April 4
EASL ABSTRACTS NOW READY TO VIEW
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The abstracts will be available on the EASL website, http://www.easl.eu as of today.
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Vertex at EASL 2012
Source
Vertex will present data on INCIVEK® (telaprevir) tablets, approved for the treatment of hepatitis C, and one of its hepatitis C medicines in development, the non-nucleoside polymerase inhibitor VX-222, at the 47th Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, April 18 to 22, 2012.
The titles of the 14 accepted abstracts are included below. The complete abstracts are now available through the EASL website at www.easl.eu.
Oral Presentation: April 20, 2012, 4:00 p.m. – 6:00 p.m. CET
•"Futility Rules in Telaprevir Combination Treatment"
Poster Presentations: April 21, 2012, 12:30 p.m. – 1:30 p.m. CET
•Poster #1094: "100% SVR in IL28b CC Patients Treated with 12 Weeks of Telaprevir, Peginterferon and Ribavirin in the PROVE2 Trial"
•Poster #1203: "All IL28b Genotypes Have High SVR Rates in Patients Treated with VX-222 in Combination with Telaprevir/Peginterferon/Ribavirin in the ZENITH Study"
•Poster #1132: "High Concordance Between SVR12 and SVR24 in Patients Receiving Telaprevir Plus Peginterferon and Ribavirin in Three Phase 3 Clinical Trials: ADVANCE, ILLUMINATE and REALIZE"
•Poster #1162: "Ribavirin Dose Modification in Treatment-Naïve and Previously Treated Patients Who Received Telaprevir Combination Treatment: No Impact on Sustained Virologic Response in Phase 3 Studies"
•Poster #1167: "Pre-Treatment IP-10 Levels and IL28b Genotype in Prediction of SVR in Prior Treatment-Experienced Genotype 1 HCV Patients Treated with Telaprevir/ Peginterferon/ Ribavirin in REALIZE Study"
•Poster #1150: "A Comprehensive Review of Patterns of Viral Load Decline in Patients Treated with Telaprevir Plus Peginterferon and Ribavirin"
•Poster #1117: "Telaprevir French Cohort Authorisation for Temporary Use in Genotype 1 Hepatitis C Cirrhotic Patients with Prior Partial Response or Relapse"
•Poster #1116: "Exposure-Response Relationships in Telaprevir Combination Therapy in Treatment-Naïve Genotype 1 Chronic HCV Patients"
•Poster #1174: "Deep Sequencing Screening for Telaprevir-Resistant Viral Variants in Previous Null Responders Fails to Identify Those Patients at Risk of Failing Telaprevir Plus Peginterferon/Ribavirin Therapy”
•Poster #1184 "Characterization of HCV Variants in Genotype 1 Treatment-Naïve Patients Administered the Combination of TVR and VX-222 in Dual Arms of ZENITH Study"
•Poster #1102: "The Cost-Effectiveness of Telaprevir (TVR) in Combination with Pegylated Interferon-Alfa and Ribavirin (PR) for the Treatment of Genotype 1(G1) Chronic Hepatitis C Patients"
•Poster #1169: "Health-Related Quality-of-Life Among Genotype 1 Treatment-Naïve Chronic Hepatitis C Patients Receiving Telaprevir Combination Treatment: Post-Hoc Analyses of Data from the ADVANCE Trial"
•Poster #1170: "Predictors of Days Unable to Work Among Genotype 1 Treatment-Naïve Chronic Hepatitis C Patients: Post-Hoc Analyses of Data from Phase 3 ADVANCE and ILLUMINATE Studies"
Media Contacts:
Erin Emlock
Dawn Kalmar
Zachry Barber
617-444-6992
Investor Relations Contacts:
Michael Partridge, 617-444-6108
Wednesday, April 4, 2012
EASL-April 2012 Revised Clinical Practice Guidelines on the Management of Chronic Hepatitis B
Revised EASL CPGs on HBV April 2012
EASL:Abbott to Present Positive Phase 2 Results from Multiple Interferon-Free Studies of Combination Regimens for the Treatment of Hepatitis C
April 4
EASL ABSTRACTS NOW READY TO VIEW
Click Here
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Public
The abstracts will be available on the EASL website, http://www.easl.eu as of today.
..
Abbott to Present Positive Phase 2 Results from Multiple Interferon-Free Studies of Combination Regimens for the Treatment of Hepatitis C
April 04, 2012
Abbott Park, Illinois (NYSE: ABT) — Abbott will present clinical trial results from two different interferon-free, Phase 2 studies for the treatment of hepatitis C (HCV) at the International Liver Congress™ 2012 (ILC 2012), the annual meeting of the European Association for the Study of the Liver (EASL), April 18-22 in Barcelona, Spain. Abstracts for the meeting were published online today.
In the study known as "Co-Pilot," different doses of ABT-450/r, plus ABT-333 and ribavirin administered for 12 weeks showed sustained virological response at 12 weeks post treatment (SVR12) in 95 percent and 93 percent of treatment-naïve genotype 1 (GT1) patients. In these patients, response was independent of HCV subtype, host IL28B genotype or dose of ABT-450/r. In addition, SVR12 was achieved in 47 percent of patients who were previous non-responders to past HCV treatment.
