December 4, 2013

Analyst: Don't underestimate AbbVie

Provided by MMM-online

DEBORAH WEINSTEIN

DECEMBER 04, 2013

humira_web_99223

Goldman Sachs's Jami Rubin asserted in her company assessment on Monday that AbbVie has become an underestimated player in fields as diverse as hepatitis C, chronic lymphoid leukemia (CLL) and breast cancer.

However there are some hang-ups surrounding AbbVie's future. Among them are its current dependence on autoimmune drug Humira. The company spun off from Abbott with this multi-indicated medication as its cornerstone, and Rubin said it provides around 50% of the company's sales. Although the patent wears off in 2016, Rubin indicated that this should not bury the drugmaker.

Instead, she expects AbbVie's pipeline will start providing financial ballast in 2015 with its hep. C contender, and then again in 2016 or 2017 if the company's CLL drug ABT-199 and its Phase-III endometriosis/Phase-II uterine fibroid treatment Elagolix meet FDA requirements.

Although the hep. C and CLL categories appear to have some built-in competition, such as Gilead's sofosbuvir and Johnson & Johnson's ibrutinib, Rubin's analysis indicated that AbbVie is in a position to exploit the weaknesses of its competitors with the everyday metric that influence sales: price.

As an example, she noted that AbbVie expects to file its hep. C drug in the first part of 2014 with a projected 2015 launch, timing which will put it right up against Gilead's all-oral program. Rubin says the pill burden—two pills twice daily along with one ribavirin pill daily for AbbVie's regimen, compared with Gilead's regimen of a once-daily pill with or without ribavirin once or twice daily—gives Gilead a superficial disadvantage because the cure rates appear similar, and payers are going to gravitate toward a cheaper option.

Rubin also noted that cheaper does not mean AbbVie would have to drop a financial tier, because on-market drugs like Vertex's Incivek and Merck's Victrelis—two currently marketed protease inhibitors—represent a floor AbbVie may not have to hit because AbbVie's experimental drug has a better virus-clearing rate.

Further, the analyst mentioned that these lower-priced drugs may not sit well with payers because both regimens require pegylated interferon and ribavirin, upping the total treatment cost. Rubin said Incivek plus pegylated interferon and ribavirin cost around $89,000 a year; Victrelis with pegylated interferon and ribavirin is $74,000; and Gilead's sofosbuvir is around $75,000 a year in Europe, jumping to $100,000 when peg-riba gets added into the regimen.

Rubin said these numbers give AbbVie room to maneuver, as long as it is willing to pursue rebating or discounting as part of its competitive hep. C model, a strategy she notes is of particular importance because government programs—Medicare, Medicaid, VA, prisons—cover around 50% of hep. C cases.

Rubin also wrote that AbbVie's ABT-199, developed with Roche, also has a chance against J&J's ibrutinib, Gilead's idelalisib, Infinity's PI3K inhibitor IPI-145, and Roche's GA101/Gazyva in the CLL space. She described the landscape as fierce but said ABT-199 looks poised to win on efficacy.

The Goldman Sachs analyst added that AbbVie's Elagolix has a large market—around 7.5 million women have endometriosis—and that AbbVie's treatment has “significant advantages over current care.”

The pipeline also has some negatives. Rubin pointed out that the MS drug daclizumab, which is being developed with Biogen Idec, has safety and tolerability issues that undercut its efficacy profile. Rubin said heat surrounding new oral agents “with less safety concerns,” limit the injection's appeal, in addition to expected competition from generic Copaxone, which is expected to surface next year.

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PARIS--(BUSINESS WIRE)--December 04, 2013--
Regulatory News:

BioAlliance Pharma SA (Euronext Paris - BIO), an innovative Company dedicated to the development of orphan oncology and to supportive care products, announces that it has received authorization to start its Phase III ReLive clinical trial in primary liver cancer in the U.S. (IND approval), following the review of the Livatag(R) development program by the FDA, as well as in Germany after the German health agency green light.

"The deployment strategy planned was to implement the clinical trial first in France, then to expand it to Europe and then to the United States in 2014. The schedule is currently fully respected as the study is already implemented in Europe since last summer, and clinical operations will now be able to start in the U.S. in order to open investigating centers", stated Pierre Attali, COO in charge of Strategy and Medical affairs.

Regarding Europe, BioAlliance Pharma is also enlarging the study to Germany following the authorization granted by the BfArM (German health agency). This extension in a territory with a strong recruitment potential follows authorizations already obtained in Spain, Italy, Russia, Hungary, Austria and Belgium.

