pegasys in combination with ribavirin is indicated for the treatment of chronic hepatitis C in treatment-naïve children and adolescents 5 years of age and older, who are positive for serum HCV-RNA.

When deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis (see section 4.4).

Detailed conditions for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.
For information, the full indications for Pegasys will be as follows1:

Chronic hepatitis B

Pegasys is indicated for the treatment of hepatitis B envelope antigen (HBeAg)-positive or HBeAg-negativechronic hepatitis B (CHB) in adult patients with compensated liver disease and evidence of
viral replication, increased ALT and histologically verified liver inflammation and/or fibrosis (see sections 4.4 and 5.1).

Chronic hepatitis C

Adult patients
Pegasys is indicated for the treatment of chronic hepatitis C (CHC) in adult patients who are positive for serum hepatitis C virus ribonucleic acid (HCV-RNA). This includes patients with compensated cirrhosis and/or co-infected with clinically stableHIV (see section 4.4).

The optimal way to use Pegasys in patients with chronic hepatitis C is in combination with ribavirin. The combination of Pegasys and ribavirin is indicated in treatment-naïve patients and in adult patientswho have failed previous treatment with interferon alpha (pegylated or non-pegylated) alone or in combination therapy with ribavirin.

Monotherapy is indicated mainly in case of intolerance or contraindication to ribavirin.

Paediatric patients 5 years of age and older:
Pegasys in combination with ribavirin is indicated for the treatment of chronic hepatitis C in treatment-naïve children and adolescents 5 years of age and older who are positive for serum HCV-RNA.

When deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis (see section 4.4).
Source

Big Pharma

Big Pharma ranks near bottom in patient attitudes

Big Pharma has got to be thankful for for-profit health insurers. They represent the only group that patients who are taking drugs are touched by that they dislike more than makers of branded drugs.

That is according to a survey recently published in PatientView Quarterly, which surveyed 500 international, national and regional patient groups, about their opinions of different parts of the drug and devicemaking, paying and delivery process. While 72% of the participants come from Europe, Forbes contributor John LaMattina says there are lessons to be drawn for the industry. LaMattina is the former president of Pfizer R&D and now senior partner at PureTech Ventures,

Pharma ranked seventh out of 8 categories.

According to the survey, which must be purchased to get to the nitty-gritty, only 34% gave pharma a good or excellent rating. Generic drugmakers didn't do much better, with 37% of respondents having good feelings about them, while biotechs were rated favorably by 44%. Patients liked their retail pharmacists the best, at 62%. Then there was medical device companies, 50%; private healthcare services, 46%; biotechs, 44%; and not-for-profit health insurers, 39%. For-profit health insurers fell a full 10 percentage points lower than pharma at 24%.

There are number of factors that influenced patients against branded drugmakers. Not surprisingly, pricing was at the top of their list. They also found drug companies too secretive, said they do a poor job of letting them know about adverse drug event news and a third of them have issues with the industry's integrity.

The former Pfizer ($PFE) R&D exec offers up some ideas on changing such attitudes. He thinks Big Pharma should provide more transparency on payments to physicians and clinical trial data, stop pushing drugs for unapproved uses and give up television advertising.

Some individual drug companies have taken these kinds of steps, although often after intense criticism. For example, GlaxoSmithKline ($GSK) has committed to open up its data vaults and let researchers peruse years of results good and bad.

But there are other signs of disaffection with the lack of transparency in the industry. Just this week, the AARP, AFL-CIO, and 17 other healthcare advocacy groups issued a letter to the Office of Management and Budget, urging the Obama administration to roll out regulations for the Physician Payments Sunshine Act. That is the legislation that mandated disclosure of financial ties between industry and doctors. The regulations to implement the act are 15 months overdue. Some doctors wrote a similar letter. Of course, this delay is not the industry's doing.
Source- Fierce Biotech
- read the Forbes piece
- here's a link to the report

Related Articles:
Will GlaxoSmithKline's transparency pledge force pharma rivals to open up?
AARP, AFL-CIO and prominent docs to White House: Get us the sunshine rules, stat
Should doc-payment rules require more info?
Senate mulls bill to keep pharma documents unsealed
Pfizer to report doctor payments

Liver

Harmful Cells May Have A Role To Play In Liver Repair

Liver damage could be repaired by the same cells that harm the organ in the first place, a study suggests.