In a separate study, known as "Pilot," 91 percent of genotype 1 infected, treatment-naïve patients taking ABT-450/r and ABT-072 combined with ribavirin administered for 12 weeks, achieved sustained viral response at 24 weeks (SVR24).
Full results with longer-term follow-up data from both studies will be presented at the meeting. Abstracts are available at www.easl.eu.
"We are extremely encouraged to see this level of sustained response with only 12 weeks of therapy in patients who were new to treatment, and to see a response in patients who had failed past treatment because options to cure this population are limited," said Fred Poordad, M.D., chief of hepatology at Cedars-Sinai Medical Center in Los Angeles, and the lead investigator for Co-Pilot and an investigator for Pilot. "These data suggest that an interferon-free, all-oral regimen of direct-acting antiviral medications could be an important new treatment option for HCV, and we look forward to presenting additional data at the meeting."
"At this meeting, Abbott will present some of the first sustained viral response data for short course, interferon-free regimens for the treatment of HCV. The data suggest that with a 12-week regimen containing just two of our direct-acting antiviral medicines, and no peginterferon, we can achieve high cure rates in treatment-naïve, genotype 1 patients," said Scott Brun, M.D., divisional vice president, Infectious Disease Development, Abbott. "Abbott's HCV pipeline includes several compounds in different drug classes and we have the flexibility to study a variety of multi-drug regimens for HCV, with a focus on interferon-free treatments. Abbott is committed to exploring a wide variety of options in our portfolio with the goal of developing optimized regimens to help patients."
Current treatments for HCV remain interferon-based and a significant number of HCV patients are unable or unwilling to take interferon due to contraindications and/or side effects. Specifically targeted antiviral therapies for HCV, such as protease inhibitors and non-nucleoside polymerase inhibitors, may have the potential to increase the proportion of patients in whom the virus can be eradicated.
These two studies represent an important part of Abbott’s broader HCV development program. Larger Phase 2 clinical trials are ongoing, and Abbott expects to present additional data later this year. In addition to its partnership with Enanta Pharmaceuticals on ABT-450 and protease inhibitors, Abbott has internal programs focused on additional viral targets. Abbott currently has investigational medicines with three different mechanisms of action in its ongoing clinical trials, including protease, polymerase and NS5A inhibitors. Abbott is well-positioned to explore combinations of these compounds, a strategy with the potential to markedly transform current treatment practices by shortening therapy duration, improving tolerability and increasing cure rates.
Study M12-746 (Co-Pilot)
Fred Poordad, et al.; Saturday, April 21, 15:30-17:30 CET / 8:30-10:30 a.m. CDT.
"12-Week Interferon-Free Regimen of ABT-450/r+ABT-333+Ribavirin Achieved SVR12 in More Than 90% of Treatment-Naïve HCV Genotype-1-Infected Subjects and 47% of Previous Non-Responders"
Study M12-267 (Pilot)
Eric Lawitz et al.; Thursday, April 19, 16:00-18:00 CET / 9:00-11:00 a.m. CDT.
"A 12-Week Interferon-Free Regimen of ABT-450/r, ABT-072, and Ribavirin was Well Tolerated and Achieved Sustained Virologic Response in 91% Treatment-Naïve HCV IL28B-CC Genotype-1-Infected Subjects"
Ritonavir Use in Treatment of HIV
Ritonavir is in a class of medicines called the HIV protease inhibitors. Ritonavir is used in combination with other anti-HIV medicines to treat people with human immunodeficiency virus (HIV) infection. Ritonavir is for adults and for children greater than 1 month in age and older.
Ritonavir does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others. People taking ritonavir may still get opportunistic infections or other conditions that happen with HIV infection. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium aviumcomplex (MAC) infections.
Ritonavir Safety in Treatment of HIV
Patients should not take ritonavir with certain medicines, as these can cause serious or life-threatening problems such as irregular heartbeat, breathing difficulties, or excessive sleepiness. Patients should not take ritonavir if they have had a serious allergic reaction to any of its ingredients. Some patients taking ritonavir may develop liver and pancreas problems, which can cause death. Patients may develop large increases in triglycerides and cholesterol, diabetes, high blood sugar, changes in body fat, increased bleeding in people with hemophilia, allergic reactions, and/or changes in heart rhythm. Patients may develop signs and symptoms of infections that they already have after starting anti-HIV medicines.
For more information, please see the Important Safety Information and full Prescribing Information for ritonavir.
About Abbott
Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacturing and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.
EASL ABSTRACTS NOW READY TO VIEW
Click Here
.
Public
The abstracts will be available on the EASL website, http://www.easl.eu as of today.
..
Abbott to Present Positive Phase 2 Results from Multiple Interferon-Free Studies of Combination Regimens for the Treatment of Hepatitis C
April 04, 2012
In the study known as "Co-Pilot," different doses of ABT-450/r, plus ABT-333 and ribavirin administered for 12 weeks showed sustained virological response at 12 weeks post treatment (SVR12) in 95 percent and 93 percent of treatment-naïve genotype 1 (GT1) patients. In these patients, response was independent of HCV subtype, host IL28B genotype or dose of ABT-450/r. In addition, SVR12 was achieved in 47 percent of patients who were previous non-responders to past HCV treatment.
In a separate study, known as "Pilot," 91 percent of genotype 1 infected, treatment-naïve patients taking ABT-450/r and ABT-072 combined with ribavirin administered for 12 weeks, achieved sustained viral response at 24 weeks (SVR24).
