Showing posts with label a-DDW 2013 meeting. Show all posts
Showing posts with label a-DDW 2013 meeting. Show all posts

Tuesday, August 13, 2013

Commentary On Sofosbuvir + Ribavirin And Other Top Liver Abstracts From EASL and DDW 2013

Gastroenterology & Endoscopy News

Experts' Picks: Top Liver Abstracts 
From EASL and DDW 2013
 Aug 13 2013

In the August edition of Gastroenterology & Endoscopy News three hepatologists offer commentary on the top liver abstracts presented at The International Liver Congress 2013/ European Association for the Study of the Liver (EASL) and the 2013 Digestive Disease Week (DDW) meeting.

The following abstracts are included:

Patrick Basu, MD
Assistant Clinical Professor
Department of Digestive and Liver Diseases
Columbia University College of Physicians and Surgeons
New York, New York
Clinical Professor
Hofstra North Shore-LIJ School of Medicine
Hofstra University
Hempstead, New York

Sofosbuvir + Peginterferon + Ribavirin for 12 Weeks Achieves 90% SVR12 in Genotype 1, 4, 5, or 6 HCV Infected Patients: The NEUTRINO Study (Lawitz E et al. EASL Abstract 1411)

All Oral Therapy With Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced GT2/3 HCV-Infected Patients: Results of the Phase 3 FUSION Trial (Nelson DR et al. EASL Abstract 6)

Telaprevir With Adjusted Dose of Ribavirin in Naive CHC-G1: Efficacy and Treatment in CHC in Hemodialysis Population. Target C Trial—A Placebo Randomized Control Clinical Trial (Basu P et al. DDW Abstract 517)

Jordan Feld, MD, MPH
Assistant Professor of Medicine
University of Toronto
Toronto, Canada
Staff Hepatologist
Division of Gastroenterology
Department of Medicine
Toronto Western Hospital
Toronto, Canada

All-Oral Sofosbuvir-Based 12-Week Regimens for the Treatment of Chronic HCV Infection: The ELECTRON Study (Gane EJ et al. EASL Abstract 14)

SVR12 Rates and Safety of Triple Therapy Including Telaprevir or Boceprevir in 221 Cirrhotic Non Responders Treated in the French Early Access Program (ANRS CO20-CUPIC) (Fontaine H et al. EASL Abstract 60)

Jacqueline O’Leary, MD, MPH
Medical Director
Inpatient Liver and Transplant Unit
Baylor University Medical Center
Dallas, Texas

Safety and Efficacy of Interferon-Free Regimens of ABT-450/R, ABT-267, ABT-333 ± Ribavirin in Patients With Chronic HCV GT1 Infection: Results From The AVIATOR Study (Kowdley KV et al. EASL Abstract 3)

Sustained Virologic Response With Daclatasvir Plus Sofosbuvir ± Ribavirin (RBV) in Chronic HCV Genotype (GT) 1–Infected Patients Who Previously Failed Telaprevir (TVR) or Boceprevir (BOC) (Sulkowski MS et al. EASL Abstract 1417)

Natural History of Inflammatory Bowel Disease After Liver Transplantation for Primary Sclerosing Cholangitis (Singh S et al. DDW Abstract 40)

 View All Top Picks and Comments here .....

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Tuesday, June 11, 2013

Telaprevir-based triple-drug therapy benefits CHC patients with ESRD

Telaprevir-based triple-drug therapy benefits CHC patients with ESRD

By: SHARON WORCESTER, Internal Medicine News Digital Network

ORLANDO – Triple-drug therapy with the protease inhibitor telaprevir plus ribavirin and peg-interferon alpha 2a provides higher sustained virologic response than traditional dual-drug therapy in chronic hepatitis C patients on hemodialysis, according to findings from the randomized, placebo-controlled Target C Trial.

Sustained virologic response after 24 months was 63% in 12 patients treated with telaprevir for weeks 0-12 plus ribavirin and peg-IFN alpha 2a for weeks 0-24 (group A) and 50% in 12 patients treated with telaprevir for weeks 0-12 plus ribavirin for weeks 13-36 and peg-IFN alpha 2a for weeks 0-36 (group B), compared with 25% in 12 patients treated with placebo plus standard dual therapy with ribavirin and peg-IFN alpha 2a for weeks 0-24 and weeks 37-48 (group C, reference arm), Dr. Patrick Basu reported at the annual Digestive Disease Week.

Telaprevir in groups A and B was given as two 750-mg tablets three times daily for 4 days and three 750-mg tablets given twice daily for 3 days after dialysis. The ribavirin dose in group A was 200 mg for weeks 0-12 and 400 mg for weeks 13-24; for group B it was 400 mg for weeks 13-36 (with placebo given for weeks 0-12). All ribavirin doses in group C were 400 mg, and peg-IFN alpha 2a doses in all three groups were 135 mcg, said Dr. Basu of Columbia University College of Physicians and Surgeons, New York.

Patients in the study included 26 men and 10 women with a mean age of 58 years, a mean body mass index of 26.6 kg/m2, and a mean viral load of 869,000 IU/mL who were treated between May 2011 and November 2012. All had end-stage renal disease and were on hemodialysis for a mean of 6 years. The groups were well balanced with respect to BMI, race, viral load, and disease genotype.

Adverse events that occurred more often in the telaprevir groups (A and/or B), compared with group C, included anemia, neutropenia less than 750 ANA, thrombocytopenia, skin rash, anorectal dysfunction, dysgeusia, depression, and constipation. Neuropathy was more common in group C.

Protease inhibitors are now part of the standard of care for treatment of chronic hepatitis C, genotype 1. Telaprevir was approved in May 2011 for this purpose.

Since the drug is primarily metabolized in the liver and excreted in the feces, thus limiting renal toxicity, it was considered a promising treatment option for the 3% of chronic hepatitis C patients with end-stage renal disease on hemodialysis – a population with progressive fibrosis and high mortality, Dr. Basu said.

The findings of this pilot study suggest that truncated triple therapy that includes telaprevir does indeed have an advantage over the standard of care for this special population, he concluded, noting that the telaprevir regimen requires further evaluation in a large prospective trial.

Dr. Basu disclosed financial relationships with Gilead Science, BMS, ROMAX, Genentech, Vertex, Otsuka, Takeda, Three Rivers, GI Pathology, and Salix.

