Saturday, July 9, 2011

Hepatitis C Weekend Update :30 thalassaemic patients have been administered Hepatitis C-infected blood

BMC Infectious Diseases June 6 2011
"We found that most patients seeking outpatient care at an urban public hospital supported universal screening for HCV, as well as HIV and diabetes. .....Patients support universal screening for HCV, even if that screening involves testing without prior consent or the routine provision of negative test results. Current screening guidelines and procedures should be reconsidered in light of patient priorities......We conducted an anonymous, self-administered, cross-sectional survey of outpatients at five clinics at Harborview Medical Center, a public urban hospital and regional trauma center in Seattle, WA, to define the importance that patients place on testing for HCV, compared to HIV and diabetes mellitus.....n summary, our findings demonstrate that patients support universal testing for HCV, as well as HIV, that an "opt-out" program would be preferred if feasible, but that patients appear to place a higher priority on being tested than they do on the process of informed consent or the receipt of negative results. These findings should inform the priorities of clinicians, public health officials, and clinical risk managers.....One-hundred twelve (56%) respondents were white, 65 (33%) were African or African-American, and 16 (8%) were Hispanic or Latino. Demographics compared to the 2010 census by clinic are presented in Table 1. Twenty-three (12%) respondents reported ever injecting drugs, 39 (20%)"...continue reading...

Clinical trials
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Achillion Initiates 12-Week Dosing in Phase 2 Trial of ACH-1625 for the Treatment of Chronic Hepatitis C

New Haven, Conn. -- June 22, 2011 -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced that the Company has initiated patient dosing in segment 2 of its Phase 2 clinical trial of ACH-1625 for the treatment of hepatitis C virus (HCV) for genotype 1 treatment-naive HCV-infected patients. ACH-1625, discovered and advanced by Achillion, is a potent small molecule inhibitor of HCV protease, an enzyme necessary for viral replication.

The clinical trial has advanced into the second segment of a Phase 2a, randomized, double-blind trial evaluating the safety, tolerability and antiviral activity of oral ACH-1625 in combination with standard of care (SOC) consisting of pegylated interferon alfa-2a and ribavirin. Patients will be randomized to receive once daily doses of 200 mg, 400 mg or 800 mg of ACH-1625 in combination with SOC for 12 weeks of dosing. Patients will continue to receive an additional 12 weeks of pegylated interferon alfa-2a and ribavirin and eligible to discontinue treatment at week 24 if they achieve extended rapid virologic response (eRVR) at week 12. Patients who do not achieve an eRVR will continue to receive SOC until week 48.

The trial will take place in the United States and Europe and is designed to enroll approximately 60 HCV-infected patients. The 12-week complete early virologic response (cEVR) trial results are anticipated to be announced in the fourth quarter of 2011.

"Initiating the second segment of this Phase 2 clinical trial allows us to build upon the robust RVR results we observed with ACH-1625, and to further augment the safety and efficacy database by taking the opportunity to study multiple doses of ACH-1625," commented Elizabeth A. Olek, DO, Vice President and Chief Medical Officer of Achillion. "We expect that the results will provide important insight to benchmark the activity of our once-daily protease inhibitor and we look forward to reporting cEVR results by the end of this year."

"This next study segment with ACH-1625 is yet another important milestone achieved for this potentially best-in-class protease inhibitor and for Achillion's broader HCV pipeline," said Michael D. Kishbauch, President and Chief Executive Officer of Achillion. "It should be recalled that, very recently, we announced the start of Phase 1 on Achillion's high-potency, pan-genotypic protease inhibitor, ACH-2684, and with the upcoming start of Phase 1 on our first NS5A inhibitor, ACH-2928, Achillion remains poised to deliver on a number of clinical milestones over the next few quarters that we believe will significantly enhance our overall position within the important and promising HCV market."

About ACH-1625

ACH-1625 is a HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. ACH-1625 has rapid and extensive partitioning to the liver, as well as high liver/plasma ratios. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50 of approximately 1nM.

In the first segment of a Phase 2a clinical study, HCV-infected patients receiving doses of 200 mg, 400 mg, or 800 mg of ACH-1625 in combination with SOC achieved a rapid viral response of 75 -- 81% compared to an RVR of 20% for patients receiving SOC only. ACH-1625 was well tolerated at all doses with no serious adverse events reported and adverse events which were reported as mild to moderate and transient.

