Video- Patient cured with breakthrough drug Sofosbuvir

San Antonio researcher makes Hepatitis C breakthrough drug 90 percent cure rate reported; no side effects reported after taking Sofosbuvir

 Author: Jessie Degollado, Reporter, jdegollado@ksat.com

Published On: May 23 2013 05:43:25 PM CDT Updated On: May 23 2013 05:44:46 PM CDT

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Related:
(May 21) European Medicines Agency Validates Gilead's Marketing Application for Sofosbuvir for the Treatment of Hepatitis C

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

A New Era in the Management of Chronic Hepatitis C
Discusses interferon free therapies, a must see video presented by Harvard Medical School
Click here to view video......

May 16
Current and Future Therapies for Hepatitis C Virus Infection, from NIH

May 2
Gilead Sofosbuvir and ledipasvir: Plans to initiate a third Phase 3 clinical trial with and without ribavirin

April
EASL: Treatment With Sofosbuvir + Ribavirin for 12 Weeks Achieves SVR12 of 78% in GT 2/3 Interferon-Ineligible, -Intolerant, or -Unwilling Patients: Results of the Phase 3 POSITRON Trial -

EASL: Phase 3 Randomized Controlled Trial of All-Oral Treatment With Sofosbuvir + Ribavirin for 12 Weeks Compared to 24 Weeks of PEG + Ribavirin in Treatment-Naïve GT 2/3 HCV-Infected Patients (FISSION)

EASL: All Oral Therapy With Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment-Experienced Genotype 2/3 HCV-Infected Patients: Results of the Phase 3 FUSION Trial

Summary from EASL 2013 for Hepatitis C - New HCV DAAs on their way soon: what do the phase III studies tell us?
The New England Journal Of Medicine (NEJM)

 

Original articles
Sofosbuvir for Hepatitis C Genotype 2 or 3 in Patients without Treatment Options
I.M. Jacobson and Others
Published Online: April 23, 2013
*Free Abstract

Sofosbuvir for Previously Untreated Chronic Hepatitis C Infection
E. Lawitz and Others
Published Online: April 23, 2013
*Free Abstract

Harvard Presents - A New Era in the Management of Chronic Hepatitis C

A New Era in the Management of Chronic Hepatitis C

May 23

Uploaded By GIHepatologyAcademy

Adverse Events Common With Triple Therapy in HCV Cirrhosis

Adverse Events Common With Triple Therapy in HCV Cirrhosis

By David Douglas

NEW YORK (Reuters Health) May 22 - In cirrhotic patients, triple-therapy against hepatitis C virus (HCV) produces a high virological response rate, but at the cost of a high rate of serious adverse events, French researchers say.

In the French CUPIC cohort, four in ten cirrhotic patients on triple therapy with pegylated interferon and ribavirin plus boceprevir or telaprevir suffered a serious complication (death, severe infection, or hepatic decompensation).

This cohort, Dr. Christophe Hézode told Reuters Health by email, consisted of "HCV genotype 1 treatment-experienced patients with compensated cirrhosis."

In a May 13th online paper in The Journal of Hepatology, Dr. Hézode of Universite Paris-Est, Creteil and colleagues say phase III trials have yielded similar results in treatment-experienced cirrhotics and non-cirrhotics, but patients were highly selected.

To evaluate the effect in "real-world" patients, the team analyzed 497 patients who reached at least week 16 in a 48-week triple therapy early access program. All had previously received interferon.

Forty percent (199 patients) had serious adverse events, with 58 patients stopping their treatment as a result. Refractory anemia was also common. Six patients died and another 32 (6.4%) had severe infection or hepatic decompensation or another serious event.

Death or severe complications were related to platelet counts at or below 100,000/mm3 (odds ratio 3.11) and albumin <35 g/dL (OR 6.33).

In patients with both of these risk factors, who accounted for 7.9% of the cohort, the rate of severe complications was 44.1%, "suggesting that they should not be treated with the triple therapy." In the remaining 92.1%, the risk was at or below 7.1%.

In an intention-to-treat analysis in the 292 patients treated with the telaprevir combination, HCV RNA was undetectable in 78.8% at week 12 and 67.1% at week 16. In the 205 given boceprevir, the corresponding proportions were 54.6% and 58.0%.

Although the safety profile of triple therapy is poor in a real-life setting, the approach "was associated with high rates of on-treatment virological response," the authors report.

Overall, they say "Serum albumin level and platelet count should be evaluated to determine the risk/benefit ratio of triple therapy in cirrhotic patients and to decide treatment."