The cells - called macrophages - cause tissue to become scarred, which can lead to cirrhosis of the liver.

University scientists have now found that the macrophages also have a role in breaking down and getting rid of damaged tissue so that the normal liver structure and function is restored.

Macrophages
Macrophages are found throughout the body and help fight infection by breaking down bacteria.

They also regulate inflammation in cells, which can cause scarring in tissue and help to seal wounds.

Researchers are identifying what triggers the cells to change their function in the liver, with a view to developing a drug that switches the cells to repair mode.

Liver cirrhosis

Liver cirrhosis occurs as a result of long-term damage that can be brought on by infection, excess alcohol consumption or obesity.

The condition, which is increasing rapidly, currently ranks as the 5th most common cause of death leading to around 1,000 deaths in the UK each year, with 700 people needing a transplant to survive.

We have shown that the very cells that provoke scarring to the liver can also help the liver to heal by getting rid of damaged tissue. While scarring of the skin, for instance, following a cut is important to help the skin heal when the liver becomes scarred this can affect how it works, preventing toxins in the bodies from being broken down properly.

Prakash Ramachandran

Medical Research Council Centre for Inflammation Research at the University

Study

The study, which has been published in PNAS, looked at the role of macrophages in liver tissue in mice.

The research was funded by the Medical Research Council, the Wellcome Trust, the Academy of Medical Sciences, the Health Foundation, Royal College of Surgeons of Edinburgh, British Heart Foundation and Sir Jules Thorn Trust.
http://www.scotsman.com/news/health/harmful-cells-could-repair-liver-1-2740020

January Pubmed Literature Review

Monthly Pubmed Review of the most relevant research on hepatitis C

Includes:

Clinical Trials, Cohort Studies, Pilot Studies
Basic and Applied Science, Pre-Clinical Studies
HIV/HCV Coinfection
Complementary and Alternative Medicine
Epidemiology, Diagnostics, and Miscellaneous Works
Liver Cancer

January Abstracts Available @ CAP Hepatitis C Literature Review

Raising Awareness

Silent Pandemic: Tackling Hepatitis C

A report published this week by the Economist Intelligence Unit in London titled "The Silent Pandemic: Tackling Hepatitis C with Policy Innovation", warns hepatitis C has become a ''silent pandemic''' that kills 350,000 people each year.

"The report highlights that worldwide, despite the significant burden of HCV, governments have failed to get a grip on the scale and impact of the disease," said Charles Gore, President of The World Hepatitis Alliance. "In both developed and developing countries, the true human and economic cost of HCV will continue to rise unless policy makers confront this urgent public health issue now."
 
Hepatitis C disease backgrounder



HCV Transmission In A Clinical Setting

Veterans exposed to HCV, HBV and HIV at Buffalo VA Medical Center

700 patients over a two-year period may have been exposed to hepatitis B, hepatitis C or HIV through the reuse of insulin pens at the Buffalo VA Medical Center.

Excerpt From Olean Times Herald;

Some local veterans affected by Buffalo VA infection risk
"Letters were sent out to veterans who were admitted to the Buffalo VA Hospital between Oct. 19, 2010, and Nov. 1, 2012. The reuse of the insulin pens was disclosed to members of Congress last week, and Rep. Chris Collins, R-Clarence, disclosed the VA infection risk on Saturday. The VA discovered the improper reuse of the insulin pens in November."
Continue reading...

