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Week Ending: March 22 , 2008
Alan Franciscus
Editor-in-Chief
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This Issue:
March 15th, 2007
Hepatitis C May Reduce EPO Requirements
http://www.renalandurologynews.com/
Jody A. Charnow
Hemodialysis patients infected with hepatitis C virus (HCV) have a significantly decreased requirement for erythropoietin (EPO) compared with hemodialysis patients with no history of HCV infection, according to researchers.
A team at Texas A & M University in Temple, led by Anand Khurana, MD, studied 66 hemodialysis patients: 22 with HCV infection and 44 age-, gender-, and race-matched controls without HCV. The mean EPO requirement for the HCV-infected group was 17,307 U/month compared with 49,134 U/month for controls, the investigators reported in Hemodialysis International (2008;12:94-99). The HCV-infected patients also tended to have higher hemoglobin levels at baseline.
“The possible explanation for these findings may be the release of hepatic EPO because of chronic hepatic inflammation secondary to HCV,” the authors wrote.
The mean dose of IV iron was higher for the HCV group than controls (120 vs. 163 mg/month), but the difference was not statistically significant.
The researchers noted that hemodialysis patients who not need EPO or have very low requirements usually prompts investigation for acquired renal cystic disease, renal cell carcinoma, or polycythemia vera. “We suggest that it should be a reason to look for occult HCV infection, given the higher risk of acquiring this infection on hemodialysis and having normal ALT levels.”
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Lubbock health officials say Nev. hepatitis problem being averted here
http://lubbockonline.com
By Kristen Hackney-redman
Avalanche-Journal
Local health officials say procedures in Las Vegas, Nev., that caused six hospital patients there to contract hepatitis C won't happen in Lubbock.
The Southern Nevada Health District and Nevada Licensure and Certification Bureau investigated the Endoscopy Center of Southern Nevada after six new cases of hepatitis C were reported in January, according to the Las Vegas Sun. The common thread: all had colonoscopies at the endoscopy center.
Investigators determined clinic staff had been using syringes more than once on a single patient, contaminating the vial of anesthetic, according to The Sun. Contaminated vials were used on multiple patients, exposing 40,000 people to HIV and hepatitis B and C, according to The Sun's reports.
Representatives of the Lubbock Health Department, University Medical Center and Covenant Health System each said his or her clinic or hospital does not reuse syringes.
Beckie Brawley, the public health coordinator for the Lubbock Health Department, said the needles and syringes used in their clinics are never reused.
"They are all disposable," she said.
After a needle has been used at the health department, it is placed into a container. The needles are then sterilized by autoclave in the laboratory and taken to the landfill, where they are buried.
Brawley added even when multiple immunizations are given to one patient, a clean needle is used for each injection.
Greg Bruce, vice president of operations at UMC, said the hospital never reuses syringes.
"Our staff works very hard to provide a safe environment for our patients and we do not reuse needles or reuse contaminated vials."
Michelle Stephens, spokeswoman for Covenant Health System, said that syringes are never reused at Covenant either.
"Once the syringe is used, it is immediately disposed of into a specially labeled sharps container," she said. "Once that container is full, it is removed from the place of practice."
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March 17th, 2007
SciClone Hosts Thymalfasin Symposium at Asian Pacific Association for the Study of the Liver
http://money.cnn.com
Experts Present Therapeutic Strategies for Hepatitis B & C
SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced that it plans to host a symposium at the 18th annual meeting of the Asian Pacific Association for the Study of the Liver (APASL), in Seoul, Korea on Tuesday, March 25, 2008.
The symposium, "Therapeutic Strategies for Hepatitis B & C - Treatment Regimens Using Thymosin a-1, an Immunomodulator," will take place on March 25, 2008, from 3:00 to 4:00 p.m. local time, at the COEX Convention Center in Seoul, Korea.
Experts in the field of liver disease will discuss ZADAXIN®, generically referred to as thymalfasin or thymosin alpha 1, and its therapeutic benefits as a treatment for hepatitis B and hepatitis C.
-- Yun-Fan Liaw, M.D., Professor of Medicine in the Liver Research Unit at Chang Gung University and Memorial Hospital in Taipei, Taiwan, will discuss ZADAXIN as an immunomodulatory treatment for patients infected with the hepatitis B virus.
-- Mario Rizzetto, M.D., Professor of Gastroenterology at San Giovanni Battista Hospital of the University of Torino in Torino, Italy, and the Principal Investigator for a nearly completed phase 3 hepatitis C triple therapy trial in Europe, will follow with a presentation on the use of triple therapy (pegylated interferon, ribavirin and thymalfasin) in the treatment of hepatitis C non-responder patients.
-- Kyusung Rim, MD, the 2007 congress chairman for the Korean Association for the Study of the Liver will serve as the meeting chairman and moderator.
"APASL is an important forum that provides the most current, innovative and advanced therapeutic technologies to prominent physicians specializing in the treatment of liver disease in Asia," commented Hans P. Schmid, President and Managing Director of SciClone Pharmaceuticals International Limited. "We are pleased to have respected experts such as Drs. Liaw and Rizzetto present thymalfasin's efficacy and safety data in the treatment of patients infected with the hepatitis B and hepatitis C viruses."
About SciClone
SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone's lead product ZADAXIN is currently being evaluated in late-stage clinical trials for the treatment of hepatitis C and malignant melanoma. ZADAXIN is approved for sale in select markets internationally, most notably in China where SciClone has an established sales and marketing operation. A key part of SciClone's strategy is to leverage its advantage and broaden its portfolio in the rapidly growing Chinese pharmaceutical market by in-licensing or acquiring the marketing rights to other products, such as DC Bead(TM). For the U.S. market, SciClone's other clinical-stage drug development candidates are RP101 for the treatment of pancreatic cancer and SCV-07 for the treatment of hepatitis C. For more information about SciClone, visit www.sciclone.com.
Corporate Contact:
Richard Waldron
Executive Vice President & Chief Financial Officer
SciClone Pharmaceuticals, Inc.
(650) 358-3437
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Contest seeks to break silence; Poster design competition aims to raise hep C awareness
http://www.thesudburystar.com/
Posted By Harold Carmichael
The way Ernie Zivny sees it, $4,000 is a miniscule amount to spend if it can prevent even a handful of people from contracting a deadly, blood-borne liver disease.