Saturday, June 8, 2013

Video- Hepatologist Urges caution among clinicians in the administration of telaprevir

Anurag Maheshwari, MD, on telaprevir-based HCV treatment
June 7, 2013

ORLANDO, Fla. — Anurag Maheshwari, MD, transplant hepatologist at the Institute for Digestive Health and Liver Disease at Mercy Medical Center in Baltimore, discusses his poster, “Sa1059: The Experience with Telaprevir-Based HCV Therapy in Community Practice Does Not Mirror the Clinical Trials Data,” at Digestive Disease Week 2013.

Maheshwari notes that the morbidity associated with telaprevir-based treatment is much greater in real-world practice than had been indicated previously. He urges caution among clinicians in the administration of telaprevir, and stresses the need for rigorous side-effect management protocol and adequate long-term follow-up for patients with HCV receiving this treatment.

Full Story »


HCV treatment improves survival among anemic patients
June 6, 2013

High serum ferritin not predictive of advanced fibrosis in NAFLD
June 5, 2013

Boceprevir benefits null, partial responders to prior HCV therapy with peginterferon/ribavirin
June 4, 2013

Friday, June 7, 2013

Simeprevir keeps HCV at bay in treatment-naive and experienced patients

Simeprevir keeps hepatitis C at bay in treatment-naive and experienced patients 

By: NEIL OSTERWEIL, Internal Medicine News Digital Network

ORLANDO – The investigational protease inhibitor simeprevir was associated with high levels of sustained virologic response in patients with both treatment-naive and relapsed hepatitis C viral infections, reported investigators at the annual Digestive Disease Week.

In the QUEST-2 phase III trial, 81.3% of previously untreated patients with hepatitis C (HCV) genotype 1 infections randomized to simeprevir (TMC435) and pegylated interferon-alfa (pegIFN/RBV) had a sustained virologic response following 12 weeks of therapy (SVR12, the primary endpoint), compared with 50% of those assigned to pegIFN/RBV and placebo (P less than .001), reported Dr. Fred Poordad from the University of Texas Health Science Center in San Antonio.

In the phase III PROMISE trial, 79.2% of patients with HCV genotype 1 infections who had a relapse following prior therapy with an interferon-based regimen had an SVR12 when treated with simeprevir, compared with 36.8% of patients treated with pegIFN/RBV and placebo (P less than .001), said Dr. Eric Lawitz, also from the University of Texas in San Antonio.

"Safety and tolerability appear to be comparable to placebo, and patient-reported outcomes support both the efficacy and the safety profiles of simeprevir," Dr. Poordad said.


Simeprevir is a once-daily oral inhibitor of the HCV NS3/4A protease with demonstrated antiviral activity against HCV genotypes 1, 2, 4, 5, and 6.

In QUEST-2, 391 patients were randomized on a 2:1 basis to receive either simeprevir 150 mg daily plus pegIFN/RBV or placebo plus pegIFN/RBV for 12 weeks, followed by an additional 12 or 36 weeks of pegIFN/RBV depending on response-guided therapy criteria. If patients had HCV RNA less than 25 IU/mL at week 4 and undetectable at week 12, they received an additional 12 weeks of pegIFN/RBV. Patients outside of the response-guided criteria received a total of 36 additional weeks of pegIFN/RBV. In both treatment arms, patients were followed for an additional 24 months, for a total of 72 months.

A total of 235 of the 257 patients assigned to simeprevir (91.4%) met the response-guided criteria by week 24, completed therapy, and were then followed until study end. Of this group, 86% (202 patients) achieved SVR12.

Simeprevir was statistically significantly superior to placebo regardless of IL28B polymorphism genotype or METAVIR (fibrosis and inflammation) scores.

On-treatment failures, defined as a confirmed detectable HCV RNA level at the actual end of treatment, occurred in 7% of patients on simeprevir and 32.1% of controls. Relapses, defined as detectable HCV RNA on one or more follow-up visits following undetectable end-of-treatment levels, occurred in 12.7% and 23.9%, respectively (P values not shown).

Of the simeprevir-treated patients who did not achieve an SVR, 97.6% had emerging mutations in the NS3 protease domain at the time of treatment failure, Dr. Poordad said.


In the PROMISE trial, 393 patients who had experienced a relapse following interferon-based therapy were randomized to response guided therapy as described in the QUEST-2 study.

As noted before, 79.2% of patients assigned to simeprevir/pegIFN/RBV met the primary endpoint of SVR12, compared with 36.8% of patients assigned to placebo/pegIFN/RBV (P less than .001).

In this trial, simeprevir was significantly better than placebo in patients with both HCV genotypes 1a and 1b, and as in QUEST-2 was superior to placebo regardless of IL28B genotype or METAVIR score.

On-treatment failures occurred in 3.1% of simeprevir-treated patients and 27.1% of those on placebo and pegIFN/RBV. The respective relapse rates were 18.5% and 48.4%. As in QUEST-2, the large majority (92.3%) of simeprevir-treated patients who did not have an SVR had emerging mutations in the NS3 protease domain.


In QUEST-2, patients on simeprevir had more cases of rash, 27% vs. 20%, and photosensitivity, 4% vs. 1%. Anemia occurred in 13.6% and 15.7%, respectively. The incidences of other adverse events were similar between the groups.

In PROMISE, the most common adverse events were fatigue, influenzalike illness, pruritus, and headache. Anemia occurred in 17% of patients on the active drug plus pegIFN/RBV, compared with 20% for those on placebo/pegIFN/RBV. Neutropenia occurred in 18% and 22%, respectively. Rates of pruritus and rash were comparable between simeprevir and placebo.

The Food and Drug Administration has granted priority review status to simeprevir for the treatment of chronic HCV genotype 1.

The studies were funded by Janssen. Dr. Poordad and Dr. Lawitz have received grants and/or research support from the company, and several of their coauthors are employees of Janssen or its parent company Johnson & Johnson.

Thursday, June 6, 2013

Watch-Hepatitis C: The Pace of Progress/Interferon-Free Treatment Still Searching

Hepatitis C: The Pace of Progress

Digestive Disease Week (DDW) 2013
Progress in Treating Hepatitis C Infection

Hello. I am Dr. Bill Balistreri, Professor at Cincinnati Children's Hospital. I am here at Digestive Disease Week (DDW) in Orlando, reporting for Medscape.