Full results with longer-term follow-up data from both studies will be presented at the meeting. Abstracts are available at www.easl.eu.
"We are extremely encouraged to see this level of sustained response with only 12 weeks of therapy in patients who were new to treatment, and to see a response in patients who had failed past treatment because options to cure this population are limited," said Fred Poordad, M.D., chief of hepatology at Cedars-Sinai Medical Center in Los Angeles, and the lead investigator for Co-Pilot and an investigator for Pilot. "These data suggest that an interferon-free, all-oral regimen of direct-acting antiviral medications could be an important new treatment option for HCV, and we look forward to presenting additional data at the meeting."
"At this meeting, Abbott will present some of the first sustained viral response data for short course, interferon-free regimens for the treatment of HCV. The data suggest that with a 12-week regimen containing just two of our direct-acting antiviral medicines, and no peginterferon, we can achieve high cure rates in treatment-naïve, genotype 1 patients," said Scott Brun, M.D., divisional vice president, Infectious Disease Development, Abbott. "Abbott's HCV pipeline includes several compounds in different drug classes and we have the flexibility to study a variety of multi-drug regimens for HCV, with a focus on interferon-free treatments. Abbott is committed to exploring a wide variety of options in our portfolio with the goal of developing optimized regimens to help patients."
Current treatments for HCV remain interferon-based and a significant number of HCV patients are unable or unwilling to take interferon due to contraindications and/or side effects. Specifically targeted antiviral therapies for HCV, such as protease inhibitors and non-nucleoside polymerase inhibitors, may have the potential to increase the proportion of patients in whom the virus can be eradicated.
These two studies represent an important part of Abbott’s broader HCV development program. Larger Phase 2 clinical trials are ongoing, and Abbott expects to present additional data later this year. In addition to its partnership with Enanta Pharmaceuticals on ABT-450 and protease inhibitors, Abbott has internal programs focused on additional viral targets. Abbott currently has investigational medicines with three different mechanisms of action in its ongoing clinical trials, including protease, polymerase and NS5A inhibitors. Abbott is well-positioned to explore combinations of these compounds, a strategy with the potential to markedly transform current treatment practices by shortening therapy duration, improving tolerability and increasing cure rates.
Study M12-746 (Co-Pilot)
Fred Poordad, et al.; Saturday, April 21, 15:30-17:30 CET / 8:30-10:30 a.m. CDT.
"12-Week Interferon-Free Regimen of ABT-450/r+ABT-333+Ribavirin Achieved SVR12 in More Than 90% of Treatment-Naïve HCV Genotype-1-Infected Subjects and 47% of Previous Non-Responders"
- The objectives of this Phase 2 study were to assess safety and tolerability of 12-week, interferon-free regimens in HCV GT1 patients who were either treatment-naïve or previous non-responders. The trial had three arms with three primary endpoints – rapid virological response (RVR) at week 4 and SVR at weeks 4 and 12.
- Enrollment was open to GT1-infected patients regardless of IL28B host genotype and ribavirin dosing was weight-based.
- 95 percent (18 of 19) of treatment-naïve patients infected with HCV GT1
(17 GT 1a, 2 GT 1b) achieved SVR12 with ABT-450/r 250/100 mg dosed once daily (QD) + ABT-333 400 mg dosed twice daily (BID) + ribavirin (Arm 1). - 93 percent (13 of 14) of treatment-naïve patients infected with HCV GT1
(11 GT 1a, 3 GT 1b) achieved SVR12 with ABT-450/r 150/100 mg QD + ABT-333 400 mg BID + ribavirin (Arm 2). - One patient in Arm 1 discontinued due to asymptomatic isolated ALT/AST elevations at week 2. One patient in Arm 2 discontinued due to noncompliance in week 1. All remaining patients in Arms 1 and 2 completed treatment and achieved SVR12. In Arm 3, six patients experienced viral breakthrough while on treatment and three patients relapsed after treatment stopped.
- In the trial the most common adverse events were fatigue (42 percent), nausea (22 percent) and headache (20 percent).
- 47 percent (8 of 17) of patients with HCV GT1 (16 GT 1a, 1 GT 1b) who had previously not responded to other HCV treatments achieved SVR12 with
ABT-450/r 150/100 mg QD + ABT-333 400 mg BID + ribavirin (Arm 3).
Eric Lawitz et al.; Thursday, April 19, 16:00-18:00 CET / 9:00-11:00 a.m. CDT.
"A 12-Week Interferon-Free Regimen of ABT-450/r, ABT-072, and Ribavirin was Well Tolerated and Achieved Sustained Virologic Response in 91% Treatment-Naïve HCV IL28B-CC Genotype-1-Infected Subjects"
- The objectives of the 12-week, Phase 2 study were to assess the safety, tolerability, pharmacokinetics and antiviral activity of ABT-450/r 150/100 mg QD and ABT-072 400 mg QD + ribavirin administered for 12 weeks.
- The study was conducted in 11 treatment-naïve adults with host IL28B "CC" genotype from multiple ethnic backgrounds with non-cirrhotic HCV GT1
(8 GT 1a, 3 GT 1b). Ribavirin 1,000-1,200 mg/day was weight-based and dosed twice daily. - The primary endpoint was percentage of patients with HCV RNA <25 IU/mL from week 4 through 12. Other trial endpoints include early virologic response, RVR and SVR through 24 weeks.