"That's why there is a $500 first prize," explained the Greater Sudbury man, about the Circle C Support Group's "Break the Silence and Win" Contest. "If they are going to do their own research, we are going to get good involvement in finding out about hep C and by putting it in their entry - 'how can I get it, how can I prevent it?' They are going to keep that with them for the rest of their life."
Zivny, who contracted hepatitis C through a tainted blood transfusion a 1978 operation and only learned he had the disease in 2001, is providing the $4,000 total prize money for the contest, which is open to all ages, but focuses on students.
The contest has four categories: elementary schools, secondary schools, college/university and others. People can enter as individuals or as a group. There is no limit to the number of entries.
Entries can be in the form of posters, videos, pamphlets or 60-second radio/television messages.
Entries will be judged on the accuracy of the information and how effective the messages are. The contest ends May 15. Winners will be announced at a Circle C Support Group barbecue at Tom Davies Square on May 23.
Entry forms and contest rules will be available at participating schools, the Sudbury and District Health Unit at 1300 Paris St. and at the mayor's office at Tom Davies Square.
According to Zivny, some 2,200 Greater Sudburians have hepatitis C. The Circle C Support Group, which he founded several years ago as a support group for local hepatitis C sufferers, currently numbers 25-30.
According to a 2004 Ontario Government study, an estimated 110,000 Ontarians were infected with hepatitis C. Active injection drug users accounted for 21,842 people or 20 per cent, of the total, while former injection drug users totalled 36,577, or 33 per cent.
Tainted blood transfusions accounted for 14,260 people, or 13 per cent, while 423 people, or 0.38 per cent, were hemophilia patients. A total of 36,898 people, or 34 per cent, contracted hepatitis C through other means.
Zivny, 60, who has been battling the effects of hepatitis C for three decades, said the disease saps a person's strength, producing flu-like symptoms and fatigue.
"I have hep C and I wouldn't wish this on my worst enemy," he said.
Two drug treatments exist that can knock hepatitis C down by reducing the "viral load," said Zivny, but they are not a cure and not all hepatitis C sufferers respond to them. The two drug treatments had no effect on Zivny.
Zivny said the contest is all about awareness.
"It's a silent epidemic," he said. "The purpose of the contest is getting to know that we exist or finding out what hepatitis C is, how they can contract it and prevent themselves from contracting it."
hcarmichael@thesudburystar.com
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Valeant Pharmaceuticals Reports Encouraging Phase IIb Results at Treatment Week 12 for Taribavirin
http://www.businesswire.com
ALISO VIEJO, Calif.--(BUSINESS WIRE)--Valeant Pharmaceuticals (NYSE:VRX) today reported results at the treatment week 12 analysis point for the Phase IIb clinical trial for its antiviral compound, taribavirin, a prodrug of ribavirin in development for the treatment of chronic hepatitis C in conjunction with a pegylated interferon.
The Phase IIb trial is a U.S. multi-center, randomized, parallel, open-label study in 278 treatment-naïve, genotype 1 patients evaluating taribavirin at 20 mg/kg, 25 mg/kg, and 30 mg/kg per day in combination with pegylated interferon alfa-2b. The control group is being administered weight-based dose ribavirin (800/1000/1200/1400mg daily) and pegylated interferon alfa-2b. Overall treatment duration is 48 weeks with a post-treatment follow-up period of 24 weeks. The primary endpoints for this study are viral load reduction at treatment week 12 and anemia rates throughout the study.
The 12-week early viral response (EVR) data from the Phase IIb study showed comparable reductions in viral load for weight-based doses of taribavirin and ribavirin. The anemia rate was statistically significantly lower for patients receiving taribavirin in the 20mg/kg and 25mg/kg arms versus the ribavirin control arm.
Key Efficacy and Safety Data Table at Treatment Week 12 (ITT Population)
|
TBV 20 mg/kg
n = 67 |
TBV 25 mg/kg
n = 70 |
TBV 30 mg/kg
n = 68 |
RBV 800-1400mg
n = 70 |
Responders(a) |
43 (64.2%) |
40 (57.1%) |
37 (54.4%) |
36 (51.4%) |
Undetectable(b) |
28 (41.8%) |
29 (41.4%) |
17 (25.0%) |
22 (31.4% |
Anemia rate(c) |
6 (9.0%) |
5 (7.1%) |
10 (14.7%) |
17 (24.3%) |
(a) HCV RNA undetectable (less than 100 copies per mL) or ≥2-log decrease in viral load using the NGI SuperQuant Assay
(b) HCV RNA less than 100 copies per mL
(c) Anemia rate defined as percentage of patients with Hgb level < 10 g/dL. p=0.022 for 20mg/kg and p=0.009 for 25mg/kg
The most common adverse events were fatigue, nausea, flu-like symptoms, headache and diarrhea. The incidence rates among treatment arms were generally comparable except with respect to diarrhea, where diarrhea was approximately twice as common in taribavirin patients as ribavirin patients. However, the diarrhea was generally mild and not treatment limiting for taribavirin or ribavirin patients.
In 2006 Valeant released data from its Phase III VISER1 and VISER2 trials of taribavirin, administered in a fixed dose of 600 mg BID (approximately equivalent to 13-18 mg/kg), in which taribavirin did not meet its primary efficacy endpoint of comparable efficacy to weight-based dose ribavirin. In 2007, the company began this Phase IIb study to evaluate higher doses of taribavirin than used in the VISER trials, while also employing a weight-based dosing regimen, consistent with the dosing regimen for ribavirin.
“Ribavirin continues to be a necessary part of hepatitis C treatment, and clinicians would welcome a ribavirin prodrug with a profile of similar efficacy with decreased anemia,” stated Fred Poordad, M.D., Chief of Hepatology at the Center for Liver Disease and Transplant, Cedars-Sinai Medical Center, Los Angeles, CA. “A drug with fewer required dose reductions for anemia or a reduced need for adjunctive growth factor therapy may subsequently improve treatment adherence and overall response rate.”
“We are encouraged that these data suggest that weight-based dosing with taribavirin at higher doses may have a role in the treatment of patients infected with hepatitis C while continuing to produce lower anemia than ribavirin,” said J. Michael Pearson, Valeant’s chairman and chief executive officer. “However, we caution that these results only represent data from the first 12 weeks of a 72-week Phase II trial that was designed to identify appropriate doses for further development. We will use these data to explore the best options for taribavirin’s continued role in our portfolio, including consideration of partnering options.”