A major focus of the research and the state-of-the-art summaries presented here at DDW has been the pace of progress in developing new treatment strategies for hepatitis C. Speakers highlighted the fact that the agents and approaches for treatment of hepatitis C virus (HCV) infection are in constant change and may, in fact, be in for an upgrade.

The standard of care for several years consisted of a combination of pegylated interferon and ribavirin. With advanced understanding of the biology of HCV came the identification of specific proteins involved in its replication and the understanding that these proteins can be targeted by protease and polymerase inhibitors.

Last year, the US Food and Drug Administration approved 2 NS3 protease inhibitors -- telaprevir and boceprevir -- for the treatment of HCV genotype 1 in combination with standard therapy. Clinical trials of the 2 agents showed significantly improved sustained virologic response (SVR) rates in treatment-naive patients. Therefore, the American Association for the Study of Liver Diseases guidelines were altered to recommend triple therapy consisting of a protease inhibitor (either telaprevir or boceprevir) plus peginterferon and ribavirin.....

Tuesday, June 4, 2013

After HCV treatment failure, some success with boceprevir-IFN-ribavirin

After HCV treatment failure, some success with boceprevir-IFN-ribavirin

By: NEIL OSTERWEIL, Internal Medicine News Digital Network

ORLANDO – Adding a protease inhibitor to pegylated interferon and ribavirin increased the rate of sustained virologic responses in patients with chronic hepatitis C infections for whom prior interferon/ribavirin therapy had failed, an investigator reported at the annual Digestive Disease Week.

Among patients with hepatitis C virus (HCV) infections who received only pegylated interferon and ribavirin (peg-IFN/RBV) in the control arms of phase II and III studies of boceprevir (Victrelis), more than 90% of those who had relapsed had a sustained virologic response for at least 24 weeks after therapy (SVR24) with combined boceprevir and peg-IFN/RBV, reported Dr. John Vierling, chief of hepatology at Baylor College of Medicine in Houston.

"Overall, the data from this final analysis lead to the conclusion that boceprevir combined with pegylated interferon/ribavirin therapy is efficacious in subjects with all three categories of nonresponse: relapsers, partial responders, and most importantly, null responders," Dr. Vierling said.

The PROVIDE study Included 168 patients (mean age, 52 years) in an intention-to-treat analysis whose peg-IFN/RBV therapy was considered a failure. The cohort included treatment-experienced patients with detectable HCV RNA after 12 weeks of peg-IFN/RBV and treatment-naive patients after 24 weeks of therapy, as well as those who had experienced virological breakthrough or relapse after having an end-of-treatment response.

Patients who had completed peg-IFN/RBV therapy within the previous 2 weeks were enrolled for 44 weeks. Those patients who had completed peg-IFN/RBV more than 2 weeks earlier were assigned to a 4-week lead-in phase with peg-IFN/RBV prior to starting on the study combination.

All participants were given boceprevir 800 mg orally three times daily with food, pegylated interferon-alpha-2b (Intron A) 1.5 mcg/kg subcutaneously once weekly, and weight-based ribavirin 600-1,400 mg daily divided into two oral doses.

Four patients dropped out of the study during the lead-in phase and thus did not receive any boceprevir, leaving 164 for a prespecified full-analysis set. A total of 60 patients discontinued therapy (including the 4 who dropped out in the lead-in phase). Of these patients, 14 stopped due to adverse events, 33 had treatment failure, and 13 dropped out for nonmedical reasons.

In the full analysis set, 27 of 28 (96%) patients who had had a relapse after prior peg-IFN/RBV had an SVR24, the primary endpoint, as did 57 of 85 (67%) prior partial responders and 20 of 49 (41%) prior null responders. Overall, 65% of patients in the full-analysis population and 63% of those in an intention-to-treat population had an SVR24.

In a breakdown by baseline characteristics of patients who had an SVR24, the authors found that SVR occurred more frequently in men than in women, in nonblack vs. black patients, among those with a viral load of 800,000 copies/mL or fewer, HCV genotype 1a vs. 1b (except among those with prior relapse), and patients with platelet counts of 200,000/mcL.

The most frequently reported adverse events were anemia in 45% of patients, dysgeusia in 35%, and neutropenia in 23%. The safety profile was similar to that reported for the combination in phase II and III studies, Dr. Vierling said.The study was sponsored by Merck. Dr. Vierling disclosed serving in an advisory capacity and receiving grants and research support from the company.

Three of his coauthors are employees of Merck, and one is a board member.

Saturday, May 25, 2013

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

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.

Thursday, May 23, 2013

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

Wednesday, May 22, 2013

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.

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 »

Interferon-free, treat-all approach cost effective, beneficial for chronic HCV

Heshaam M. Mir
Interferon-free, treat-all approach cost effective, beneficial for chronic HCV
ORLANDO, Fla. — An orally administered, interferon-free regimen with a treat-all approach for patients with chronic hepatitis C may be more beneficial and more cost effective than interferon-based triple therapy, according to data presented at Digestive Disease Week.

Researchers used a decision analytic Markov model to compare four methods of treatment for chronic HCV genotype 1: Triple therapy with pegylated interferon, ribavirin and a direct-acting antiviral (DAA) with (method 1) or without biopsy guidance (method 2); and an orally administered, interferon-free regimen with (method 3) or without biopsy guidance (method 4). The methods that incorporated biopsy began treatment at fibrosis stage F2 – F4, with repeated biopsies every 5 years until patients were aged 70 years.

A treatment-naive, 50 year-old patient served as a reference case. Investigators based treatment outcomes for methods 3 and 4 on study results presented at scientific meetings, and baseline cost and utility for methods 3 and 4 were calibrated to match triple therapy.

“As all-oral regimens are in the process of being developed by various pharmaceutical and biotechnology companies, interest has been focused on efficacy and side-effect profiles of these therapies,” researcher Heshaam M. Mir, MD, director of research in the Liver & Obesity program at Inova Fairfax Hospital in Falls Church, Va., told “We did not see a great deal published in the literature nor presented at the major liver conferences discussing the economic impact of these all-oral regimens. We thought it would be an area of interest for the medical community.”

Method 4 was the most cost-effective approach, with an incremental cost-effectiveness ratio (ICER) of $16,289 per quality-adjusted life-year (QALY). Departure from baseline cost and utility of oral therapy did not raise the ICER above $50,000/QALY for this approach. This treatment also presented the lowest risk for developing cirrhosis (6.8%), decompensation or hepatocellular carcinoma (11%) and transplantation (2.7%) and was linked to the largest number of QALYs (18.351) compared with the other methods.