The Buffalo News Reports:

FDA warned in 2009 not to reuse insulin pens

WASHINGTON – The Food and Drug Administration warned hospitals nationwide against reusing insulin pens on multiple patients in March 2009, 19 months before the Buffalo VA Medical Center began a practice that could have prompted its nurses to do that very thing.
What’s more, the hospital continued running the risk of spreading deadly viruses through those insulin pens for more than two years until last Nov. 1, despite a January 2012 alert from the Centers for Disease Control and Prevention reiterating the FDA’s earlier warning.
Continue reading....

ARIZONA: Hepatitis C Lawsuit Filed Against Bullhead City Clinic

A Mohave County resident is suing the Ear & Sinus Center of the Southwest in Bullhead City, Ariz., after allegedly contracting hepatitis C while having a voice box nodule examined with an endoscope in January 2012. On November 30, 2012, the clinic sent the patient a letter stating that the equipment used in the procedure may not have been sterilized properly. The clinic suggested that the patient get tested for a variety of diseases. The patient filed a lawsuit in Maricopa Superior Court on December 27, 2012, after testing positive for hepatitis C. The patient claims that the equipment used for the procedure was not properly sterilized. Robert Mosier of the law firm Hodes, Milman, Liebeck, and Mosier is representing the patient. The latest inspection report for the clinic on the Arizona Department of Health’s website is dated October 29, 2012, and shows no violations. Mosier states, "What we want to know is why did it take the clinic until November [2012] to notify [the patient] of the problem? How many other patients were put at risk and why were procedures not followed?" Mosier’s office has not yet heard back from Ear & Sinus Center of the Southwest.
Source

Second Hepatitis C case diagnosed at BHC clinic
A second person treated at the Ear & Sinus Center of the Southwest in Bullhead City has tested positive for Hepatitis C. Las Vegas attorney Gerald Gillock said his client was treated at least nine times at the clinic, including several procedures with an endoscope. An endoscope is a flexible tube with a camera and sometimes surgical instruments that doctors can use to check out the insides of the sinuses, throat, windpipe and colon. In November, The clinic sent letters to its patients saying that its staff may not have followed proper sterilization procedures for its endoscopes and recommending tests for a variety of diseases, including Hepatitis C. Gillock is fairly certain his client's infection came from the clinic.
 
 Continue reading...

Exeter hepatitis C outbreak malpractice cases hit court today
David Kwiatkowski, whom prosecutors have called a "serial infector," is charged with stealing painkillers from Exeter Hospital and replacing them with saline-filled syringes tainted with his own blood. He pleaded not guilty earlier this month to 14 federal drug charges and has been in jail since his arrest in July.
Continue reading..

Health Care-Related Exposure Linked to HCV, HBV Infection in Older Adults
Researcher Joseph Perz reported that older patients who received healthcare had increased risk of becoming infected with hepatitis C or hepatitis B. Patients' behavioral risks -- being in jail, using "non-injected illicit drugs," or having sex with hepatitis-infected partners or with multiple partners -- had no relation to this increased risk. The study included 48 hepatitis-infected patients ages 55 and older who showed hepatitis symptoms within six months of exposure to healthcare settings.
Continue reading @ The Body.com

HCV Transmission

Online tattoo and piercing kits could be spreading Hepatitis C
"We do know that tattooing is incredibly popular, becoming more so, body piercing is very popular and there are now online kits.
"So you've got this situation where people are getting involved in tattooing parties and body piercing parties among themselves.
"They're doing some good stuff but they don't have the knowledge or the equipment to sterilise the equipment."
Tattoo and body piercing kits are widely available online for about $100 or less. Many of them are advertised as being "for beginners".
Continue reading...

Association of tattooing and hepatitis C virus infection: A multicenter case-control study

Carney K, Dhalla S, Aytaman A, Tenner CT, Francois F.
Source NYU Langone Medical Center, New York, NY.