Patient Demographics
|
20 mg/kg
n = 67 |
25 mg/kg
n = 70 |
30 mg/kg
n = 68 |
Ribavirin
n = 70 |
Age (yrs, mean) |
48.5 |
47.5 |
49.6 |
49.7 |
| Gender (female) |
52.2% |
35.7% |
36.8% |
31.4% |
| Race (Caucasian) |
74.6% |
58.6% |
61.8% |
64.3% |
| Weight (>75 kg)(d) |
64.2% |
61.4% |
63.2% |
62.9% |
| Plasma HCV RNA ≥ 2 million copies(d) |
73.1% |
72.9% |
72.1% |
70.0% |
(d) Study stratified patients by weight and viral load
In the study, the following percentages of patients completed 12 weeks of treatment in the taribavirin and ribavirin arms: 20mg/kg: 87.0%; 25mg/kg: 80.0%; 30mg/kg: 82.6%; ribavirin 74.3%. The following percentages of patients had adverse events leading to dose modification or interruption of taribavirin or ribavirin: 20mg/kg: 11.9%; 25mg/kg: 15.7%; 30mg/kg: 25.0%; ribavirin 28.6%.
In the Intent to Treat Analysis, the Rapid Virological Responses (RVR - virus undetectable at treatment week 4) in this study were 20mg/kg: 16.4%; 25mg/kg: 14.3%; 30mg/kg: 16.2 %; ribavirin: 11.4%.
Conference Call and Webcast Information:
Valeant will host a conference call and webcast on Thursday, March 27, 2008 at 12:00 p.m. EDT (9:00 a.m. PDT) to discuss the Company’s Strategic Plan as well as the results from this Phase IIb clinical trial. A webcast of this event will be available live over the Internet along with a slide presentation. The webcast may be accessed through the investor relations section of Valeant’s corporate Web site at www.valeant.com. The dial-in number to participate on this call is (877) 295-5743, confirmation code 39808652. International callers should dial (706) 679-0845, confirmation code 39808652. Interested parties will have access via the Internet and on the conference call to ask questions following the presentation. A replay will be available approximately two hours following the conclusion of the conference call and can be accessed by dialing (800) 642-1687, or (706) 645-9291, confirmation code 39808652.
About Taribavirin
Taribavirin is an investigational compound that has not been found by the Food and Drug Administration (FDA) or any other regulatory agency to be safe or effective in the diagnosis, mitigation, treatment or cure of any disease or illness. It may not be sold or promoted in the United States unless and until FDA has approved a New Drug Application. Similar restrictions apply in other countries.
About Valeant
Valeant Pharmaceuticals International (NYSE:VRX) is a global specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, infectious disease and dermatology. More information about Valeant can be found at www.valeant.com .
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements, including, but not limited to, statements regarding the potential efficacy and safety of taribavirin in the treatment of hepatitis C, and the continuing role of ribavirin or taribavirin in the treatment of hepatitis C, that are based on management’s current expectations and involve risks and uncertainties, including, but not limited to, risks and uncertainties relating to the clinical development of new products, regulatory approval processes, that results from treatment week 12 in a phase IIb clinical trial are not necessarily predictive of the entire phase IIb trial or a phase III trial, and other risks detailed from time to time in the company’s SEC filings. The company cautions the reader that these factors, as well as other factors described in its SEC filings, are among the factors that could cause actual results to differ materially from the expectations described in the forward-looking statements. The company also cautions the reader that undue reliance should not be placed on any of the forward-looking statements, which speak only as of the date of this press release. The company undertakes no responsibility to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.
Contacts
Valeant Pharmaceuticals
Laurie W. Little, 949-461-600
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GPs need new liver function guidance say experts
http://www.pulsetoday.co.uk
By Nigel Praities
Patients with abnormal liver function tests picked up in primary care are not being followed up because of a lack of clear referral guidance, experts warn.
A new study finds GPs are not routinely employing cautionary measures such as tests for underlying disease or referrals to specialist treatment in the event of a raised liver function test.
The research, presented at the British Society of Gastroenterology annual meeting in Birmingham last week, found screening for underlying viral, metabolic or autoimmune liver disease was only requested in 12% of the 172 cases analysed.
Hepatitis A, B and C serology was requested in only 16%, 35% and 32% of patients respectively. Only 15% of patients were referred to a specialist and only around a fifth of patients received lifestyle advice.
The researchers, from Queen Mary’s Hospital in Sidcup, said improvements were needed in the response to abnormal tests. ‘Implementation of guidelines for the evaluation of abnormal liver function tests in primary care should be considered,’ they concluded.
Dr Richard Stevens, a GP in Oxford and chair of the Primary Care Gastroenterology Society, said abnormal liver function tests were an increasing and ‘genuine problem’ in general practice – and that GPs needed better advice.
‘There is no doubt that we are doing more tests and turning up more abnormalities. What we need is a pathway or an algorithm, to show what we need to do in certain circumstances,’ he said.
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Management of Patients with Concurrent HBV and HCV Infection
www.newsrx.com
Hepatitis Weekly
According to recent research from Taiwan, "Studies have shown that concurrent infection of hepatitis B virus and hepatitis C virus may be associated with severe forms of chronic liver disease or with rapid progression. However, very little is known about the role and course of concurrent HBV and HCV infection in patients with acute viral hepatitis."
"This study retrospectively compared the clinical features of 83 patients diagnosed with HBV- or HCV-related chronic hepatitis with acute exacerbation (12 with concurrent HBV and HCV infection, 46 with HBV infection alone, and 25 with HCV infection alone) encountered at Chia-Yi Chang Gung Memorial Hospital, Taiwan, between January 2003 and December 2005. The clinical course of chronic hepatitis with acute exacerbation in patients with concurrent HBV and HCV infection is similar to patients with single HBV infection, and more severe than patients with single HCV infection, evidenced by increased hepatic decompensation (P = 0.05), failure (P = 0.036), and mortality (P = 0.036). Elevated serum HCVRNA-negative percentage in HBVDNA-positive patients and low serum HBVDNA concentrations in HCVRNA-positive patients imply reciprocal interference of HBV and HCV in patients with concurrent HBV and HCV infections during acute-phase hepatitis. In patients with concurrent HBV and HCV infection, the mortality rate for detectable HBVDNA patients seemed higher than that for undetectable HBVDNA patients, although it did not reach statistical significance (P = 0.066). virus interference existed in chronic hepatitis with acute exacerbation patients with concurrent HBV and HCV infections. Clinical outcome for patients positive for serum HBVDNA was much worse than those negative for serum HBVDNA," wrote C.S. Chuang and colleagues.