"Patients combining a platelet count of less 100,000 /mm3 and serum albumin below 35 g/L should not be treated with a triple combination," Dr. Hézode stressed.

"The other patients," the team concludes, "could be treated cautiously and carefully monitored."

Commenting on the findings by email, Dr. Savino Bruno of A. O. Fatebenefratelli e Oftalmico, Milan, Italy told Reuters Health that "risk overcame benefit" in a number of patients. However, "a more reliable on-treatment stopping rule... may maximize benefit and minimize risk."

Other research on the CUPIC cohort that was recently presented at the 48th annual meeting of European Association for the Study of the Liver, sheds more light on a related strategy. In that study, by investigators including Dr. Hézode found that independently of cirrhosis severity, baseline concentration of apolipoprotein H was associated with early virological response.

SOURCE: http://bit.ly/14S1CwV

J Hepatol 2013.

Some Physicians Are Warehousing/Preparing Hepatitis C Patients for the Next Generation of Treatments

The Majority of Physicians that Treat Hepatitis C Virus (HCV) Have Begun "Warehousing" and Preparing Their HCV Patients for the Next Generation of HCV Treatments

Sixty Percent of Surveyed Physicians Agree That They Are Beginning To Warehouse HCV Patients Until New Interferon-Free Regimens Are Available, According to a Recently Published BioTrends Report

EXTON, Pa., May 23, 2013 /PRNewswire/ -- BioTrends Research Group, one of the world's leading research and advisory firms for specialized biopharmaceutical issues, finds that, unaided, one in five surveyed gastroenterologists, hepatologists, and infectious disease specialists reported that in the past six months, they have begun warehousing patients (e.g., intentionally delaying treatment) in anticipation of the next generation of HCV treatments—notably more physicians than six months ago, when only 6 percent reported that they had begun warehousing patients.

Furthermore, only one in five physicians agrees that they are satisfied with currently available treatment options, underscoring the high unmet need for alternatives to treat chronic HCV infections. The trending analyses of physician-reported anticipated prescribing in TreatmentTrends®: Hepatitis C Virus (US), Wave 1 also finds that, for the first time in a year, surveyed physicians are expecting to treat a greater proportion of their genotype 1 (3 percent) and 2/3 (3 percent) patients in the next six months with regimens that are not currently available. Unaided responses from most physicians who expect to be using other treatments suggest they are expecting products in development, potentially interferon-free regimens, to be available for use in the next six months.

In aided physician responses, Gilead's sofosbuvir and Janssen/Medivir's simeprevir garnered the highest degree of familiarity for use in HCV treatment, followed closely by Bristol-Myers Squibb's daclatasvir and asunaprevir. Additionally, 20 percent of the surveyed physicians believe that Gilead's sofosbuvir is the most promising product in development, primarily due to its favorable tolerability, oral dosing, pan-genotypic activity, and its possibility to be utilized as an interferon-free regimen.

"The protease inhibitors, Vertex's Incivek and Merck's Victrelis, were very important advances in the management of HCV infections," said BioTrends Research Group Associate Director, Lynn Price . "However, there is still a clear unmet need for alternative HCV therapies and the recent NDA filings for simeprevir and sofosbuvir have physicians hopeful for new treatment options that are highly efficacious and more tolerable than the currently available protease inhibitors."

TreatmentTrends®: Hepatitis C Virus (US), Wave 1 is a report that covers the use of agents for the treatment of HCV infections. This bi-annual study focuses on current and future use of leading HCV treatment regimens, patient market share, perceived strengths and weaknesses of the key brands, barriers to broader usage, sales force performance, and perceived value of manufacturers' patient assistance programs. In addition, this report assesses potential impact of regimens in development, including Abbott's ABT-267, ABT-333, and ABT-450, Boehringer Ingelheim's BI-207127 and faldaprevir, Bristol-Myers Squibb's asunaprevir and daclatasvir, Janssen's simeprevir, and Gilead's sofosbuvir and ledipasvir. In the current wave of research, BioTrends surveyed 101 U.S. gastroenterologists, hepatologists, and infectious disease specialists in March 2013.

About BioTrends Research Group
BioTrends Research Group provides syndicated and custom primary market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets. For information on BioTrends publications and research capabilities, please contact us at www.bio-trends.com. BioTrends is a Decision Resources Group company.

About Decision Resources Group
Decision Resources Group is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources Group at www.DecisionResourcesGroup.com.

All company, brand, or product names contained in this document may be trademarks of their respective holders.