- 100 percent of patients maintained HCV RNA levels <25 IU/mL from weeks
4 through 12 of treatment, and all had undetectable HCV RNA from week 5 to the end of treatment. - 91 percent of patients (10 of 11) achieved SVR24.
- In the trial, the most common adverse events reported were headache, fatigue, nausea and dry skin. There were no premature discontinuations.
ABT-450 is being developed with low dose ritonavir (ABT-450/r), which enhances the pharmacokinetic properties of ABT-450. The use of ritonavir 100 mg with ABT-450 for the treatment of HCV is investigational
In addition to the oral presentations, Abbott has six poster presentations at ILC 2012:
.
.
- Tami Pilot-Matias et al.; Friday, April 20 (11:00-11:30, 12:30-14:00, 15:30-16:00 CET)
"In vitro combinatory effect of HCV NS3/4A protease inhibitor ABT-450, NS5A inhibitor ABT-267, and non-nucleoside NS5B polymerase inhibitor ABT-333" - Robert W. Baran et al.; Friday, April 20 (11:00-11:30, 12:30-14:00, 15:30-16:00 CET)
"Hepatitis C Virus Patient Reported Outcomes (HCVPRO): Development and Validation of a Disease-Specific Patient Reported Outcomes Instrument for Health-Related Quality of Life Measurement" - Eric Lawitz et al.; Saturday, April 21 (11:00-11:30, 12:30-13:30, 15:00-15:30 CET)
"Safety and antiviral activity of ABT-267, a novel NS5A inhibitor, during 3-day monotherapy: first study in HCV genotype-1 (GT1)-infected treatment-naïve subjects"
- J Greg Sullivan et al.; Saturday, April 21 (11:00-11:30, 12:30-13:30, 15:00-15:30 CET)
"ABT-267 combined with pegylated interferon alpha-2a/ribavirin in genotype 1 (GT1) HCV-infected treatment-naïve subjects: 12 week antiviral and safety analysis" - Eric Lawitz et al; Saturday, April 21 (11:00-11:30, 12:30-13:30, 15:00-15:30 CET)
"ABT-450/ritonavir (ABT-450/r) combined with pegylated interferon alpha-2a/ribavirin after 3-day monotherapy in genotype 1 (GT1) HCV-infected treatment-naïve subjects: 12-week sustained virologic response (SVR12) and safety results" - Fred Poordad et al.; Saturday, April 21 (11:00-11:30, 12:30-13:30, 15:00-15:30 CET)
"ABT-072 or ABT-333 combined with pegylated interferon/ribavirin after 3-day monotherapy in HCV genotype 1 (GT1)-infected treatment-naïve subjects: 12-week sustained virologic response (SVR12) and safety results"
About the Hepatitis C Virus
Hepatitis C is a liver disease affecting as many as 170 million people worldwide. The virus is primarily spread through direct contact with the blood of an infected person.HCV increases a person's risk of developing chronic liver disease, cirrhosis, liver cancer and death, and liver disease associated with HCV infection is growing rapidly.Ritonavir Use in Treatment of HIV
Ritonavir is in a class of medicines called the HIV protease inhibitors. Ritonavir is used in combination with other anti-HIV medicines to treat people with human immunodeficiency virus (HIV) infection. Ritonavir is for adults and for children greater than 1 month in age and older.
Ritonavir does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others. People taking ritonavir may still get opportunistic infections or other conditions that happen with HIV infection. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium aviumcomplex (MAC) infections.
Ritonavir Safety in Treatment of HIV
Patients should not take ritonavir with certain medicines, as these can cause serious or life-threatening problems such as irregular heartbeat, breathing difficulties, or excessive sleepiness. Patients should not take ritonavir if they have had a serious allergic reaction to any of its ingredients. Some patients taking ritonavir may develop liver and pancreas problems, which can cause death. Patients may develop large increases in triglycerides and cholesterol, diabetes, high blood sugar, changes in body fat, increased bleeding in people with hemophilia, allergic reactions, and/or changes in heart rhythm. Patients may develop signs and symptoms of infections that they already have after starting anti-HIV medicines.
For more information, please see the Important Safety Information and full Prescribing Information for ritonavir.
About Abbott
Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacturing and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.
EASL: ACH-1625 -Watch Achillion Pharmaceutical for Upcoming Phase IIa Data
Good Morning Folks,
April 4
EASL ABSTRACTS NOW READY TO VIEW
Click Here
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Public
The abstracts will be available on the EASL website, http://www.easl.eu as of today.
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In The News
Idenix Pharmaceuticals Inc. and Achillion Pharmaceuticals Inc. will both present at the European Association for the Study of the Liver (EASL) meeting in Barcelona on April 18-22.
Watch Achillion Pharmaceutical for Upcoming Phase IIa Data
Brian Wilson
Source
Continue Reading...
April 4
EASL ABSTRACTS NOW READY TO VIEW
Click Here
.
Public
The abstracts will be available on the EASL website, http://www.easl.eu as of today.
.
In The News
Idenix Pharmaceuticals Inc. and Achillion Pharmaceuticals Inc. will both present at the European Association for the Study of the Liver (EASL) meeting in Barcelona on April 18-22.