The researchers concluded: "When chronic hepatitis with acute exacerbation occurs in patients with concurrent HBV and HCV infection, aggressive management should be investigated and antiviral therapy targeting of HBV infection should be administered early."
Chuang and colleagues published their study in Digestive Diseases and Sciences (Clinical features and outcome of chronic viral hepatitis with acute exacerbation in patients with concurrent infections of hepatitis B and C virus. Digestive Diseases and Sciences, 2008;53(2):511-516).
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Inovio Biomedical Reveals Safety Results Of Tripep's ChronVac-C Delivered Using Inovio's Electroporation Delivery Systems
http://www.rttnews.com/
Biomedical company Inovio Biomedical Corp. (INO) said that its partner Tripep AB of Sweden reported preliminary results from its Phase I/II clinical study of therapeutic hepatitis C virus, or HCV, vaccine, ChronVac-C, which was delivered using Inovio's electroporation-based DNA delivery system.
The primary objective of the study is to assess safety of ChronVac-C. It would also test whether the treatment boosts the immune response to HCV and its effect on virus replication in the liver.
The study's intended enrollment is 12 patients divided into three dose groups with increasing doses of ChronVac-C. Each patient receives four ChronVac-C vaccinations one month apart. After the last vaccination, patients are followed for another six months. This first reported data was from the first patient in the lowest dose group. Five patients have been treated and no unexpected side effects have been observed.
Samples taken before, during and after treatment showed that before vaccination the patient did not have a detectable cell-mediated immune response against HCV but such an immune response became detectable after treatment was completed. Inovio's electroporation delivery technology is intended to enhance the potency of DNA-based immunotherapies, including DNA vaccines, against cancers and infectious diseases.
ChronVac-C is a therapeutic DNA vaccine being given to individuals already infected with hepatitis C virus with the aim to clear the infection by boosting a cell-mediated immune response against the virus. It is known that patients who spontaneously clear their infection have also developed this type of immune response.
INO is currently trading at $1.06, up 10 cents or 10.42% from its previous closing of $0.96.
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FDA Halts Studies of Hepatitis Vaccine From Merck and Dynavax Over Safety Worries
http://biz.yahoo.com
WHITEHOUSE STATION, N.J. (AP) -- Merck Inc. and Dynavax said Monday federal regulators have halted studies of their experimental hepatitis vaccine due to safety concerns.
The Food and Drug Administration placed a hold on trials for the companies' Heplisav vaccine after one patient in the U.S. was diagnosed with a rare disease that causes blood vessels to inflame.
The companies said there have been no other reports of the disease in about 2,500 patients tested with the treatment over the past seven years.
No additional studies of the vaccine will be launched until after FDA lifts its hold, the companies said.
Shares of Merck & Co. Inc. rose 15 cents Monday to $42 in after-hours trading, following an earlier close at $41.85. Shares of Dynavax Technologies fell $2.25, or 43 percent, to $2.97 in after-hours trading. Earlier, shares fell 73 cents, or 12.3 percent, to close at $5.22 in regular trading.
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March 18th, 2007
Vertex Pharmaceuticals and Tibotec Announce Start of Phase 3 'ADVANCE' Study with Telaprevir in Treatment-Naive, Genotype 1 HCV Patients
http://www.therapeuticsdaily.com
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar 13, 2008 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Tibotec today announced that patient screening has begun in the ADVANCE study, a pivotal Phase 3 clinical study with the hepatitis C virus (HCV) protease inhibitor telaprevir in combination therapy for treatment-naive patients with chronic HCV infection. Telaprevir is the most advanced HCV protease inhibitor in clinical development targeting treatment of hepatitis C, a disease that afflicts more than 3 million people in the United States alone, and 170 million worldwide. The ADVANCE trial will enroll 1,050 treatment-naive genotype 1 HCV patients and will evaluate two 24-week telaprevir-based regimens in comparison to a 48-week control arm. The primary endpoint of the study is sustained viral response (SVR), defined as undetectable HCV RNA (<10 IU/mL) 24 weeks after the completion of treatment. In this study, rapid viral response (RVR) criteria will be used to determine which telaprevir patients can stop all treatment at 24 weeks.
"This is the first Phase 3 study conducted to evaluate whether an investigational medicine for HCV may be able to both increase the rate of sustained viral response and shorten the duration of therapy to 24 weeks in patients with genotype 1 HCV infection compared to current treatment of 48 weeks. This is important given the expectation that approximately 40 to 50 percent of people with genotype 1 HCV who undergo treatment with current therapies achieve SVR," said John McHutchison, M.D., Associate Director, Duke Clinical Research Institute and a principal investigator for the ADVANCE study. "We're interested to see whether this trial will confirm the encouraging results seen thus far in Phase 2 studies of telaprevir. This study is another important step forward in the evaluation of novel medicines for the treatment of HCV."
"Following discussions with the U.S. FDA in January, we have been able to rapidly finalize the Phase 3 pivotal trial protocol and begin patient screening at the first sites," said John Alam, M.D., Executive Vice President, Medicines Development and Chief Medical Officer of Vertex. "The initiation of the ADVANCE trial underscores our commitment to evaluating the potential for telaprevir to address significant unmet medical needs in HCV."
The ADVANCE Study
The ADVANCE study (A New Direction in HCV Care: A Study of Treatment-Naive Hepatitis C Patients with telaprevir) will be conducted at more than 100 centers in the U.S., E.U. and certain other countries. Patient recruitment is being initiated in the U.S., while sites in other countries will start recruitment as national Clinical Trial Applications (CTAs) for each country are approved. The study arms will include:
- 24 weeks of therapy, with telaprevir dosed at 750 mg every eight hours (q8h) for 12 weeks in combination with standard doses of pegylated interferon alfa-2a (peg-IFN) and ribavirin (RBV) for 12 weeks, then continuing for another 12 weeks with peg-IFN and RBV alone;
- 24 weeks of therapy, with telaprevir dosed at 750 mg every eight hours (q8h) for 8 weeks in combination with standard doses of peg-IFN and RBV for 8 weeks, then continuing for another 16 weeks with peg-IFN and RBV alone; and
- A control arm with standard doses of peg-IFN and RBV dosed for 48 weeks.