For more information, contact:

Decision Resources Group
Christopher Comfort
781-993-2597
ccomfort@dresources.com

SOURCE BioTrends Research Group

RELATED LINKS
http://www.bio-trends.com

DDW 2013 - Key Drivers and Barriers to Starting HCV treatment with Interferon

*As seen in figure 1, the objective of this study was to understand factors that motivate or provide barriers to individuals initiating and adhering to IFN-based HCV treatment.


Key Drivers and Barriers to Treatment Initiation and Adherence in Individuals with Hepatitis C  

Reported by Jules Levin
DDW May 18-21 2013 Orlando Florida

View Additional Slides @ NATAP

Infection with hepatitis C virus (HCV) is associated with high morbidity and increased mortality but many patients avoid initiation of treatment or report challenges with treatment completion. The study objective was to identify motivators and barriers for treatment initiation and completion in a community sample of HCV-infected patients in the United States.

Methods: Survey methods were employed to identify factors reported by patients as important in their decision to start or complete HCV treatment.

Study participants included 120 HCV-infected individuals: 30 had previously completed treatment with pegylated interferon/ribavirin (PR), 30 had discontinued PR, 30 were treated with PR at the time of the survey, and 30 were treatment-naive. Telephone interviews occurred between May and August of 2011 and employed a standardized guide.

Participants assigned factors a rating from 1 (not at all important) to 5 (extremely important). Trained researchers coded and analyzed interview transcripts.

Results: Of 33 factors, expected health problems from not treating HCV infection was reported as most encouraging for treatment initiation and completion, while treatment side effects was most discouraging.

Sixty-nine percent of participants reported that the ability to obtain information during treatment on the likelihood of treatment success (i.e ., results of viral load testing) would motivate them to initiate therapy. Median preferred timing for learning about test results was 5 weeks (range: 1--23 weeks).

Conclusion: Understanding challenges and expectations from patients is important in identifying opportunities for education to optimize patient adherence to their HCV treatment regimen.

Author: Lauren FusfeldJyoti AggarwalCarly DougherMontserrat Vera-LlonchStephen BubbMrudula DonepudiThomas F Goss

Credits/Source: BMC Infectious Diseases 2013, 13:234
 NATAP

DDW 2013: Does Treating Herpes Help Suppress Hepatitis C Virus?

DDW 2013: Does Treating Herpes Help Suppress Hepatitis C Virus?

Details Category: HCV Treatment

Published on Wednesday, 22 May 2013 00:00

Written by Liz Highleyman

Treating herpes simplex virus type 2 (HSV-2) with valacyclovir (Valtrex) was associated with a substantial reduction in plasma hepatitis C virus levels in dually-infected individuals, according to a small study presented at the Digestive Disease Week conference (DDW 2013)this week in Orlando.

Mary Jane Burton from the G.V. Sonny Montgomery VA Medical Center in Jackson, Mississippi, and colleagues performed a pilot study to evaluate the safety and impact of valacyclovir on HCV levels in veterans with HSV-2 and HCV coinfection

Continue reading @ HIV and Hepatitis

Watch Dr. Andrew Muir Discuss the latest Hepatitis C research presented at DDW 2013

Dr. Andrew Muir, Duke University hepatologist, offers an update of the latest Hepatitis C research being presented at DDW 2013 in Orlando, Fla., and what benefits may accrue to patients in the coming years. 

With many new drugs coming forward, Muir said he provides his patients with time frames on the availability of these medications, including the much-anticipated interferon-free regimens. By understanding the regimens, a patient’s liver disease and what’s right for them, he says individualizing plans allows clinicians to better guide patients on timelines and expectations.

 

http://video.healio.com/video/Andrew-Muir-MD-DDW-2013

DDW 2013 - Interferon‐free Regimens

Frederick A. Nunes, MD, on trial results for difficult-to-treat patients with HCV

May 22, 2013

ORLANDO, Fla. — Frederick A. Nunes, MD, associate professor of medicine, at Penn Health Systems, discusses his presentation, “Interferon‐free Regimens of ABT‐450/r, ABT‐267, ABT‐333, and Ribavirin Achieve High Sustained Virologic Response 4 Weeks Post‐Treatment (SVR4) Rates in Patients With Chronic HCV Genotype 1 Regardless of Race, Ethnicity, or Other Baseline Characteristics” during Digestive Disease Week 2013.

Among HCV patients who are difficult to treat, including African-Americans, those with high BMI and insulin resistance, achieved a very high sustained response using three direct-acting antivirals and ribavirin, Nunes says.

Full Story »