Watch Achillion Pharmaceutical for Upcoming Phase IIa Data
Brian Wilson
Source
Achillion’s pipeline also includes one preclinical-stage drug being developed for bacterial infections, although the bulk of the company’s resources are being spent on HCV (hepatitis C virus). Achillion have five separate HCV drugs in various stages of development, most notable is ACH-1625 which is classified as a protease inhibitor.
The hepatitis C virus, in order to replicate, needs particular protease enzymes to construct new virions which allow the disease to continue to attack the body. ACH-1625 is an inhibitor of the HCV NS3 protease, which means this drug should prove effective if it can prevent this protein from functioning. The NS3 protein that is targeted by ACH-1625 has been studied extensively, and serves critical functions in the HCV infection process. All non-structural proteins with regards to HCV are processed by NS2 and NS3, and due to their necessary interaction, inhibition of NS3 should hypothetically be a nearly-insurmountable obstacle for HCV replication. As of now, ACH-1625 has passed Phase I trials which have validated its relative safety and lack of side-effects. Phase II trials will give further insight into the efficacy of the drug against viral replication by HCV.
ACH-2684 is a broader protease inhibitor being developed to suppress the natural variants of the hepatitis C virus by the same mechanism. According to the company, the compound is also potent against standard genotypes of HCV which means it could be just as (if not more) effective than inhibition of just the NS3 protein, although the company claims that it has actually been tailored to affect the NS3 protease. The efficacy of this broader ranged protease inhibitor is difficult to determine at this stage, since it has only proven potency in the “low pico-molar range” (an incredibly small volume), but the fact that it might target mutant strands of HCV makes it worthwhile.
The third drug in the pipeline that has begun its clinical trials is ACH-2928, which acts through another mechanism by inhibiting HCV NS5A. This protein actively antagonizes a cell’s response to a viral infection through RNA-binding, and research is being done to investigate its suspected role in genome replication. The second generation version of this, ACH-3102, is being developed with enhanced abilities to fight off resilient strains of HCV that would be less susceptible to ACH-2928.
ACH-1625 will be releasing results of its Phase IIa clinical trials on April 18-22, at the International Liver Conference being hosted in Barcelona. Shares have already rocketed up at the start of 2012, but there’s reason to believe that some early confirmation of ACH-1625′s efficacy in a larger sample size could be immensely beneficial for the stock. News may be slow after this since many fresh studies are being started this year, but investors may jump the gun if the data on this generation of protease inhibitors gives hope on stopping HCV.
Continue Reading...
Tuesday, April 3, 2012
Highest-Risk Individuals Missed by Current HCV Screening
Medscape Medical News from the: International Conference on Viral Hepatitis (ICVH) 2012
From Medscape Medical News
Highest-Risk Individuals Missed by Current HCV ScreeningApril 3, 2012 (New York, New York) — An analysis involving more than 30 million medical claims from a commercial insurance provider and from Medicare suggest that current recommendations for hepatitis C virus (HCV) testing are not being followed.
In fact, the adult demographic with the lowest incidence of HCV infection — young women — is the most likely to be tested, according to data presented here at the International Conference on Viral Hepatitis 2012.
"The CDC is looking at changing the HCV guidelines to mandate a 1-time HCV antibody test for everybody born between 1945 and 1965," said lead analyst Camilla Graham, MD, who is vice president of global medical affairs for Vertex Pharmaceuticals.
Recent studies have suggested that the 1945 to 1967 birth cohort accounts for 81% of all people diagnosed with HCV infection. "This study was done to look at who is actually getting tested for HCV in the United States under current risk-based screening recommendations."
The analysis was performed using records from the Thomson Medstat MarketScan commercial database, a resource comprising medical and outpatient pharmacy claims from employer-sponsored health insurance plans and including more than 30 million commercially insured and 3 million Medicare supplemental-insured individuals. Claims made from 2004 to 2008 were used for this study.
People who had undergone HCV testing were identified on the basis of Current Procedural Technology codes for HCV antibody or HCV RNA testing, birth cohort, and sex. People diagnosed with HCV infection after testing were identified with International Classification of Diseases, Ninth Revision (ICD-9) codes. "Filters were also employed to find people newly identified with HCV as of 2008," said Dr. Graham, "to get a sense of diagnosis trends."
For 2008, only 1.1% of individuals in the payer population and 1.7% in the Medicare population had been tested for HCV. "This is actually an increase from 2004, and a maximum for the study period," Dr. Graham noted.
"When we look at the commercial database, we see that there are more women being tested than men [62% vs 38% in 2008]," she said. The sex distribution in the Medicaid population was about even for men and women (51% vs 49%).
Although this finding seems balanced on the surface, data continue to accrue showing that men have higher exposure to HCV and a greater likelihood of having chronic HCV infection. Of the currently identified 800,000 HCV-related cases of cirrhosis in the United States, 75% are men.
Current testing practices do not reflect actual rates of HCV infection as indicated by birth cohort, Dr. Graham said. Only 32.8% of people born from 1945 to 1964 have been tested, even though this cohort has the highest rate of infection. In contrast, 48.2% of people born from 1970 to 1989 have been tested, although their rate of HCV infection is known to be much lower.
"Interestingly, in this younger group, almost twice as many women as men are being tested," she said.
