Sunday, August 14, 2011

Hepatitis News; Weekend Update

HCV In The News; Highlights

FYI-Which New Hepatitis C Drug do MDs Prefer? Incivek vs. Victrelis
Podcast; New Treatments for Hepatitis C
Realize the advance in Hepatitis C treatment, but remain cautious.
Hepatitis c-Insurers raising co-pays for expensive drugs

Weekend Updates;

From: HIV and Hepatitis
Treatment of HIV/HCV Coinfected People with Compensated Liver Cirrhosis
HIV positive people with compensated liver cirrhosis related to chronic hepatitis C virus responded as well to treatment with pegylated interferon and ribavirin as coinfected patients without cirrhosis, but they should receive closer monitoring and may need more intensive management of side effects....

HCV Abstracts

J Hepatol. 2011 Aug 6. [Epub ahead of print]
Telaprevir with peginterferon and ribavirin for treatment-naive patients chronically infected with HCV of genotype 1 in Japan.
Kumada H, Toyota J, Okanoue T, Chayama K, Tsubouchi H, Hayashi N.
Department of Hepatology, Toranomon Hospital, Tokyo, Japan.

Background & Aims: To evaluate the efficacy and safety of telaprevir in combination with peginterferon-α2b (PEG-IFN) and ribavirin (RBV) in patients with chronic hepatitis C.

In a multi-center randomized clinical trial in Japan, 126 patients were assigned to telaprevir for 12 weeks along with PEG-IFN and RBV for 24 weeks (Group A), while 63 to PEG-IFN and RBV for 48 weeks (Group B) who were infected with HCV of genotype 1.

HCV RNA disappeared more swiftly in patients in Group A than B, and the frequency of patients without detectable HCV RNA at week 4 (rapid virological response [RVR]) was higher in Group A than B (84.0% vs. 4.8%, p < 0.0001). Grade 3 and 4 skin disorders, including Stevens-Johnson syndrome and drug rashes with eosinophilia and systemic symptoms, as well as Grade 3 anemia (< 8.0 g/dL), occurred more frequently in Group A than B (skin disorders, 11.9% vs. 4.8%; anemia, 11.1% vs. 0.0%). The total RBV dose was smaller in Group A than B (47.0% vs. 77.7% of the target, p < 0.0001). Despite these drawbacks, sustained virological response (SVR) was achieved more frequently in Group A than B (73.0% vs. 49.2%, p = 0.0020).

Although the triple therapy with telaprevir-based regimen for 24 weeks resulted in more adverse events and less total RBV dose than PEG-IFN and RBV for 48 weeks, it was able to achieve higher SVR within shorter duration by carefully monitoring adverse events and modifying the RBV dose as required.

Copyright © 2011. Published by Elsevier B.V.
[PubMed - as supplied by publisher]

Ann Pharmacother. 2011 Aug 9. [Epub ahead of print]
Boceprevir: A Protease Inhibitor for the Treatment of Chronic Hepatitis C (September).
Foote BC, Spooner LM, Belliveau PP.
School of Pharmacy Worcester/Manchester, Massachusetts College of Pharmacy and Health Sciences, Worcester, MA.

To review the pharmacology, pharmacokinetics, safety, and efficacy of boceprevir, a novel oral hepatitis C virus (HCV) nonstructural 3 (NS3) protease inhibitor for the treatment of chronic HCV infection, specifically, genotype 1.

A literature search was conducted through MEDLINE and EMBASE (1966-May 2011) using the terms boceprevir and SCH 503034. Data from the package insert, abstracts obtained from conferences, and unpublished Phase 2-3 clinical trials, obtained through, were also reviewed.

All English-language articles identified from the data sources were evaluated. References from selected articles were used to identify other pertinent citations. Article selection focused on pharmacology, clinical trials, safety analyses, and resistance. Preference was given to human data.

