Research & Treatment News
April 27, 2007
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Researchers' recent discovery of a protein may lead to the development of new Hepatitis C drugs. Learn what protein is involved in stopping the virus from replicating, making it critical in the search for medications capable of preventing infection.
New Protein Controls Growth Of Hepatitis C Virus
www.sciencedaily.com
Date: April 24, 2007
Science Daily — Researchers reveal a new protein that prevents the hepatitis C virus from replicating, which could help devise new drugs against hepatitis C.
Hepatitis C is a blood-borne, infectious disease that can cause liver inflammation, fibrotic scarring of the liver -- or cirrhosis -- and liver cancer. The virus spreads within its host by replicating its RNA and using it to build proteins that form new viruses and by inhibiting various antiviral proteins inside host cells. By understanding both mechanisms, scientists hope to prevent the virus from replicating, thus stopping the infection.
Stanley M. Lemon and colleagues discovered a new protein involved in stopping the virus from replicating. Called p21-activated kinase 1, the protein is known to play a role in several cellular signaling pathways, but it has not been shown previously to be involved in regulating the replication of hepatitis C virus.
Article: "p21-activated Kinase 1 Is Activated through the Mammalian Target of Rapamycin/p70 S6 Kinase Pathway and Regulates the Replication of Hepatitis C Virus in Human Hepatoma Cells" by Hisashi Ishida, Kui Li, MinKyung Yi, and Stanley M. Lemon
Note: This story has been adapted from a news release issued by American Society for Biochemistry and Molecular Biology.
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April 20, 2007
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Achillion recently revealed progress in preventing Hepatitis C viral replication. Although discontinued due to its strain on the kidneys, clinical trials with ACH-806 demonstrated potent HCV anti-viral activity. Find out how those results may shape the development of the next generation of drugs that carry the hope of finding a more effective HCV treatment.
Achillion Presents Positive Data on Novel Mechanism for Treating HCV at EASL Annual Meeting
PR Newswire Europe (inc. UK Disclose) - Apr. 16, 2007
NEW HAVEN, Conn., April 16 /PRNewswire-FirstCall/ -- Achillion Pharmaceuticals, Inc. today announced the presentation of data validating the clinical antiviral activity of one of Achillion's NS4A antagonists, ACH-806, for the treatment of hepatitis C virus (HCV) infection at the 42nd Annual Meeting of the European Association for the Study of the Liver (EASL). In three separate presentations, Achillion researchers discussed the potent antiviral activity in HCV-infected subjects, synergy with other classes of HCV inhibitors, and the unique mode of action of a NS4A antagonist. Achillion has shown that blocking NS4A, a viral protein that binds to a portion of HCV protease, inhibits HCV replication. This program is part of a collaboration and exclusive license agreement with Gilead Sciences for the research, development and commercialization of compounds for the treatment of chronic HCV.
In a late-breaker session on April 14th at 5:00 PM, John Pottage, M.D., Senior Vice President and Chief Medical Officer at Achillion, discussed clinical data in a presentation titled, "Short-term Antiviral Activity and Safety of ACH-806 (GS-9132), an NS4A Antagonist, in HCV Genotype 1 Infected Individuals." The randomized, double-blind, placebo-controlled dose-escalation trial measured the antiviral activity, safety and pharmacokinetics of 300 mg of ACH-806 or placebo, dosed orally twice daily as a monotherapy over 5 days. The mean change in HCV RNA (log10) at day 5 was a decrease of 0.91 from baseline for treated subjects versus an increase of 0.05 for control subjects. Elevations in serum creatinine (a marker of kidney function) were observed in ACH-806 treated subjects and were reversible after completion of dosing.
"This study provides the first demonstration of human antiviral activity of an NS4A antagonist for HCV," said Dr. Pottage. "While we and our partner Gilead decided to discontinue development of ACH-806 based upon the increase in serum creatinine levels, we do not believe this effect was target-related. The antiviral activity of the compound validates NS4A as a novel therapeutic target and therefore supports our continued work with Gilead to identify and evaluate next-generation compounds with the same mechanism of action."
A second presentation on April 12 at 6:30 PM, titled "In Vitro Evaluation of Combination Treatment of ACH-806 with Interferon, VX-950 and NM 107," was led by Mingjun Huang, Ph.D., Senior Director of Virology at Achillion, who discussed in vitro evaluations of ACH-806 in combination with interferon, a protease inhibitor, and a polymerase inhibitor. The data revealed that the NS4A antagonist did not show in vitro cross-resistance with agents from these other HCV therapeutic classes, and that NS4A antagonism appears to have a synergistic antiviral effect in combination in vitro with the HCV protease inhibitor VX-950 and the polymerase inhibitor NM 107.
Finally, in a third presentation on April 12 titled "ACH-806: A Potent Inhibitor of HCV Replication with a Novel Mechanism of Action," Dr. Huang described the novel mechanism of action of NS4A antagonists. Achillion's studies demonstrated that these antagonists block the formation of functional viral replication complexes, thereby preventing HCV replication independent of protease or polymerase inhibition.
"The high mutation rate of HCV necessitates the combination use of drugs with complimentary mechanisms of action in order to suppress viral resistance. Therefore, the possibility that candidates with the unique NS4A antagonism mechanism may be complementary to protease and polymerase inhibitors will be an important benefit in treating HCV infection," stated Pottage.
Posted by Editors at 5:09 PM --- Printer-friendly version
April 19, 2007
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An analysis of several recent clinical trials shows how important early responses to treatment are for clearing the Hepatitis C virus. Now doctors can tell earlier than ever, the chances patients can be cured. Find out just how soon doctors can now determine the success of treatment and what this means for newly diagnosed patients.
