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
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)
HCV New Drug Research
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.
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.
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.
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: email@example.com.
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.
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.
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
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
AbbVie's Investigational Hepatitis C Virus Regimen Gets Breakthrough-Therapy Designation
Digestive Disease Week
Investigational noninterferon HCV treatment effective across patient groups
By: SHARON WORCESTER, Internal Medicine News Digital Network
|Dr. Frederick Nunes|
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.
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
San Antonio researcher makes Hepatitis C breakthrough drug 90 percent cure rate reported; no side effects reported after taking Sofosbuvir
Author: Jessie Degollado, Reporter, firstname.lastname@example.org
Published On: May 23 2013 05:43:25 PM CDT Updated On: May 23 2013 05:44:46 PM CDT
Continue reading here.....
(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......
Current and Future Therapies for Hepatitis C Virus Infection, from NIH
Gilead Sofosbuvir and ledipasvir: Plans to initiate a third Phase 3 clinical trial with and without ribavirin
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)
Sofosbuvir for Hepatitis C Genotype 2 or 3 in Patients without Treatment Options
I.M. Jacobson and Others
Published Online: April 23, 2013
Sofosbuvir for Previously Untreated Chronic Hepatitis C Infection
E. Lawitz and Others
Published Online: April 23, 2013
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.
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
SOURCE BioTrends Research Group
*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
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HCV In The News
DDW 2013 - May 18-21, 2013 - Orlando, FL
Digestive Disease Week - The conference will showcase the latest advances in GI research, medicine and technology in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery
Hot Topics - May 2013
If the past is a harbinger of the future, therapy for HCV infection will probably continue to advance at a brisk pace. Many additional potent agents are in the clinical pipeline, and interferon-free regimens are likely to dominate the HCV therapeutic landscape within the next 5 years.....
At this year's EASL in Amsterdam with over 9600 delegates the phase III study results for the two "second wave HCV protease inhibitors" faldaprevir and simeprevir each in combination with pegylated interferon (PEG-IFN) and ribavirin (RBV) for HCV genotype 1 patients were presented as well as the phase III findings for the polymerase inhibitor sofosbuvir again in combination with PEG-IFN/RBV for treatment of genotypes 1,4,5 and 6. In addition phase III results of the first interferon free combination of sofosbuvir with ribavirin for treatment of genotype 2 and 3 were presented....
Care for hepatitis C is evolving rapidly, with increasingly effective and better-tolerated antiviral therapies being evaluated and approved for use. It's clear, however, that not everyone who would qualify for therapy has been tested and identified, referred for appropriate care, and offered or given the best therapy available. Furthermore, currently used antiviral drugs - pegylated interferon and ribavirin "base" plus either telaprevir or boceprevir - can cost more than $70,000 for a full course of therapy. It is expected that the new oral antiviral agents will be just as expensive, at least in the short term.
Hepatitis C Therapy Update 2013-What About Interferon-free Regimens?
U.S. FDA grants priority review to Simeprevir (TMC435) for combination treatment of genotype 1 chronic hepatitis C
AbbVie's ABT-450- Breakthrough Therapy Designation from the U.S. Food and Drug Administration Granted to Investigational HCV Regimen
Gilead Sofosbuvir and ledipasvir: Plans to initiate a third Phase 3 clinical trial with and without ribavirin
Cost will limit uptake of off-label Gilead/Bristol-Myers Squibb Hep C combo, despite best-in-class data
ViewPoints: New Hep C data validates Gilead's solo approach
Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir (GS-7977) for the Treatment of Hepatitis C-- Sofosbuvir Would Form Basis of First All-Oral Regimen for HCV Genotype 2 and 3 Patients, and Interferon-Sparing Regimen for Genotype 1 Patients --
Anemia Top Side Effect of HCV Antivirals
Hepatitis C Virus Infection: Looking for Interferon Free Regimens
Review: NS5A Inhibitors in the Treatment of Hepatitis
VX-135/daclatasvir: Vertex signs agreement with Bristol-Myers for all-oral midstage studies for hepatitis C treatments
Simeprevir (TMC435) - Janssen Submits New Drug Application to U.S. FDA
Miravirsen- Hepatitis C drug goes after patients’ RNA
Update on Phase 3 Study of Oral Fixed-Dose Combination of Sofosbuvir and Ledipasvir for Genotype 1 Hepatitis C Patients
Hepatitis C - Presidio Collaboration with Boehringer Ingelheim for interferon-free Phase IIa clinical trial
Gilead hepatitis C drug sofosbuvir (GS-7977) meets goal of fourth late-stage study
EASL-Burden of Liver Disease in Europe: Looks at leading causes of cirrhosis and primary liver cancer in Europe
Gilead Announces SVR Rates from Two Phase 3 Studies of Sofosbuvir (GS-7977) for Hepatitis C
Potential IFN-Free Regimens For HCV
IDX184 and IDX19368 - Idenix drops development of hepatitis C drugs
Interferon free regimens for the “difficult to treat”: are we there?