“A validated Markov model showed that an all-oral, interferon-free, treat-all regimen was the most cost-effective approach for treating chronic hepatitis C genotype 1 patients,” Mir said. “In addition to the economic advantage, it reduced the number of chronic hepatitis C patients reaching advanced liver disease, and increased life expectancy.”

Disclosure: Researcher Zobair M. Younossi reported serving on advisory committees/review panels for Salix Pharmaceuticals, Vertex Pharmaceuticals, Tibotec and GlaxoSmithKline, along with consulting services for Gilead Sciences and Conatus Pharmaceuticals.

For more information:
Younossi ZM. Sa1067: Interferon-Based and Interferon-Free Regimens for Patients with Chronic Hepatitis C, Genotype 1: Potential Cost-Effectiveness of Biopsy-Guided Treatment Versus Treat All Strategies. Presented at: Digestive Disease Week 2013; May 18-21, Orlando, Fla.

Additional Meeting Coverage@ Healio

Tuesday, May 21, 2013

DDW 2013 Video - Simeprevir (Tmc435) Plus Sofosbuvir (Gs-7977) With or Without Ribavirin HCV GT 1 Null Responders.

DDW 2013 Late Breaker

Eric J. Lawitz, MD discusses his late-breaking poster: Sa2073: Svr4 Results of a Once Daily Regimen of Simeprevir (Tmc435) Plus Sofosbuvir (Gs-7977) With or Without Ribavirin (RBV) in HCV GT 1 Null Responders. Dr. Lawitz is Medical Director, principal investigator for Alamo Medical research

DDW 2013 - Janssen's Simeprevir Phase 3 PROMISE Study demonstrating (SVR12) in 79 percent of patients

Primary Efficacy and Safety Findings from Phase 3 Study of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients

ORLANDO, Fla., May 21, 2013 /PRNewswire/ -- Janssen R&D Ireland (Janssen) today announced primary efficacy and safety results from the global Phase 3 PROMISE study demonstrating that use of the investigational protease inhibitor simeprevir (TMC435) led to sustained virologic response 12 weeks after the end of treatment (SVR12) in 79 percent of treatment-experienced genotype 1 chronic hepatitis C adult patients with compensated liver disease, including all stages of liver fibrosis, when administered once daily with pegylated interferon and ribavirin.

In the study, 37 percent of patients receiving placebo plus pegylated interferon and ribavirin achieved SVR12. In the simeprevir arm, on-treatment failure rates were 3 percent and relapse rates were 19 percent, compared to 27 percent and 48 percent in the placebo arm. All patients had previously relapsed following pegylated interferon-based therapy. The data were presented today as a late breaker oral presentation at Digestive Disease Week 2013 in Orlando, Florida based on abstract number 869b, "Simeprevir (TMC435) With Peginterferon/Ribavirin for Treatment of Chronic HCV Genotype 1 Infection in Patients Who Relapsed After Previous Interferon-Based Therapy: Results From PROMISE, a Phase III Trial."

"Hepatitis C is a complex disease and physicians need multiple treatment options to provide their patients the best possible chance at successful therapy," said Eric Lawitz, M.D., professor of medicine at University of Texas Health Science Center, Vice President, scientific and research development, The Texas Liver Institute and principal investigator of the PROMISE trial. "I'm pleased that the primary efficacy and safety results from the PROMISE study of simeprevir show sustained virologic response in patients who had relapsed following previous treatment with interferon-based regimens."

In PROMISE, patients were randomized to receive simeprevir or placebo for 12 weeks plus pegylated interferon and ribavirin for 24 or 48 weeks. In findings related to a secondary endpoint, 93 percent of patients receiving simeprevir were able to shorten therapy with pegylated interferon and ribavirin to 24 weeks as a result of meeting response-guided therapy criteria. Eighty-three percent of those patients meeting response-guided therapy criteria to stop treatment at 24 weeks achieved SVR12.

Patients enrolled in PROMISE were stratified by hepatitis C virus (HCV) genotype 1 subtype and IL28B genotype. SVR12 rates among patients treated with simeprevir according to IL28B genotype were 89 percent for the CC allele, 78 percent for the CT allele, and 65 percent for the TT allele, compared to 53 percent for the CC allele, 34 percent for the CT allele and 19 percent for the TT allele in the placebo arm. Among patients with METAVIR scores F0 to F2, 82 percent of patients treated with simeprevir and 41 percent with placebo achieved SVR12. Among patients with METAVIR scores F3 and F4, 73 percent and 74 percent of patients treated with simeprevir and 20 percent and 26 percent treated with placebo achieved SVR12, respectively. The METAVIR score is used to quantify the degree of inflammation and fibrosis of the liver and patients are scored on a five-point scale.

"Janssen is pleased to share the primary endpoint results from PROMISE with the scientific community alongside primary data from our Phase 3 QUEST-1 and QUEST-2 studies of simeprevir, which are also being presented at DDW," said Maria Beumont, M.D., medical leader for simeprevir, Janssen. "We now have robust data for simeprevir in both treatment-experienced and treatment-naïve patients that demonstrate primary efficacy and safety in patients with genotype 1 chronic hepatitis C."

The most common adverse events seen in patients receiving simeprevir versus placebo in PROMISE were fatigue (32 percent versus 42 percent), headache (32 percent versus 36 percent) and influenza-like illness (30 percent versus 20 percent), respectively. In addition, rash (19 percent versus 14 percent), itching (24 percent versus 17 percent), neutropenia (15 percent versus 17 percent), anemia (11 percent versus 6 percent), increased bilirubin (6 percent versus 2 percent), and photosensitivity conditions (4 percent versus none) were also observed. One patient in the simeprevir arm and no patients in the placebo arm discontinued treatment due to an adverse event.

Digestive Disease Week(R) (DDW(R)) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 18 -- 21, 2013, at the Orange County Convention Center, Orlando, Florida. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at


PROMISE is a global, Phase 3, randomized, double-blind, placebo-controlled clinical trial assessing the efficacy, safety and tolerability of simeprevir plus pegylated interferon and ribavirin versus pegylated interferon and ribavirin alone in adult patients with genotype 1 chronic hepatitis C with compensated liver disease, including all stages of liver fibrosis, who relapsed after previous interferon-based therapy.