ReLive, an international phase III randomized trial, aims to demonstrate the efficacy of Livatag(R) on survival in 400 patients with hepatocellular carcinoma after failure or intolerance to sorafenib. To date, twenty centers have been opened and more than 80 patients have been enrolled, in line with the recruitment objectives set by the Company.

The international extension of Livatag(R) trial is necessary to meet the recruitment timelines objectives which anticipate an end of recruitment in 2015 and preliminary results in 2016.

"The IND approval of our Phase III clinical trial protocol in the United States is a key milestone for BioAlliance. In addition to the geographic expansion and the acceleration of patient enrollment, the implementation of ReLive in the United States will allow world's leading experts in hepatology and oncology to build their own experience on the product", stated Judith Greciet, CEO of BioAlliance Pharma.

About BioAlliance Pharma

Dedicated to cancer and supportive care treatment with a focus on resistance targeting and orphan products, BioAlliance Pharma conceives and develops innovative products, for specialty markets especially in the hospital setting and for orphan or rare diseases.

Created in 1997 and introduced to the Euronext Paris market in 2005, BioAlliance Pharma's ambition is to become a leading player in these fields by coupling innovation to patient needs. The company's teams have the key competencies required to identify, develop and register drugs in Europe and the USA.

BioAlliance Pharma has developed an advanced product portfolio:

Specialty products

Loramyc(R) /Oravig(R) (oropharyngeal candidiasis in immunocompromised patients): Registered in 26 countries (EU, US, Korea), commercialized in Europe and in the U.S.

Sitavig(R) (Acyclovir Lauriad(R) ) (labialis herpes): Registered in the U.S. and in 8 European countries, registration status in the other European countries.

Fentanyl Lauriad(R) (chronic cancer pain): Positive preliminary Phase I results

Orphan Oncology products

Livatag(R) (Doxorubicin Transdrug(TM)) (primary liver cancer): Phase III on going

Validive(R) (Clonidine Lauriad(R) ) (mucositis): Phase II on going

AMEP(R) (invasive melanoma): Phase I on going

For more information, visit the BioAlliance Pharma web site at www.bioalliancepharma.com

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning BioAlliance Pharma SA and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioAlliance Pharma SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioAlliance Pharma SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of BioAlliance Pharma SA to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the 2012 Reference Document filed with the AMF on April 18, 2013, which is available on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma SA's website (http://www.bioalliancepharma.com).

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Gut doi:10.1136/gutjnl-2013-306102

Leading article

Salvatore Petta, Fabio Salvatore Macaluso, Antonio Craxì

+ Author Affiliations

Correspondence to
Dr S Petta, Gastroenterologia and Epatologia, Piazza delle Cliniche 2, Palermo 90127, Italy;
petsa@inwind.it

Received 17 September 2013
Revised 14 November 2013
Accepted 17 November 2013
Published Online First 2 December 2013

Introduction

HCV infection, metabolic disorders and cardiovascular alterations, considered alone or in combination, are common conditions in a large proportion of the general population. Consequently, determining whether the association of HCV infection with cardiometabolic disorders is simply coincidental or, conversely, caused by pathogenetic mechanisms (in)directly linking chronic HCV infection to these disorders, would be of extreme relevance.

Several clinical studies have shown that metabolic disorders—namely, type 2 diabetes,1insulin resistance (IR)2 and hepatic steatosis3—are highly prevalent in patients with chronic hepatitis C (CHC) compared with non-infected patients. Experimental and clinical studies have shown that HCV is able to directly influence glucose and lipid metabolism and thus can perturb the metabolic homeostasis of the host, leading to extrahepatic consequences.4 ,5 However, unlike the classic forms of metabolic disturbances, CHC is associated with a favourable lipoprotein profile—that is, reduced levels of apolipoprotein B containing lipoproteins, such as low density lipoprotein and very low density lipoprotein cholesterol.6

The discordance between the increased prevalence of IR, steatosis and diabetes, and the favourable lipoprotein profile in CHC compared with non-infected individuals, may account for the similar prevalence of metabolic syndrome (ie, the presence of at least three of the following: visceral obesity, hyperglycaemia, arterial hypertension, low levels of high density lipoprotein cholesterol and high triglycerides levels)7 reported in data from the database of the third National Health and Nutrition Examination Survey (NHANES-III).8

These data raise the question of whether HCV infection per se and/or via induction of metabolic/inflammatory dysfunctions is associated with an increased cardiovascular risk.

