Peginterferon plus Chinese herbal therapy is associated with a higher virological response than only peginterferon therapy in chronic hepatitis C

Eur J Clin Microbiol Infect Dis. 2013 Sep 11. [Epub ahead of print]

Cheng D, Liu E, Li Y, Liu R, Bai L, Chen Y, Wang Y, Chu Y, Wu M, Cheng G, Zhao S.

Key Laboratory of Environment and Genes Related to Diseases of the Education Ministry, Xi'an Jiaotong University School of Medicine, Shaanxi, China.

Abstract

Traditional Chinese herbal therapies are widely used for the treatment of chronic hepatitis C (CHC) in China and several Asian countries. The aim of this study was to perform a meta-analysis of randomized controlled trials (RCTs) comparing peginterferon therapy with peginterferon plus Chinese herbal therapy for the treatment of CHC. The Cochrane Central Register of Controlled Trials, Medline, Science Citation Index, EMBASE, China National Knowledge Infrastructure, Wanfang Database, and China Biomedical Database were searched to identify RCTs that evaluated the virological response of CHC patients to peginterferon therapy and peginterferon plus Chinese herbal therapy. We statistically combined data using a fixed-effects meta-analysis according to the intention-to-treat principle. The literature search yielded 905 studies and nine RCTs composed of 858 patients matched the selection criteria. Overall, sustained virological response (SVR) was significantly higher in patients treated with peginterferon plus Chinese herbs than in patients treated with peginterferon alone (81 % vs. 64 %, respectively; odds ratio, 2.60; 95 % confidence interval: 1.32-5.14; p < 0.05). A combined therapy of peginterferon plus Chinese herbs was also superior to peginterferon therapy in achieving an early viral response (EVR, 80 % vs. 70 %, respectively), a viral response at week 24 of treatment (82 % vs. 73 %, respectively), and end-of-treatment viral response (ETVR, 73 % vs. 62 %, respectively). The combined therapy resulted in fewer relapses, fewer adverse events, and more rapid alanine transaminase normalization; however, both treatments yielded a similar rapid viral response (RVR, 53 % vs. 57 %, respectively). The current evidence suggests that combined therapy of peginterferon plus Chinese herbs yields a higher viral response and results in fewer relapses and fewer adverse events than peginterferon therapy alone.

PMID: 24022094 [PubMed - as supplied by publisher]

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NYC launches initiative to control hepatitis C prevalence in the city

Provided by Vaccine News

Published on October 11, 2013 by Jessica Limardo

The New York City Department of Health and Mental Hygiene on Monday announced the launch of an initiative to combat Hepatitis C infection, a disease which now accounts for more annual deaths than HIV/AIDS.

“This is a very hopeful time for persons living with hepatitis C,” Health Commissioner Dr. Thomas Farley said. “After many years in which the infection was very difficult to treat, hepatitis C can now be cured. We also expect that medications that are easier to use and even more effective will be available in just a few months, and many other promising drugs should be approved for use in the next few years.”

The initiative is titled Hepatitis C in New York City: State of the Epidemic and Action Plan. It is estimated approximately 146,500 people in New York are carrying HCV and only half are aware that they have the infection. Most will not experience symptoms until 10 to 30 years after infection, when life-threatening conditions, such as liver disease, develop as a result of the initial infection.

“Unfortunately, roughly half of those living with HCV infection do not know that they are infected,” Farley added. “With new opportunities to treat and cure this disease, all health care providers in New York City must become familiar with current recommendations for testing and treatment.”

The new initiative seeks to educate the public and health care workers about the importance of getting screened for HCV early. The Health Department also seeks to develop policies to promote accessible testing and treatment for HCV.

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Also See: Approximately 146,500 New Yorkers are infected with hepatitis C; roughly 50 percent do not know that they are infected

Hep C prevalence in Jordan below regional levels

by Khetam Malkawi | Oct 10, 2013 | 22:43

DUBAI — Despite the high prevalence of hepatitis C in the region, Jordan has managed to maintain a low prevalence of this viral disease, experts said.

Experts who met in Dubai this week to discuss hepatitis prevalence in the region said more than nine million people in the Middle East and North Africa are infected with hepatitis C virus (HCV) but only an estimated one third of those infected have been diagnosed.