In the PROMISE trial, 393 patients were randomized to receive one 150 mg capsule of simeprevir or placebo once daily plus pegylated interferon and ribavirin for 12 weeks, followed by pegylated interferon and ribavirin alone for either 12 or 36 weeks based on response-guided therapy criteria. Patients in the simeprevir arm were considered to have met response-guided therapy criteria if their HCV RNA levels were <25 IU/mL (detectable or undetectable) at week 4 and <25 IU/mL undetectable at week 12. In patients meeting response-guided therapy criteria, HCV therapy was stopped at week 24. All other patients continued treatment until week 48.

About Simeprevir

Simeprevir (TMC435) is an investigational NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including all stages of liver fibrosis. Simeprevir works by blocking the protease enzyme that enables the hepatitis C virus to replicate in host cells. New drug applications were recently submitted for simeprevir in Japan and the United States for the treatment of genotype 1 hepatitis C, and a Marketing Authorisation Application was submitted to the European Medicines Agency seeking approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C. The U.S. FDA has granted Priority Review to the New Drug Application.

Global Phase 3 studies of simeprevir include PROMISE in adult patients who have relapsed after prior interferon-based treatment, QUEST-1 and QUEST-2 in treatment-naïve adult patients, and ATTAIN in prior null-responder adult patients. In parallel to these trials, Phase 3 studies for simeprevir are ongoing in treatment-naïve and treatment-experienced HIV-HCV co-infected patients and HCV genotype 4 patients. To date, 3,787 patients have been treated with simeprevir in clinical trials.

Simeprevir is also being studied in Phase 2 interferon-free trials with and without ribavirin in combination with: -- Janssen's non-nucleoside inhibitor TMC647055 and ritonavir in treatment-naïve genotype 1a and 1b HCV patients; -- Gilead Sciences, Inc.'s nucleotide inhibitor sofosbuvir (GS-7977) in treatment-naïve and previous null-responder genotype 1 HCV patients; and -- Bristol-Myers Squibb's NS5A replication complex inhibitor daclatasvir in treatment-naive and previous null-responder genotype 1 HCV patients.

In addition, Janssen Pharmaceuticals, Inc. has entered into a non-exclusive collaboration with Vertex Pharmaceuticals to evaluate in a Phase 2 study the safety and efficacy of an all-oral regimen of simeprevir and Vertex's investigational nucleotide analogue polymerase inhibitor VX-135 for the treatment of HCV. As a first step, Janssen Pharmaceuticals, Inc. is conducting a drug-drug interaction (DDI) study with simeprevir and VX-135. Janssen Pharmaceuticals, Inc. also has plans to initiate a Phase 2 trial of an investigational interferon-free regimen with simeprevir, TMC647055 and Idenix's IDX719, a once-daily, pan-genotypic NS5A inhibitor, with and without ribavirin.

For additional information about simeprevir clinical trials, please visit

About Hepatitis C

Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease, is the focus of a rapidly evolving treatment landscape. Approximately 150 million people are infected with hepatitis C worldwide and 350,000 people per year die from the disease globally. When left untreated, hepatitis C can cause significant damage to the liver including cirrhosis. Additionally, hepatitis C may increase the risk of developing complications from cirrhosis, which may include liver failure.

About Janssen R&D Ireland

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen R&D Ireland is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit for more information.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen R&D Ireland, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; impact of business combinations; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at, or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

SOURCE Janssen R&D Ireland

/CONTACT: Media Contact: Daniel De Schryver, +49 173 76 89 149, or Craig Stoltz, +1 (215) 325-3612; Investor Contact: Stan Panasewicz, +1 (732) 524-2524

/Web site:

DDW 2013 - Experts review NAFLD treatment options

Experts review NAFLD treatment options

Non-alcoholic fatty liver disease (NAFLD) is a common condition that, without signs of fibrosis, may be benign. But with fibrosis, NAFLD can progress to non-alcoholic steatohepatitis (NASH), cirrhosis of the liver and death, according to speakers at Saturday’s DDW Combined Clinical Symposium on Therapeutic Approaches in NAFLD.

The risk factors for progression of NAFLD include older age (50 years and older), race (especially Mexican Americans), weight gain, insulin resistance and diabetes, said Kris V. Kowdley, MD, FASGE, AGAF, director of the Liver Center of Excellence in the Digestive Disease Institute at Virginia Mason Medical Center and clinical professor of medicine at the University of Washington, Seattle.

“Cardiovascular disease is much more common than liver disease as a cause of death in NAFLD patients,” Dr. Kowdley said. Studies have shown that cardiovascular disease accounts for about 25 percent of deaths in these patients versus 13 percent from liver disease. In addition, the risk of mortality increases as fibrosis advances from minimal to severe.

NAFLD can also progress to hepatocellular cancer. One study indicated that about 13 percent of patients with hepatocellular cancer have NAFLD, with the greatest risk of cancer among obese men over 50 years of age, Dr. Kowdley said.

Lifestyle modifications such as weight loss, increased exercise, getting a good night’s sleep, and eating healthy foods have been used to improve the histopathology of NAFLD and help patients manage comorbidities, said Stephen A. Harrison, MD, associate dean of the Uniformed Services Health Education Consortium and professor of medicine at the Uniformed Services University of the Health Sciences, San Antonio, TX.

Dr. Harrison recommended a loss of nine to 10 percent of body weight to improve the histological findings of NASH and moderate exercise three to five times a week to help reduce the risk of cardiovascular disease and diabetes. “Exercise coupled with a moderate caloric-restricted diet utilizing low-glycemic index foods is optimal,” he said.

If lifestyle changes don’t work, pharmaco-therapy holds promise, said Paul Angulo, MD, professor of medicine and chief of hepatology at the University of Kentucky College of Medicine, Lexington. “Achieving and maintaining appropriate body weight is a difficult task to accomplish by most obese people,” Dr. Angulo noted.

Several drugs have been tested in NASH patients, including the insulin sensitizers metformin and pioglitazone, the weight-loss medications orlistat and rimonabant, the ACE inhibitors losartan and telmisartan, and the lipid-lowering statins and fibrates. However, metformin, orlistat, rimonabant and losartan have been found to be either minimally effective or unsafe in this patient population.