With this in mind, cross sectional and prospective studies have evaluated the presence and occurrence of both cardiovascular alterations and cardiovascular mortality in HCV infected patients compared with non-infected patients, with contrasting results.6 ,9–34

This review was prompted by …

Full text of this article

Simeprevir (Olysio) J & J Patient Access Programs

Provided by NATAP

Following the approval of OLYSIO, here are website links and phone numbers for individuals seeking information about OLYSIO's patient access, education and other support programs.

Patients who lack adequate financial resources and do not have prescription coverage can apply to the Johnson & Johnson Patient Assistance Foundation, Inc., to determine if they meet eligibility criteria for financial assistance for OLYSIO:

Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, private, nonprofit organization that assists patients who do not have financial resources or prescription drug coverage to obtain free prescription products that are donated by Johnson & Johnson operating companies. Janssen Therapeutics donates medicines, including OLYSIO, to JJPAF For additional information, please visit the JJPAF Web site at www.jjpaf.org or call and speak to one of our patient assistance program specialists at 1-800-652-6227

Patients with prescription drug coverage that may require significant out-of-pocket (co-pay or co-insurance) expenses for OLYSIO may apply for assistance through OLYSIO Support:

Patients who qualify for the OLYSIO patient savings program will pay no more than $25 per month for a total of $75 for three months out-of-pocket costs. This program is available to cover co-pays and co-insurance costs. Additional important information about the OLYSIO patient savings program:

  • Subject to a $25,000 annual maximum, 12 months after activation, or 3 fills (12-week supply), whichever comes first
  • Not valid for patients enrolled in Medicare (e.g., Medicare Part D) or Medicaid
  • Information on the OLYSIO patient savings program and other access support services can be found atwww.olysio.com or by calling 1-855-5-OLYSIO

As mentioned above, the patient savings program is part of OLYSIO Support, a comprehensive array of educational information and tools that may help individuals through their treatment journey. OLYSIO Support is available online atwww.olysio.com or by calling 1-855-5-OLYSIO. Here are a few examples of the programs and tools that are available, in addition to the patient savings program other access assistance:

  • A 24/7 Nurse Support hotline
  • A support group finder to help individuals connect with other people in their area who are seeking support on their hepatitis C journey
  • A variety of resources to help individuals keep track of their treatment inclusive of a mobile app, dosing diary, treatment calendar, and reminder calls

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Antimicrob Agents Chemother. 2013 Dec 2. [Epub ahead of print]

Gane EJ, Rouzier R, Wiercinska-Drapalo A, Larrey DG, Morcos PN, Brennan BJ, Le Pogam S, Nájera I, Petric R, Tran JQ, Kulkarni R, Zhang Y, Smith P,Yetzer ES, Shulman NS.

Auckland Clinical Studies, Auckland, New Zealand.

Abstract

Background & Aims: Danoprevir (DNV) is a hepatitis C virus (HCV) protease inhibitor that achieves high sustained virologic response (SVR) rates in combination with peginterferon alfa-2a/ribavirin in treatment-naive HCV genotype (G)1-infected patients. This study explored the efficacy and safety of ritonavir-boosted DNV (DNVr) plus peginterferon alfa-2a/ribavirin in G1 prior peginterferon/ribavirin null responders.Methods: Null responders (<2-log10 reduction in HCV RNA at week 12) were given open-label DNVr 100/100 mg q12h + peginterferon alfa-2a/ribavirin for 12 weeks. All patients achieving an early virologic response (EVR; ≥2-log10 decrease in HCV RNA by week 12) continued treatment with peginterferon alfa-2a/ribavirin; those without an EVR discontinued all study drugs.Results: Twenty-four prior null responders were enrolled; 16 patients (67%) were infected with HCV G1b, and 8 (33%) with G1a. 96% of patients had an IL28B non-CC genotype. An SVR24 was achieved in 67% of patients, with a higher rate in G1b-infected (88%) vs. G1a-infected (25%) patients. Resistance-related breakthrough occurred in 4/8 G1a and 1/16 G1b patients through the DNV resistance-associated variant (RAV) NS3 R155K. NS3 R155K was also detected in 2/2 G1a patients who relapsed. Treatment was well tolerated. Two patients withdrew prematurely from study medications due to adverse events. Two serious adverse events were reported; both occurred after completion of DNVr therapy and were considered unrelated to treatment. No Grade 3/4 ALT elevations were observed.Conclusions: DNVr plus peginterferon alfa-2a/ribavirin demonstrated high SVR24 rates in HCV G1b prior null responders and was well tolerated.