An analysis of HCV diagnosis during the study period illustrates a displaced diligence in HCV screening. "When we look at the people who were actually diagnosed, young women have a much lower prevalence than older men."
For the birth period of 1945 to 1954, 3.5% of women and 7.4% of men were diagnosed with HCV. For 1955 to 1964, 2.9% of women and 5.7% of men were diagnosed with HCV.
"Medicare is a more complicated population," because some patients are enrolled on the basis of disability rather than age, said Dr. Graham. "But again, you see a shockingly high prevalence of HCV in men." Medicare data show that 16.1% of men and 10.4% of women in the 1945 to 1954 cohort and 19.1% of men and 13.3% of women in the 1955 to 1974 cohort are HCV-positive.
"Is Medicare aware of this serious HCV problem as the leading edge of the boomers are entering the program?" she wondered.
The precise reason for the tilt toward the more prevalent HCV testing of women is not known, but Dr. Graham speculated that the driver is prenatal testing.
Findings "Not a Surprise"
"I've looked at the data from my own institution," said Natalie Kil, MPH, project manager in the division of general internal medicine at Mount Sinai Hospital in New York City. "I can tell you that it is not at all common for a primary care doctor to order a routine hep C test. They're only doing it by way of known risk factors, and most clinicians, from my understanding, are not really asking about risk factors."
Through Kil's involvement in Mount Sinai's community outreach program to help identify HCV-infected individuals, she has noted no small measure of misplaced trust.
International Conference on Viral Hepatitis (ICVH) 2012: Abstract 79332. Presented March 26, 2012.
This coverage is not sanctioned by, nor a part of, the International Association of Physicians in AIDS Care.
From Medscape Medical News
Highest-Risk Individuals Missed by Current HCV ScreeningApril 3, 2012 (New York, New York) — An analysis involving more than 30 million medical claims from a commercial insurance provider and from Medicare suggest that current recommendations for hepatitis C virus (HCV) testing are not being followed.
In fact, the adult demographic with the lowest incidence of HCV infection — young women — is the most likely to be tested, according to data presented here at the International Conference on Viral Hepatitis 2012.
"The CDC is looking at changing the HCV guidelines to mandate a 1-time HCV antibody test for everybody born between 1945 and 1965," said lead analyst Camilla Graham, MD, who is vice president of global medical affairs for Vertex Pharmaceuticals.
Recent studies have suggested that the 1945 to 1967 birth cohort accounts for 81% of all people diagnosed with HCV infection. "This study was done to look at who is actually getting tested for HCV in the United States under current risk-based screening recommendations."
The analysis was performed using records from the Thomson Medstat MarketScan commercial database, a resource comprising medical and outpatient pharmacy claims from employer-sponsored health insurance plans and including more than 30 million commercially insured and 3 million Medicare supplemental-insured individuals. Claims made from 2004 to 2008 were used for this study.
People who had undergone HCV testing were identified on the basis of Current Procedural Technology codes for HCV antibody or HCV RNA testing, birth cohort, and sex. People diagnosed with HCV infection after testing were identified with International Classification of Diseases, Ninth Revision (ICD-9) codes. "Filters were also employed to find people newly identified with HCV as of 2008," said Dr. Graham, "to get a sense of diagnosis trends."
For 2008, only 1.1% of individuals in the payer population and 1.7% in the Medicare population had been tested for HCV. "This is actually an increase from 2004, and a maximum for the study period," Dr. Graham noted.
"When we look at the commercial database, we see that there are more women being tested than men [62% vs 38% in 2008]," she said. The sex distribution in the Medicaid population was about even for men and women (51% vs 49%).
Although this finding seems balanced on the surface, data continue to accrue showing that men have higher exposure to HCV and a greater likelihood of having chronic HCV infection. Of the currently identified 800,000 HCV-related cases of cirrhosis in the United States, 75% are men.
Current testing practices do not reflect actual rates of HCV infection as indicated by birth cohort, Dr. Graham said. Only 32.8% of people born from 1945 to 1964 have been tested, even though this cohort has the highest rate of infection. In contrast, 48.2% of people born from 1970 to 1989 have been tested, although their rate of HCV infection is known to be much lower.
"Interestingly, in this younger group, almost twice as many women as men are being tested," she said.
An analysis of HCV diagnosis during the study period illustrates a displaced diligence in HCV screening. "When we look at the people who were actually diagnosed, young women have a much lower prevalence than older men."
For the birth period of 1945 to 1954, 3.5% of women and 7.4% of men were diagnosed with HCV. For 1955 to 1964, 2.9% of women and 5.7% of men were diagnosed with HCV.
"Medicare is a more complicated population," because some patients are enrolled on the basis of disability rather than age, said Dr. Graham. "But again, you see a shockingly high prevalence of HCV in men." Medicare data show that 16.1% of men and 10.4% of women in the 1945 to 1954 cohort and 19.1% of men and 13.3% of women in the 1955 to 1974 cohort are HCV-positive.
"Is Medicare aware of this serious HCV problem as the leading edge of the boomers are entering the program?" she wondered.
The precise reason for the tilt toward the more prevalent HCV testing of women is not known, but Dr. Graham speculated that the driver is prenatal testing.