Boceprevir is an oral protease inhibitor that binds to the NS3 protein of HCV, ultimately inhibiting viral intracellular replication. Boceprevir displays linear pharmacokinetics and is rapidly absorbed upon oral administration. In clinical studies of treatment-naïve and treatment-experienced patients, boceprevir, in combination with standard of care (pegylated interferon [Peg-IFN]-α-2b with or without ribavirin) achieved greater sustained viral response (SVR) rates compared to standard of care. Safety analyses showed an increased incidence of adverse effects when boceprevir was used with Peg-IFN-α-2b and ribavirin. The most common adverse events reported include fatigue, headache, nausea, dysguesia, and anemia; the incidence of the latter 2 adverse effects may be increased if boceprevir is added to standard therapy. Additional Phase 2 and 3 studies are currently enrolling participants.

Boceprevir should be used in combination with Peg-IFN-α-2b and ribavirin in the treatment of chronic HCV genotype 1 infection. The improved response rates achieved with that combination will make boceprevir a viable option compared with other developing and approved NS3 protease inhibitors for treatment-naïve and treatment-experienced nonresponders/relapsers. Additional data are needed to clarify the potential for resistance and drug interactions.

Current Issue GI & Hepatology
August 2011
Download PDF Interactive Version
Adding Boceprevir Achieved SVR of 64%Phase III data indicate that the oral protease inhibitor boceprevir increases antiviral activity when combined with peginterferon alfa-2a and ribavirin in patients with hepatitis C genotype 1 who failed prior therapy.

NIH-AARP Study: Diabetes Linked to Several GI Cancers
Diabetes appears to be associated with an increased risk of several types of cancer and with an increased risk of cancer-related mortality in both men and women, findings from a large...

Aug 13, 2011
The Lancet,
Vol. 378 No. 9791 pp 571-583
Global epidemiology of hepatitis B and hepatitis C in people who inject drugs: results of systematic reviews
Injecting drug use is an important public health issue around the world: 16 million people injected drugs in 2007 (range 11—21 million).1 Much of the estimated burden of disease attributable to the use of illicit drugs is probably due to blood-borne viral infections through unsafe drug injection.2 Hepatitis B and C viruses (HBV and HCV, respectively) are even more efficiently spread by this practice than is HIV.3

About 80% of individuals exposed to HCV develop chronic infection,4 and 3—11% of people with chronic HCV infection will develop liver cirrhosis within 20 years,5 with associated risks of liver failure and hepatocellular carcinoma.6

Transmission of HCV increasingly occurs through injecting drug use,7 but in many developing countries unsafe medical injections and transfusions are predominant sources of infection. The emergence of injecting drug use is an additional threat in settings where the prevalence of HCV is high (eg, Africa, the Middle East, and southeast Asia).

HBV is highly contagious through parenteral, sexual, and vertical (perinatal transmission) routes. About 5% of adults exposed to HBV develop chronic HBV infection;4 most of the 350 million chronically infected people worldwide were infected in childhood.8 Cirrhosis and death because of hepatocellular carcinoma are important sequelae of chronic HBV infection.9
Despite the higher prevalence and transmissibility of viral hepatitis, the disease has received far less global attention than has HIV. WHO called prevention and control efforts “successful but fragmented…[with no] comprehensive strategy for viral hepatitis”.10 At WHO's 63rd World Health Assembly in May, 2010, a resolution was passed to establish “goals and strategies for disease control, increasing education and promoting screening and treatment”10 of people infected with HBV and HCV.WHO argues that injecting drug users (IDUs) are a key group that need to be specifically targeted for prevention and treatment of viral hepatitis.10 For such efforts to be appropriately scaled and targeted, policy makers and health-care professionals need accurate and detailed data for the size of the population at risk, as exist for HIV.1
There have been no global systematic reviews of HBV prevalence in IDUs.11

Previous reviews of HCV in this population have been selective in their geographical coverage,12 have not provided sources or estimation methods,13 or did not make estimates of population size.14 Here, we report a systematic search and critical review of the peer-reviewed and grey literature on hepatitis C antibodies (anti-HCV), hepatitis B core antibodies (anti-HBc), and hepatitis B surface antigens (HBsAg) in IDUs, showing the best available country-level data, and the first regional and global estimates of the number of IDUs living with HCV and HBV.