Treatment Optimisation With PEGASYS Plus COPEGUS Offers Patients With Hepatitis C an Excellent Chance for a Cure
www.presseportal.de
High Response Rates Confirmed in 'Real-Life' Study and Clinical
Trials
BASEL, Switzerland, April 13 /PRNewswire/
Patients with hepatitis C who respond quickly to treatment have an
excellent chance of being cured of the disease, according to data
presented today at the 42nd Annual Meeting of the European
Association for the Study of the Liver (EASL). Patients with genotype
1 hepatitis C (HCV) who clear the virus within a month of starting
treatment with PEGASYS (peginterferon alfa-2a (40KD)) plus COPEGUS
(ribavirin) have up to a 91% chance of achieving a sustained
virological response (SVR), considered a cure by researchers.
"Now we can tell earlier than ever - at just week 4 of treatment -
whether a patient has a good chance to be cured." said Professor
Patrick Marcellin, Hôpital Beaujon, Clichy, France. "Knowing their
virus levels in the first and third months of treatment helps
patients take ownership of beating the disease and helps motivate
them to stay on treatment. This information should be made available
for everyone starting therapy."
Early Response to Treatment Means Patients Have an Excellent
Chance for a Cure
An analysis of six different clinical trials highlights the value
of checking how well patients with genotype 1 HCV have responded to
treatment at weeks 4 and 12 of therapy(1). The results of the
analysis showed that of those patients treated with PEGASYS 180 mcg
weekly plus COPEGUS 1,000-1,200 mg daily:
- Up to one in five cleared the virus by week 4 of therapy
(called rapid viral response)
- 83-91% of patients with a rapid viral response went on to be
cured of their hepatitis C
- About 40% of patients who did not achieve a rapid viral response
managed to clear the virus by week 12 of therapy (called complete
early virological response); 65-67% of these patients were cured
Excellent Chance for a Cure for Rapid Viral Responders Confirmed
in 'Real-Life' Study
A large real-life study involving 4,377 patients conducted by the
Association of German Independent Gastroenterologists confirms that
these results can be replicated in clinical practice(2):
- One quarter of patients with 'difficult-to-cure' genotype 1
or 4 HCV who had their viral levels tested at week 4 of treatment
achieved a rapid viral response
- While the study is not yet complete, over 70% of those who have
finished their 6-month post-treatment follow-up period were cured
"These are really important results," said Dr Elmar Zehnter,
Gastroenterologist and Hepatologist, Dortmund, Germany, and
researcher in the study. "This study confirms that the high cure
rates reported for rapid viral responders in clinical trials
translate into clinical practice and are relevant to the patients we
see every day. At the moment, testing viral levels at 4 weeks of
treatment is not standard practice. Based on these results, however,
testing viral levels at 4 weeks of therapy should become a routine
test."
About Hepatitis C
Hepatitis C, the most common chronic blood-borne infection, is
transmitted primarily through blood or blood products. Hepatitis C
chronically infects 180 million people worldwide, which makes it more
than four times more prevalent than HIV(3,4). Alarmingly, many people
infected with hepatitis C don't even know they carry the virus. For
example, it is estimated that 80-90% of people with hepatitis C in
the UK are unaware that they are infected(5). Hepatitis C is a
leading cause of cirrhosis, liver cancer and liver failure, despite
the fact that many patients can be cured with treatments that are
available today.
About PEGASYS
PEGASYS, the market leader worldwide in hepatitis C therapy,
provides significant benefit over conventional interferon therapy in
HCV patients of all genotypes. The benefits of PEGASYS are derived
from its large 40 kilodalton (KD) branched-chain polyethylene glycol
(PEG) construction, which allows for sustained drug levels over the
course of a full week. PEGASYS also distributes more readily to the
liver (the primary site of infection) than conventional interferon.
PEGASYS is the only pegylated interferon available as a
ready-to-administer solution. Each weekly subcutaneous injection
contains 180 mcg of pegylated interferon alfa-2a (40KD), which is the
approved dose for all patients, regardless of body weight.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's
leading research-focused healthcare groups in the fields of
pharmaceuticals and diagnostics. As the world's biggest biotech
company and an innovator of products and services for the early
detection, prevention, diagnosis and treatment of diseases, the Group
contributes on a broad range of fronts to improving people's health
and quality of life. Roche is the world leader in in-vitro
diagnostics and drugs for cancer and transplantation, a market leader
in virology and active in other major therapeutic areas such as
autoimmune diseases, inflammation, metabolism and central nervous
system. In 2006 sales by the Pharmaceuticals Division totalled 33.3
billion Swiss francs, and the Diagnostics Division posted sales of
8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide and
has R&D agreements and strategic alliances with numerous partners,
including majority ownership interests in Genentech and Chugai.
Additional information about the Roche Group is available on the
Internet at www.roche.com.
All trademarks used or mentioned in this release are protected by
law.
Film footage is available for broadcast journalists from The
NewsMarket at www.thenewsmarket.com. Video is compressed in MPEG2 and
is available for download to your FTP server.
References
1. Marcellin P, Hadziyannis S, Berg T, et al. Virological response
at 4 and 12 weeks predict high rates of sustained virological
response in genotype 1 patients treated with peginterferon alfa-2a
(40KD) plus ribavirin. In: 42nd Annual Meeting of the European
Association for the Study of the Liver; 2007 April 11-15; Barcelona,
Spain; 2007.
2. Zehnter E, Mauss S, Boeker K, et al. Potential relevance of
rapid viral response for SVR and optimisation of the treatment of
hepatitis C (CHC) with peginterferon alfa-2a (PEG) and ribavirin
(RBV). In: 42nd Annual Meeting of the European Association for the
Study of the Liver; 2007 April 11-15; Barcelona, Spain; 2007.
3. AIDS Epidemic Update. 2006. (Accessed February 27, 2007, at
http://www.who.int/hiv/mediacentre/2006_EpiUpdate_en.pdf.)
4. Initiative for Vaccine Research, Viral Cancers, Hepatitis C.
World Health Organization, 2006. (Accessed July 24, 2006, at http://w
ww.who.int/vaccine_research/diseases/viral_cancers/en/index2.html.)
5. The hepatitis C scandal. London: All-Party Parliamentary Group
on Hepatology; 2004.
ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de
Contact:
Contact: Janet Kettels, Roche, +1-862-596-9084; Natalie Henson, Axon
Communications, +44(0)20-843-99-406
Posted by Editors at 9:25 AM --- Printer-friendly version
April 18, 2007
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Symptoms of Hepatitis C and damp heat both include jaundice, fever and thirst. Learn how to determine if you're suffering from damp heat accumulation, as well as foods you should add to or eliminate from your diet that will make a profound difference in your health.
by Nicole Cutler, L.Ac.
One of the reasons acupuncturists and Chinese herbalists have success in helping people with chronic Hepatitis C is because they approach each client as an individual. As practitioners of Traditional Chinese Medicine (TCM), these professionals see past the medical diagnosis to the pattern of imbalance blocking each person’s wellness.
There are approximately ten, very different, major TCM imbalances responsible for progression of the Hepatitis C virus. According to this system of medicine, damp heat accumulation is commonly seen in individuals with Hepatitis C. While the best way of benefiting from TCM is to visit one of its practitioners, here is a general guide for deciding if damp heat accumulation is part of your imbalance and how to approach it nutritionally.
Basic Theory
According to TCM, health is largely dependant upon the continual transformation and movement of various energetic and material substances throughout the body. When the body’s fluids are prevented from being properly transformed and moved to their destination, dampness ensues. Treating dampness is challenging because it is sticky, heavy and tends to further clog all surrounding avenues. This is why imbalances diagnosed by TCM as damp are often long-term, chronic conditions. Additionally, people with Hepatitis C are encouraged to reduce dampness because infections thrive in damp environments.
Dampness is usually accompanied by a weakness in the body’s digestive system. Responsible for separating food into nutrition and waste, a weak digestive system causes the excretion of nutritional elements, and allows unhealthy substances to remain in our systems. When a weak digestive system allows material that should be excreted to circulate, proper fluid movement is hampered, causing dampness.
Heat is generated when dampness resides in the body for any extended period of time. The accumulation of damp heat in the body can be compared to an overheated engine. As sludge builds up in the moving parts of an engine, there is increased resistance to its proper functioning. With increasing resistance, the parts get hotter and hotter, drying up any remaining lubricants. If nothing is done to break the cycle, this unfortunate chain of events ends in an overheated engine.
Damp Heat Manifesting
Although diagnosing damp heat as the predominant imbalance requires a knowledgeable practitioner’s evaluation, those aware of what is happening with their bodies can get a general idea if they are living with this disharmony. Since TCM diagnosis is based on pattern differentiation, every given symptom of an imbalance will not fit each person. Interestingly, many classic symptoms of acute Hepatitis C are synonymous with symptoms of damp heat. These include:
· Jaundice – Bright yellow coloring of the eyes or face. While jaundice can be a dull or pale yellow, bright yellow is more characteristic of a damp heat disharmony.
· Nausea, vomiting and/or reduced appetite – It is important to separate a love of food from listening to the food desires communicated by your body. Nausea, vomiting and low appetite are all signs that dampness may be obstructing the digestive system.
· Fever – Whether it is high or low grade, fever is a manifestation of heat.
· Abdominal or rib-area pain – In TCM, sharp or intense pain is characteristic of stagnation. As damp heat is a type of fluid stagnation, this is one explanation behind this type of pain.
· Thirst – Damp heat characteristically involves thirst (as a result of the heat), but with actual little to no desire to drink (as a result of the dampness).
Dietary Balancing
One branch of TCM is using dietary therapy to help balance the body. In the case of damp heat, there are four primary goals to accomplish: cool the heat, dry the dampness, move the congestion, and strengthen digestion. The following foods perpetuate stagnation, heat and dampness, and should be avoided:
· Oily and fatty; these qualities perpetuate dampness
· Raw; this takes more energy for an already weak digestive system to break down
· Sugary; refined sugar and other concentrated sweeteners contribute to dampness’ sluggish quality
· Spicy; perpetuates heat
· Alcohol; anything containing alcohol worsens both heat and dampness
In general, foods that are bitter, cooling and alkalizing help neutralize damp heat conditions. When experiencing an acute bout of damp heat-related symptoms, the following dietary advice will make the person more comfortable and headed in a healthy direction:
· Focus your food choices around light soups, broths and herbal teas.
· Include aduki beans, mung beans, lima beans, celery, carrots, winter squash, potatoes with skins, asparagus, mushrooms, dandelion leaves, lemons, cranberries, and huckleberries in your food selection.
· Lightly cook vegetables (instead of a raw salad) to help your digestive system extract nutrients.
Symptoms dominated by a TCM damp heat imbalance can be turned around with dietary therapy. While this dietary advice may seem limiting, remember that it is only intended to get you through the rough times. By including some of the food suggestions and avoiding some of the contributors to damp heat, your body will get a break from the self-perpetuating cycle dampness encourages. Just because an engine has accumulated some sludge, and is working harder to drive around, doesn’t mean it is doomed to overheating. The beauty of the human body is that by paying attention to what it is telling you, you can use something as simple as your diet to reset it in order to live a long, healthful life.
References:
Cohen, Misha, OMD, L.Ac., Hepatitis C Virus: The Silent Epidemic, Part Two, Acupuncture Today, October 2002.
Pitchford, Paul, Healing with Whole Foods, North Atlantic Books, Berkeley, CA, 1993.
www.acupuncture.com, Dampness and the Circle of Wellness, Aram Akopya, Cyber Legend, Ltd., 2007.
Posted by Editors at 4:37 PM --- Printer-friendly version
April 5, 2007
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Important research examining the risks of Hepatitis C transmission through heterosexual relationships has recently been conducted. Discover whether heterosexual couples were found to be at an increased risk for acquiring HCV in consideration of additional risk factors.