PMID: 24295986 [PubMed - as supplied by publisher]

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Cochrane Database Syst Rev. 2013 Dec 2;12:CD006573. [Epub ahead of print]

Gurusamy KS, Tsochatzis E, Toon CD, Davidson BR, Burroughs AK.

Department of Surgery, Royal Free Campus, UCL Medical School, Royal Free Hospital,, Rowland Hill Street, London, UK, NW3 2PF.

Abstract

BACKGROUND: It is not clear whether prophylactic antiviral therapy is indicated to improve patient and graft survival in patients undergoing liver transplantation for chronic decompensated hepatitis C virus (HCV) infection.

OBJECTIVES: To compare the benefits and harms of different prophylactic antiviral therapies for patients undergoing liver transplantation for chronic HCV infection.

SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 1, 2013), MEDLINE, EMBASE, and Science Citation Index Expanded to February 2013.

SELECTION CRITERIA: Only randomised clinical trials irrespective of language, blinding, or publication status and comparing various prophylactic antiviral therapies (alone or in combination) in the prophylactic treatment of patients undergoing liver transplantation for chronic HCV infection.

DATA COLLECTION AND ANALYSIS: Two authors collected the data independently. We calculated the risk ratio (RR) or mean difference (MD) or hazard ratio (HR) with 95% confidence intervals (CI) using the fixed-effect and the random-effects models based on available case analysis.

MAIN RESULTS: A total of 501 liver transplant recipients undergoing liver transplantation for chronic HCV infection were randomised in 12 trials to various experimental interventions and control interventions. The proportion of genotype I varied between 49% and 100% in the seven trials that reported the genotype. Only one or two trials were included under each comparison. All the trials were of high risk of bias. Ten trials including 441 liver transplant recipients provided data for this review.There were no significant differences in the 90-day mortality (1 trial; 81 participants; 5/35 (adjusted proportion: 14.2%) in interferon group versus 5/46 (10.9%) in control group; RR 1.31; 95% CI 0.41 to 4.19); mortality at maximal follow-up (2 trials; 105 participants; 7/47 (adjusted proportion: 14.8%) in interferon group versus 10/58 (17.2%) in control group; RR 0.86; 95% CI 0.36 to 2.08); long-term mortality (1 trial; 81 participants; HR 0.45; 95% CI 0.13 to 1.56); mortality at maximal follow-up (1 trial; 54 participants; 1/26 (3.9%) in pegylated interferon group versus 2/28 (7.1%) in control group; RR 0.54; 95% CI 0.05 to 5.59); 90-day mortality (1 trial; 115 participants; 5/55 (9.1%) in pegylated interferon plus ribavirin group versus 3/60 (5.0%) in control group; RR 1.82; 95% 0.46 to 7.25); 90-day mortality (3 trials; 53 participants; 3/37 (adjusted proportion: 4.3%) in HCV antibody group versus 1/16 (6.3%) in placebo group; RR 0.69; 95% CI 0.15 to 3.11); or 90-day mortality (2 trials; 31 participants; 2/14 (adjusted proportion: 16.2%) in HCV antibody high-dose group versus 1/17 (5.9%) in HCV antibody low-dose group; RR 2.75; 95% CI; 0.30 to 25.35). There were no significant differences in the retransplantation at maximal follow-up (2 trials; 105 participants; 2/47 (adjusted proportion: 4.0%) in interferon group versus 2/58 (3.4%) in control group; RR 1.17; 95% CI 0.22 to 6.2); 90-day retransplantation (1 trial; 18 participants; 1/12 (8.3%) in HCV antibody group versus 0/6 (0%) in control group; RR 1.71; 95% CI 0.09 to 32.93); or 90-day retransplantation (1 trial; 12 participants; 1/6 (17.7%) in HCV antibody high-dose group versus 0/6 (0%) in HCV antibody low-dose group; RR 3.00; 95% CI 0.15 to 61.74). There were no significant differences in serious adverse events, graft rejection, worsening of fibrosis, or HCV recurrence between intervention and control groups in any of the comparisons that reported these outcomes. None of the trials reported quality of life, liver decompensation, intensive therapy unit stay, or hospital stay. Life-threatening adverse events were not reported in either group in any of the comparisons.