Abstract
Although injection drug use (IDU) and blood transfusions prior to 1992 are well-accepted risk factors for hepatitis C virus (HCV) infection, many prior studies that have evaluated tattooing as a risk factor for HCV infection did not control for a history of IDU or transfusion prior to 1992.

In this large, multicenter case-control study we analyzed demographic and HCV risk factor exposure history data from 3,871 patients, including 1,930 with chronic HCV infection (HCV RNA positive) and 1,941 HCV negative (HCV antibody negative) controls.

Crude and fully adjusted odds ratios of tattoo exposure by multivariate logistic regression in HCV infected versus controls were determined. As expected, injection drug use (65.9% vs. 17.8%, p < 0.001), blood transfusions prior to 1992 (22.3% vs. 11.1%, p < 0.001), and history of having one or more tattoos (OR = 3.81; 95% CI 3.23 - 4.49, p<0.001) were more common in HCV-infected patients than in control subjects.

After excluding all patients with a history of ever injecting drugs and those who had a blood transfusion prior to 1992, a total of 1,886 subjects remained for analysis (465 HCV positive and 1,421 controls).

Among these individuals without traditional risk factors, HCV positive patients remained significantly more likely to have a history of one or more tattoos after adjustment for age, sex, and race/ethnicity (OR = 5.17; 95% CI 3.75 - 7.11, p<0.001).

Conclusion: Tattooing is associated with HCV infection, even among those without traditional HCV risk factors such as injection drug use and blood transfusion prior to 1992. (HEPATOLOGY 2013.).
Hepatology. 2013 Jan 12. doi: 10.1002/hep.26245.

New Research into survival of HCV outside of the syringe

Juliane Doerrbecker from the Medical School of Hannover and Helmholtz Centre for Infection Research and colleagues in Germany looked at the risk of HCV transmission associated with water used to dilute drugs, water containers, and filters (such as cotton).

Experiments were designed to replicate the practices of people who inject drugs, with routinely used injection equipment.

Viral stability in water was assessed by adding HCV to 100 mL of bottled water and letting it stand for several days at room temperature. Stability in containers was determined by filling aluminum, glass, and plastic containers with water, adding HCV, emptying the water, and refilling the container with new water. Transmission associated with filters was determined by drawing virus through a filter, wrapping it in foil, and incubating it to release viral particles....

Continue reading @ hivandhepatitis.com

Cancer

National cancer forecast: 1.66 million new cases in 2013
More than 1.66 million new cases of cancer will be diagnosed in 2013, while more than 580,000 Americans are expected to die of the disease, according to the annual statistics report of the American Cancer Society.
Although cancer rates are declining for most types of cancer, they are increasing among both sexes for melanoma of the skin and cancers of the liver, thyroid and pancreas.
Continue reading....

Medical Journals

Coming Soon....

New Issue of CLD to Explore Current Issues in HCC

Clinical Liver Disease, an online learning resource from AASLD, is pleased to announce an issue devoted to the important topic of Current Issues in Hepatocellular Carcinoma. Guest Editor Jorge A. Marrero, MD, MS, Professor of Medicine, Chief of Clinical Hepatology, Medical Director of Liver Transplantation, UT Southwestern Medical Center, assembled a team of experts from leading centers to address:
Molecular Epidemiology of HCC
Risk factors for HCC
Natural History and Staging for HCC
Current Issues and Future Trends in Surveillance for HCC
Radiologic Diagnosis of HCC
Pathologic Diagnosis of HCC
Systemic targeted therapy beyond sorafenib
What primary care providers need to know about HCC
And More.....

Using a blended content delivery format incorporating audio, video, text, and other interactive learning activities, CLD lets you learn at your own pace, in the location of your choice. Access is free, and CME credit is available.
Source - AASLD

This Week

Journal of Hepatology

Early hepatocellular carcinoma – Is there such a thing as too early?