Lack of evidence for the heterosexual transmission of hepatitis C
http://qjmed.oxfordjournals.org
G. Neumayr, A. Propst, H. Schwaighofer, G. Judmaier and W. Vogel
From the Division of Gastroenterology, Department of Internal Medicine, University of Innsbruck, Austria
Received 14 April 1999 and in revised form 5 July 1999
Dr G. Neumayr, Department of Internal Medicine, University of Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria
Summary
The importance of sexual transmission in the epidemiology of hepatitis C virus (HCV) infection is still controversial. To assess the risk of heterosexual HCV transmission, we examined eighty patients with chronic HCV-associated liver disease and their spouses in a cross-sectional clinical and serological cohort study. Serum samples from index patients and their spouses were assayed for HCV antibodies and HCV RNA. In the couples positive for both, further HCV genotyping was done. A questionnaire addressing points such as additional risk factors for HCV infection, sexual behaviour or duration of partnership was completed by all couples. HCV antibodies were detected in four (5%) spouses, of whom three (4%) were also positive for HCV-RNA. HCV genotyping revealed concordance (genotype 1) in two couples, indicating a risk of interspousal HCV transmission of 2.5%. Spouses of patients with HCV viraemia and chronic liver disease have a low risk for acquiring HCV. Even long-term spouses seem not to be at increased risk. We therefore suggest that the risk of HCV transmission between monogamous sex partners does not depend on the duration of sexual exposure.
Introduction
The use of advanced gene technology made possible the characterization of hepatitis C virus (HCV) by Choo and coworkers in 1989. Soon HCV was identified as the major cause of non-A, non-B hepatitis worldwide.1–4 Epidemiological studies showed that its most efficient route of transmission is parenteral, by transfusion of blood or blood products, by intravenous drug abuse, occupational needle-stick injuries, haemodialysis and organ transplantation. Parenteral transmission is well established, and accounts for the high rates of HCV among haemophiliacs and intravenous (i.v.) drug users. In about 30–40% of HCV cases, the routes of transmission remain unknown.5,6 Sexual transmission or other close human contact could play a role in these sporadic or community-acquired infections.
Many studies have addressed this question and achieved somewhat conflicting results. The high prevalence of HCV found in prostitutes,7 male homosexuals,8–10 sex partners of patients infected with both HCV and human immunodeficiency virus11 and patients attending sexually-transmitted-disease clinics,9,12,13 suggests that sexual transmission may occur. Other studies, however, having investigated monogamous sex partners of HCV-infected transfusion recipients and of patients with acute or chronic hepatitis C, reveal infrequent or no sexual HCV transmission.14–20,25,26
Results from Asian countries indicate that interspousal transmission becomes more important with longer duration of partnership.21–23 Similar data from Western countries are rare.24–26 To evaluate the prevalence of interspousal transmission of HCV for Central Europe, we investigated the heterosexual partners of 80 referred patients with HCV viraemia and chronic liver disease in a cross-sectional study, and compared the HCV genotype among the infected couples.
Methods
From January to September 1998, spouses of 80 patients with chronic HCV-associated liver disease were screened for HCV infection at our Division of Gastroenterology at the University of Innsbruck. Chronic HCV-associated liver disease was defined as elevated liver enzymes for at least 6 months and a positive reaction in a second-generation anti-HCV assay. A total of 80 patients were enrolled: 43 men (54%) and 37 women (46%) with a mean age of 47.1 years (range 24–83). Forty-six (57.5%) had chronic persistent hepatitis, six (7%) chronic active hepatitis, 24 (30%) cirrhosis, and four (5%) hepatocellular carcinoma. The diagnoses were confirmed by liver biopsy in 54 patients (68%). In the majority of cases the aetiology and duration of HCV infection were unknown; in 38 (48%), parenteral exposure was considered to be the source of infection.
The couples completed a questionnaire addressing the occurrence of premarital non-A, non-B hepatitis or other liver diseases, history and timing of blood transfusion or injuries by needle stick, use of illicit intravenous drugs, tattoos and piercings, duration of their present marriage, sexual activity, such as weekly frequency of intercourse, various sexual practices, the use of condoms, extramarital relationships, sharing of personal hygiene implements such as toothbrush or razor, and at least weekly alcohol intake and nicotine consumption.
Serum samples from study patients and their spouses were collected and assayed for anti-HCV with a second-generation assay (Abbott Laboratories). Serum HCV RNA was detected by reverse-transcription nested polymerase chain reaction (PCR) with primers deduced from the 5'-noncoding region (Amplicor, Roche Diagnostic Systems). HCV genotypes in spouses and corresponding patients were determined by a PCR typing assay (Inno-Lipa HCV 2, Innogenetics).
Frequencies between groups were compared using the {chi}2 test and Fisher's exact test. A p value of <0.05 was considered significant.
Results
Forty-three (54%) of the 80 spouses were female, 37 (46%) were male. Their mean age was 44.6 years (range 24–81). All had a sexual relationship with the study patient. The couples were divided into six groups according to the duration of partnership: 0–5 years (n=8); 6–10 years (n=17); 11–20 years (n=17); 21–30 years (n=14); 31–40 years (n=14); and >40 years (n=10). The mean length of sexual relationship was 21.4 years; 75 couples (94%) remained sexually active, and five (6%) did not. The average rate of sexual intercourse was 1.6 times per week, estimated for the whole period of partnership. All but three couples (96%) conducted unprotected sexual intercourse (without condom), 33 (41%) reported practicing oral sex, and four (5%) anal intercourse. Nicotine consumption was recorded in 33 cases (41%), former i.v. drug abuse in nine (11%) and the mean intake of alcohol per week was about 70 g. Five partners (6%) had received blood transfusions, seven (9%) had tattoos and/or piercings, and one woman reported having suffered several needle-stick injuries in her occupation as a nurse.
Of the 80 spouses negative for hepatitis B surface antigen, four (5%) were positive for anti-HCV antibodies, of whom three (4%) were positive for HCV RNA as well. The characteristics of these study patients and their spouses are summarized in the table. One female partner tested positive for HCV antibodies but negative for HCV RNA several times; she was a former i.v. drug user, had normal levels of liver enzymes, and had no clinical or biochemical evidence of liver disease. All other spouses positive for anti-HCV had no history of premarital hepatitis or extramarital relationship. All were sexually active with the study patient, and denied using condoms or sharing personal hygiene implements.