Findings "Not a Surprise"
"I've looked at the data from my own institution," said Natalie Kil, MPH, project manager in the division of general internal medicine at Mount Sinai Hospital in New York City. "I can tell you that it is not at all common for a primary care doctor to order a routine hep C test. They're only doing it by way of known risk factors, and most clinicians, from my understanding, are not really asking about risk factors."
Through Kil's involvement in Mount Sinai's community outreach program to help identify HCV-infected individuals, she has noted no small measure of misplaced trust.
International Conference on Viral Hepatitis (ICVH) 2012: Abstract 79332. Presented March 26, 2012.
Scripps Research Institute Scientists Find Promising Vaccine Targets on Hepatitis C Virus
LA JOLLA, CA – April 3, 2012 – A team led by scientists at The Scripps Research Institute has found antibodies that can prevent infection from widely differing strains of hepatitis C virus (HCV) in cell culture and animal models.
HCV’s very high rate of mutation normally helps it to evade its host’s immune system. The newly discovered antibodies, however, attach to sites on the viral envelope that seldom mutate. One of the new antibodies, AR4A, shows broader HCV neutralizing activity than any previously reported anti-HCV antibody.
“These antibodies attach to sites on the viral envelope that were previously unknown, but now represent promising targets for an HCV vaccine,” said Mansun Law, an assistant professor at Scripps Research. Law is the senior author of the new report, which appears online this week in the Proceedings of the National Academy of Sciences.
A Desperate Need
An effective HCV vaccine is desperately needed. The World Health Organization (WHO) estimates that the virus has established mostly silent infections in 130 to 170 million people worldwide—nearly 3 percent of the human population—and spreads to 3 to 4 million new people annually. HCV principally infects liver cells, and is thought to cause chronic, often-unnoticed liver inflammation, which eventually can lead to serious liver ailments. The virus already is responsible for about a quarter of annual US cases of liver cirrhosis and primary liver cancer, and it is the leading cause of liver transplants. In some developing countries, HCV prevalence is extremely high; studies suggest that in Egypt, as many as 22 percent of the population is infected—apparently due to poor screening of blood products and past re-use of syringes. Even in developed countries, HCV infections represent a looming public health crisis. In the United States and Europe, up to 14 million people are now HCV-positive, and each year an estimated 150,000 people are newly infected.
The current leading treatment for HCV infection involves a 12- to 36-week course of the immune-stimulating protein interferon-alpha, the antiviral drug ribavirin and HCV protease blocker. But it is not completely effective, and it causes significant adverse side effects—aside from being very expensive. To fully stamp out the HCV pandemic, especially in developing countries, scientists will have to develop a cheap preventive vaccine.
Yet an effective HCV vaccine has so far been elusive. The virus mutates very rapidly, and thus, antibodies raised against one isolate of HCV typically won’t protect against a subsequent HCV infection. Hospital samples of HCV suggest that the virus’s genes, and the proteins for which they code, are highly variable even within an individual patient.
“One of the big goals of HCV vaccine development has been to find an accessible spot on the virus that doesn’t change constantly,” said Law.
Searching for Vulnerabilities
To find such vulnerable spots, researchers sift through antibodies sampled from infected people and look for those antibodies that can neutralize a broad range of viral strains. The locations on the virus where those broadly neutralizing antibodies bind mark the vulnerable viral structures that can be used as the bases of a broadly effective, antibody-stimulating vaccine. Previous studies, including a 2008 study in Nature Medicine, for which Law was lead author, have found some broadly neutralizing HCV antibodies. But for the present study, Law and his colleagues used a more thorough approach, known as “exhaustive panning,” to see if they could find new and even more broadly neutralizing antibodies. “Exhaustive panning is a powerful technique for finding rare antibodies that might otherwise go undetected,” Law said.
HCV employs a complex of two envelope glycoproteins, E1 and E2, to grab and fuse with target cells. Erick Giang, a research assistant in Law’s lab, harvested this viral E1-E2 complex from HCV-producing cells in a lab dish and used it as “bait” for a panel of antibodies derived from the blood of a person with chronic HCV infection. The exhaustive panning technique involves exposing this bait protein to different anti-HCV antibodies in sequence, so that the known antibody-binding sites on the complex are progressively covered until only new ones are left.
In this way, Giang catalogued 73 new anti-HCV antibodies, which bind to five distinct “antigenic regions” on the E1-E2 complex. In standard cell culture tests of HCV-neutralizing ability, several of these antibodies showed an ability to neutralize infection by a wide range of HCV strains. One, AR4A, turned out to bind to an almost-unvarying spot on E1-E2 complex, close to the surface of the virus’s outer coat of fat molecules. AR4A showed significant neutralizing ability against all 22 HCV strains in a test panel—not only in tests in Law’s lab, but also in confirmatory tests at the University of Copenhagen.
The Broadest Neutralizing Activity Yet
The new antibody thus is more broadly protective than the previous top contender, AR3A, which Law described in his 2008 Nature Medicine paper. “This human antibody AR4A has the broadest HCV-neutralizing activity known to the field,” Law said.
Collaborating researchers at Rockefeller University, who recently engineered a line of HCV-infectable mice, showed that AR4A antibodies protected these mice from two widely different HCV strains. A combination of half-doses of AR3A and AR4A antibodies worked less well.
The next step for Law and his colleagues is to start making and testing prototype vaccines based on the vulnerable HCV binding sites that have been revealed by these antibody studies. The researchers also plan to use the new antibodies to study the structure and function of HCV proteins such as the all-important E1-E2 complex.