To date, vitamin E therapy has shown the strongest evidence of efficacy for NASH patients. In one study, vitamin E therapy was associated with a significant improvement in NASH patients compared to placebo. But the same study showed that the rate of improvement associated with pioglitazone therapy was not significant, Dr. Angulo said. However, vitamin E therapy has not been evaluated in NASH patients with diabetes.

Bariatric surgery is another potential treatment option for the management of NAFLD and NASH, said Raj Vuppalanchi, MD, associate professor of medicine in the division of gastroenterology and hepatology at Indiana University School of Medicine, Indianapolis. A variety of procedures are used, including gastric banding, sleeve gastrectomy and Roux-en-Y surgery.

A Cochran analysis of 21 prospective or retrospective cohort studies has shown that bariatric surgery reduces steatosis or inflammation in NASH, and four of those studies described some deterioration in the degree of fibrosis, Dr. Vuppalanchi said. However, no randomized clinical trials or quasi-randomized clinical studies have been conducted to assess the safety and effectiveness of bariatric surgery for NASH, he added.

And, although bariatric surgery may be safe to pursue in NAFLD patients who satisfy the criteria for this therapy, cirrhosis with portal hypertension appears to be a contra-indication, Dr. Vuppalanchi said.

Finally, extrahepatic complications and comorbidities of NAFLD such as obesity, type 2 diabetes, dyslipidemia and the metabolic syndrome, should be assessed and addressed in all patients with NAFLD, said Naga P. Chalasani, MD, professor of medicine and chief of gastroenterology and hepatology at Indiana University School of Medicine.

Since these patients are at significant risk for cardiovascular morbidity and mortality, clinicians should consider providing aggressive lipid-lowering therapy and advising patients to avoid consuming heavy amounts of alcohol, though evolving evidence suggests that non-heavy drinking may have hepatic and metabolic benefits, Dr. Chalasani said.

DDW 2013 - Pioneering researcher details the history and future of organ transplantation

Intestinal transplantation will become the third most common organ transplant in the very near future, surpassing heart transplants.

That’s the prediction from Thomas E. Starzl, MD, PhD, the clinician-researcher known to many as the “father of transplantation.” He “retired” in 1991 but remains active as Distinguished Service Professor of Surgery at the University of Pittsburgh School of Medicine, PA, where the Thomas E. Starzl Transplantation Institute is named in his honor.

On Sunday, Dr. Starzl delivered the annual AGA Morton I. Gossman Lectureship, which he titled “Anatomy of an Error.”

“Cadaver intestinal transplants could revolutionize the practice of gastroenterology in the same way that liver transplantation has revolutionized the practice of hepatology,” Dr. Starzl said. “The need clearly exists.”

Liver transplantation has become the standard of care for most patients with lethal hepatic disease, a prediction Dr. Starzl first published in The New England Journal of Medicine in 1989. But it could have become the standard of care years, possibly decades, earlier if clinician-researchers had questioned the accepted medical dogma of the day.

The delay in developing successful liver transplant procedures stems from two grave errors, Dr. Starzl suggested. The first error was the assumption that the amount of blood flow to the liver, not the source of the blood flow, is critical in maintaining hepatic homeostasis. The second error was the assumption that engraftment and rejection are not related to donor leukocytes. It took researchers more than three decades to put these two beliefs to experimental challenge and discover that both are wrong.

Dr. Starzl did much of the work to debunk them. He began by looking at experimental results in dogs with altered hepatic blood supply and reasoned that livers didn’t simply need a specific volume of blood, but blood from a specific source, the portal vein. His hypothesis was that portal blood is uniquely enriched with some unknown liver-supporting factor or factors that are not found in high concentration in blood from other sources. That hypothesis led him down two avenues of research: one uncovered the metabolic interactions of different abdominal organs, while the other led to human organ transplantation.

The metabolic question was solved first. Portal blood was found to have unique properties that affect lipid metabolism. Work in dogs eventually identified insulin as the first of several hepatotropic factors in portal blood.

But assuring portal blood supply was only half of the challenge. Rejection of alographic organ transplants was not recognized as an immune reaction until the 1950s and the role of graft leukocytes in rejection was not recognized until much later.

Pre-transplant irradiation and other immunosuppressive treatments showed early success in dogs, but human results were less positive. Early immunosuppression helped boost survival in kidney transplants, but liver transplants were not successful.

Dr. Starzl conducted a series of liver transplants in the early 1960s, but the patients died in less than a month. The problem was not overt rejection, but infection and widespread thrombi. Researchers in Europe had similar problems, leading to a worldwide moratorium on liver transplants.

Meanwhile, development continued in kidney transplantation. And when azathioprine emerged as an effective immunosuppressant, Dr. Starzl and others used the drug successfully in liver transplantation. But there were still reservations.

“Despite repeated success, the verdict was that liver transplantation was possible but not feasible,” Dr. Starzl said. “That changed with the appearance of cyclosporine.”

Of his first 14 liver transplant patients treated with cyclosporine plus and prednisone, 12 lived up to 14 months, a survival record. In 1983, an NIH consensus panel concluded that liver transplantation had become a clinical service rather than an experimental procedure.

Thirty years later, few clinicians are following an appropriate immunosuppression protocol, Dr. Starzl said. Decades of experimental work and clinical experience have shown that it’s possible to minimize, and sometimes eliminate immunosuppressants following transplantation if recipient immunosuppression begins before transplantation. Recipient pre-treatment with adjunct donor cells and immunosuppressive agents minimizes the need for post-transplant immunosuppression.

Monday, May 20, 2013

DDW 2013 - New Direct-Acting Antivirals Promising for Hepatitis C Treatment

New Direct-Acting Antivirals Promising for Hepatitis C Treatment

Antiviral hepatitis C drugs on the horizon could spur more people to accept treatment and improve patient outcomes, Andrew J. Muir, MD, MHS, associate professor of medicine and clinical director of hepatology at Duke University in Durham, NC, reported at Digestive Disease Week 2013, held May 18-21, 2013, in Orlando, Fla.

“It’s a great time in hepatitis C and for telling patients the great things that are going to come to help them,” Muir said.

According to Muir, approximately 3.2 million people have hepatitis C, and about half of the cases have been detected while one third have been referred to care. Only 5 percent to 6 percent of patients have been successfully treated, Muir said.