Of the three spouses positive for HCV antibodies and HCV RNA, one suffered from cirrhosis, one from chronic persistent hepatitis and the last, although not biopsied, was considered to be an healthy HCV carrier. Their HCV genotypes were analysed and compared with those of the study patients. In two couples (2.5%) the genotypes were concordant (genotype 1b, the predominant type in Western Europe) and in one discordant. In the latter case, the partner, a nurse who had suffered several needle-stick injuries, was infected with genotype 2b, while her partner, a former i.v. drug user, was infected with genotype 3. Analysis of the questionnaires completed by the two couples with concordant HCV genotypes showed that one case involved an additional risk factor for HCV infection, namely a blood transfusion in 1996 that tested negative for anti-HCV. The other case showed no additional risk factors. A male spouse reported having had bloody sexual intercourse with his wife several times over many years. He had suffered from phimosis, which was later treated by circumcision.
There was no statistical difference in sex distribution, mean age, mean peak serum ALT level, stage of liver disease, duration of marriage, sexual behaviour, amount of alcohol and nicotine consumption or risk factors for acquiring HCV infection between study patients with anti-HCV-positive and anti-HCV-negative spouses.
Discussion
Our study finds no convincing evidence for the heterosexual transmission of hepatitis C. The HCV seroprevalence in spouses of patients with chronic HCV infection and viremia is 5%. Sexual transmission, however, appears possible in only 2.5%, due to the results of HCV genotyping. The real risk of interspousal transmission may even be half that (1.25%) when excluding spouses with concordant but additional independent risk factors for HCV infection.
During the last few years, some shifts in the epidemiological patterns of HCV transmission have been observed. In the past, transfusion of blood and blood products was the classical source of infection, but it is believed that currently, high-risk drug and sexual exposures accounts for most HCV transmissions. The source of infection is unknown in 30–40% of all HCV infections. Sexual and intrafamilial transmission have been discussed as possible routes of transmission. So far, discordant results have been reported, and the importance of sexual HCV transmission remains unclear. The controversy of previous reports is probably due to the small sample size of many studies investigating heterogeneous groups at varying risk, to the various means of testing, especially the lack of genotyping, and to geographic differences. The reported risk for heterosexual transmission is estimated at between 0% and 27%.14–18,21–28 The highest rates were reported in studies conducted in the Far East or Southeast Asia,21,22 citing a risk of between 17% and 27% for heterosexual transmission, and emphasizing older age and longer duration of marriage as the most evident risk factors. In Southeast Asia, however, the prevalence of HCV is much higher, and common external sources, such as dentistry, acupuncture or medical injections, may interfere with interspousal transmission of concordant genotypes.
In Western societies, there is little evidence to show that sexual transmission of HCV is of epidemiological importance. The few studies27,28 reporting high rates of 11% to 14% were performed with small sample sizes (n=21) and unreliable screening methods (first-generation ELISA). In contrast, there are many reports documenting a low or absent risk of sexual transmission.14–20,25,26 Some of the discrepancies in the literature among reported seroprevalence rates for groups with sexual risk factors may also be due to missing or inadequate information about additional parenteral exposure. Particularly in studies investigating the sexual risk of prostitutes, homosexual men and STD clients, accurate histories of former i.v. drug abuse may not be available.
Our study does not find an increased risk for couples for acquiring HCV. This finding is all the more significant with a view to the high percentage of long-lasting sexual partnerships (the median sexual relationship was 21.4 years) and to the high frequency of unprotected sexual intercourse. Evaluation of the questionnaires and statistical analysis revealed no risk factors for HCV transmission in the everyday life of couples. Neither sex, stage of liver disease, duration of marriage, sexual behavior nor condom use had an influence on the risk of interspousal transmission. Further special risk factors like phimosis or other conditions causing bleeding during intercourse, seem to be needed to cause sexual transmission. An example of this is couple 2 (Table 1Go) with concordant HCV genotype 1b, absent additional risk factors for HCV infection, but bleeding during intercourse.
The sample size of our trial is small, and studies on larger samples are needed to be able to draw more conclusions. However, the findings are significant and confirmed by recent results from Italy25,26 where similar HCV seroprevalences (7.3%) were found in larger sex partner studies, and sexual transmission did not seem to play a role in the intrafamilial spread of HCV infection. The risk of heterosexual HCV transmission calculated in this study is 2.5%. In the USA, the United States Public Health Service estimates that the risk of sexual transmission is approximately 5%, well below the risk of sexual transmission of hepatitis B or human immunodeficiency virus.29
In conclusion, the heterosexual transmission of HCV is possible but infrequent in monogamous sex partners of patients with HCV viraemia and chronic liver disease. The risk of sexual transmission does not seem to correlate with intensity and duration of sexual exposure.