About Achillion Pharmaceuticals

Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including hepatitis C and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000

Also See: Update; Hepatitis Clinical Trials
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HIV
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New tool reveals mutations that cause HIV-drug resistance
July 8, 2011

Protease inhibitor drugs are one of the major weapons in the fight against HIV, the virus that causes AIDS, but their effectiveness is limited as the virus mutates and develops resistance to the drugs over time. Now a new tool has been developed to help predict the location of the mutations that lead to drug resistance.

First discovered in 1995, protease inhibitor drugs have dramatically reduced the number of AIDS deaths. Taken in combination with two other anti-HIV drugs, protease inhibitors work by halting the action of the protease enzyme, a protein produced by HIV that is necessary for replication of the virus. However, almost half of HIV patients who initially respond to treatment with protease inhibitors develop drug-resistance strains and stop responding to treatment within eight to 10 months. .... Continue reading..


Targeted viral load testing to confirm treatment failure reduced unnecessary treatment regimen switches four-fold compared to clinical-immunological criteria alone (viral load <1000 copies/ml 12.4% and 46.9%, p<0.001, respectively) among 250 patients in six African ...

Transmission clinical setting

Ludhiana (Punjab), July 9 (IANS)

Around 30 thalassaemic patients have been administered Hepatitis C-infected blood in various cities of Punjab, a hospital said Saturday.


The thalassaemia patients, who require regular transfusion of blood, are currently admitted at Dayanand Medical College and Hospital (DMCH) here.

“There are around 30 thalassaemic patients who were given infected blood at various blood banks across the state. They have tested positive for Hepatitis C during the screening examination conducted at DMCH recently,” in-charge of the thalassaemia wing of the hospital, Praveen Sobti, said.

“The union health ministry has made it mandatory for blood banks to conduct Hepatitis C tests of blood donors. But many people do not adhere to the rules. We are trying our level best to treat the 30 patients, who are between 5 to 26 years. Hepatitis C virus causes damage to the liver,” Sobti added.

According to DMCH officials, the patients were administered infected blood in various parts of the state, including Jalandhar, Moga, Ludhiana, Bathinda, Faridkot and Amritsar.

“Monthly expense for the treatment of a thalassaemic patient go up to Rs.4,000. However, treatment of Hepatitis C for a thalassaemic patient would cost above Rs.2 lakh. We are contacting various NGOs and pharmaceutical companies and seeking their help,” a DCMH official said.

Ludhiana, the industrial hub of Punjab, is around 100 km away from state capital Chandigarh.

Diabetes

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Stem Cells
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Northwestern-Baxter Heart Stem Cell Study Shows Progress - July 08, 2011
CHICAGO (Chicago Tribune) -- A treatment that uses adult stem cells to rebuild failing hearts reduced severe chest discomfort, known as angina, in patients and improved their tolerance for exercise a year after injection, according to a study led by a Northwestern University researcher working with Baxter International Inc.
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Lab-Grown Trachea Implanted in Patient
A 36-year-old cancer patient is the recipient of the first-ever bioartificial trachea grown on a synthetic substrate using the patient's own stem cells, researchers at the Karolinska Institute announced.
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A Dose of Reality on Alternative Stem Cell Treatments: What you don’t know can hurt you
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.,Stem Cell Tourism From Paul Knoepfler at UC Davis July Podcast Listen Here
,5 Topics
–Stem Cell Tourism in the U.S.
–CIRM
–Article in the Hill by stem cell opponent
–Stem cell hype on aging
http://www.ipscell.com/


Off The Cuff

From Scope
There’s an interesting interview (subscription required) in tomorrow’s Science magazine with Deborah Zarin, MD, who directs the ClinicalTrials.gov database at the National Institutes of Health.


For Your Reading Pleasure
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Grand Rounds
Grand Rounds is a weekly summary of the best health blog posts on the Internet. Each week a different blogger takes turns hosting Grand Rounds, and summarizing the best submissions for the week
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Grand Rounds Vol. 7 No. 40
Welcome to Grand Rounds!  It’s the third time we’ve hosted Grand Rounds at the Colorado Health Insurance Insider and we’re honored to be hosting again. It was a pleasure to read so many great articles for this edition.  Since our blog tends to focus on health care policy and reform, I’m starting things off with the posts that pertain to that topic.  Enjoy!
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A Few Topics
Treating diabetes with medications has left many doctors and patients stuck between a rock and a hard place lately, with concerns being raised about the safety of various diabetes drugs.  Dr.Pullen gives us the details

Dr. Val Jones of Get Better Health writes about the importance of yearly eye exams
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Psychologist Will Meek, PhD details the five stage process that most people go through when making a change in their lives – quitting smoking, for example



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