Dubbed the “silent killer”, the virus’ prevalence in Jordan stands at 0.65 per cent.

“This means that around 30,000 to 35,000 Jordanians are infected with this virus,” Waseem Hamoudi, consultant for gastroenterology and hepatology and head of the internal medicine department at Al Bashir Hospital, told The Jordan Times over the phone.

The highest prevalence of the disease in the region is in Egypt, according to Mustafa Abdul Aziz, consultant for gastroenterology and hepatology at UAQ Hospital in the UAE.

According to figures he presented, the prevalence of the disease in Egypt is more than 14 per cent.

“HCV is the most dangerous type of hepatitis… as in many cases there are no symptoms to that the patient has the disease,” Abdul Aziz said at a press conference held on the sidelines of the HCV Middle East summit organised by MSD in Dubai.

More than 200 doctors from the region attended the summit to discuss the virus, the best ways to manage it and the medical breakthroughs that may help save the lives of hepatitis C sufferers.

Figures presented in the conference showed that the prevalence of the disease in Saudi Arabia is 1.8 per cent, while it is 0.8 per cent in Kuwait and 1 per cent in Lebanon. In the UAE, 13.9 out of every 100,000 people have the disease.

“Hepatitis has already become an epidemic, with the WHO estimating that 3 per cent of the world’s population or around 170 million are already infected with the virus,” Ramsey Murad, managing director of MSD in the Middle East, said.

He added that the Middle East and North Africa already ranks amongst the highest in the world in terms of both prevalence and incidence.

Hepatitis C in MENA

More than nine million people in the Middle East and North Africa are infected with hepatitis C, only one-third of whom have been diagnosed

Limited public awareness of hepatitis C drives the spread of the disease, as undiagnosed carriers continue to spread it unknowingly

Around 75 per cent of those exposed to the virus develop chronic hepatitis, nearly 20 per cent to 30 per cent of whom develop liver cirrhosis , while around

10 per cent of them will suffer from liver failure

The cost of treating chronic hepatitis C infections is on average $15,000 per patient

The costs of treating the 20 per cent to 30 per cent of the total patient population who develop hepatitis-related chronic liver disease and the resulting complications are huge

Source: MSD

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Herbal product contamination 'considerable,' DNA tests find

Unlisted ingredients and fillers could pose 'serious health risks'

CBC News Posted: Oct 11, 2013 7:21 AM ET Last Updated: Oct 11, 2013 7:21 AM ET

Medicinal herbs such as Echinacea are the fastest growing segment of the North American alternative medicine market, but there are no best practices for identifying the various ingredients, researchers say. (iStock)

A DNA test of herbal products has found that most of them contained cheaper fillers and plant ingredients not listed on the label, some of which pose "serious health risks."

Researchers at the University of Guelph used DNA barcode testing to test 44 herbal products from 12 companies. DNA barcoding uses a short sequence of DNA from a standard segment in plants to identify the species rapidly and accurately.

"Product substitution occurred in 20/44 of the products tested and only 2/12 companies had products without any substitution, contamination or fillers," Steven Newmaster, an integrative biology professor at the University of Guelph and his co-authors concluded in Friday's issue of the journal BMC Medicine.

"Some of the contaminants we found pose serious health risks to consumers."

The World Health Organization calls adulteration of herbal products a threat to consumer safety.

In the study, one product labelled as St. John's wort contained Senna alexandrina, a plant with laxative properties. S. alexandrina isn't meant for prolonged use as it can cause chronic diarrhea and liver damage, and a study suggests it can interact with immune cells in the colon.

Several herbal products contained Parthenium hysterophorus (feverfew), which can cause swelling and numbness in the mouth, oral ulcers and nausea. It also reacts with medications metabolized by the liver and may increase the risk of bleeding, especially if taken with blood-thinning medications, the researchers said.

One ginkgo product was contaminated with Juglans nigra (black walnut), which could be dangerous for people with nut allergies.

Most herbal products 'poor quality'

Newmaster's team said the target crop may have been harvested along with walnut leaves that contain a toxic compound.

The tests identified several potential fillers, including rice, soybean and grasses such as wheat that could pose a health concern for people allergic to those plants and for consumers seeking gluten-free products.