We do not report estimates of chronic hepatitis A, D, or E viral infection (HAV, HDV, and HEV, respectively). Chronic HAV infection does not occur, and in developing countries most adults are immune, making epidemics uncommon; however, with increased sanitation this epidemiological pattern might change in some populations.15 HDV has been associated with injecting drug use; however, the extent of the published work on HDV (which needs concurrent HBV for infection to be established) is small and the diversity in prevalence, even in countries with a high prevalence of HBV, makes extrapolation between countries difficult.16 HEV is enterically transmitted and HEV data for IDUs is scarce... Click Here For Full Text
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Clinical Hub and Global Health Portal launched
Two key areas of The Lancet—clinical medicine and global health—are showcased by new areas of this website. In the Clinical Hub you will find Clinical Series, Specialty Collections, clinical video and audio, and the latest Clinical Pictures and Case Reports from across The Lancet and The Lancet's specialty journals. The Global Health Portal offers free and unlimited access to all global health content in one location including Series, Regional Reports, multimedia content, and from our World Report and Perspectives sections.

Are you inking yourself with the Hepatitis virus?
By: Priyanka Vora
Date: 2011-08-14
Place: Mumbai

The tattoo craze among city youth could lead to a steep rise in the cases of Hepatitis B and C, say medical experts

With an increase in the number of youngsters opting for tattoos, medical experts in the city are worried that this could lead to rise in the number of Hepatitis B and C cases.

Recent international studies have shown an alarming link between both forms of the virus and people who sport tattoos. According to these reports, both Hepatitis B and C viruses can be contracted if an individual uses a needle and ink that has been previously used on an infected person.

Another recent study conducted by doctors from MIOT Hospital in Chennai has found that India is likely to emerge as the global capital of the Hepatitis B virus. This form of the virus is responsible for 60 per cent of all liver cancer cases in the world. According to the study, currently the number of Hepatitis B carriers in India is estimated to be over 40 million or four crore.

Doctors in the city are reporting a high number of cases of youngsters who have tattoos getting infected by the virus. "Recently, I came across three or four patients with tattoos who had tested positive for Hepatitis B and C. If a needle has been used on someone with Hepatitis B or C, it can easily transmit the virus to the next person who uses the needle, because the needle penetrates deep into the skin during tattooing. The fad of people opting for tattoos is causing a major risk," Dr Abha Nagral, consultant Gastroenterologist and Hepatologist in Bhatia and Jaslok Hospital said....


From Pharmalot;
Pfizer Confesses About ‘Potential’ Overseas Bribes
In another instance in which a drugmaker appears to have bribed overseas officials, Pfizer has “voluntarily” provided the US Department of Justice and the US Securities and Exchange Commission with information concerning “potentially improper payments” made by Pfizer and Wyeth personnel in connection with certain unspecified sales activities outside the US...
In April, Johnson & Johnson was fined $70 million for bribing public doctors in several European countries - and paying kickbacks to Iraq - to illegally obtain business (read this). And over the past year, at least five other drugmakers, including Merck and Eli Lilly, received letters as the feds seeks to uncover any FCPA violations....

Deal in Place for Inspecting Foreign Drugs
Generic drug makers would pay $299 million a year to underwrite government inspections of manufacturing plants abroad, reducing the risk of tainted drugs and speeding approval of their products....

Big Pharma's Newest Gimmick: 'Progressive' Depression
The discovery that many people with life problems or occasional bad moods would willingly dose themselves with antidepressants sailed pharma through the 2000s. A good chunk of pharma's $4.5 billion direct-to-consumer advertising has been devoted to convincing people they don't have problems with their job, the economy and their family, they have depression. Especially because depression can't be diagnosed from a blood test.


Canada: 'Fractured' Health-Care System Failing Patients, Doctors Say
Gloria Galloway(The Globe and Mail, Toronto, August 10, 2011)
"Canadians have told Canada’s doctors that they want better value for their health dollars through an expanded public system that treats illnesses faster and covers a wider range of services. The majority of participants in a year-long public consultation on the health system conducted by the Canadian Medical Association [CMA] said the money spent on health could be allocated more efficiently and that patients are still waiting too long for the care they need…Large numbers of people told the CMA that the future of medicine in this country must include healthier communities through a health promotion strategy, as well as improved access to long-term care, home-based care and pharmacare."

