Last Updated: March 16, 2011
Among patients with hepatitis C virus-related vasculitis, those with polyarteritis nodosa have a more severe and acute clinical presentation and a higher rate of clinical remission, according to a study published online Feb. 25 in Arthritis Care & Research.
WEDNESDAY, March 16 (HealthDay News) -- Among patients with hepatitis C virus (HCV)-related vasculitis, those with polyarteritis nodosa (PAN) have a more severe and acute clinical presentation and a higher rate of clinical remission, according to a study published online Feb. 25 in Arthritis Care & Research.
David Saadoun, M.D., Ph.D., of Groupe Hospitalier Pitié-Salpêtrière in Paris, and colleagues investigated the prevalence and characteristics of PAN in a cohort of 161 patients with chronic HCV-related vasculitis. The features and outcomes of 31 patients with HCV-PAN were compared with those patients with HCV-associated mixed cryoglobulinemia (HCV-MC).
The researchers found that, compared to HCV-MC, a more severe and acute presentation was seen in patients with HCV-PAN. They had more frequent fever and weight loss, severe hypertension, involvement of the gastrointestinal tract, severe and acute multifocal neuropathy, kidney and liver microaneurysms, and elevated C-reactive protein. However, clinical remission occurred in 79.3 percent of those with HCV-PAN compared to 57.5 percent of those with HCV-MC. A complete clinical response of HCV vasculitis was independently correlated with skin involvement and PAN-type vasculitis; whereas, a glomerular filtration rate less than 70 mL per minute was negatively correlated with the clinical response. Among the entire HCV-related vasculitis cohort, the five-year survival rate was 86 percent, irrespective of the type of vasculitis.
"HCV-PAN accounts for 19.3 percent of our cohort of HCV-related vasculitis. HCV-PAN compared to HCV-MC displays a more severe and acute clinical presentation, a distinct pathogenic pathway, and a higher rate of clinical remission," the authors write.
One of the study authors disclosed financial ties with several pharmaceutical companies.
Abstract
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March 16, 2011
In New York, A Rare Case of HIV Transmission From a Live Organ Donor
March 16, 2011, 5:38 PM ET
By Laura Landro
The New York State Department of Health alerted hospitals and transplant centers Tuesday that an organ recipient recently contracted the virus that causes AIDS from a live kidney donor in an unnamed city hospital. It’s the nation’s first documented case of HIV transmission via a transplant from a living donor since a sensitive test for the virus was approved and implemented for donor screening in 1985, according to the health department.
A department spokeswoman tells the Health Blog that the hospital followed acceptable protocols in an initial screening of the donor, but that he apparently had “unsafe sex” after the test and prior to donating the organ. “Of course this is a rare case, but we felt like we needed to alert centers to this possibility so they can talk to potential donors about risks and do testing closer to the time of surgery,” she says.
The state declined to name the hospital in the interest of protecting the privacy of the patient.
The department is now recommending that hospitals test donors for HIV and the hepatitis C and B viruses within 14 days before the organ donation, using nucleic acid testing. NAT can detect viral infections weeks to months before antibodies are detectable by standard serologic tests. It hasn’t been recommended for testing organs from deceased donors because of the time pressure of transplanting the organs before they deteriorate, but that time crunch shouldn’t apply to potential living donors, the state notes in its advisory.
Testing for infectious disease has all but eliminated the transmission of HIV through organ, tissue and blood donation. The Centers for Disease Control and Prevention last issued HIV-specific organ-donation screening recommendations in 1994 and is expected to update its recommendation this year.
The state is advising hospitals to question living organ donors about risky behavior, including the use of non-medical injectable drugs. Compliance with the specific recommendation is voluntary but the department is urging all centers to update their policies for screening living donors as necessary.
The transplant community’s most recent testing recommendations, which appeared in the American Journal of Transplantation last year, said that average-risk donors do not require NAT screening; they didn’t address the timing of screening. The health department says it doesn’t believe those recommendations are sufficiently protective because of the challenges of detecting behavioral risks and learning about the infection status of a donor’s sexual partners.