Current Prospects for Interferon-free Treatment of Hepatitis C in 2012
Numerous other DAAs are in clinical development, and phases 2 and 3 trials are evaluating interferon-free combination DAA therapy. Interferon-free sustained virologic responses have now been achieved with combinations of asunaprevir and daclatasvir; sofosbuvir and ribavirin; sofosbuvir and daclatasvir; faldaprevir and BI207127; ABT-450, ritonovir and ABT-333; ABT-450, ritonovir and ABT-072; miracitabine, danoprevir and ritonavir; and alisporivir and ribavirin. Some drugs are genotype-specific in their activity, whereas others are pan-genotypic, and differential responses for the genotype 1 subtypes 1a and 1b have emerged with many DAA combinations. Viral breakthrough and resistance are important considerations for future trial design. The prospect of interferon-free combination DAA therapy for hepatitis C virus is now finally becoming a reality.
2013-Guide to Clinical Trials for People with Hepatitis C
Bristol-Myers to Hold Talks On Settling Claims of Hepatitis C Patients
Treat Now or Wait?
The debate rather to treat HCV now or wait is ongoing, in the journal "Liver International" factors which affect the decision to treat now or delay therapy are discussed. You can view the article here: Patients with HCV and F1 and F2 fibrosis: treat now or wait?
Lucinda K. Porter, RN Shares A Personal Experience: Starting 12 weeks of sofosbuvir, GS-5885, and ribavirin
Coming in September 2013
A second book authored by Lucinda K. Porter, RN: Hepatitis C Treatment One Step at a Time: Inspirational Readings and Practical Tips for Successful Hepatitis C Treatment
FREE FROM HEPATITIS C
Clinical Trial Updates
ClinicalTrials.gov: updated in the last 30 days
HCV PipelineHCV Advocate - News & Pipeline Blog
Chronic Hepatitis C Infection: Treat Now or Wait?
INCIVEK® (telaprevir)-Updates label after reports of a ‘small number of fatal skin reactions’
Vertex discloses Hep C drug deaths
HCV Transplant Studies GS-7977 Also Telaprevir & Boceprevir
Perspectives and challenges of interferon-free therapy for chronic hepatitis C
Hepatitis C–What Are Your Treatment Choices: New Webinar
Setbacks in HCV Drug Development Highlight Uncertainties in Treat or Wait Decisions
So You Think You’re a Hepatitis C Expert
Back in July Clinical Care Options released part one of a three part online quiz containing 35 questions on hepatitis C, answered by nine world-renowned hepatology experts. In October CCO released part two of the series which included case scenarios from 11 leading international experts on hepatitis C, and today part three was released!
Idenix: FDA Places IDX19368 Hepatitis C Treatment on Clinical Hold
IDX184-Idenix hepatitis C drug put on partial hold
BMS halts the development of BMS-986094 due to patient death
BMS-986094-Bristol-Myers Sued Over Heart Damage In Hepatitis C Drug Trial
The International Liver Congress 2013 of the European Association for the Study of the Liver (EASL), will take place April 24 to 28 in Amsterdam, The Netherlands.
EASL Website - Press Room
EASL Abstract Search
Click here for a downloadable PDF version of the Abstract Book.
Tips For Viewing Hepatitis C Abstracts
Download now the ILC 2013 congress app and have full access to the scientific programme, posters, abstracts, floorplans and more!
