April 15, 2015

Caffeinated drinks associated with decreased risk of liver scarring

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Provided by Baylor School of Medicine

Julia Parsons
713-798-4710 Houston, TX - Apr 14, 2015

Modest daily consumption of caffeinated drinks is associated with less advanced liver scarring in people with hepatitis C, according to a recent study by Baylor College of Medicine researchers that appears online in the journal Clinical Gastroenterology and HepatologyClinical Gastroenterology and Hepatology.

Dr. Hashem El-Serag, chief of gastroenterology and hepatology at Baylor and at the Michael E. DeBakey Veterans Affairs Medical Center and lead author of the study, said the results showed that the risk of liver scarring in hepatitis C patients was decreased when individuals regularly consumed caffeinated coffee, and to a lesser extent tea and soda.

“We found that participants who drank caffeinated coffee daily had the best results,” he said. “This is most likely do to the fact that one coffee drink has more caffeine than tea or sodas.”

He said the researchers saw no benefit to patients who drank decaffeinated coffee, tea and soda.

This cross-sectional study consisted of 910 participants aged 18 to 70 years of age with confirmed hepatitis C who were not receiving antiviral therapy.

“We specifically chose to study hepatitis C patients because they are at an increased risk for hepatic fibrosis (liver scarring), and there is limited data on the effects of coffee or caffeine on the progression of scarring within this patient population,” said El-Serag, also a member of the Dan L. Duncan Cancer Center at Baylor.

Liver scarring can lead to cirrhosis of the liver, liver failure and liver cancer, and may require liver transplantation.

Of the participant study population, 37.6 percent of them had advanced liver scarring while 62.4 percent had milder scarring. Participants with advanced fibrosis were significantly older, more likely to have type 2 diabetes and were more likely to be overweight or obese.

“Most participants reported drinking caffeinated coffee, and about half of those drank one or more cups of coffee per day,” El-Serag said. “Patients with milder liver scarring had a higher average daily intake of caffeinated coffee compared to those with more advanced cases.”

“An estimated 100 milligrams of caffeine from coffee, tea or soda was associated with approximately one-third reduction of advanced scarring, and higher consumption didn’t produce an additional benefit,” he said.

Others who took part in this study include Natalia Khalaf, Donna White, Fasiha Kanwal, David Ramsey, Sahil Mittal, Shahriar Tavakoli-Tabasi and Jill Kuzniarek, all of Baylor.

This research was funded in part by a VA Clinical Research and Development Merit Award (H-22934, PI: El-Serag) and the National Institute of Diabetes Digestive and Kidney Diseases (R03 DK095082, PI:  White).  The efforts of White and El-Serag effort were supported in part by the National Institute of Diabetes Digestive and Kidney Diseases (K24 DK04-107 and K01 DK081736, respectively) and the Houston VA Health Services Research and Development Center of Excellence (HFP90-020).

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- AbbVie's investigational, interferon and ribavirin-free treatment in Japan consists of a 12-week, two direct-acting antiviral, fixed-dosed combination of paritaprevir/ritonavir with ombitasvir, dosed once daily
- New Drug Application, based on the Phase 3 GIFT-I study results in Japanese patients with genotype 1b hepatitis C virus (HCV) infection, was submitted in February 2015
- GIFT-I met its primary endpoint, achieving 95 percent sustained virologic response rate at 12 weeks post-treatment (SVR12); two patients (0.9 percent) discontinued treatment due to adverse events
- Approximately 1.5 to 2 million people are living with hepatitis C in Japan(1); genotype 1 is most common, accounting for 60 to 70 percent of all patients infected with HCV(2)

NORTH CHICAGO, Ill., April 15, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted priority review for its investigational, two direct-acting antiviral treatment of ombitasvir/paritaprevir/ritonavir. This all-oral treatment is interferon (IFN) and ribavirin (RBV)-free and will be dosed once daily. The MHLW grants priority review to certain medicines on the basis of clinical usefulness and severity of the disease, including diseases like hepatitis C, which affects approximately 1.5 to 2 million people in Japan.1 AbbVie's investigational hepatitis C treatment was submitted for marketing approval in Japan in February 2015. The New Drug Application is for the treatment of patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection and is supported by the Phase 3 GIFT-I study in Japanese genotype 1b (GT1b) HCV patients.

"AbbVie is pleased that the Japanese MHLW has granted priority review for our interferon and ribavirin-free, 12-week, two direct-acting antiviral treatment regimen. This marks another important advancement in our HCV clinical development program as we aim to provide our HCV treatment to patients across the world," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "If approved, AbbVie's HCV treatment holds the potential to be a promising new treatment option for patients living with this chronic infection in Japan."

AbbVie studied a two direct-acting antiviral treatment regimen without RBV in Japan due to patient and viral characteristics specific to the Japanese population, including high prevalence of GT1b. In Japan, GT1 is the most common HCV genotype and accounts for 60 to 70 percent of all patients infected with HCV.2 Of those patients, about 95 percent are infected with the GT1b sub-type.2

Additional information about AbbVie's GIFT-I study can be found on www.clinicaltrials.gov.

About AbbVie's Investigational Two Direct-Acting Antiviral HCV Treatment
For the treatment of genotype 1 chronic hepatitis C virus (HCV) infection in Japan, AbbVie's investigational, two direct-acting antiviral treatment consists of the fixed-dosed combination of paritaprevir/ritonavir (150/100 mg) with ombitasvir (25 mg), dosed once daily.

AbbVie's chronic HCV treatment combines two direct-acting antivirals, each with a distinct mechanism of action that targets and inhibits specific HCV proteins of the viral replication process.

About AbbVie's HCV Clinical Development Program in Japan
AbbVie's HCV clinical development program in Japan focuses on its investigational, two direct-acting antiviral treatment and is designed to achieve high SVR rates in chronic HCV infected patients, including additional genotypes and patients with compensated cirrhosis.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.

Ombitasvir/paritaprevir/ritonavir is an investigational product and its safety and efficacy have not been established in Japan.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs more than 26,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission.

AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

1 Kohnodai Hospital. National Center for Global Health and Medicine [cited 20 February 2013]. Available from:
http://www.ncgm.go.jp/center/forpatient_hcv.html

2 Hajarizadeh B et al. Nat Rev Gastroenterol Hepatol 2013; 10: 553-562. http://www.nature.com/nrgastro/journal/v10/n9/fig_tab/nrgastro.2013.107_F1.html. Accessed December 2014

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