Sofosbuvir Works for Patients Who Cannot Take Peginterferon

 
Sofosbuvir Works for Patients Who Cannot Take Peginterferon

Two phase III studies confirm the efficacy of a sofosbuvir and ribavirin therapy in patients with HCV genotype 2 or 3 infection for whom peginterferon is not an option.

In patients infected with hepatitis C virus (HCV) genotype 2 or 3, treatment with peginterferon plus ribavirin has a sustained virologic response (SVR) of 70% to 85%. However, adverse effects of peginterferon are a barrier to treatment for many patients. Now, two industry-funded, phase III trials have evaluated the efficacy of sofosbuvir (400 mg daily) plus ribavirin (1000 mg–1200 mg daily) in these patients.

In a blinded, placebo-controlled trial, investigators randomized 280 patients for whom peginterferon therapy was not an option (e.g., adverse effects, contraindications for interferons, and patient refusal) to receive sofosbuvir/ribavirin or matching placebo for 12 weeks. In a blinded, active-control trial, researchers randomized 202 patients with prior nonresponse to peginterferon therapy to receive 12 or 16 weeks of sofosbuvir/ribavirin. The primary endpoint in both studies was SVR at 12 weeks after therapy ended.

In patients for whom peginterferon therapy was not an option, SVR was 78% for treatment with sofosbuvir/ribavirin compared with 0% for placebo (P<0.001). In previously treated patients, SVR was 50% for 12 weeks of therapy versus 73% for 16 weeks (P<0.001). SVR rates were lower for patients with genotype 3 versus genotype 2 in both treatment-naive patients (61% vs. 93%) and treatment-experienced patients who received therapy for 12 weeks (30% vs. 86%) or 16 weeks (62% vs. 94%).

SVR rates were lower in patients with cirrhosis than without, both in treatment-naive patients (overall, 61% vs. 81%; genotype 3 vs. 2, 21% vs. 94%) and treatment-experienced patients (overall, 66% vs. 76%; genotype 3 vs. 2 in 16-week group, 61% vs. 78%). In both studies, investigators found no evidence of resistance development, and discontinuation rates were low (1%–2%).

Comment: Oral sofosbuvir plus ribavirin is effective in patients with HCV genotypes 2 or 3 for whom peginterferon-based therapy is not an option or was previously ineffective. Of note, these sustained virologic response rates for sofosbuvir plus ribavirin are comparable to or higher than those previously reported for therapy with peginterferon plus ribavirin in this population.

Atif Zaman, MD, MPH

Published in Journal Watch Gastroenterology May 24, 2013

 CITATION(S):
Jacobson IM et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med 2013 May 16; 368:1867. (http://dx.doi.org/10.1056/NEJMoa1214854)

Medline abstract (Free)

Hepatitis C: Am I At Risk For Liver Cancer?


Hepatitis C: Am I At Risk For Liver Cancer?

Offered on the blog today are a few studies that look at the risk for developing liver cancer in people who are - or who have been - infected with chronic hepatitis C.   The CDC reported hepatitis C is the leading cause of liver cancer which is the fastest rising cause of cancer-related death in the U.S. Without a doubt this disease can lead to serious health problems including liver damage, cirrhosis, liver cancer and liver failure.

In the United States the CDC has implemented screening strategies to identify people at high risk for hepatitis C. Included in the risk group are people born between 1945 and 1965 - age 47 to 67, who currently account for about 75% of the estimated 2.7 and 3.9 million people infected with the virus.

*Learn more about who is at risk and why here.

I often ask myself why people forgo HCV testing if they fall into this high risk population. Most people would agree, preventive strategies for cancer or liver damage are worth the time it takes for a routine blood test.

Additionally a large portion of people are unaware they are infected. These people are in need of clinical evaluation and counseling including prevention strategies; using alcohol, supplements, over-the-counter medications or prescription drugs can cause additional liver damage.

Alcohol And HCV

Older studies have confirmed in patients with hepatitis C heavy alcohol intake contributes to HCV-associated liver disease and can cause significantly more liver scarring or cirrhosis, a more recent study has shown even moderate alcohol increases the risk for liver-related mortality. Last month in the medical journal Alimentary Pharmacology & Therapeutics, researchers concluded; Although chronic hepatitis C is associated with increased risks for overall and liver-related mortality, these risks are even higher for patients consuming moderate and excessive amounts of alcohol. Here is a comment from the study's lead author Zobair Younossi; For instance, the risk of liver-related death among people with hepatitis C who averaged two or fewer drinks a day was 74 times that of similar people without hepatitis C. Check out the interview here.