Annals of Internal Medicine

Screening for Hepatitis C Virus Infection in Adults: A Systematic Review for the U.S. Preventive Services Task Force

Comparative Effectiveness of Antiviral Treatment for Hepatitis C Virus Infection in Adults: A Systematic Review

Reducing Risk for Mother-to-Infant Transmission of Hepatitis C Virus: A Systematic Review for the U.S. Preventive Services Task Force

A Few Of My Favorite Peer Reviewed Medical Journals

The Lancet
You are able to search for articles on hepatitis C and are able to view the abstracts free of charge; full text articles can be viewed for a fee.

The New England Journal of Medicine
Many abstracts and full text articles to view without a fee.
Specialties & Topics ;
Infectious Disease
Gastroenterology

The World Journal of Gastroenterology
Abstracts, and full text articles to view, again without a fee.

For Your Viewing Pleasure

Catching Hepatitis Before It's Too Late - Medical Minute

Hepatitis C is a silent killer that can stay dormant inside the body for decades without showing any symptoms. In Paula's case it was more than 30 years.



Source - AveraMcKennan

Medscape's Predictions for 2013

In this slideshow Medscape editors and advisors looked at the clinical and policy healthcare news in 2012 and have offered their predictions on how key events will play out this year.

One prediction - More hep C treatments

There is an "avalanche" of new drugs in the pipeline to treat hepatitis C. Unlike HIV and HBV, HCV can be cured, and the new drugs will make that possible for most.
View the slideshow @ Medscape

*Free registration required - I know, I hate that too. If its free why do we have to register?

For Your Listening Pleasure

As Hepatitis C Sneaks Up On Baby Boomers, Treatment Options Grow

@ NPR discusses new hepatitis C treatments, listen to the program here or view the transcript here.

Hepatitis C Newsletters And Blogs

Just published

HepCBC’s MONTHLY NEWSLETTER, the hepc.bull, has been “Canada’s hepatitis C journal” since the late 1990′s and has been published nonstop since 2001.

It contains the latest research results, government policy changes, activities and campaigns you can get involved in, articles by patients and caregivers, and a list of support groups plus other useful links.

January, 2013
Download - hepc.bull -- 01 2013

In This Issue
Hep C in the News
Rob’s Story 
HCV Around the World
If it Itches... 
HCV on the Internet
MerckCARE/PegAssist/Neupogen
Michael’s Story

SIGN UP for free EMAIL hepc.bull and occasional email notices from HepCBC. Confidential.

New From The Hepatitis C Trust

The updates from The Hepatitis C Trust aim to bring you regular information on the work we are doing each month.
Download - Jan 15 2013 Issue (762kb)

Gastroenterology & Endoscopy News - January Issue

Articles from the January issue of Gastroenterology & Endoscopy News are now online.

FDA Adds Boxed Warning for Serious Skin Reactions to Telaprevir
Serious skin reactions, some fatal, have been reported with the use of telaprevir, an HCV protease inhibitor, used in combination with peginterferon alfa and ribavirin, according to an FDA drug safety communication issued on Dec. 19. Some patients died when they continued to receive the combination therapy after developing a progressive skin rash and systemic symptoms.

Click here to read all the top stories from this month’s issue.

Blogs

Boceprevir/Victrelis Treatment diary
I have had Hepatitis C since 2000, sub type 1a/b. I was treated using PegInterferon and Ribavirin in 2007 but didn't make the 2log drop in virus levels, so the treatment was stopped after 12 weeks. After recovering from the treatment I did feel better though. Generally my virus levels have been quite low - e.g. 12 months ago, 124,000.

Entry Jan 18 2013:
Treatment starts on Friday 1 March. The letter from the hospital arrived on Wednesday. 
I've told my boss, and he's being supportive. He didn't say much, just, "thanks for letting me know".
Continue reading...

Defeating Hep C

1987 - Houston TX:Contracted HCV genotype 1a via blood transfusion during chemotherapy treatment for leukemia at age 12 (acute myelocytic leukemia).