EASL: Direct-acting antivirals now ready for prime time with promising alternatives on the way
AbbVie is a new, independent biopharmaceutical company composed of Abbott’s former proprietary pharmaceutical business
ABT-267, ABT-333-non- nucleoside, ABT-450/r
r = ritonavir
Faldaprevir/ (BI 201335)
MK-5172 and Daclatasvir
MK-5172 and Daclatasvir-Merck Enters Agreement with Bristol-Myers Squibb to Conduct a Phase II Clinical Trial
CCO's independent conference coverage
An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver Diseases
Long-term management of the successful adult liver transplant: 2012 practice guideline by the -AASLD
VA guidelines for management and treatment of HCV, published in the American Journal of Gastroenterology
UK consensus guidelines for the use of the protease inhibitors boceprevir and telaprevir in genotype 1 chronic hepatitis C infected patients
Nonalcoholic Fatty Liver Disease (NAFLD)
New Clinical Practice Guideline Developed for Nonalcoholic Fatty Liver Disease
2012-New guidelines on the management of hepatocellular carcinoma (HCC).
These guidelines result from a joint collaboration between the European Association for the Study of the Liver (EASL) and the European Organization for Research and Treatment of Cancer (EORTC).
EASL-April 2012 Revised Clinical Practice Guidelines on the Management of Chronic Hepatitis B
HCV Information and Educational Resources
Clinical Liver Disease -Digital Liver Disease Journal
This journal is an official digital educational resource from the American Association for the Study of Liver Diseases.
Visitors are able to view videos, full data, and download files in either HTML or PDF formats
View all issues here.
Projects In Knowledge
Offered at the site is a program series of HCV Video Case Vignettes. In the videos individual patient case studies are discussed, topics include side effects, drug-drug interactions, treatment duration, and outcome.
AASLD - Liver Learning
If you haven't yet explored the "Liver Learning" section available @ the AASLD web site you're missing out on the November meeting webcasts, video podcasts, abstracts and more.
Other HCV Sites:
These links will take you to the premier Hepatitis C sites and keep you informed with breaking news, clinical studies, new drugs, podcasts, newsletters, support, personal experiences, chat rooms, forums and more.
2012 Articles Of Interest
2012-New Antiviral Agents for Hepatitis C
This article describes the direct acting antivirals and host-targeted agents that have recently been approved or have been tested in HCV-infected patients and discusses their two current paths of clinical development: with or without interferon-α.
Standardization of Terminology of Virological Response in the Treatment of Chronic Hepatitis C
Protease inhibitors: Silver bullets for chronic hepatitis C infection?
Recent trials evaluated the safety and efficacy of two protease inhibitors, boceprevir (Victrelis) and telaprevir (Incivek), added to standard care with pegylated interferon and ribavirin, in patients with chronic hepatitis C virus (HCV) infection. These drugs open the door for triple therapy and other new therapies involving combinations of other direct-acting antiviral agents to become the new standard of care for this population.
Treatment of chronic hepatitis C genotype 1 with triple therapy comprising telaprevir or boceprevir
A significant increase in the number of patients with CHC to be treated is expected for 2012, with triple therapy regimens that are more complex. These expected developments represent a significant challenge and will stretch current resources.
The present Swiss Association for the Study of the Liver (SASL) expert opinion statement is not intended as guideline but shall provide some guidance on the management of CHC genotype 1 and the use of TPV and BOC
If you have just been diagnosed with hepatitis C or considering HCV therapy click here for easy to understand information.
Patient Assistance Program
INCIVEK/Telaprevir and VICTRELIS (Boceprevir) Patient Assistance Programs
Prescribing Information for INCIVEK including the Medication Guide.
VICTRELIS™- Boceprevir: Prescribing Information and Medication Guide
Hepatitis C-New Protease Inhibitor (NS3/4A) Drug Resistance Test
LabCorp has begun offering nationwide its hepatitis C GenoSure NS3/4A assay, which is designed to identify NS3 and NS4A mutations and NS3-associated resistance to a pair of recently approved HCV protease inhibitors.