AUTHORS' CONCLUSIONS: There is currently no evidence to recommend prophylactic antiviral treatment to prevent recurrence of HCV infection either in primary liver transplantation or retransplantation. Further randomised clinical trials with adequate trial methodology and adequate duration of follow-up are necessary.

PMID: 24297303 [PubMed - as supplied by publisher]

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PUBLIC RELEASE DATE: 4-Dec-2013

Contact: Jim Fessenden
james.fessenden@umassmed.edu
508-856-2000
University of Massachusetts Medical School

Monoclonal antibody designed to prevent hepatitis C recurrence in liver transplant patients

BOSTON, MA – MassBiologics of the University of Massachusetts Medical School (UMMS) has received an orphan drug designation from the U.S. Food and Drug Administration (FDA) for MBL-HCV1, a monoclonal antibody developed to prevent hepatitis C virus (HCV) recurrence in patients receiving a liver transplant.

Complications from chronic HCV infection are the most common indications for liver transplantation today. For patients with end-stage liver disease or hepatocellular carcinoma resulting from HCV infection, liver transplantation is often the only treatment option, but it is not a cure for the disease. In almost all cases, the new donor liver becomes infected with HCV soon after transplantation.

MassBiologics' monocloncal antibody, currently in a Phase 2 clinical trial, is intended to prevent HCV from damaging the transplanted liver.

"Being granted orphan drug status facilitates the goal of bringing this investigational product to patients," says Deborah C Molrine, MD, deputy director of clinical affairs at MassBiologics and professor of pediatrics at University of Massachusetts Medical School. "The economic incentives available to MassBiologics and potential commercial partners through the Orphan Drug Act will contribute greatly to bringing this monoclonal antibody to market as a treatment option for patients receiving liver transplants as a result of HCV infection."

The Orphan Drug Act was established by Congress in 1983 to aid the development of new therapies for rare medical conditions or diseases that affect less than 200,000 patients annually. To help stimulate new drug development for these less common conditions, the FDA provides financial benefits to companies that achieve orphan drug designation, including market exclusivity for 7 years, tax incentives, fee waivers and potential grant support.

Developed by MassBiologics, MBL-HCV1 is a fully human monoclonal antibody that targets a region of the hepatitis C virus on its surface envelope, preventing it from infecting liver cells. MBL-HCV1 has been shown to be safe in healthy human subjects and is currently being studied in patients with chronic hepatitis C infection undergoing liver transplantation.

"Infusions of the monoclonal antibody have been well-tolerated in transplant patients and allow for delivery of the targeted HCV treatment to begin just before the removal of the diseased liver and to continue through the early post-transplant period," said Dr. Molrine. "A Phase 2 study is underway in liver transplant patients that combines the monoclonal antibody with one of the first two oral HCV direct acting anti-virals to be licensed by the FDA. We anticipate having data to present soon on the effect of this treatment on HCV detection after liver transplantation."

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About MassBiologics

MassBiologics, formerly known as the Massachusetts Biologic Laboratories, is the only non-profit FDA- licensed manufacturer of vaccines and other biologic products in the United States. MassBiologics produces 20-30 percent of the US tetanus/diphtheria vaccine supply. In addition to the HCV monoclonal antibody program, MassBiologics has discovered and developed human monoclonal antibodies to severe acute respiratory syndrome (SARS),Clostridium difficile and to rabies virus. MassBiologics traces its roots to 1894, and since then has maintained a mission to improve public health through applied research, development and production of biologic products. MassBiologics has been a part of the University of Massachusetts Medical School since 1997.

About the University of Massachusetts Medical School

The University of Massachusetts Medical School (UMMS), one of five campuses of the University system, is comprised of the School of Medicine, the Graduate School of Biomedical Sciences, the Graduate School of Nursing, a thriving research enterprise and an innovative public service initiative, Commonwealth Medicine. Its mission is to advance the health of the people of the Commonwealth through pioneering education, research, public service and health care delivery with its clinical partner, UMass Memorial Health Care. In doing so, it has built a reputation as a world-class research institution and as a leader in primary care education. The Medical School attracts more than $240 million annually in research funding, placing it among the top 50 medical schools in the nation. In 2006, UMMS's Craig C. Mello, PhD, Howard Hughes Medical Institute Investigator and the Blais University Chair in Molecular Medicine, was awarded the Nobel Prize in Physiology or Medicine, along with colleague Andrew Z. Fire, PhD, of Stanford University, for their discoveries related to RNA interference (RNAi). The 2013 opening of the Albert Sherman Center ushered in a new era of biomedical research and education on campus. Designed to maximize collaboration across fields, the Sherman Center is home to scientists pursuing novel research in emerging scientific fields with the goal of translating new discoveries into innovative therapies for human diseases.