Anti-HCV antibodies such as AR4A and AR3A could have some therapeutic use, too. Although they wouldn’t be able to clear existing HCV infections and would be too expensive and difficult to use on a large population to prevent new infections, they could be useful in preventing new HCV liver infections in liver transplant patients. Such infections can spread from HCV reservoirs in the patient’s body to the newly transplanted liver tissue.
“Antibody-based treatment has worked extremely well for liver transplants to patients with hepatitis B virus, and we hope the new HCV antibodies can be just as helpful to HCV liver transplant patients,” Law said.
In addition to Law and Giang, contributors to the paper, “Human broadly neutralizing antibodies to the envelope glycoprotein complex of hepatitis C virus,” were Marcus Dorner, Charles M. Rice, and Alexander Ploss of Rockefeller University in New York; Jannick C. Prentoe and Jens Bukh of the University of Copenhagen; Matthew J. Evans of the Mount Sinai School of Medicine; and Marlène Dreux and Dennis Burton at Scripps Research.
The Law laboratory’s research is supported by the National Institutes of Health.
About The Scripps Research Institute
The Scripps Research Institute is one of the world's largest independent, non-profit biomedical research organizations. Scripps Research is internationally recognized for its discoveries in immunology, molecular and cellular biology, chemistry, neuroscience, and vaccine development, as well as for its insights into autoimmune, cardiovascular, and infectious disease. Headquartered in La Jolla, California, the institute also includes a campus in Jupiter, Florida, where scientists focus on drug discovery and technology development in addition to basic biomedical science. Scripps Research currently employs about 3,000 scientists, staff, postdoctoral fellows, and graduate students on its two campuses. The institute's graduate program, which awards Ph.D. degrees in biology and chemistry, is ranked among the top ten such programs in the nation. For more information, see www.scripps.edu.
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Source: http://www.scripps.edu/news/press/20120403law.html
Hepatitis C Experimental Drug Daclatasvir:Drug Interactions With HIV Medications.
More News on Drug Interactions With New HCV Drugs -- This Time With Daclatasvir
By Barbara McGovern, M.D.
April 3, 2012
Continue Reading @ The Body
By Barbara McGovern, M.D.
April 3, 2012
Daclatasvir was studied along with asunaprevir (an HCV protease inhibitor in development) in a small study of HCV-monoinfected patients who previously didn't respond to PEG interferon plus ribavirin. In results presented at CROI 2012, the use of "quad" (four-drug) therapy consisting of daclatasvir plus asunaprevir plus PEG intereferon plus ribavirin led to cures for 9 of 10 patients. In addition, 4 of 11 patients who only got the two new HCV drugs (i.e., not PEG interferon or ribavirin) were cured of their HCV infection. Although this is a small study to “test out the waters,” these are pretty amazing results. Much larger trials are now planned in HCV-monoinfected patients.
To get ready for future trials in HIV/HCV-coinfected patients, the makers of daclatasvir did three separate studies in healthy volunteers. One study looked at drug interactions between the NRTI Viread (tenofovir) and daclatasvir; another at drug interactions between the NNRTI Sustiva (efavirenz) and daclatasvir; and the last one looked at interactions between daclatasvir and the protease inhibitor Reyataz (atazanavir) boosted with Norvir (ritonavir).....
Continue Reading @ The Body
TheStreet Exposes Unfair Selective Disclosure Policy of Prominent European Medical Association, Resulting in Change That Favors Investors
Press release April 3, 2012, 10:29 a.m. EDT
Source: Market WatchNEW YORK, Apr 3, 2012 (GlobeNewswire via COMTEX) -- Investigative journalism by TheStreet /quotes/zigman/65006/quotes/nls/tst TST -0.92% , a leading digital financial media company, has caused a prominent European medical association to enact a major change in its disclosure policy, a move that will help level the playing field for ordinary investors.
As reported by TheStreet biotechnology reporter Adam Feuerstein on March 20, 2012 ( www.thestreet.com/story/11462003/1/easl-gives-wall-streets-privileged-investors-sneaky-preview-to-key-hep-c-data.html ), the European Association for the Study of the Liver (EASL) was set to selectively disclose, to a group that includes hedge funds and sell-side equity analysts, potentially market moving data involving clinical studies of experimental treatments for hepatitis C -- three weeks before the data was going to be announced to the public at EASL's International Liver Congress gathering to be held April 18-22. The conference will include reports on important studies by Gilead Sciences (GILD), Bristol-Meyers Squibb (BMY), Abbott (ABT), Idenix Pharmaceuticals (IDIX), Vertex Pharmaceuticals (VRTX) and Merck (MRK), among others.
TheStreet's article pointed out that many medical and scientific groups, such as the American Society of Clinical Oncology, make research abstracts publicly available in advance of major conferences in light of ability of such information to cause significant movement to the share price of various public medical industry companies.
Two days after TheStreet's exposure of EASL's unfair selective disclosure policy, EASL reversed course and announced that the research abstracts would be disclosed by making the data publicly available online on April 4 -- see http://www.thestreet.com/story/11465904/1/easl-backs-down-will-publicy-disclose-key-hep-c-data.html .
TheStreet commends EASL on taking appropriate action and changing its unfair policies.
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