References
1. Choo QL, Kuo G, Weiner AL, Overby LR, Bradley D, Houghton M. Isolation of a cDNA clone derived from blood-borne non-A, non-B hepatitis genome. Science 1989; 244:359–62.[Abstract/Free Full Text]
2. Kuo G, Choo QL, Alter HJ, Gitnick GL, Redecker AG, Purcell RH, et al. An assay for circulating antibodies to a major etiologic virus of human non-A, non-B hepatitis. Science 1989; 244:362–4.[Abstract/Free Full Text]
3. Alter MJ, Hadler SC, Judson FN, Mares A, Alexander WJ, Hu PY, et al. Risk factors for acute non-A, non-B hepatitis in the United States and association with hepatitis C virus infection. JAMA 1990; 264:2231–5.[Abstract]
4. Dienstag JL. Non-A, non-B hepatitis. I. Recognition, epidemiology and clinical features. Gastroenterology 1983; 85:439–62.[ISI][Medline]
5. Alter MJ. Transmission of hepatitis C virus: Route, dose, and titer. N Engl J Med 1994; 330:784–6.[Free Full Text]
6. Neumayr G, Judmaier G, Stöffler G, Dietze O, Vogel W. Die Bedeutung der Infektionswege für die Hepatitis-C-Virus-assoziierte Lebererkrankung. Z Gastroenterol 1994; 32:338–41.[ISI][Medline]
7. Nakashima K, Kashiwagi S, Hayashi J, Noguchi A, Hirata M, Kajiyama W, et al. Sexual transmission of hepatitis C virus among female prostitutes and patients with sexually transmitted diseases in Fukuoka, Kyushu, Japan. Am J Epidemiol 1992; 136:1132–7.[Abstract/Free Full Text]
8. Osmond DH, Charlebois E, Sheppard HW, Page K, Winkelstein W, Moss AR, et al. Comparison of risk factors of hepatitis C and hepatitis B virus infection in homosexual men. J Infect Dis 1993; 167:66–71.[ISI][Medline]
9. Tedder RS, Gilson RJC, Briggs M, Loveday C, Cameron CH, Garson JA, Kelly GE, Weller IVD. Hepatitis C virus: evidence for sexual transmission. Br Med J 1991; 302:1299–302.[ISI][Medline]
10. Melbye M, Biggar RJ, Wantzin P, Krogsgaard K, Ebbesen P, Becker NG. Sexual transmission of hepatitis C virus: cohort study (1981–9) among European homosexual men. Br Med J 1990; 301:210–12.[ISI][Medline]
11. Eysters ME, Alter HJ, Aledort LM, Quan S, Hatzakis A, Goedert JJ. Heterosexual co-transmission of hepatitis C virus (HCV) and human immunodeficiency virus (HIV). Ann Int Med 1991; 115:764–8.[ISI][Medline]
12. Weinstock HS, Bolan G, Reingold AL, Polish LB. Hepatitis C virus infection among patients attending a clinic for sexually transmitted diseases. JAMA 1993; 269:392–4.[Abstract]
13. Thomas DL, Zenilman JM, Alter HJ, Shih JW, Galai N, Carella AV, et al. Sexual transmission of hepatitis C virus among patients attending Sexually Transmitted Diseases Clinics in Baltimore—an analysis of 309 sex partnerships. J Infect Dis 1995; 171:768–75.[ISI][Medline]
14. Bresters D, Mauser-Bunschoten ED, Reesink HW, Roosendaal G, van der Poel CL, Chameleau RA, et al. Sexual transmission of hepatitis C. Lancet 1993; 342:210–11.[ISI][Medline]
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Posted by Editors at 1:40 PM --- Printer-friendly version
April 4, 2007
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Chronic fatigue, the most commonly reported symptom of Hepatitis C infection, affects between 65 and 75 percent of those diagnosed with the disease. Learn what factors contribute to excessive tiredness and lack of energy associated with Hepatitis C, and discover what steps you can take to help manage fatigue.
by Nicole Cutler, L.Ac.
Although Western medicine has yet to find the reason behind the excessive fatigue associated with Hepatitis C, research has uncovered several contributing factors:
· Poor sleep and lack of rest
· Drug and alcohol use
· Stress and depression
· Other diseases
· Chronic pain
· Lack of exercise
· Poor nutrition
· Not drinking enough water and fluids
· Impaired immune system
· Certain medical treatments (such as interferon therapy)
The following four reasons likely play a part in HCV-related fatigue:
1. Energy Storage - Understanding the liver’s role in energy production clarifies how HCV can result in fatigue. One of its many physiological functions, the liver is intimately involved in supplying the body with energy. In addition to its well-known responsibility for filtering the blood, the liver also converts food into glucose, storing it for later use. When the body needs energy, the liver releases stored glucose to provide fuel for creating a burst of energy. By producing, storing and supplying the body with glucose, the liver is a key player in preventing fatigue. A liver unaffected by disease releases glucose between meals, or whenever the cells need nourishment and energy. While a healthy liver maintains a steady level of energy throughout the day, one hampered by advanced disease and scarring has a reduced ability to produce glucose, and less space to store it.
2. Interferon - In addition to being the preferred drug treatment for HCV, interferon therapy causes fatigue. This drug is synthesized to match one of the immune system’s naturally occurring interferons. Part of the protection mechanism against infection, interferons are proteins that help the body recognize a foreign substance. Interferon is believed to cause flu-like symptoms, including fatigue, which typically disappears once the treatment is over.
3. Ribavirin - As those who have undergone treatment with ribavirin are aware, this medication can cause anemia. A condition where the body does not have enough oxygen-carrying red blood cells, anemia causes substantial fatigue. All the cells in the body need oxygen from red blood cells to maintain their health. During HCV therapy with ribavirin, additional medications may be administered to prevent anemia from occurring.
4. Neurotransmitter-Immune Dysfunction - The continued, long-term response of the immune system to chronic Hepatitis C contributes to fatigue. The release of neurotransmitters (chemicals in the brain) is part of a healthy immune system response. When the body is physically or emotionally stressed, the immune system activates, causing the brain to release the appropriate substance for self-protection. Liver disease causes a chronic, uncontrollable stress to the patient, weakening the immune system and decreasing the release of certain neurotransmitters.
In a study led by Steven M. Kerfoot of the Immunology Research Group at the University of Calgary in Canada and published in the January 2006 issue of Hepatology, researchers determined that certain types of liver damage are associated with an immune response affecting the central nervous system. The researchers found that rats with a specific type of liver disease had decreased levels of hypothalamic corticotropin-releasing hormone (CRH), an essential neurotransmitter for activating a stress response. Implicated as a cause of clinical fatigue, scientific studies have found a defect in CRH in people with chronic fatigue syndrome.
Managing Fatigue
Fatigue is a very real and problematic symptom of HCV. While certain lifestyle factors can reduce its impact, most people with Hepatitis C must learn how to manage their fatigue. Being informed about the detrimental effects of alcohol, drug use, poor sleep, dietary habits and a highly stressful life can empower the individual to make positive lifestyle changes. In addition to making healthful lifestyle decisions to reduce fatigue, these changes will also support the liver and strengthen the immune system.