Source
By Laura Landro
The New York State Department of Health alerted hospitals and transplant centers Tuesday that an organ recipient recently contracted the virus that causes AIDS from a live kidney donor in an unnamed city hospital. It’s the nation’s first documented case of HIV transmission via a transplant from a living donor since a sensitive test for the virus was approved and implemented for donor screening in 1985, according to the health department.
A department spokeswoman tells the Health Blog that the hospital followed acceptable protocols in an initial screening of the donor, but that he apparently had “unsafe sex” after the test and prior to donating the organ. “Of course this is a rare case, but we felt like we needed to alert centers to this possibility so they can talk to potential donors about risks and do testing closer to the time of surgery,” she says.
The state declined to name the hospital in the interest of protecting the privacy of the patient.
The department is now recommending that hospitals test donors for HIV and the hepatitis C and B viruses within 14 days before the organ donation, using nucleic acid testing. NAT can detect viral infections weeks to months before antibodies are detectable by standard serologic tests. It hasn’t been recommended for testing organs from deceased donors because of the time pressure of transplanting the organs before they deteriorate, but that time crunch shouldn’t apply to potential living donors, the state notes in its advisory.
Testing for infectious disease has all but eliminated the transmission of HIV through organ, tissue and blood donation. The Centers for Disease Control and Prevention last issued HIV-specific organ-donation screening recommendations in 1994 and is expected to update its recommendation this year.
The state is advising hospitals to question living organ donors about risky behavior, including the use of non-medical injectable drugs. Compliance with the specific recommendation is voluntary but the department is urging all centers to update their policies for screening living donors as necessary.
The transplant community’s most recent testing recommendations, which appeared in the American Journal of Transplantation last year, said that average-risk donors do not require NAT screening; they didn’t address the timing of screening. The health department says it doesn’t believe those recommendations are sufficiently protective because of the challenges of detecting behavioral risks and learning about the infection status of a donor’s sexual partners.
Source
FDA Hepatitis Update - FDA Advisory Committee meeting to consider boceprevir and telaprevir, April 27 and April 28, 2011
From: U.S. Food & Drug Administration (FDA)
You are receiving this message as a subscriber to the FDA hepatitis electronic list serve. The purpose of the list serve is to relay important information about viral hepatitis-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.
Please do not reply to this message.
The Food and Drug Administration will convene its Antiviral Drugs Advisory Committee on April 27 and 28, 2011 to provide advice and recommendations to the Agency on two drugs intended to treat hepatitis C.
On April 27, 2011, from 8 a.m. to 5 p.m., the Committee will discuss a new drug application (NDA) 202–258, boceprevir (a hepatitis C virus protease inhibitor), manufactured by Merck & Co., Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin (two medicines approved to treat chronic hepatitis C infection) in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
On April 28, 2011, the committee will discuss a new drug application (NDA) 201–917, telaprevir (a hepatitis C virus protease inhibitor), manufactured by Vertex Pharmaceuticals, Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin (two medicines approved to treat chronic hepatitis C infection) in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.
The meeting will be held on both days from 8 a.m. to 5 p.m. at the FDA White Oak Campus, located at
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002.
Please note that visitors to the White Oak Campus must enter through Building 1, which is located at the circle at the entrance to the campus via Mahan Road from New Hampshire Avenue. (Google Maps)
FDA intends to make background material about these meetings available to the public no later than 2 business days before the meeting at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.
Scroll down to the link for the Antiviral Drug Committee, and click on appropriate meeting dates.
If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.
Public Participation Information
This FDA advisory committee meeting is free and open to the public without prior registration.
Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee.
Written submissions may be made to
Paul Tran, R.Ph
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO31-2417
Silver Spring, MD 20993-0002
Phone: 301-796-9001
Fax: 301-847-8533
E-mail: Paul.Tran@fda.hhs.gov
on or before April 14, 2011.