Patients in both telaprevir arms who achieve RVR, defined in this study as undetectable (less than 10 IU/mL) HCV RNA levels by the end of week 4, and who stay undetectable at week 12 will receive 24 weeks of treatment. Patients in these treatment arms who do not meet these RVR criteria but are undetectable at week 24 will continue on peg-IFN and RBV for a total duration of 48 weeks.
Updates on the status of Vertex and Tibotec's clinical trials of telaprevir are available at www.clinicaltrials.gov .
About Telaprevir
Telaprevir (VX-950) is an investigational oral inhibitor of HCV protease, an enzyme essential for viral replication, and is one of the most advanced investigational antiviral agents in development that specifically targets HCV. The types of adverse events that have been commonly observed with peg-IFN and RBV were seen across all treatment arms in Phase 2b trials of telaprevir. The most common adverse events, regardless of treatment assignment, were fatigue, rash, headache and nausea, with rash being the most common reason for treatment discontinuation. Gastrointestinal disorders, skin adverse events (rash, pruritus) and anemia were more common in the telaprevir arms compared to the control arm over the dosing period.
About Hepatitis C
Hepatitis C is a liver disease caused by the hepatitis C virus, which is found in the blood of people with the disease. HCV, a serious public health concern affecting 3.4 million individuals in the United States, is spread through direct contact with the blood of infected people. Though many people with HCV infection may not experience symptoms, others may have symptoms such as jaundice, abdominal pain, fatigue and fever. Chronic HCV significantly increases a person's risk for developing long-term infection, chronic liver disease, cirrhosis or death. The burden of liver disease associated with HCV infection is increasing, and current therapies typically provide sustained benefit in less than half of patients with genotype 1 HCV, the most common strain of the virus.
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, inflammation, autoimmune diseases, cancer, pain and bacterial infection. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Disclosure: Dr. McHutchison receives research support, as does the Duke Clinical Research Institute, from Vertex, and he has served in an advisory capacity for the company.
Lexiva is a registered trademark of the GlaxoSmithKline group of companies.
SafeHarbor Statement
This press release contains forward-looking statements, including statements (i) that the ADVANCE Phase 3 clinical trial will evaluate whether an investigational medicine for HCV may be able to increase the rate of SVR and shorten the duration of therapy to 24 weeks in patients with genotype 1 HCV; (ii) regarding the possibility that the ADVANCE Phase 3 clinical trial will confirm the encouraging results seen thus far in Phase 2 studies of telaprevir; (iii) regarding our commitment to evaluating the potential for telaprevir to address significant unmet medical needs in HCV; (iv) that the ADVANCE clinical trial is a pivotal trial that will enroll 1,050 patients; (v) about the design of the treatment arms and control arm of the ADVANCE clinical trial and the manner in which rapid viral response criteria will be used to determine which telaprevir patients can stop all treatment after 24 weeks; (vi) that the ADVANCE clinical trial is another important step forward in the evaluation of novel medicines for the treatment of HCV and (vii) our expectations regarding the number and location of the sites for the ADVANCE clinical trial and our ability to obtain approval to commence screening in foreign countries. While we believe the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that the outcomes for each of our ongoing or planned clinical trials and in particular the ADVANCE clinical trial may not be favorable or may not confirm results from earlier clinical trials, that there may be varying interpretations of data produced by one or more of our clinical trials, that enrollment in the ADVANCE clinical trial may be more difficult or slower than we currently anticipate and other risks listed under Risk Factors in our annual report on Form 10-K, which was filed with the Securities and Exchange Commission on February 11, 2008. We disclaim any obligation to update the information contained in this press release as new information becomes available.
Contact
Vertex Pharmaceuticals Incorporated
Michael Partridge, 617-444-6108
Senior Director, Strategic Communications
or
Lora Pike, 617-444-6755
Manager, Investor Relations
or
Patricia Farrell, 617-444-6533
Director, Public Relations
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OctoPlus announces publication of Phase I Locteron results in the Journal of Interferon and Cytokine Research
http://www.therapeuticsdaily.com
OctoPlus N.V. ("OctoPlus" or "the Company") (Euronext: OCTO), the drug delivery and development company, announces today the publication of results from its Phase I study with Locteron, its controlled-release formulation of alfa interferon for the treatment of chronic hepatitis C, in the current issue of the Journal of Interferon & Cytokine Research. In the randomised Phase I trial, the administration of Locteron demonstrated bioactivity over a two-week period and resulted in flu-like symptoms that were less frequent, milder and of a shorter duration in a head-to-head comparison with PEG-Intron, the standard of care used as the control arm in the study.
OctoPlus also announces that updated results from its SELECT-1 Phase IIa trial of Locteron have been selected for presentation at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL) conference April 23-27, 2008 in Milan, Italy.
Phase I Publication
The Phase I results were reported in the Journal of Interferon & Cytokine Research under the title "Novel Controlled-Release Lemna-Derived IFN-alfa 2b (Locteron): Pharmacokinetics, Pharmacodynamics, and Tolerability in a Phase 1 Clinical Trial" (28:113-122 (2008) by De Leede et al.).
The Phase I dose escalation study was designed to evaluate safety, pharmacokinetics and biomarker response of Locteron in comparison with PEG-Intron in healthy volunteers. The results show that Locteron, given as single doses to healthy volunteers, was well tolerated and safe. They confirm a gradual release of alfa interferon after injection, thus avoiding both high peak and low trough plasma levels. Flu-like symptoms among the groups receiving Locteron in the study were reported to be less frequent, less severe and of shorter duration than in the subjects receiving PEG-Intron. The pharmacokinetics and biomarker response profile of Locteron support the once-every-two-weeks dosing regimen of this product.
For further information, please contact: Rianne Roukema, Corporate Communications: telephone number +31 (71) 524 1071, e-mail IR@octoplus.nl .
About Locteron
Locteron is designed to be a best-in-class therapeutic for patients with chronic hepatitis C, with the potential to reduce side effects, improve patient compliance and provide a more convenient once-every-two-week dosing schedule compared with current therapies.
Locteron is currently in Phase II trials. OctoPlus and its co-development partner Biolex Therapeutics plan to commence SELECT-2, a Phase IIb trial with Locteron, in the fourth quarter of 2008. The 12-week results of the Phase IIb trial will be used as the basis for dose selection for the commencement of the Phase III development program.