By stepping outside the confines of Hepatitis C’s possible causes of fatigue, scientists have teamed with nutritionists to develop a novel approach to this problem. Through evaluating how to best support the body’s production of energy on a cellular level, researchers found that the energy-producing parts of a cell, the mitochondria, function best when their membrane is fully intact. Combining several nutritional ingredients capable of restoring the mitochondria membrane, NT Factor has been proven to improve energy levels. While taking an all-natural nutritional product for energy restoration must be discussed with a physician, this effective approach has helped many exhausted Hepatitis C sufferers.
In addition to traditional healthful lifestyle approaches, balancing daily activities can help manage fatigue. The following are some helpful tips:
· Try to avoid overloading your day with a busy schedule by prioritizing necessities.
· Work at the time of the day when you feel your best and arrange to do things then.
· When possible, conserve your energy by sitting down to perform activities you typically do while standing.
· Rather than trying to sleep when you are fatigued, rest or do a lighter, easier activity since you will regain more energy from this sort of break.
· Pace yourself by including regular breaks in your day.
· Pass on large, heavy meals in favor of smaller, more frequent ones.
· Since hot temperatures can be draining, take warm showers.
· Establish a pre-sleep routine at night to wind-down and prepare your body for sleep.
If you have HCV and are fatigued, you are not alone. Fortunately, you do have options. Reclaim your energy by supporting your liver and immune system through healthful lifestyle changes and be sure to discuss nutritional supplements containing NT Factor with your physician. While the power to rid yourself of HCV may be just beyond your grasp, you do have the ability to help your body overcome fatigue.
References:
Piche, T, et al., Fatigue is associated with high circulating leptin levels in chronic hepatitis C, Gut, 51, 2002.
www.eurekalert.org, Understanding Fatigue in Chronic Liver Disease, AAAS, 2007.
www.hcvadvocate.org, Easy C Facts, Hepatitis C Support Project, April 2005.
www.hcvadvocate.org, Hepatitis C and Fatigue, Peter Hauser, MD, Hepatitis C Support Project, 2007.
www.healthlink.mcw.edu, Hepatitis C – Or Its Treatment – Can Cause Fatigue, Julie L. Mitchell, MD, MS, Medical College of Wisconsin, 2007.
www.hepatitisc.org.au, Fatigue and HCV, Hepatitis C Council of NSW, March 2004.
www.hepnet.com, Fatigue as a Symptom of Liver Disease, Mark G. Swain, MD, Schering Canada, Inc., 2007.
www.hepnet.com, Understanding how your Liver Works, John Lauerman, Schering Canada, Inc., 2007.
www.natap.org, Fatigue, HCV/HIV Coinfection, Transmission, Disease Progression & Interferon, David Bernstein, MD, National Aids Treatment Advocacy Project, 2007.
www.webmd.com, Managing Hepatitis C, WebMD, Inc., 2007.
Posted by Editors at 12:40 PM --- Printer-friendly version
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Since interferon medication is quickly broken down by a person's circulatory and digestive systems, its potency is typically short-lived. By resisting rapid breakdown, Nautilus Biotech's newly engineered interferon-alpha drug, Belerofon, shows promise in increased effectiveness against Hepatitis C. Now in a Phase I study, we will soon learn of Belerofon's safety and tolerability.
Nautilus Biotech Begins Phase I Clinical Trial In The USA For Subcutaneous Belerofon(R), Its Long-Lasting, Interferon-Alpha Drug
www.medicalnewstoday.com
Article Date: 03 Apr 2007 - 0:00 PDT
Nautilus Biotech has announced that it has initiated a Phase I clinical trial for subcutaneous Belerofon(R), its long-lasting human Interferon (IFN) alpha. Belerofon has therapeutic potential for the treatment of a number of conditions, including chronic Hepatitis C.
Following recent approval by the US Food and Drug Administration, the Phase I clinical trial is being held in Austin, Texas in the USA and involves six treatment groups of eight male and female volunteers, aged 18 to 50 years. The trial is an open-label, ascending dose study of four doses of subcutaneous (SC) Belerofon, which will be compared to SC administered IntronA(R) (a Schering-Plough product) and Pegasys(R) (pegylated Interferon alfa-2a (40KD), a Roche product).
The primary objective of the trial is to evaluate SC Belerofon in healthy adult subjects, for safety, tolerability and pharmacokinetics in comparison with IntronA and Pegasys. The second objective is to evaluate the comparative pharmacodynamics of the three products. Nautilus Biotech expects initial results from the trial to be available during Q3 2007.
Belerofon is an engineered variant of IFN-alpha. It has a single point mutation for lower sensitivity to protease-mediated degradation, unchanged molecular weight and specific antiviral activity compared to non-pegylated IFNs. Following subcutaneous administration in animals, SC Belerofon shows a longer half-life and subsequently improved exposure profile compared to native IFN alpha and pegylated derivatives.
"We are confident that Belerofon has the potential to set a new Gold Standard Interferon in the treatment and management of Hepatitis C," said Nautilus Biotech's CEO, Manuel Vega. "The start of a clinical trial for subcutaneous Belerofon is a major milestone in our move to become a leading drug development company."
"The commencement of a Phase I clinical trial for SC Belerofon represents an important development in our pipeline of novel engineered protein drugs," said Paul Martin, Nautilus Biotech's Vice President Strategy. "It demonstrates Nautilus Biotech's ability to move novel engineered proteins from design to the clinic quickly and efficiently."
In addition to the injectable Belerofon evaluated in this clinical study, Nautilus Biotech has formulated lyophilized Belerofon together with inactive ingredients to produce enteric-coated tablets for oral administration and filed an IND for oral Belerofon in February 2007. All currently marketed Interferon alpha drugs are administered by injection.
About Hepatitis C
Hepatitis C (HCV) is the most prevalent liver disease in the world. HCV infection causes chronic inflammation in the liver that can lead to cirrhosis, liver failure, liver cancer or death. HCV infection represents a significant medical challenge worldwide. Currently, there is no vaccine that can prevent hepatitis C.