Oral presentations from the public will be scheduled between approximately 1:00 p.m. to 2:00 p.m., on April 28, 2011. Those desiring to make formal oral presentations should notify Paul Tran and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 6, 2011.
Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 7, 2011.
Please call the FDA Advisory Committee Information Line for up-to-date information on this meeting at
1-800-741-8138
(301-443-0572 in the Washington DC area)
Enter code: 3014512531
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Paul Tran at (301) 796-9001 at least 7 days in advance of the meeting.
Information regarding special accommodations due to a disability, or information about visitor parking and transportation may be accessed at: Public Meetings at the FDA White Oak Campus
Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. FDA is committed to the orderly conduct of its advisory committee meetings.
Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
You are receiving this message as a subscriber to the FDA hepatitis electronic list serve. The purpose of the list serve is to relay important information about viral hepatitis-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.
Please do not reply to this message.
The Food and Drug Administration will convene its Antiviral Drugs Advisory Committee on April 27 and 28, 2011 to provide advice and recommendations to the Agency on two drugs intended to treat hepatitis C.
On April 27, 2011, from 8 a.m. to 5 p.m., the Committee will discuss a new drug application (NDA) 202–258, boceprevir (a hepatitis C virus protease inhibitor), manufactured by Merck & Co., Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin (two medicines approved to treat chronic hepatitis C infection) in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
On April 28, 2011, the committee will discuss a new drug application (NDA) 201–917, telaprevir (a hepatitis C virus protease inhibitor), manufactured by Vertex Pharmaceuticals, Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin (two medicines approved to treat chronic hepatitis C infection) in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.
The meeting will be held on both days from 8 a.m. to 5 p.m. at the FDA White Oak Campus, located at
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002.
Please note that visitors to the White Oak Campus must enter through Building 1, which is located at the circle at the entrance to the campus via Mahan Road from New Hampshire Avenue. (Google Maps)
FDA intends to make background material about these meetings available to the public no later than 2 business days before the meeting at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.
Scroll down to the link for the Antiviral Drug Committee, and click on appropriate meeting dates.
If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.
Public Participation Information
This FDA advisory committee meeting is free and open to the public without prior registration.
Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee.
Written submissions may be made to
Paul Tran, R.Ph
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO31-2417
Silver Spring, MD 20993-0002
Phone: 301-796-9001
Fax: 301-847-8533
E-mail: Paul.Tran@fda.hhs.gov
on or before April 14, 2011.
Oral presentations from the public will be scheduled between approximately 1:00 p.m. to 2:00 p.m., on April 28, 2011. Those desiring to make formal oral presentations should notify Paul Tran and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 6, 2011.
Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 7, 2011.
Please call the FDA Advisory Committee Information Line for up-to-date information on this meeting at
1-800-741-8138
(301-443-0572 in the Washington DC area)
Enter code: 3014512531
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Paul Tran at (301) 796-9001 at least 7 days in advance of the meeting.
Information regarding special accommodations due to a disability, or information about visitor parking and transportation may be accessed at: Public Meetings at the FDA White Oak Campus
Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings. FDA is committed to the orderly conduct of its advisory committee meetings.
Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
Hepatitis C virus infection in USA: an estimate of true prevalence
Liver International
Early View (Articles online in advance of print)
Eric Chak 1, Andrew H. Talal 2, Kenneth E. Sherman 3, Eugene R. Schiff 4, Sammy Saab 5
Article first published online: 15 MAR 2011
DOI: 10.1111/j.1478-3231.2011.02494.x
© 2011 John Wiley & Sons A/S
Author Information
1 Department of Medicine, UCLA-Olive View Medical Center, University of California at Los Angeles, Sylmar, CA, USA
2 Division of Gastroenterology and Hepatology and Center for the Study of Hepatitis C, Department of Medicine, Weill Cornell Medical College, Cornell University, New York, NY, USA
3 Department of Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA
4 Department of Medicine, University of Miami School of Medicine, Miami, FL, USA
5 Department of Medicine and Surgery, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA, USA
* Correspondence: Correspondence Sammy Saab, MD, MPH, AGAF, UCLA Pfleger Liver Institute, 200 Medical Plaza, Suite 214, Los Angeles, CA 90095, USA Tel: +1 310-206-6705 Fax: +1 310-206-4197 e-mail: ssaab@mednet.ucla.edu
Abstract
Keywords :hepatitis C virus;prevalence
The recent National Health and Nutrition Examination Survey (NHANES) sampled only the civilian, non-institutionalized population of USA and may have underestimated the prevalence of hepatitis C virus (HCV) in this country. We searched the database MEDLINE, the Bureau of Justice Statistics, Center for Medicare and Medicaid and individual states Department of Corrections for all epidemiological studies regarding the prevalence of HCV in populations not sampled by the NHANES survey namely the incarcerated, homeless, nursing home residents, hospitalized and those on active military duty. Because of their relatively low frequency in the NHANES sample, we also expanded our search to include healthcare workers and long-term dialysis patients. Although included in the NHANES sample, we also performed searches on drug users (injection and non-injection) and veterans to confirm the findings of the NHANES study. Based on the prevalence of studies identified meeting our inclusion criteria, our most conservative estimates state that there at least 142 761 homeless persons, 372 754 incarcerated persons and 6805 persons on active military duty unaccounted for in the NHANES survey. While the NHANES estimates of drug users (both injection and non-injection) appear to be reasonable, the survey seems to have underestimated the number of HCV-positive veterans. Our most conservative estimates suggest that there are at least 5.2 million persons living with HCV in USA today, approximately 1.9 million of whom were unaccounted for in the NHANES survey.
Source
Early View (Articles online in advance of print)
Eric Chak 1, Andrew H. Talal 2, Kenneth E. Sherman 3, Eugene R. Schiff 4, Sammy Saab 5
Article first published online: 15 MAR 2011
DOI: 10.1111/j.1478-3231.2011.02494.x
© 2011 John Wiley & Sons A/S
Author Information
1 Department of Medicine, UCLA-Olive View Medical Center, University of California at Los Angeles, Sylmar, CA, USA
2 Division of Gastroenterology and Hepatology and Center for the Study of Hepatitis C, Department of Medicine, Weill Cornell Medical College, Cornell University, New York, NY, USA
3 Department of Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA
4 Department of Medicine, University of Miami School of Medicine, Miami, FL, USA
5 Department of Medicine and Surgery, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA, USA
* Correspondence: Correspondence Sammy Saab, MD, MPH, AGAF, UCLA Pfleger Liver Institute, 200 Medical Plaza, Suite 214, Los Angeles, CA 90095, USA Tel: +1 310-206-6705 Fax: +1 310-206-4197 e-mail: ssaab@mednet.ucla.edu
Abstract
Keywords :hepatitis C virus;prevalence
The recent National Health and Nutrition Examination Survey (NHANES) sampled only the civilian, non-institutionalized population of USA and may have underestimated the prevalence of hepatitis C virus (HCV) in this country. We searched the database MEDLINE, the Bureau of Justice Statistics, Center for Medicare and Medicaid and individual states Department of Corrections for all epidemiological studies regarding the prevalence of HCV in populations not sampled by the NHANES survey namely the incarcerated, homeless, nursing home residents, hospitalized and those on active military duty. Because of their relatively low frequency in the NHANES sample, we also expanded our search to include healthcare workers and long-term dialysis patients. Although included in the NHANES sample, we also performed searches on drug users (injection and non-injection) and veterans to confirm the findings of the NHANES study. Based on the prevalence of studies identified meeting our inclusion criteria, our most conservative estimates state that there at least 142 761 homeless persons, 372 754 incarcerated persons and 6805 persons on active military duty unaccounted for in the NHANES survey. While the NHANES estimates of drug users (both injection and non-injection) appear to be reasonable, the survey seems to have underestimated the number of HCV-positive veterans. Our most conservative estimates suggest that there are at least 5.2 million persons living with HCV in USA today, approximately 1.9 million of whom were unaccounted for in the NHANES survey.
Source
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