Locteron combines OctoPlus' proprietary PolyActive(TM) drug delivery technology with BLX-883, a recombinant alfa interferon produced by Biolex Therapeutics in its patented LEX System(SM). Locteron is produced in OctoPlus' cGMP manufacturing facilities in Leiden, the Netherlands.
About OctoPlus
OctoPlus N.V. is a product-oriented biopharmaceutical company committed to the creation of improved pharmaceutical products that are based on OctoPlus' proprietary drug delivery technologies and have fewer side effects, improved patient convenience and a better efficacy/safety balance than existing therapies. Rather than seeking to discover novel drug candidates through early stage research activities, OctoPlus focuses on the development of long-acting, controlled-release versions of known protein therapeutics, other drugs, and vaccines.
OctoPlus' pipeline consists of 5 products in pre-clinical and clinical development. The lead product is Locteron, a controlled-release formulation of interferon alfa for the treatment of chronic hepatitis C, which the Company is co-developing with Biolex Therapeutics. Locteron is currently in Phase II clinical studies. Furthermore, the pipeline comprises a product candidate for the treatment of chronic middle ear infection, which is in Phase II clinical development, a pre-clinical GLP-1 analogue product candidate for the treatment of diabetes type 2 and two pre-clinical-stage single-shot vaccines.
In addition, OctoPlus is a European leading provider of advanced drug formulation and clinical scale manufacturing services to the pharmaceutical and biotechnology industries, with a focus on difficult to formulate active pharmaceutical ingredients. The earnings and expertise that the Company derives from rendering formulation and manufacturing services help to support the Company's own drug development programs.
OctoPlus is listed on Euronext Amsterdam by NYSE Euronext under the symbol OCTO. For more information about OctoPlus, please visit the website on www.octoplus.nl.
This document may contain certain forward-looking statements relating to the business, financial performance and results of OctoPlus N.V.
and the industry in which it operates. These statements are based on OctoPlus N.V.'s current plans, estimates and projections, as well as its expectations of external conditions and events. In particular the words "expect", "anticipate", "predict", "estimate", "project", "plan", "may", "should", "would", "will", "intend", "believe" and similar expressions are intended to identify forward-looking statements. We caution investors that a number of important factors, and the inherent risks and uncertainties that such statements involve, could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements. In the event of any inconsistency between an English version and a Dutch version of this document, the English version will prevail over the Dutch version.
http://hugin.info/137076/R/1200026/244996.pdf
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March 19th, 2007
Gilead's Viread Gets Hepatitis B Nod
http://biz.yahoo.com
Gilead Sciences Receives European Regulatory Recommendation for Viread As a Hepatitis B Drug
FOSTER CITY, Calif. (AP) -- Biotechnology company Gilead Sciences Inc. said Wednesday a European regulatory agency's advisory committee recommended approving the drug Viread (tenofovir)as a hepatitis B treatment.
The drug is currently used to treat HIV. Gilead has also asked U.S. regulators to approve it as a hepatitis B treatment.
The European Medicines Agency's Committee for Medicinal Products for Human Use made the recommendation. It will be forwarded to the European Commission, which will likely update Viread's label to add hepatitis B as a treatment in a few months. The new use would be effective in 27 countries of the European Union.
Shares of Gilead rose 14 cents to $47.70 in after-hours trading after falling 53 cents to close at $47.56 during regular trading.
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China's Hepatitis B carriers face gloomy future
http://news.yahoo.com
By Tan Ee Lyn
HONG KONG (Reuters) - Madam Yan and 11 other mothers in China turned to the All-China Women's Federation for help after their toddlers were denied places in kindergarten after testing positive for the Hepatitis B virus.
"When I see other children going to school happily and mine is alone, my heart drips with blood," Yan wrote.
Hepatitis B is preventable through vaccination and there are drugs to control the replication of the virus in carriers, such as Yan's child, who shows no symptoms.
Risk of infection through casual contact is minimal, and in many places worldwide, most carriers go about their own business whether in school or at work, facing little or no discrimination. But in China, fear of the virus has reached hysterical proportions, health experts say.
Ignorance and relentless advertisements by drugmakers making misleading claims about the disease and touting all kinds of magic cures have built a climate of terror surrounding the virus, and discrimination against carriers, they add.
Many schools, universities and companies now subject students and staff to regular health checks to screen for the virus.
Toddlers who test positive are refused entry to school, older students are expelled, men and women can't find work and some couples are forced into separation by terrified in-laws.
Qing Song, an activist who helps carriers fight discrimination at work, related a case where a young pregnant woman discovered her carrier status during a prenatal check.
"Her mother-in-law advised her to abort the child and fix her own health before trying to conceive again. But after the abortion, she was forced into a divorce and driven out of the family home," said Qing, who is based in southern Shenzhen city.
Beijing Acts
Hepatitis B is endemic in parts of Asia and Africa.
Worldwide, there are 360 million carriers and a whopping third of that, or between 120-130 million, are in China.
China's hepatitis B rate has historically been high but the reasons are unclear and it is not known if it may be due to genetic susceptibility.
Though 10 percent of its population are carriers, that figure is believed to be as high as 17 percent in its southern provinces, such as Guangdong and Guangxi.
The chief mode of transmission is from mother to child. Others include sex, blood transfusions and contaminated needles, including the reuse of needles to vaccinate children which was a common practice in China up until recently.
While a mature immune system in an older child or adult can flush out the virus, this is not the case for children under the age of 5 who contract the virus. It remains in their bodies, replicating quietly.
Drugs can only control the virus but not get rid of it and most of these younger children become carriers for life.
One in four of them are at risk of developing cirrhosis -- scarring of the liver -- or liver cancer later in life.
The Chinese government introduced free universal vaccinations for newborns in 2002, but actual coverage is inconsistent. Medical experts say more babies are vaccinated in the cities than in rural areas.
Discrimination
The government has tried to stop discrimination in recent years, reversing an age-old policy banning carriers from the civil service. Last year it banned companies from screening employees for the virus in health checks and using a positive test result as a condition to fire staff or reject new hires.
But these laws are difficult to enforce.
"Employers don't give a reason anymore. They say you are a danger to others or that you will suffer prejudice. They persuade you to resign and they don't have to compensate you," said a lawyer, who carries the virus and declined to be identified.