2012 - Gilbert AZ:
Began triple therapy as a patient at Mayo Clinic:
(1) Pegasys/peginterferon alfa-2a,
(2) ribavirin,
(3) Incivek/telaprevir

Entry Dec 10 2012
38 Weeks - How are you?
That's the question I get asked the most these days. My answer? "The same." This response may sound stand off-ish, but it's actually quite accurate - and honest.
"The same" is not a bad thing.
So...what do I mean when I say it?
"The same" means that the effect of this treatment remains unpredictable. It means that I can have a good day or a bad day and not know which is coming. It means that I am exhausted no matter how much sleep I get. It means that sometimes I am forgetful. It means that sometimes I am slow to respond. I end up remembering and I end up responding, but my "processor" is "congested" (with drugs) so the response isn't always immediate.

AL D. Rodriguez Liver Foundation

LiverTox: Liver and Drug Research Made Easy

Entry Jan 14
The liver is central in processing anything and everything we take in – from our favorite breakfast cereal, vitamins and medications, to our late night snack of chocolate and wine. For many people, caring for the liver may not come easily with all the medications they must take. But just how dangerous are drugs to the liver? Using a new database, finding out the specific effects of a pharmaceutical drug to the liver is now just a few mouse clicks away. 
This month of October, the National Institute of Health (NHI) proudly introduced LiverTox, a free pharmaceutical database that provides accurate and updated information on a wide range of drugs including prescription and non-prescription medicines, herbal products and dietary supplements. It provides a thorough report on a particular drug, including its chemical structure, manufacturer information, and related case studies.....
Continue reading....

Best of Medical Blogs - weekly review and blog carnival

The “Best of Medical Blogs - weekly review and blog carnival” is a weekly summary of the best posts from medical blogs. Best of Medical Blogs (BMB) is published every Tuesday, just like the old Grand Rounds
Check it out here....

New Websites

Hep C Redefined

Boehringer Ingelheim recently launched a website, HepCRedefined.com, to help improve the lives of people with hepatitis C virus (HCV) infection. Created in collaboration with HCV community advocates and health care providers, the portal offers a range of interactive resources that can be shared via social media channels, embedded on other websites or viewed on various smart devices...Read More..

Hepatitis C News

A new website, aimed at providing practical advice and support to people living with hepatitis C http://hepatitiscnews.com/ 

Healthy You And The Flu

How Can I Prevent The Spread Of Flu



Flu season 'bad one for the elderly,' CDC says
Flu hospitalizations among the elderly rose sharply last week, prompting federal officials to take unusual steps to make more flu medicines available and to urge wider use of them as soon as symptoms appear.... 
So far, half of confirmed flu cases are in people 65 and older. Lab-confirmed flu hospitalizations totaled 19 for every 100,000 in the population, but 82 per 100,000 among those 65 and older, "which is really quite a high rate," Frieden said.
Continue reading...

Of Interest

Video Animation on How a Flu Virus Works

This year’s flu, called H3N2, is affecting many people this season and this three minute video with NPR’s Robert Krulwich and medical animator David Bolinsky explains how a flu virus can trick a single cell into making a million more viruses.

A lot of you have had it by now, or are having it or are about to be exposed. This year’s flu is called “H3N2″ and this week it’s doing big business in about 47 states, Chicago and New York. If you’ve had a flu shot and if you wash your hands several times a day for 20 seconds, (which is the time it takes to hum “Happy Birthday to You” two times through) you might reduce your odds of getting sick.

But your biggest ally is your immune system. It’s hard, during flu season, to avoid inhaling a virus or two (or three, or 10,000), but that doesn’t mean they’re going to take you over. You have an army of defenders in you, ready to take them on.
The above video shows what the battle looks like, deep down in your cells. This is the happy version — when you win.

Source: Robert Krulwich, NPR/read more here.