Disease Progression

Medscape reported: Out of 100 people that contract the infection, 75–85 people will develop chronic infection, 60–70 people will develop chronic liver disease, five to 20 people will develop cirrhosis over the course of their chronic infection and one to five people will die of complications including hepatocellular carcinoma (HCC). The good news is that the overall percentage of people with HCV who develop cirrhosis or liver cancer is low, unless that person is you, then its at 100%.

Liver Cancer Without Cirrhosis?

In the June 2013 issue of American Journal of Roentgenology researchers investigated liver cancer in patients with chronic HCV - without advanced fibrosis or cirrhosis.

AJR Am J Roentgenol. 2013 Jun;200(6):W610-W616.

Hepatocellular Carcinoma in Chronic Hepatitis C in the Absence of Advanced Fibrosis or Cirrhosis.

Lewis S, Roayaie S, Ward SC, Shyknevsky I, Jibara G, Taouli B.

Source
1 Department of Radiology/Body MRI and Translational and Molecular Imaging Institute, Ichan School of Medicine at Mount Sinai, One Gustave Levy Pl, Box 1234, New York, NY 10029.

Abstract

OBJECTIVE. The objective of our study was to describe the cross-sectional imaging appearance of hepatocellular carcinoma (HCC) in patients with chronic hepatitis C virus (HCV) infection in the absence of advanced fibrosis and cirrhosis.

MATERIALS AND METHODS. This study is a retrospective review of our surgical database to identify patients with chronic HCV infection and HCC who underwent hepatectomy and who had undergone preoperative CT or MRI. Only patients with a Metavir fibrosis score of F0, F1, or F2 on pathology were included. Patients with hepatitis B virus coin-fection or other causes of chronic liver disease and patients with histopathologic evidence of advanced fibrosis or cirrhosis (Metavir scores F3 and F4) were excluded. Contrast-enhanced CT or MRI examinations performed within 2 months before surgery were reviewed for the number, size, and location of tumors; tumor enhancement characteristics; and presence of macrovascular invasion.

RESULTS. Two hundred forty-five resections of HCC in patients with HCV were performed in our institution from 1987 to 2012. Of this group, 26 patients (10.6%) had a Metavir fibrosis score of F0, F1, or F2; of those patients, 19 (18 men and one woman; 18 non-Asian patients and one Asian patient; mean age, 64 years) had imaging studies available for review. Twenty-one HCCs (mean size, 4.5 cm; range, 0.9-14.8 cm) were evaluated at imaging. Typical wash-in and washout characteristics were seen in 16 of 19 viable lesions (84.2%). The remaining two HCCs were completely necrotic after transarterial chemoembolization. Eighteen patients had a solitary tumor. Most tumors (15/21, 71.4%) developed in the right hepatic lobe.

CONCLUSION. HCC can develop in patients with chronic HCV without advanced fibrosis or cirrhosis, most frequently in older non-Asian men, and usually appears as a large solitary tumor with a typical wash-in-washout enhancement pattern.

Liver Cancer With Cirrhosis After Successful HCV Therapy

Last month in Clinical Infectious Diseases, researchers concluded: 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 of developing HCC remains for up to 8 years.

This month the in-depth clinical information website, Healio.com featured the study:

HCC risk persists 8 years after HCV eradication

May 9, 2013

The long-term risk for hepatocellular carcinoma among patients with hepatitis C remains up to 8 years after sustained virological response to antiviral therapy, researchers reported in Clinical Infectious Diseases.

The number of patients with cancer was too low to draw any firm conclusion, but it was nevertheless somewhat surprising that the risk remained for such a prolonged time period,” Soo Aleman, MD, PhD, of the departments of gastroenterology and hepatology and infectious diseases at Karolinska Institutet in Stockholm, told Infectious Disease News.

“We need to know how long this risk persists and which subgroups of patients are at the highest risk after achieving sustained virological response (SVR). Future studies are needed to answer these questions.”

Aleman and colleagues conducted a prospective study that included patients who had HCV-related cirrhosis.

Among the 351 patients, 110 reached SVR, 193 did not and 48 were untreated. The study was initiated in 2001 and the patients were followed for a mean of 5.3 years.