"It (carrier status) has deep repercussions whether in employment, marriage or social relationships. If people know you have it, they will reject you because they think you will infect them," said Ah Peng, who applied to work at a hotel but was rejected after a pre-employment health check showed he had the virus.
Consequences of such discrimination can be tragic.
Walter Shuai managed to escape health checks at his company for three years, but depression and the constant stress of being found out finally drove him to quit his job and leave China.
"You can't imagine the situation if your colleagues come to know you're a carrier. People are selfish and ignorant because of misleading (information) from the government and some doctors," said Shuai, who works at a scientific institute in South Africa.
Ah Tian, also a carrier, said his childhood friend died at the age 26 from an overdose of drugs that a doctor prescribed with an assurance that it would get rid of the virus.
"There is so much prejudice, suffering, pressure and people are desperate, he was so anxious to get well," said Ah Tian.
"This virus affects my job, family and love life, what else can be closer to us? Even my brother wouldn't sit at the same table with me. I think of suicide sometimes."
(Editing by Megan Goldin)
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March 20th, 2007
Hepatitis B Foundation Testifies Before Congressional Appropriation Committee and Urges More Federal Funding for Hepatitis B
http://www.prnewswire.com
DOYLESTOWN, Pa., March 20 /PRNewswire-USNewswire/ -- Hepatitis B Foundation President Dr. Timothy Block testified about the public health challenge of chronic hepatitis B before the Congressional Appropriations Subcommittee on Labor, Health and Human Services on March 13 in Washington, DC, at the request of Honorable David Obey, chairman, Committee on Appropriations. Dr. Block spoke about the urgent need to strengthen and increase funding for hepatitis B programs at the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH).
"The recent crisis in a Nevada clinic, where 40,000 people were placed at risk for infection with hepatitis B and C, is a problem that the CDC thinks might just be the tip of the iceberg," said Dr. Block. "This incident highlights critical deficiencies in our public health and research programs, and if we don't act with urgency, more and more people will suffer."
The Foundation believes that a well-equipped CDC is our best hope to manage the public health problem of hepatitis B. Two million chronically infected Americans are depending upon the NIH to search for new interventions to treat hepatitis B and liver cancer, a fatal outcome of chronic hepatitis B and the fastest growing cancer in the U.S. today. Both the CDC and NIH have performed admirably with the limited resources they are provided; however, much more is needed to achieve effective, lasting solutions.
Dr. Block concluded his testimony by urging the appropriations subcommittee to restore in FY 2009 the overall CDC budget to $7.4 billion with a $50 million increase for the Division of Viral Hepatitis, and to provide a 6.7% increase for the NIH bringing the total to $31.2 billion, including a $40 million annual increase for hepatitis B research.
Chairman David Obey was sympathetic and commented on the importance of restoring cuts to the NIH and CDC budget to address important health issues.
About the Hepatitis B Foundation
The Hepatitis B Foundation is a national nonprofit organization dedicated to finding a cure and improving the quality of life for those affected with hepatitis B worldwide through research, education and patient advocacy. For more information, visit http://www.hepb.org or call (215) 489-4900.
SOURCE Hepatitis B Foundation
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Presidio Pharmaceuticals buys rights to hepatitis C program
http://www.bizjournals.com
San Francisco Business Times
Presidio Pharmaceuticals Inc. will pay $4 million up front to XTL Biopharmaceuticals Ltd. for the rights to a treatment aimed at hepatitis C.
San Francisco-based Presidio could pay as much as $104 million in milestones, plus further royalties, if the treatment is successfully developed and marketed. The research in this program centers around the NS5A protein, which is important in the replication of the hepatitis C virus.
PRNewswire
“The Program focuses on the development of novel small molecule inhibitors against the Hepatitis C virus, and is presently in advanced stages of lead optimization. The current lead compounds target NS5A - a viral protein that is essential for viral production. NS5A is distinct from the protease and polymerase. The Program's lead compounds are highly potent inhibitors of viral replication in the replicon assay, which is known to have good correlation with clinical efficacy and is currently the leading method for preclinical testing of inhibitors of the Hepatitis C Virus.”
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Hepatitis Open Forum Scheduled For Monday, March 24thhttp://www.ktnv.com/
A legislative committee will meet on Monday to hear the public's thoughts on the Hepatitis scare.
It is an open forum and everyone is invited.
The meeting will take place at the Grant Sawyer Building downtown on Monday, March 24th at 5 PM.
Keep it tuned to Channel 13 Action News for the latest on the Hepatitis scare.
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March 21st, 2007
Criminal Charges Could Void Victim Awards in Hep C Lawsuits
http://www.injuryboard.com
Posted by Jane Akre
With the FBI, Las Vegas Police and District Attorney’s office all looking into criminal charges against the clinic whose practices have led to the largest public health notification in history — comes disclosure that those charges could supercede any monetary awards from patients who turn up positive for hepatitis C, B or HIV.
Hundreds of former patients have joined class action lawsuits against the Endoscopy Center of Southern Nevada, Dr. Dipak Desai, co-owner, who, CNN’s Nancy Grace adds on her program, just moved into a four million dollar luxury home.
On her cable program, Grace asked her guest attorneys about any assault, aggravated battery or reckless endangerment charges that could be filed against nurses, managers and assistants of the clinic who knowingly used unsafe public health practices on patients.
Attorney Ray Guidice suggests, “if you have knowledge that something you’re doing can reasonably lead to harm you can be charged.”
However he adds that criminal actions can void insurance policies for negligence.
That’s because insurance policies cover negligence or gross negligence and not intentional criminal acts.
Attorney Geoff White of White, Meany and Wetherall LLP, (a partner of Injuryboard.com) explains to IB News:
“ If the evidence in the cases show that the nurses and doctors at the Endoscopy Center of Southern Nevada "intended" that their patients would be exposed to the risk of getting hepatitis C or HIV, that would exclude coverage under the policy, and it would also make their conduct "criminal.
“The "gray area" is if the clinic workers acted in reckless disregard of the consequences of their actions, i.e. they didn't "intend" that their patients would be exposed to the risk of getting hepatitis C or HIV, but they KNEW that was a possibility from their actions and they threw caution to the wind.
“The insurance company would argue that this was "intentional" or otherwise so reckless as to border on the intentional such that there should be no insurance coverage.”
But White, whose firm has several hundred former patients enrolled in a class action lawsuit, says he would argue that such conduct was ALSO negligent and therefore covered.