Understanding of Probiotics 'Still in Its Infancy'
By: DOUG BRUNK, Internal Medicine News Digital Network
SAN DIEGO – With consumers buzzing about the advertised benefits of probiotics for a healthy gut, what’s a primary care physician to recommend?
At a meeting on primary care medicine sponsored by the Scripps Clinic, Dr. Walter J. Coyle emphasized that while probiotics may play a role in the treatment and management of certain gastroenterological conditions, "there are not a lot of well-done randomized, placebo-controlled trials of these drugs. Most GI physicians use probiotics regularly, but our understanding of how these products work and interact with our immune systems and gut lining is still in its infancy."
The majority of probiotics are gram-positive lactic acid producers such as Bifidobacterium and Lactobacillus species, "which survive in transit through the stomach and duodenum," said Dr. Coyle, a gastroenterologist who directs the Scripps Clinic Gastroenterology Fellowship Program. Others include nonpathogenic streptococci, enterococci, Escherichia coli Nissle 1917, and Saccharomyces boulardii (yeast).

Dr. Coyle discussed the potential benefits of several probiotics on the market:
– VSL #3. This product contains four lactobacilli organisms (L. plantarum, casei, acidopholus, and delbrueckii), three bifidobacteria organisms (B. infantis, breve, and longum), and one streptococcus organism (Streptococcus salivarius subsp. thermophilus). "It’s fairly expensive and has to be kept refrigerated," Dr. Coyle said. "Randomized placebo-controlled trials have shown it’s very good for pouchitis." A more recent study of its use in ulcerative colitis patients found that it was superior to placebo in mild to moderate activity (Am. J. Gastroenterol. 2010; 105:2218-27). "It’s not one of my first-line therapies for inflammatory bowel disease, but it is out there as an alternative," he said.

– Digestive Advantage for IBS. This product contains Ganeden BC30, a patented bacteria strain of Bacillus coagulans, erythritol, cellulose, and other minor ingredients. One small, randomized, double-blind, placebo-controlled trial found it to be an effective treatment of abdominal pain and bloating in patients with irritable bowel syndrome (Postgrad. Med. 2009;121 [doi: 10.3810/pgm.2009.03.1984]). "I’ll try it if the patients fail to have symptom improvement with other therapies, but there are no really well done randomized, placebo-controlled trials, which is the problem with most probiotics," Dr. Coyle said.

– Align. This product contains a patented strain of Bifidobacterium infantis 35624. In two large trials, it demonstrated decreased symptoms in IBS patients, "mostly in bloating and a little bit on flatulence," he said. This probiotic was also shown in trials to decrease the mucosal levels of IL-6, a known inflammatory cytokine. (See Gastroenterol. 2005;128:541-51 and Am. J. Gastroenterol. 2006;101:1581-90.) "I often try Align for my irritable bowel patients," he said.
– Florastor (Saccharomyces boulardii). This product has been shown to help prevent recurrent Clostridium difficile infections and to decrease diarrhea associated with antibiotic use. The dosing in one randomized, placebo-controlled study (JAMA 1994;271:1913-8) was two tablets twice per day, "which is expensive," Dr. Coyle said. "I typically recommend one tablet twice a day. However, for those patients who have had multiple recurrences of C. difficile, I do use the higher dose of two tablets twice per day."

– Actimel. This yogurt-type drink contains the patented yogurt culture known as Lactobacillus casei Immunitas. In a 2007 randomized, placebo-controlled trial of 135 hospitalized patients on antibiotics, those who received an Actimel-like product were significantly less likely to develop hospital-acquired diarrhea, compared with those who received placebo (12% vs. 34%, respectively). A similar association was seen in the prevention of hospital-acquired C. difficile (BMJ 2007;335:80 [doi: 10.1136/bmj.39231.599815.55]).