- (PPI-668) w-Faldaprevir (BI201335) and BI207127 (1)
- 2012 -168 Pages Of HCV FAQs (1)
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- A Guide 2012-Guideline for Nonalcoholic Fatty Liver Disease (1)
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- Sofosbuvir Works for Patients Who Cannot Take Pegi...
- Hepatitis C: Am I At Risk For Liver Cancer?
- AbbVie's Investigational noninterferon HCV treatme...
- Risks small between HCV patients’ use of DAAs, neu...
- Video- Patient cured with breakthrough drug Sofosb...
- Harvard Presents - A New Era in the Management of ...
- Adverse Events Common With Triple Therapy in HCV C...
- Some Physicians Are Warehousing/Preparing Hepatiti...
- DDW 2013 - Key Drivers and Barriers to Starting HC...
- DDW 2013: Does Treating Herpes Help Suppress Hepat...
- Watch Dr. Andrew Muir Discuss the latest Hepatitis...
- DDW 2013 - Interferon‐free Regimens
- Hepatitis C: A 21st Century Success Story (Op-Ed)
- Interferon-free, treat-all approach cost effective...
- European Medicines Agency Validates Gilead's Marke...
- DDW 2013 Video - Simeprevir (Tmc435) Plus Sofosbuv...
- DDW 2013 - Janssen's Simeprevir Phase 3 PROMISE St...
- DDW 2013 - Experts review NAFLD treatment options
- DDW 2013 - Pioneering researcher details the histo...
- DDW 2013 - New Direct-Acting Antivirals Promising ...
- What About Us? - Hepatitis C Treatment Advances Bu...
- SCOTLAND'S APPROACH TO FIGHTING HEPATITIS C
- DDW 2013 - New therapy for patients with hepatitis...
- DDW 2013- HCV patients with late viral breakthroug...
- In Case You Missed It Sunday- Watch:100,000+ infec...
- EASL 2013: New Wave of Hepatitis C Treatments On t...
- DDW 2013 - Patients with Medicaid less likely to r...
- DDW 2013 - HBV may increase risk for non-hodgkin ...
- NATAP - Summary EASL 2013 - New HCV DAAs on their...
- Watch - Dr. Krajden speak on Hepatitis C in Britis...
- DDW 2013 - Digestive Health: Vitamin D, Diet Chang...
- DDW 2013 - New Colonscope Provides Ground-Breaking...
- DDW 2013 - Coffee consumption associated with redu...
- Johns Hopkins News Roundup - New treatment for hep...
- Organ donor cards hard to implement in China, offi...
- Hepatitis C infections unknown to many of those in...
- Triple therapy for hepatitis C is effective after ...
- Elevated Cadmium Levels Linked to Liver Disease
- Advanced Liver Cancer - Bayer Initiates Phase III ...
- Janssen's simeprevir (TMC435) - US FDA grants prio...
- EASL Review Results -HCV Phase III Investigational...
- Hepatitis C Therapy Update 2013-What About Interfe...
- Is There a Future for Milk Thistle In HCV?
- Toward Improved Outcomes in HCV Mono- and Coinfect...
- Hepatitis C: Infectious diseases weigh on primary ...
- Spring Hepatitis Newsletters- Waiting for Approval...
- U.S. FDA grants priority review to Simeprevir (TM...
- Hepatitis C Clinical Trials - Updates For May/Apri...
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How Soon Should I Get Tested After Exposure ?
After the exposure (especially if the blood exposure involved another person known to have the hepatitis C virus), it is recommended that testing for the hepatitis C antibody be performed at 4 to 6 months after the exposure OR that testing for the hepatitis C virus itself (a test often called an HCV PCR or hepatitis C viral load test) be performed 4 to 6 weeks after the potential exposure. These tests are done to determine whether or not hepatitis C infection has occurred as a result of the exposure.;
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- New HCV Drugs
- Keeping current on the potential arrival of new improved hepatitis C drugs. As once a hepatitis C patient myself (I successfully treated the virus with standard HCV therapy in 2000) I understand the difficult decisions and overwhelming fear that ensues after being diagnosed with this serious and life-changing disease. This blog serves as a starting point for information on the rapidly evolving number of new agents in development to treat hepatitis C. Tina