Six patients who achieved SVR developed hepatocellular carcinoma (HCC), for an incidence of 1 per 100 person-years. Two patients were diagnosed within a year after achieving SVR at 0.5 and 7.7 months, and the remaining four were diagnosed at 2.4, 7.4, 7.4 and 7.6 years.

All of the patients were tested for HCV RNA at HCC diagnosis, and all were negative.

Among patients who did not achieve SVR or who were untreated, the risk for HCC was higher. The risk for any liver-related complication, liver-related death or overall death was lower among patients who achieved SVR. These differences were similar after controlling for alcohol use, age, sex and diabetes.

“Patients who have liver cirrhosis prior to the eradication of HCV should continue to undergo surveillance with ultrasound regularly for early detection of hepatocellular carcinoma,” Aleman said.

Soo Aleman, MD, PhD, can be reached at Department of Gastroenterology and Hepatology, and Infectious Diseases, Karolinska University Hospital at Karolinska Institute, 171 76 Stockholm, Sweden; email: soo.aleman@ki.se.

Disclosure: Aleman reports financial relationships with Gilead, Janssen, MSD and Roche.

Screening For Liver Cancer

According to WHO  in 25 % of liver cancer patients, the underlying cause is hepatitis C. Long-term management of chronic hepatitis C infection for patients with cirrhosis include routine screening for liver cancer. These tests might mean an ultrasound once a year, and twice-yearly measurements of  alpha-fetoprotein (AFP) levels in the blood, which is a liver-cancer marker.

Get Tested

If any of the risk factors mentioned in this article pertain to you, I urge you to please consider the CDC's recommendation and get tested once for hepatitis C. If the test is positive additional testing is needed.

According to the CDC Telebriefing on Hepatitis C testing held this month;

Today's data show that even among young people who get tested positive, only about half had follow-up tests to see if they were still infected. That's what you need to get appropriate care and treatment. Right now there are better Hepatitis C treatments available than ever and there are more treatments coming in the coming year. So confirming that someone is more infected is more important than ever. Not everyone with Hepatitis C will need treatment, but everyone with Hepatitis C should be linked to care so that they can monitor how their liver is doing, determine when and if treatment is warranted, avoid things like excess alcohol which can damage their liver, and avoid medications that could also damage their liver as well as getting vaccinated against hepatitis b to protect their liver. Liver disease is something which is causing an increasing number of deaths, and many of those deaths could be prevented with the current treatments and with preventive actions that people can take if, but only if, they know that they're infected. Today CDC is also issuing updated guidance for doctors and other health care providers about how to test for Hepatitis C and how to provide follow-up.

Need To Talk To Someone ?

Help is available, recently "Project Inform" announced the launch of a new national helpline, 877-HELP-4-HEP (877-435-7443), run by and for people affected by hepatitis C.

AbbVie's Investigational noninterferon HCV treatment effective across patient groups



Frederick A. Nunes, MD, Associate Professor of Medicine, Penn Medicine. Discussing his presentation at Digestive Disease Week 2013 in Orlando, Fla.: #514; 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.
Source - Healio

View Slides @ NATAP
DDW
Response to 3 DAAs + RBV by Patient Characteristics: INTERFERON-FREE REGIMENS OF ABT-450/r, ABT-267, ABT-333, AND RIBAVIRIN ACHIEVE HIGH SUSTAINED VIROLOGIC RESPONSE 12 WEEKS POST-TREATMENT (SVR12) RATES IN PATIENTS WITH CHRONIC HCV GENOTYPE 1 REGARDLESS OF RACE, ETHNICITY, OR OTHER BASELINE CHARACTERISTICS

May 6
AbbVie's Investigational Hepatitis C Virus Regimen Gets Breakthrough-Therapy Designation


May 24

Digestive Disease Week
Investigational noninterferon HCV treatment effective across patient groups

By: SHARON WORCESTER, Internal Medicine News Digital Network



Dr. Frederick Nunes
ORLANDO – Both 12- and 24-week regimens of an investigational interferon-free therapy for hepatitis C were associated with high sustained virological response rates at 12 weeks post treatment in a phase II study of patients with hepatitis C virus genotype 1 who had baseline characteristics associated with poor response to interferon-based therapies.

The findings of this subgroup analysis of the randomized, open-label, multicenter Aviator trial demonstrate that the high response rates recently reported for the entire cohort also apply to patients with older age, black race, Hispanic/Latino ethnicity, interleukin (IL)-28B non-cc genotype, and higher body mass index (BMI), Dr. Frederick Nunes reported at the annual Digestive Disease Week.