In this trial, "you only needed to treat five patients to prevent one case of hospital-acquired diarrhea, and you only needed to treat six patients to prevent one case of hospital-acquired C. difficile," Dr. Coyle said. "Why are we not doing this in the hospital?"
– Activia. This yogurt product contains Bifidus regularis and Bifidobacterium animus, and has been shown in scientific studies to increase transit time in women and in older adults. "If you like the taste of Activia, take it," he commented. "I don’t think I’d take it for making your gut healthier. It may, but we don’t have the data. It does help in patients who are often constipated. I’m fine with that, but I’m not sure I would classify it as a medical food."

– Culturelle. This product contains Lactobacillus rhamnosus GG and has been shown in scientific studies to be superior to placebo for diarrheal illnesses. "It’s proven to survive transit through the stomach and small intestine, and binds to human colonocytes," Dr. Coyle said. "It’s a reasonable choice for diarrhea patients and it’s been around for a long time."

He noted that current studies of prebiotics – ingested substances that selectively stimulate the proliferation or activity of desirable bacterial populations present in the host intestinal tract – have the potential for significant impact in the field of gastroenterology. "Is it possible to design a food, sugar, protein, or fat that would alter your gut flora to promote weight loss? That concept is exciting," he said. "I think you’re going to see a lot coming down the line on this."
Dr. Coyle said that he had no relevant financial disclosures.

Off The Cuff

FRONTLINE The Pot Republic

Watch the full episode. See more FRONTLINE.


From The New York Times
Hot Chemotherapy Bath: Patients See Hope, Critics Hold Doubts
SAN DIEGO — This is cancer therapy at its most aggressive, a treatment patients liken to being filleted, disemboweled and then bathed in hot poison.

The therapy, which couples extensive abdominal surgery with blasts of heated chemotherapy to the abdominal cavity and its organs, was once a niche procedure used mainly against rare cancers of the appendix. Most academic medical centers shunned it.

More recently, as competition for patients and treatments intensifies, an increasing number of the nation’s leading medical centers has been offering the costly — and controversial — therapy to patients with the more common colorectal or ovarian cancers. And some hospitals are even publicizing the treatment as a hot “chemo bath.”

To critics, the therapy is merely the latest example of one that catches on with little evidence that it really works. “We’re practicing this technique that has almost no basis in science,” said Dr. David P. Ryan, clinical director of the Massachusetts General Hospital Cancer Center.
But to some patients, the procedure, however grueling and invasive, represents their best hope for survival: “It’s throwing everything but the kitchen sink at cancer,” said Gloria Borges, a 29-year-old Los Angeles lawyer who had her colon cancer treated with what she called the “pick it out, pour it in” procedure.

For hours on a recent morning at the University of California, San Diego, Dr. Andrew Lowy painstakingly performed the therapy on a patient.
After slicing the man’s belly wide open, he thrust his gloved hands deep inside, and examined various organs, looking for tumors. He then lifted the small intestine out of the body to sift it through his fingers.....Read Full Article Here

Click Here To Listen To Podcast
Omega tau podcast – viruses, bacteria, and other parasites
After a listener made the Omega tau podcast his pick of the week on TWiV129, I sent a note to the show’s author, Marcus Völter. He responded by inviting me on his program. I brought Dickson Despommier with me and we recorded a wide-ranging conversation on viruses, bacteria, and parasites. It is very basic, so if you have ever felt that TWiV, TWiP, or TWiM are too advanced, you might like this episode.

Informational Links

About hepatitis C
Hepatitis C is a blood-borne virus that predominantly infects the cells of the liver. This can result in inflammation and significant damage to the liver. It can also affect the liver’s ability to perform its essential functions. Although it has always been regarded as a liver disease - ‘hepatitis’ means ‘inflammation of the liver’ - recent research has shown that HCV affects a number of other areas of the body. These can include the digestive system, the lymphatic system, the immune system and the brain....

Financial Support Assistance Programs
Many companies offer patient assistance programs which give medications free of charge to physicians whose patients might not otherwise have access to necessary medicines

Hepatitis C New Drug Research and Liver Health
These links will take you to the premier Hepatitis C sites and keep you informed with breaking news, clinical studies, new drugs, podcasts, newsletters, support, personal experiences and more.

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