According to the World Health Organization, more than 170 million people worldwide suffer from chronic HVC. With only half of all HCV patients benefiting from current therapy, there is considerable market potential for new medical solutions. The HCV market is expected to grow from $2.2 billion in 2005 to $4.4 billion in 2010 and $8.8 billion in 2015 due to improved market penetration and better diagnosis rates (source: Datamonitor).
About Nautilus Biotech
Nautilus Biotech is a drug discovery and development company with a pipeline of next-generation therapeutic proteins with superior pharmacological profiles that address unmet clinical needs. The company's protein engineering technology can significantly improve the pharmacological characteristics of important blockbuster protein drugs, offering improvements in drug stability and administration. The company is also creating proprietary 'third generation' therapeutic proteins which are, per se, suitable for oral administration.
The therapeutic proteins market is currently valued at over $35bn, and growing at a rate of 10-15% per annum. Nautilus Biotech has created a portfolio of next-generation therapeutic proteins with improved profiles, including long-lasting Interferon alpha (Belerofon), hGH (Vitatropin(R)), Interferon beta, Erythropoietin, Interferon gamma, Clotting Factor IX (in collaboration with Wyeth Pharmaceuticals) and HMGB1 (in collaboration with Creabilis Therapeutics). Nautilus Biotech has established a strong intellectual property position covering enhanced versions of these multibillion dollars molecules and is rapidly moving these products into clinical development.
Nautilus Biotech
Nautilus Biotech is a private company with headquarters in Genopole(R) biopark, (Evry, France). For more information about Nautilus Biotech visit http://www.nautilusbiotech.com/
Nautilus Biotech
http://www.nautilusbiotech.com/
Posted by Editors at 12:36 PM --- Printer-friendly version
April 3, 2007
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The results from the Phase I study with XTL-6865, a new compound being tested in patients with chronic Hepatitis C, are promising. In addition to the detailed outcome of this study, you'll learn how XTL-6865 may become a viable treatment option for patients with Hepatitis C undergoing liver transplantation, or for individuals with chronic Hepatitis C who have low viral loads.
XTL Announces the Completion of Phase I Study with XTL-6865 in Patients with Chronic Hepatitis C
29 Mar 2007
www.pipelinereview.com
XTL Biopharmaceuticals Ltd. announced today the completion of the Phase I study with XTL-6865.
NEW YORK, NY, USA | Mar 29, 2007| XTL Biopharmaceuticals Ltd. announced today the completion of the Phase I study with XTL-6865. The primary goal of this Phase I study was to evaluate safety and pharmacokinetic properties of XTL-6865 in patients with chronic hepatitis C. XTL-6865, which targets the E2 envelope protein of the hepatitis C virus, is comprised of two fully-human monoclonal antibodies and is administered intravenously. The study enrolled 32 patients into 8 cohorts, each comprised of 3 treated patients and 1 placebo patient. Of the 8 cohorts in the study, the first 7 were single administration cohorts with doses ranging from 5mg to 2400mg. The 8th cohort received 1200mg for 5 consecutive days.
In this study, XTL-6865 was shown to be safe at high doses (up to 1200mg for 5 consecutive daily doses and a single dose of 2400mg). The study also enabled the Company to establish the pharmacokinetic properties of XTL-6865 in patients with chronic hepatitis C. For all single doses, the t-max was reached immediately at the end of the XTL-6865 infusion. For the highest single dose, 2400mg, the C-max was between 500 and 1000 microg/ml and the t1/2 was approximately 5 days. For the lower single doses, the t1/2 was 2-3 days. The study provided evidence of binding of the antibody to circulating virus and the formation of immune complexes (antibody-virus), believed to be important for virus neutralization in the serum. No statistically significant changes in HCV-RNA were observed. Given the short duration of administration of XTL-6865, and the fact the patients in this study had a high rate of viral replication at baseline, no significant change in viral load was to be expected.
The results of this Phase I trial potentially pave the way for trials that would evaluate XTL-6865 in patients with hepatitis C undergoing liver transplantation - a potential target patient population for this drug - or in chronic hepatitis C patients with low viral load. XTL intends to seek a collaborative partnership for the future development of this compound.
Ron Bentsur, CEO of XTL Biopharmaceuticals, commented, "This trial enabled us to determine the pharmacokinetic properties of XTL-6865, and to demonstrate that it could be safely administered to patients at high doses. This study also clearly demonstrated that the antibody binds to the circulating virus in the serum. We believe that XTL-6865 could potentially play a role in certain clinical settings, such as preventing re-infection of hepatitis C following liver transplantation or in chronic hepatitis C patients who have low viral loads following treatment with other anti-hepatitis C drugs. We believe this is now an appropriate time to seek to out-license the compound." Mr. Bentsur continued, "We intend to focus our resources on commencing our clinical program for Bicifadine, for the treatment of diabetic neuropathic pain, and on completing our Phase I study for XTL-2125, our small-molecule compound for the treatment of chronic hepatitis C."
About XTL Biopharmaceuticals Ltd.
XTL Biopharmaceuticals Ltd. ("XTL") is engaged in the acquisition, development and commercialization of therapeutics for the treatment of neuropathic pain and hepatitis C. XTL is developing Bicifadine, a serotonin and norepinephrine reuptake inhibitor, for the treatment of neuropathic pain. In addition, XTL is developing XTL-2125 - a small molecule, non-nucleoside inhibitor of the hepatitis C virus polymerase. XTL-2125 is currently in a Phase I clinical trial in patients with chronic hepatitis C. XTL is also developing XTL-6865 - a combination of two monoclonal antibodies against the hepatitis C virus. XTL's hepatitis C pipeline also includes several families of pre-clinical hepatitis C small molecule inhibitors. XTL also has an active in-licensing and acquisition program designed to identify and acquire additional drug candidates. XTL is publicly traded on the NASDAQ, London, and Tel-Aviv Stock Exchanges.
SOURCE: XTL Biopharmaceuticals Ltd.
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