The Aviator trial assessed the safety and efficacy of various dosing regimens and combinations of three AbbVie investigational direct-acting antivirals (DAAs) with or without ribavirin, including the potent hepatitis C virus (HCV) protease inhibitor ABT-450 dosed with 100 mg of ritonavir (ABT-450/r, dosed at 100 or 150 mg daily), the NS5A inhibitor ABT-267 (25 mg daily), and the non-nucleoside NS5B inhibitor ABT-333 (400 mg twice daily). A total of 247 patients were included in the subanalysis, Dr. Nunes reported at the meeting.

The regimen that included all three investigational drugs and ribavirin, known as 3 DAA/RBV, was associated with sustained virological response rates of 99% and 93% at 12 weeks in treatment-naive patients and previous peg-interferon/ribavirin (peg-IFN/RBV) null responders, respectively, said Dr. Nunes, who is clinical associate professor of medicine in the University of Pennsylvania Health System, and section chief of gastroenterology at Pennsylvania Hospital, Philadelphia.

In the current analysis, high sustained virological response rates at 12 weeks (SVR12) were also achieved in the 247 patients with chronic HCV genotype 1, including 159 treatment-naive and 88 previous peg-IFN/RBV null responders, who were assigned to 12 or 24 weeks of 3 DAA/RBV. The virological response rates were 99% and 93% for the treatment-naive 12- and 24-week groups, respectively, and 93% and 98% for the null responder 12- and 24-week groups.

The high responses occurred regardless of treatment duration, age, race, ethnicity, BMI, Homeostatic Model of Assessment–Insulin Resistance (HOMA-IR), IL-28B host genotype, or baseline viral load. The rates did not differ significantly on any comparison made in treatment-naive patients or previous null responders, he said.

In the treatment-naive patients, no breakthroughs occurred, although 1% of those in the 12-week treatment arm relapsed, and 3% of the 24-week treatment group relapsed.

In the null responder group, no relapses occurred, but breakthroughs occurred in 7% of those in the 12-week treatment arm, and in 2% of the 24-week treatment arm, he said.

Treatment was safe and generally well tolerated. Four patients discontinued treatment due to drug-related adverse events, most commonly fatigue (in 32.7% and 23.9% of treatment-naive and null responders, respectively) and headache (31.4% and 30.7%, respectively).

One patient had a serious adverse event (arthralgia) considered to be possibly related to the study drug regimen.

Because ribavirin was included in the treatment regimens, it is impossible to tease out whether the adverse events were associated with that drug or with the investigational DAAs, Dr. Nunes noted.

Patients included in the study were noncirrhotic adults aged 18-70 years with a BMI between 18 and 38 kg/m2, and HCV genotype 1.
 
"The overall efficacy was excellent irrespective of the baseline grouping. So black race, Hispanic/Latino ethnicity, age greater than 50, BMI over 30, male gender, HOMA-IR greater than 3, IL-28B non-cc genotype, and viral load greater than 7 logs all had very high SVR12 response rates," Dr. Nunes said.
 
The safety and efficacy of this interferon-free 3 DAA/RBV therapy will be further explored in phase III studies, he said.
 
Dr. Nunes has received grant or research support from Merck, Abbott Laboratories, and Roche Pharma AG.
 

Risks small between HCV patients’ use of DAAs, neuropsychiatric events

Risks small between HCV patients’ use of DAAs, neuropsychiatric events

Sockalingam S. BMC Gastroenterol. 2013;doi:10.1186/1471-230X-13-86.

May 24, 2013
The risks for neuropsychiatric adverse events among patients with hepatitis C virus being treated with direct-acting antivirals appear minimal, but the risks for drug-drug interactions are high, according to recent study results.

Researchers conducted a literature search of PubMed from 2000 to April 2013 using the search terms, “hepatitis C” and “boceprevir” or “telaprevir,” along with “mental disorders,” “psychotropic drugs” and “drug interactions.” The analysis was designed to evaluate studies on neuropsychiatric adverse effects as a result of direct-acting antivirals (DAAs) and drug-drug interactions (DDIs) involving psychotropic medications and DAAs among hepatitis C virus (HCV) patients.

Continue Reading @ Healio

Video- Patient cured with breakthrough drug Sofosbuvir

video platformvideo managementvideo solutionsvideo player


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

Continue reading here.....

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