To avoid paying any applicable claims, the insurance company and the Court would both have to agree that the clinic workers’ actions were intentional.
White adds that if intentional actions were covered by insurance, “everyone would be beating each other up without restraint or financial deterrent.”
So far there are seven confirmed cases of hepatitis C contracted from the Endoscopy Center of Southern Nevada and another clinic owned by Dr. Dipak Desai.
As a cost-cutting measure workers were told to reuse syringes which likely contaminated a vial of sedative used on multiple patients.
40,000 are being tested for hepatitis C, B and HIV and those results won’t be in for months.
Also on the CNN program, attorney Guidice says there may be another avenue to charge Dr. Desai.
There are more doctors sitting in jail today because of tax fraud charges, he says, which are easier to prove than criminal charges and may be the avenue prosecutors choose to put Dr. Desai in jail.
“There may also be insurance fraud, Medicaid fraud Medicare fraud if these were separately billed. It sounds insignificant but 40,000 needles and syringes that are bill to insurance company if this doctor is being paid for that, that’s a slam dunk insurance fraud case “says Guidice.
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New Method Disrupts Hepatitis C Virion Production
http://www.sciencedaily.com
ScienceDaily (Mar. 21, 2008) — HCV is a significant human pathogen, infecting more than three percent of the world's population. The incidence of infection in the United States has been estimated to be as high as 4 million cases. In the March issue of the journal PLoS Pathogens, Timothy Tellinghuisen, an assistant professor in the Department of Infectology at Scripps Florida, and his colleagues describe how they used mutations of the viral NS5A phosphoprotein to disrupt virus particle production at an early stage of assembly. NS5A has long been proposed as a regulator of events in the HCV life cycle, but exactly how it orchestrates these events has been unclear.
"The interesting thing about this mutant is that while it triggers totally normal RNA replication, it causes severe defects in the output of infectious virus--in fact, it releases no infectious virus that we can detect," says Tellinghuisen. "And though this discovery isn't a cure for HCV, it is an important research tool that stops the assembly pathway." Total disruption of the replication process would be a cure for the disease, he adds, and that's the team's long-term goal.
HCV infection is roughly five to seven times more prevalent than HIV, underscoring the pandemic nature of HCV infection. HCV occurs when blood from an infected person enters the body of someone who is not infected. Most new HCV infections are due to illegal drug injections and sharing needles. However, those who had blood transfusions prior to blood donor screening in 1991, healthcare workers who had needle stick accidents, and hemodialysis patients are also at risk for developing HCV infection.
The virus predominantly infects the liver, and following many decades of virus reproduction serious disease such as hepatitis (liver inflammation), cirrhosis (liver scarring), and carcinoma (liver cancer) develop. Ultimately, HCV infection destroys the liver, resulting in death. Attempts at curing HCV infections with drug therapy have been only marginally successful.
Before more effective therapies can be developed, scientists need to understand, at the molecular level, the detailed mechanisms HCV uses to infect cells, replicate itself, assemble progeny virus, and exit the cell. Each of these processes could potentially be a target for a new drug to eliminate HCV infection. HCV, like all viruses, requires the normal cellular machinery for its replication and has developed strategies to utilize normal cell physiology for its own benefit (often to the detriment of the host).
The Tellinghuisen team, which includes Research Assistants Katie L. Foss and Jason Treadaway, has focused recent efforts on NS5A to understand the regulation of events used by the virus to assemble infectious copies of itself and exit the cell. NS5A is a three-domain protein, which means it is comprised of three compactly folded regions roughly 50 to 300 amino acids in length. The requirement of domains I and II for RNA replication is well documented. NS5A domain III, however, is not required for RNA replication, and the function of this region in the HCV life cycle is unknown.
Using standard molecular biology, the researchers removed from domain III of NS5A a coding sequence corresponding to roughly 15 amino acids. Then they generated a clone of the virus, transcribed the RNA from that clone, and purified the RNA. This RNA, which is directly infectious, was then transfected into a liver cell line where it produced all the HCV proteins that are encoded by that RNA genome.
"Those proteins assemble in the cell to make a structure called a replicase that then copies the viral RNA," Tellinghuisen explains. "We measured that RNA accumulation and observed no defect in RNA replication, but found, surprisingly, that no infectious viral particles were released from the cells." The team also found that no viral RNA nor nucleocapsid protein are released from cells, indicating that an early event in virus assembly had been affected.
Using genetic mapping and biochemical analyses, the authors were able to show that their deletion altered a phosphorylation signal controlling the switch from RNA replication to virus particle assembly. This signal was attributed to the activity of a cellular kinase that when inhibited by genetic or chemical means led to a reduction in infectious virus production without altering HCV RNA replication.
"These data provide the first evidence for a function of domain III of NS5A and implicate NS5A as an important regulator of the RNA replication and virion assembly of HCV," Tellinghuisen says. "The ability to uncouple virus production from RNA replication may be useful in understanding HCV assembly and may become therapeutically important."
Charles M. Rice, head of the Center for the Study of Hepatitis C at Rockefeller University, comments, "This is a spectacular advance linking a specific phosphorylation event by a cellular kinase to hepatitis C virus assembly. Remarkably, the target is a viral nonstructural protein, NS5A, and the data point to a pivotal role for this protein in regulating RNA amplification and infectious virus production. These new data make this multifunctional protein an even more attractive target for developing new anti-virals for treating hepatitis C."
This project was funded by a Career Development Award from the National Institutes of Allergy and Infectious Diseases of the National Institutes of Health, and by the State of Florida.
Adapted from materials provided by Scripps Research Institute, via EurekAlert!, a service of AAAS.
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Ex-nurse accused of infecting patients with hepatitis
http://www.news8austin.com
Associated Press
EL PASO, Texas -- At least 15 military service members or their relatives are believed to have been infected with hepatitis by a former Army hospital nurse in El Paso.
Retired Army captain Jon Dale Jones was arrested this month. He's also suspected of stealing painkillers from his patients during surgeries.
Federal prosecutors said Jones spread the disease in 2004 during surgeries. They believe the 45-year-old diverted fentanyl -- a powerful painkiller often used for anesthesia -- from patients to himself.
Jones pleaded not guilty and is free on bond. He has denied using dirty needles.
Hepatitis C is a blood-borne disease that can lead to cirrhosis of the liver or liver cancer.
It is treatable, but there is no cure.
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