“I hope the new drugs and response rates will bring people out,” Muir said. “We need to be proactive to make that happen.”

The Centers for Disease Control and Prevention has recommended screening baby boomers for hepatitis C, but the U.S. Preventive Services Task Force has been less enthusiastic, issuing a Grade B recommendation for people at risk and a Grade C recommendation for people at average risk who were born between 1945 and 1965.

Muir indicated the field has been held back by the inability to prove treatment has saved lives. However, more recent studies have shown reductions in liver-related mortality and transplants.

“There is proof that effective treatment leads to improved clinical outcomes,” Muir said, later adding that “sustained virologic response rates show we can cure most people.”

But Muir noted there are still issues with side effects and treatment duration, which is currently 24 to 48 weeks. Muir called the infection rate found in the CUPIC (Compassionate Use of Protease Inhibitors in Cirrhotics) trial concerning, as more than half of the patients who had compensated cirrhosis and were taking the three drug regimen of pegylated interferon/ribavrin and telaprevir or boceprevir experienced a serious adverse event.

“The infection often began a cascade that led to their demise,” Muir said. He continues to use the therapies but indicated he has changed how he counsels patients to avoid scaring them off. Also, the U.S. Food and Drug Administration (FDA) has added a black box warning to telaprevir related to patients dying after a progressive rash and systemic symptoms.

The OPTIMIZE trial assessed whether a twice-daily regimen of telaprevir was as effective as a thrice-daily regimen when both are administered with pegylated interferon/ribavrin, and it found a similar outcome. Muir called twice-daily dosing a “reasonable option” for patients challenged by the thrice-daily regimen, though he cautioned that the FDA has not yet approved it.

Reporting on three new drugs — simeprevir, faldoprevir, and sofusbuvir — Muir noted, “We are starting to get more drugs demonstrating nice potency.” Clinical trials are also under way on interferon-free regimens. Since many patients continue to hold off on starting treatment because they are waiting for new options, Muir recommended educating them about liver wellness. For patients with significant liver disease, he suggested clinicians discuss benefits and risks and document the session.

With more treatment options in the pipeline, Muir called it an “amazingly wonderful time to be a physician in a liver clinic,” because patients have options and most who receive treatment can live well for years.

“Bottom line: Interferon-free treatments are at hand and just around the corner,” moderator Adrian M. Di Bisceglie, MD, FACP, FACP, Bander chair of internal medicine and chief of hepatology at the Saint Louis University School of Medicine, in Missouri, said after the session. He expects approvals for some uses as soon as the end of the year.

“When we have that, it will transform how we think about the treatment of hepatitis C,” Di Gisceglie added. “An easy, one- to two-drug treatment regimen — that’s what we are looking forward to.” -

View Additional DDW Conference Coverage @ HCPlive

DDW 2013 - New therapy for patients with hepatitis C examined

Pharmaceutical advances offer new options for health outcomes

Research presented at DDW® 2013 feature new drugs for IBS, hepatitis C

Orlando, FL (May 20, 2013) — Research presented at Digestive Disease Week® (DDW) explores pharmaceutical advances for treating irritable bowel syndrome with diarrhea (IBS-D) and hepatitis C.

An international study holds promising results for patients suffering from IBS-D. In the phase II study, researchers found that the drug ibodutant significantly improved symptoms in more than 50 percent of the individuals treated.

"While there's been a lot of progress in medicines for IBS with constipation, we haven't seen the same in IBS with diarrhea," said Jan Tack, MD, professor and director of the division of gastroenterology and internal medicine at Leuven University in Belgium. "Up to this point, we haven't been able to provide a pharmaceutical option for this patient group that successfully manages the pain associated with the condition."

IBS is an extremely common condition, affecting an estimated 10 percent of adults. Funded by Menarini, the double-blind, multinational study recruited 559 patients with IBS-D who were randomized and treated with 1, 3 or 10 mg of ibodutant or a placebo. Patients took an oral tablet once daily for eight consecutive weeks. Researchers found that 10 mg was the most effective dose and that it worked best for females.

"These are exciting findings that could bring a lot of relief to many patients," said Dr. Tack said. "We're looking forward to moving into phase III to confirm our findings with a much larger sample of patients."

New therapy for patients with hepatitis C examined

New research suggests that an investigational therapy for patients with hepatitis C can achieve high response rates in a wide range of patients, even those who respond poorly to current treatments. The study examined the safety and efficacy of interferon-free regimens, including three direct-acting antiviral drugs with and without ribavirin, for 12 or 24 weeks, in patients with chronic hepatitis C who were either treatment-naïve or had previously failed standard treatment with peginterferon and ribavirin.

In the phase II study, researchers found that the treatment regimens achieved high sustained virologic response (SVR) rates, an efficacy measure of a hepatitis C treatment, in non-cirrhotic patients with HCV genotype-1 (GT 1). SVR was achieved by 98.7 percent of treatment-naïve patients and 93.3 percent of prior nonresponders after 12 weeks of treatment with three direct-acting agents with ribavirin.

"Hepatitis C genotype 1 is the most common type of hepatitis in the U.S., and many of these patients are still quite difficult to treat with current interferon-based therapies," said Frederick Nunes, MD, clinical associate professor of medicine at Penn Medicine. "This includes specific populations such as African Americans and patients with high body mass or pre-diabetes. These results suggest that highly effective regimens like this one may overcome that difficulty, without the need for interferon."

Assigning 247 patients to 12- or 24-week regimens, researchers found that four weeks after treatment, SVR rates were high regardless of patient characteristics previously associated with poorer response to interferon therapy. Funded by AbbVie (formerly Abbott), the study's results hold particular significance for patients who are older, black, Hispanic or have a higher body mass index.

Dr. Tack will present data from the study "Efficacy of ibodutant, a selective antagonist of neurokinin 2 receptors, in irritable bowel syndrome with diarrhoea (IBS-D): the results of a double-blind, randomised, placebo-controlled, parallel-group phase II study (The IRIS-2)," abstract 520, on Monday, May 20, at 8 a.m. ET in Room 300 of the Orange County Convention Center.

Dr. Nunes will present data from the study "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" abstract 514, on Monday, May 20, at 8 a.m. ET in Room 203AB of the Orange County Convention Center.

Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 18 to 21, 2013, at the Orange County Convention Center, Orlando, FL. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at

Sunday, May 19, 2013

DDW 2013- HCV patients with late viral breakthrough have similar characteristics

HCV patients with late viral breakthrough have similar characteristics
May 19, 2013

ORLANDO, Fla. — Viral breakthrough during the interferon/ribavirin phase of hepatitis C triple therapy was associated with genotype 1a and advanced liver fibrosis, similar to findings in previous clinical trials, according to study data presented here at Digestive Disease Week.

“We’ve noticed that there are patients who were experiencing viral breakthrough later in treatment,” Kali Zhou, MD, a resident in the department of medicine at the University of California, Los Angeles, told Infectious Disease News. “We did see later viral breakthrough in clinical trials, but we haven’t evaluated whether the characteristics of our breakthrough patients were similar to those who broke through in clinical trials.”...
Continue reading @ Healio

HCV prevalence higher among Asian-Americans
 May 19, 2013

ORLANDO, Fla. — There was a higher prevalence of hepatitis C infection among Asian-Americans than among non-Asians who received care at a free community clinic, researchers reported at Digestive Disease Week.

“Among non-Asians, the prevalence of HCV was similar to what was seen in NHANES data,” Mindie Nguyen, MD, associate professor of medicine at Stanford University, told Infectious Disease News. “Worldwide, a large amount of the HCV burden is in Asia, and we lacked data on whether Asian-Americans have a higher HCV prevalence that is similar to that in their countries of origin. We found that the prevalence of HCV among Asian-Americans was similar to the reported prevalence in many parts of Asia and Southeast Asia.”
Continue reading@ Healio

Additional headlines from Digestive Disease Week 2013 Meeting @ Healio

No difference in IVF success rates in IPAA vs non-IPAA patients
May 19, 2013
Meeting News Coverage

Long-term study data indicates sustained improvement in GERD
May 19, 2013
Meeting News Coverage

HCV prevalence higher among Asian-Americans
May 19, 2013
Meeting News Coverage

H. pylori infection less common among patients with Barrett's esophagus, erosive esophagitis
May 19, 2013
Meeting News Coverage

HCV patients with late viral breakthrough have similar characteristics
May 19, 2013
Meeting News Coverage

Patients with Medicaid less likely to receive HCV treatment
May 18, 2013
Meeting News Coverage

Coffee consumption linked to reduced risk for primary sclerosing cholangitis
May 18, 2013
Meeting News Coverage

HBV may increase risk for non-Hodgkin lymphoma
May 18, 2013
Meeting News Coverage

Patterns of exhaled volatile organic compounds differ between obese, healthy children
May 18, 2013

Saturday, May 18, 2013

DDW 2013 - Patients with Medicaid less likely to receive HCV treatments

Patients with Medicaid less likely to receive HCV treatment

May 18, 2013

ORLANDO — Although diagnosed hepatitis C infection was more common among people with Medicaid insurance, the treatment rates were lower compared with people who had commercial insurance, research presented here at Digestive Disease Week suggests.

“These results were pretty much what we expected,” Jenny Griffith, PharmD, senior manager of clinical epidemiology at AbbVie, told Infectious Disease News. “We knew that people who have Medicaid insurance are typically sicker, and we expected to find the same thing in HCV. The one thing that was unexpected was that the rate of diagnosed HCV was double in the Medicaid group. One hypothesis for this is that people with Medicaid typically have a lower socioeconomic status, and according to NHANES data, there is a higher prevalence of HCV among those with a lower socioeconomic status.”

Griffith and colleagues conducted a retrospective analysis that included approximately 28 million commercial beneficiaries from Jan. 2000 to Dec. 2009 and 3.2 million Medicaid beneficiaries from July 1999 to June 2009. They evaluated the prevalence of HCV and treatment estimates, as well as comorbidities and possible contraindications to treatment.

The 10-year prevalence of HCV was 302 per 100,000 among people with commercial insurance and 663 per 100,000 among people with Medicaid. The prevalence of treatment, however, was 26.5% among patients with commercial insurance and 19.5% among Medicaid beneficiaries. Those with Medicaid had higher rates of most evaluated comorbidities, including drug abuse, ascites, COPD, depression, autoimmune disease and pregnancy. More patients on Medicaid also had possible contraindications to treatment with ribavirin and/or interferon.

“The take-home message is that if you have someone who has Medicaid insurance, they are more than likely to be sicker and have more comorbidities that will make it more difficult to treat them,” Griffith said. “The development of interferon-free treatment may increase eligibility for treatment and hopefully eliminate this gap.”

For more information:
Griffith J. #Sa1066. Presented at: Digestive Disease Week; May 18-21, 2013; Orlando.

Disclosure: Griffith is an employee of AbbVie.

Source Healio

Additional headlines from Digestive Disease Week 2013Meeting @ Healio

HBV may increase risk for non-hodgkin lymphoma
Coffee consumption linked to reduced risk for primary sclerosing cholangitis

DDW 2013 - HBV may increase risk for non-hodgkin lymphoma

Healio Infectious DiseaseGastrointestinal InfectionsNews

HBV may increase risk for non-hodgkin lymphoma

May 18, 2013

ORLANDO — Infection with hepatitis B virus may be a risk factor for non-hodgkin lymphoma, according to data presented here at Digestive Disease Week 2013

Researchers from the Marshfield Clinic in Wisconsin conducted a meta-analysis that included 19 case-control studies performed throughout the world. The analysis included a total of 13,947 cases and 1,559,448 controls. In nine of the studies, the controls were non-lymphoma cancer/hospital patients; eight studies incorporated healthy controls, and two studies included both types of controls. In most of the studies (17), patients were diagnosed with hepatitis B by detection of HBsAg, while hepatitis B was self-reported in the remaining two studies. All incidences of non-hodgkin lymphoma (NHL) were diagnosed with histopathology.

Among the patients with NHL, 1,205 had hepatitis B infection and among the controls, there were 40,592 cases of infection. The risk of hepatitis B was higher for patients with NHL compared with controls (OR=2.53; 95% CI, 2.10-3.03). Significant heterogeneity was not observed across the evaluated studies.

The increased risk of hepatitis B infection was present in both developing and developed countries in subgroup analysis. There was also no difference in risk among controls based in the hospital- and population-based controls.

For more information:
Kanth R. #Sa1020. Presented at: Digestive Disease Week; May 18-21, 2013; Orlando.
Disclosure: The researchers report no relevant financial disclosures