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Medical Forum / Diseases and Disorders / Hepatitis / August 2004Serum Biochemical Markers Accurately Predict Liver Fibrosis in HIV and HCV Co-Infected Patients
http://vhaaidsinfo.cio.med.va.gov/news_service/2003/03-21.htm Serum Biochemical Markers Accurately Predict Liver Fibrosis in HIV and Hepatitis C Virus Co-Infected Patients Robert P. Myers ; Yves Benhamou ; Françoise Imbert-Bismut ; Vincent Thibault ; Marie Bochet ; Frédéric Charlotte ; Vlad Ratziu ; François Bricaire ; Christine Katlama ; Thierry Poynard . AIDS 2003; 17(5):721-725 Objective: Liver biopsy, the gold standard for assessing hepatitis C virus (HCV)-related fibrosis, is invasive and prone to complications. Our aim was to determine the operating characteristics of a non-invasive index of biochemical markers for the prediction of fibrosis in patients with HIV/HCV co-infection. Design: In a cross-sectional, cohort study in a French tertiary-care hospital 130 HIV/HCV-co-infected patients with a liver biopsy and serum were tested for markers of liver fibrosis. Methods: An index incorporating age, sex, a2-macroglobulin, apolipoprotein A1, haptoglobin, bilirubin, and ?-glutamyl-transpeptidase (GGT), derived using multivariate logistic regression, was compared with liver histology. HIV-specific indices including the CD4 cell count and HIV-RNA load were also constructed. The diagnostic values of the indices were compared using receiver operating characteristic (ROC) curves. Main outcome measure: Septal fibrosis (F2-F4) by the METAVIR classification. Results: By multivariate analysis, the most informative markers were a2-macroglobulin, apolipoprotein A1, GGT, and sex. The area under the ROC curve of the five-marker index was 0.856 ± 0.035; not significantly different from the HIV-specific indices. On a scale from zero to 1.00, the five-marker index had a positive predictive value of 86% for scores greater than 0.60, and a negative predictive value of 93% for scores of 0.20 or less. These thresholds could reduce the necessity for liver biopsy by 55% while maintaining an accuracy of 89%. Conclusion: An index including five biochemical markers accurately predicts significant fibrosis in patients with HIV/HCV co-infection, and may substantially reduce the necessity for liver biopsy. >http://vhaaidsinfo.cio.med.va.gov/news_service/2003/03-21.htm > [quoted text clipped - 3 lines] >Marie Bochet ; Frédéric Charlotte ; Vlad Ratziu ; François Bricaire ; Christine >Katlama ; Thierry Poynard . AIDS 2003; 17(5):721-725 Again a study by the very same people who license FibroTest... Thomas  SignatureTo reach me, complete my last name in the address. >Thomas Wagner tomw@capecod.com >Date: 25/08/2004 7:46 PM Eastern Standard Time [quoted text clipped - 11 lines] > >Again a study by the very same people who license FibroTest... Yeah Thomas, when we were debating the pro's and cons of Peg Trials all you posted was studies from Schering. so what? Kim >Thomas >>Thomas Wagner tomw@capecod.com >>Date: 25/08/2004 7:46 PM Eastern Standard Time [quoted text clipped - 14 lines] >Yeah Thomas, when we were debating the pro's and cons of Peg Trials all you >posted was studies from Schering. NOT TRUE. The studies on Peg were done by people who were NOT directly involved with profiting from Schering's sales (past the payment for the trial itself). Ethical and FDA rules forbid the participation of employees of the company initiating the trial in the trial itself. Poynar et al ARE direct employees of the license holders of FibroTest and ARE holding a direct financial interest in the outcome of the trials. Enough incentive to tweak the outcome, and enough incentive to protest trials who fail to replicate their results. That other researchers consistently fail to get the glorious results the makers themselves get should give any thinking person reason to pause. But I'm probably presuming too much... Thomas SignatureTo reach me, complete my last name in the address. >Subject: Re: Serum Biochemical Markers Accurately Predict Liver Fibrosis in >HIV and HCV Co-Infected Patients >From: Thomas Wagner tomw@capecod.com >Date: 26/08/2004 10:04 AM Eastern Standard Time >Message-id: <k5rri0peca101n536lsvhggjujhktrp9v3@4ax.com> >>Yeah Thomas, when we were debating the pro's and cons of Peg Trials all you >>posted was studies from Schering. >NOT TRUE. The studies on Peg were done by people who were NOT directly >involved with profiting from Schering's sales (past the payment for the >trial itself). Ethical and FDA rules forbid the participation of >employees of the company initiating the trial in the trial itself. Oh, so who are these guys conducting this study presented to the DDW? I must be completely dense. http://www.sch-plough.com/schering_plough/news/release.jsp?releaseID=526383 >Poynar et al ARE direct employees of the license holders of FibroTest >and ARE holding a direct financial interest in the outcome of the [quoted text clipped - 5 lines] > >Thomas >Oh, so who are these guys conducting this study presented to the DDW? Independent researchers not employed by Schering, for example: "Results from a Prospective, Randomized, Controlled, Multicenter Trial S. Flamm et al." >I must be >completely dense. By golly, you got it! (Sorry, couldn't resist...) I still can't understand why you want to suppress the information that there is disagreement about the reliability of those tests. What is your motive? Why do you lash out at me even though I pointed people at FibroTest/FibroSpect myself in the past (use Google if you don't believe me) and repeated several times that the tests should become a standard instrument in initial diagnosis? Is it just your bruised ego that someone dares to post information that you haven't approved? Or what? Thomas SignatureTo reach me, complete my last name in the address. Thomas, like I said, you can oppose the info all you like. I know people who have had the test and have had no trouble with it. A person can discuss it with thier doctor. If the publishers of the blood test are not by law enforced to have an outside lab test it, then why would they pay someone to do it. Although, the Australlians did find good results in thier independant study. You seem to be the one with the problem. The randomized controlled multicenter trial was