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Nature Reviews Gastroenterology & Hepatology
DECEMBER 2013 VOL 10 NO 12
10, 713–728 (2013) doi:10.1038/nrgastro.2013.163
Published online 10 September 2013

NATURE REVIEWS GASTROENTEROLOGY & HEPATOLOGY | REVIEW

Paul M. Trembling, Sudeep Tanwar, William M. Rosenberg & Geoffrey M. Dusheiko

Abstract

The primary aim of antiviral therapy for chronic hepatitis C (CHC) is the prevention of progressive disease. A response to interferon (IFN) treatment is associated with an improvement in all-cause mortality and liver-related mortality from hepatitis C. Unless contraindicated, patients with CHC are thus potential candidates for treatment. Improved response rates are observed in patients with HCV genotype 1 infection treated with first-generation protease inhibitors. However, treatment with current first-generation protease inhibitors and IFN is complex and can result in appreciable adverse effects. The advent of potent, pan-genotypic all-oral direct-acting antiviral (DAA) regimens necessitates a critical examination of the immediate application of PEG-IFN, ribavirin and DAA regimens in patients with CHC. Current guidelines and position statements do not make clear recommendations, and are behind the emerging data. Some aspects of the conundrums facing physicians and patients are summarized in this Review. Cirrhosis presents an immediate threat of disease, and ideally treatment should be targeted at those patients who have advancing or advanced disease; unfortunately, a disparity exists, as response rates are reduced in patients with cirrhosis and the risks of adverse events are increased. On balance, patients with mild disease could consider deferring treatment.

Source

Journal of Hepatology

Article in Press

Meike Heeren, Faina Sojref, Ramona Schuppner, Hans Worthmann, Henning Pflugrad, Anita B. Tryc, Thomas Pasedag, Karin Weissenborn

Received 19 June 2013; received in revised form 23 November 2013; accepted 26 November 2013. published online 04 December 2013.
Accepted Manuscript

Abstract

Background and Aims

More than 50% of patients with chronic hepatitis C with only mild liver disease complain about chronic fatigue, daytime sleepiness and poor sleep quality. The aim of the present study was to characterize and objectify the sleep disturbances in hepatitis C virus-infected patients.

Methods

Twenty-five women who had been infected with hepatitis C virus contaminated anti-D immunoglobulin in 1978/79 and 22 age-matched female healthy controls underwent actigraphy over a period of 5 days to measure motor activity and thereby sleep-wake-rhythm and in addition completed questionnaires for depression, health-related quality of life, fatigue and sleep and a sleep diary. Liver cirrhosis, a history of neurological or psychiatric disease, history of intravenous drug abuse, shift work, or current medication with effect upon the central nervous system were exclusion criteria.

Results

The patients achieved higher scores for depression, fatigue and sleep disturbances and lower quality of life scores than the healthy controls. Actigraphy showed higher nocturnal activity and worse sleep efficiency in the patients, while the 24-hour activity level did not differ between groups. Fatigue and quality of life scores correlated with bad sleep quality and daytime sleepiness.

Conclusion

Our data indicate that chronic fatigue is associated with bad sleep quality and increased nocturnal activity in HCV-infected patients suggesting an alteration of sleep architecture behind fatigue in HCV-associated encephalopathy.

Abbreviations: APRI, aspartate aminotransferase-to-platelet ratio index, PSQI, Pittsburgh Sleep Quality Index, ESS, Epworth Sleepiness Scale, FIS, Fatigue Impact Scale, BDI, Becks Depression Inventory, HADS, Hospital Anxiety and Depression Scale, SF-36, Short-Form questionnaire, QoL, Quality of Life, WASO, wake after sleep onset, cpm, counts per minute, MVPA, moderate to vigorous physical activity,CSF, Cerebrospinal fluid, FSS, Fatigue Severity Scale

Keywords: Actigraphy, Fatigue, Hepatitis C, Sleep disturbances

No full text is available. To read the body of this article, please view the PDF online.

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