"Most of the herbal products tested were of poor quality, including considerable product substitution, contamination and use of fillers," the study's authors concluded.

Medicinal herbs are the fastest growing segment of the North American alternative medicine market, previous studies suggest.

But there are currently no best practices for identifying the species of various ingredients used in herbal products, the researchers said.

They're proposing that the herbal industry voluntarily use DNA barcoding to authenticate herbal products by testing raw materials to gain consumer confidence.

Canada has regulated natural health products since 2004, but a licensing backlog exists. 

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NICE final draft guidance recommends drugs to treat chronic hepatitis C in children and young people

(Ref: NICE)

October 11th, 2013

In final draft guidance published today NICE has confirmed its earlier draft guidance recommending peginterferon alfa in combination with ribavirin as an option for treating chronic hepatitis C in children and young people.

Hepatitis C is a blood-borne virus that infects the liver. Children and young people get the disease primarily from their mothers at birth. If the virus is not cleared from the body after an acute infection (defined as the first 6 months following initial infection) the condition can progress to chronic hepatitis C (long term infection, lasting more than 6 months). Although hepatitis C rarely causes serous liver damage in children, if left untreated chronic hepatitis C infection increases the risk of scarring of the liver(fibrosis and cirrhosis), liver failure and liver cancer in the future. Peginterferon alfa-2a (Pegasys, Roche Products) and peginterferon alfa-2b (ViraferonPeg, Merck Sharp and Dohme (MSD)), in combination with ribavirin are the only treatments currently licensed in the UK for the treatment of chronic hepatitis C in children and adolescents. They are also licensed for the treatment of chronic hepatitis C in adults.

Professor Carole Longson, NICEHealth Technology Evaluation Centre Director, said: "The independent Appraisal Committee concluded that treatment with peginterferon alfa and ribavirin can decrease the hepatitis C virus to undetectable levels, effectively providing a cure for the disease. Early successful treatment is also likely to lessen the social stigma that can be associated with hepatitis C infection later in life. By widening access to these drugs this guidance will give clinicians and people living with hepatitis C more treatment options."

NICE has not yet issued final guidance to the NHS. Consultees now have the opportunity to appeal the draft guidance. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its guidance on a technology it replaces local recommendations across the country.

Final guidance is likely to be published in November 2013.

Ends

1. The draft guidance will be available from 00:01hrs on Friday 11 October from the NICE website

2. Estimates from the Health Protection Agency in 2011 indicate that 26 people aged 1 year or less and 21 people between the ages of 1 and 14 years were newly diagnosed with HCV in England in 2010. Estimates for chronic infection in children and young people are not available.

3. The Assessment Group calculated that, based on an average age of 11 years, a body weight of 35.5 kg and a body surface area of 1.19 m², a 24-week course of peginterferon alfa-2a and ribavirin costs approximately £3700 while a 48-week course of treatment costs approximately £7400.

4. A 24-week course of peginterferon alfa-2b and ribavirin oral solution costs approximately £4000, while a 48-week course of treatment costs approximately £8100.

5. Ribavirin is manufactured by Roche Products (Copegus) and MSD (Rebetol). Each product is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with peginterferon alfa or interferon alfa. The marketing authorisation for Copegus does not include specific recommendations for use in children. Copegus should be administered only in combination with the interferon products made by Roche Products (peginterferon alfa-2a or interferon alfa-2a). Rebetol (MSD) is available as an oral solution and 200 mg hard capsules and has a UK marketing authorisation for children and adolescents aged 3 years and older in combination only with MSD products peginterferon alfa-2b or interferon alfa-2b.

6. The cost effectiveness results suggested that peginterferon alfa-2a and peginterferon alfa-2b (each in combination with ribavirin were more effective and less costly than best supportive care.

7. The comparison between peginterferon alfa-2a and peginterferon alfa-2b was not robust enough for the Committee to recommend one treatment over the other.

8. NICE technology appraisals apply across the NHS in England and Wales.

9. The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Formerly the National Institute for Health and Clinical Excellence, our name changed on 1 April 2013 to reflect our new and additional responsibility to develop guidance and set quality standards for social care, as outlined in the Health and Social Care Act (2012).