conducted, supervised and approved for publication by schering, and so was the news release. Kim >Thomas, > [quoted text clipped - 6 lines] >Australlians did find good results in thier independant study. You seem to be >the one with the problem. Oh well, your mind is closed, no hope of ever getting through to you. For the last time, I am not opposing ANY information. Instead, I have provided ADDITIONAL information. Information you, unfortunately, couldn't stomach. You're the one trying to oppose that information by downplaying it, twisting it, and denying that it even exists. No, I don't have a problem. But I posted the information about who does have a problem - those were two specialists in the field. Plus your beloved Australians had a problem, a problem severe enough that the makers of the product had to go hewing and crying about the errors and faults in that Australian study. You posted it yourself, and now you're denying that it says what it says. And all because... well? What's your motive? >The randomized controlled multicenter trial was conducted, supervised and >approved for publication by schering, and so was the news release. No, it was not conducted or supervised by Schering, that would have been an ethics violation. Why do you keep claiming things you know aren't true? Thomas SignatureTo reach me, complete my last name in the address. >: Thomas Wagner tomw@capecod.com >Date: 26/08/2004 3:03 PM Eastern Standard Time >Message-id: <4acsi0pmgg8l7tce9qggoj7geu2pkv1nue@4ax.com> >No, it was not conducted or supervised by Schering, that would have been >an ethics violation. Why do you keep claiming things you know aren't >true? Gee I don't know Thomas, could have something to do with Schering pleading guilty to unethical practices and agreeing to pay a multi million dollar fine in bribing doctors as recently as 3 months ago. Or, maybe I just don't like them because of the $500Million fine levy'd on them in 2001 for poor manufacturing, both in thier Jersey plant, and the one in Peurto Rico. IMHO... they are criminals, and have admitted it and paid thier fines over and over and over again to prove it. I'm not claiming anything that is not untrue, that was a Schering press release. If it were not satisfactory to Schering themselves, they would not have released it for publication in thier own website. Why do you keep claiming anything is beyond me. A person has the option to ask thier doctor about a fibrospect/fibrosure/ or acti blood test vs. a biopsy, and bring, be it a press release by the company, or an outside study into the physician to ask his or her opinion. Whether you are comfortable with the test or not, I could care less, your not a practicing doctor, or scientist, and if you'd like to have another 10 biopsies, that is certainly your perogative, and I'm not going to stop you now am I? Why you have such a problem believing that is quite funny. Kim >A person has the option to ask thier doctor about a fibrospect/fibrosure/ or >acti blood test vs. a biopsy, and bring, be it a press release by the company, [quoted text clipped - 4 lines] > >Why you have such a problem believing that is quite funny. You again are trying to divert attention from your errors by posting unrelated crap about Schering, which has nothing to do with the topic at hand. Again you twist my words until they become unrecognizable, again you ignore everything I really said, and again you are lying even about stuff you posted yourself. Oh well, I'll leave you hanging by your own thread. Enough already. Thomas SignatureTo reach me, complete my last name in the address. > Serum Biochemical Markers Accurately Predict Liver Fibrosis in HIV and HCV >Co-Infected Patients >From: Thomas Wagner tomw@capecod.com >Date: 26/08/2004 11:25 PM Eastern Standard Time >Message-id: <t4ati09j7noinel3sf3onda1ghhen4hi9a@4ax.com> >You again are trying to divert attention from your errors by posting >unrelated crap about Schering, which has nothing to do with the topic at >hand. #1. You cry fowl over a study produced by the makers of the fibro test. Because they indicated the results that did not match the Australlians independent study. Even though the independent study on the blood test produced good results, the makers of that particular fibrotest claimed they found even better studies. #2. You call me a liar and say Begin Quote: Thomas Wrote: NOT TRUE. The studies on Peg were done by people who were NOT directly involved with profiting from Schering's sales (past the payment for the trial itself). Ethical and FDA rules forbid the participation of employees of the company initiating the trial in the trial itself. End Quote: Schering conducts thier own studies all the time and people work for them and are paid by Schering to do the studies. Then Schering presents thier findings to the FDA for approval. Then the drug is marketed by Schering or any other drug company. Schering, yes Schering, Roche whoever does it/pays for it themselves. themselves. Starts with a clinical "multicenter" trial, conducted by the pharm. (now whether the people in the other centers are working for schering, schering is still paying them to do the work) The very well could be independent people...but at the time of the sponsoring of any study, they are paid by schering and chosen by the pharm. See here: Q: Who is sponsoring the IDEAL study? A: Schering-Plough Research Institute, in collaboration with leading U.S. study centers, is conducting the study. Back to Top Q: When will the IDEAL study start? A: The IDEAL study will start enrolling in January 2004. http://www.idealstudy.com/faqs.html#Q5 That is written in regards to this study: http://www.medicinenet.com/script/main/art.asp?articlekey=32694 So knick it off alright? Who cares who does what study. The makers of drugs, blood tests and everything else are ultimately in charge and have one common goal in mind. Market it, and profit from it. You know it, I know it and so does everyone else. The biochemical markers are an option. That is all I intended to say before you took your spaz. They do work in at least 50% of the patients, and can be used and are being used. Many people are not aware of them, so It's alright to let them know what is available. Whatever a person chooses is fine by me. Kim |
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