Off The Cuff

Get Smarter: A Powerful Brain-Boosting Supplement You've Never Heard Of

An article written by Melanie Haiken on the supplement phosphatidylcholine, points to potential research that it may improve brain health, check it out @ Forbes. The author writes;
Doctors often recommend phosphatidylcholine (PC) to people living with hepatitis C for its liver-protective benefits, particularly in conjunction with interferon therapy. By protecting the cells that line the digestive tract and reducing inflammation, PC may also ease conditions such as ulcerative colitis and IBS.
Read the in-depth article here.

JUST FOR FUN !

Enjoy a video by the one and only ZDoggMD




Friday, August 31, 2012

Dr. Paul Sax seeks answers to three questions about the future of hepatitis C virus treatment




Paul Sax • August 25th, 2012 Categories: Infectious Diseases, Patient Care, Research
Source - http://infectious-diseases.jwatch.org/

On HCV, These Questions Three

Dr. Paul Sax seeks answers to three questions about the future of hepatitis C virus treatment:
1-What does the bad news on BMS-986094 mean for other investigational HCV nucleotides?
2-When can we abandon the "alphabet soup" of terms used to describe treatment response?
3-When will new drugs become available? 
 
In the fastest-moving area of ID drug development, answers are eagerly sought to the following questions three:

1 - What does the bad news on BMS-986094 — formerly INX-189 — mean for other investigational HCV nucleotides?
Severe cardiotoxicity, fatal in one case, has ended the drug’s development. Importantly, nothing similar has thus far been observed with the structurally-similar IDX184, but that drug has been placed on “clinical hold” by the FDA. By contrast, the nucleotide GS-7977 is apparently different enough chemically that studies are for now continuing. One take-home message: drug development is risky business.

2 - When will the alphabet soup of terms used to describe HCV treatment response be abandoned?
HCV treatment either works, and you’re cured, or it doesn’t. But because the treatment is so cumbersome and so long, there’s a whole slew of ways to describe how things are going before you get to that point. Let’s see, there’s RVR (rapid virologic response, or no virus detected at 4 weeks); eRVR (extended rapid virologic response, or no virus detected at weeks 4 and 12 — used in this study of daclatasvir); EVR (early virologic response, which really isn’t that early, because it’s week 12, and it can be either pEVR — for “partial” — which means HCV RNA drops by more than 2 log but is still detected, or cEVR — for “complete”, which means it’s undetectable); ETR (end of treatment response, or no virus detectable at end of treatment); and of course SVR (sustained virologic response, now available in many flavors, depending on the week after stopping treatment you want to measure it — 2, 4, 8, 12, 16, 24,etc). For now, with IF/RBV +/- telaprevir/boceprevir and “response-guided” therapy still ruling the day, we’re stuck with this mish-mosh of terms, but I suspect most of this stuff will be irrelevant pretty soon, except for the bottom line — how many are cured? Doesn’t that sound better than “How many are SVR-12′d?”

3 - So when precisely will these new drugs become available?
Seems pretty obvious right now that if you’ve got HCV and can wait for better treatments, you should. Treatment became more effective with telaprevir and boceprevir, but it also got more complicated, toxic, and expensive. Things have to get better, and they will — especially with interferon-free options. Regardless, no one knows exactly when these new drugs will be available for use outside of clinical trials — 2013-2014 a broad estimate — and all kinds of things could hold up their approval (see #1 above). Plus, some patients can’t and shouldn’t wait for better options because they have advanced liver disease. Just this last week, two such individuals came in for evaluation — both with HIV, both with prior treatment failure on IF/RBV, both with Stage 3/4 fibrosis on liver biopsy. Should they wait for daclatasvir, GS-7977, TMC-435, ABT-450/r + ABT-333, etc? Probably not.

http://blogs.jwatch.org/hiv-id-observations/index.php/on-hcv-these-questions-three/2012/08/25/?q=snotice_id