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provideare value for money, in order to reduce inequalities and variation.

Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.

To find out more about what we do, visit our website: www.nice.org.uk and follow us on Twitter: @NICEcomms

To read more Press Release articles, click here.

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A survey of hepatitis C treatment clinical practice patterns using the newly approved protease inhibitors

J Clin Gastroenterol. 2013 Oct;47(9):800-6. doi: 10.1097/MCG.0b013e31828a37c0.

Chen EY, Lee WM, Hynan LS, Singal AG.

*Department of Internal Medicine, Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center and Parkland Health and Hospital System Departments of †Clinical Sciences ‡Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX.

Abstract

GOALS: To describe current hepatitis C virus (HCV) treatment practices in the United States and identify physician characteristics associated with the use of first generation direct-acting antivirals (DAAs).

BACKGROUND: HCV treatment practice patterns have not been assessed after the introduction of DAA, which are now considered standard of care for most HCV genotype 1 patients.

STUDY: We sampled nationally representative physicians treating HCV patients with DAAs through a web-based survey. Stepwise multivariate logistic regression was performed to identify physician characteristics associated with the use of DAAs in 4 clinical vignettes (early stage fibrosis, prior null response, human immunodeficiency virus (HIV) co-infection, and post-liver transplantation).

RESULTS: Of 1658 deliverable emails, 337 (20.3%) clinicians responded. Fifty percent of providers recommended DAA therapy for treatment-naive patients with early stage fibrosis, whereas 49% of providers would await new therapies. For prior null responders with significant fibrosis, 74% would attempt retreatment using DAAs and 26% would await new therapies. Off-label use of DAAs was recommended by 69% of providers for patients with HIV infection and 48% of providers for post-liver transplant patients. Academic affiliation was significantly associated with higher rates of off-label use in both HIV and post-liver transplant patients.

CONCLUSIONS: Despite more potent and less toxic therapies on the horizon, many physicians recommended DAAs in treatment-naive patients with early stage fibrosis. Providers also frequently recommended DAAs for off-label uses, such as treating post-liver transplant patients and those coinfected with HIV.

PMID: 23470640 [PubMed - in process] PMCID: PMC3732573 [Available on 2014/10/1]

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Various predictors of sustained virologic response in different age groups of patients with genotype-1 chronic hepatitis C

J Clin Gastroenterol. 2013 Oct;47(9):794-9. doi: 10.1097/MCG.0b013e31829d2064.

Lin CY, Sheen IS, Chen JY, Huang CW, Huang CH, Jeng WJ, Chen WT.

Departments of *Gastroenterology and Hepatology ‡Rheumatology, Allergy and Immunology, Linkou Medical Center, Chang Gung Memorial Hospital †School of Medicine, College of Medicine, Chang Gung University, Taoyuan, Taiwan.

Abstract

BACKGROUND: Age is one of the sustained virologic response (SVR) predictors for genotype-1 chronic hepatitis C patients treated with pegylated interferon-α/ribavirin. However, variation of SVR predictors in different age groups was not explored before. We therefore conducted this study for investigating this issue.

METHODS: We retrospectively analyzed 265 genotype-1 chronic hepatitis C patients who received pegylated interferon-α/ribavirin treatment. These patients were divided into 3 age groups. Clinical parameters including the genotype of rs12979860 were analyzed.

RESULTS: SVR rate was highest in patients younger than 45 years and lowest in patients older than 65 years even through propensity score matching analysis. As for rapid virologic response (RVR) predictors, genotype of rs12979860 was the predictor for the patients younger than 45 years and patients aged between 45 and 65 years, but no RVR predictor was found for patients older than 65 years. As for the SVR predictors, HbA1c, baseline viral load, and RVR but not genotype of rs12979860 were the predictors in patients younger than 45 years. For patients between 45 and 65 years, the predictors for SVR were liver fibrosis, genotype of rs12979860, and RVR. For patients older than 65 years, RVR was the only predictor for SVR.

CONCLUSIONS: SVR predictors are various in different age groups. RVR is the SVR predictor for all age groups, but the genotype of rs12979860 is the SVR predictor only for patients with age between 45 and 65 years but not younger or older patients.

PMID: 23842218 [PubMed - in process]

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