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16076Re: [GIWorld-Hepatitis] FW: NATAP: EPO-does it improve SVR??

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  • avansi7465
    Jan 31, 2006
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      Hi Alley:

      boy have you been busy! MitchellSchiffman is one of my hepatologists. He asked me if I wanted to be in this study. I declined because he couldn't guarantee what medication I would receive and I was NOT willing to go back through hemalitic anemia without REALLY good cause. I think I made the correct decision.

      How you feeling, gal.......

      Happy Monday,
      Anne

      -----Original Message-----
      >From: alleypat <alleypat@...>
      >Sent: Jan 31, 2006 4:04 PM
      >To: happyheppers@yahoogroups.com, GIWorld-Hepatitis@yahoogroups.com
      >Subject: [GIWorld-Hepatitis] FW: NATAP: EPO-does it improve SVR??
      >
      >
      >Study Finds EPO Improved SVR Only in High Dose RBV Group
      >
      >Reported by Jules Levin
      >
      >The results of this study reported at AASLD Nov 2005 did not find EPO
      >improved SVR rates nor did it increase the average dose of RBV in patients
      >who took EPO compared to patients who did not take EPO when standard
      >weight-based dosing of RBV was used; although hemoglobin declines to <10
      >g/dl were reduced, and maximal HB declines were reduced, and the percent of
      >patients with RBV dose reductions was reduced, and the mean dose reduction
      >was less (27 mg/d vs 179 mg/d) in patients receiving standard weight-based
      >dosing of RBV. Still, mean RBV dose (mg/d) was the same in the group
      >receiving EPO & group not receiving EPO among patients receiving standard
      >weight-based RBV dosing. ONLY in the patients receiving RBV high
      >weight-based dosing (1000-1600 mg/d) was the use of EPO found to improve SVR
      >rates. I'm not sure I am convinced by this study, something seems not right
      >here but I can't put my finger on it.
      >
      >bTREATMENT OF CHRONIC HCV GENOTYPE 1 WITH PEGINTERFERON ALFA-2B (PEGIFN),
      >HIGH WEIGHT BASED DOSE RIBAVIRIN (RVN) AND
      >EPOETIN ALFA (EPO) ENHANCES SUSTAINED VIROLOGIC RESPONSE (SVR)b
      >
      >Mitchell L. Shiffman, Virginia Commonwealth University Medical Center,
      >Richmond, VA; Angie Price, Sarah Hubbard, Mary Wilson, Jennifer Salvatori,
      >Virginia Commonwealth University Medical Center, Richmond, VA; Richard K.
      >Sterling, Virginia Commonwealth University Medical Center, Richmond, VA; R
      >T. Stravitz, Virginia Commonwealth University Medical Center, Richmond, VA;
      >Velimir A. Luketic, Virginia Commonwealth University Medical Center,
      >Richmond, VA; Arun J. Sanyal, Virginia Commonwealth University Medical
      >Center, Richmond, VA
      >
      >There were 3 patient study groups in this study:
      >
      >150 patients with HCV genotype 1, naD1ve to prior treatment, were randomly
      >assigned to one of three treatment groups (50/group):
      >
      >--Group 1: PEGIFN alfa-2b (1.5 mcg/kg/wk) + weight based RVN (WBRBN) 13.3
      >mg/kg/day (800-1400 mg/day);
      >--Group 2: PEGIFN alfa-2b + WBRVN + EPO (40,000 U/wk) or
      >--Group 3: PEGIFN alfa-2b + a higher dose of WBRVN (HDWBRVN) 15.2 mg/kg/day
      >(1000-1600 mg/day) + EPO.
      >
      >Hypothesis for study: Successful treatment of chronic HCV with PEGIFN and
      >RVN is hampered by adverse events (AEs). One of the most common AEs is
      >anemia and this frequently requires that RVN either be dose reduced or
      >prematurely discontinued. RVN dose reduction, particularly during the first
      >24 weeks of therapy, is associated with a significant reduction in SVR;
      >particularly in patients with HCV genotype 1. Our hypothesis was that
      >utilizing EPO at the onset of PEGIFN and RVN therapy would reduce the
      >frequency of anemia, the need to dose reduce RVN, allow for use of higher
      >RVN dosing and this in turn could enhance SVR.
      >
      >In groups 2 and 3 EPO was initiated at the onset of therapy if hemoglobin
      >was <15 gm/dl as soon as the Hb <15 g/dl. Starting RPO dose was 40,000
      >U/week and titrated between 20,000 -60,000 U/wk to maintain the hemoglobin
      >(Hb) between 12-15 gm/dl. EPO dose was increased to 60,000/wk if Hb did not
      >increase 1 gm/dl after 4 weeks. EPO dose was held if Hb >15 g/dl. In all
      >groups, the RVN dose was reduced by 200 mg increments if the Hb declined
      >below 10 gm/dl or for management of other side effects as needed, and
      >discontinued in patients who developed severe hemoglobin <8.6 g/dl or severe
      >AEs not responding to dose reduction. All patients underwent liver biopsy
      >prior to treatment. HCV RNA was assessed by Taqman PCR.
      >
      >Patients were excluded for:
      >Any other co-existant liver disorder besides hcv
      >Decompensated cirrhosis
      >Hemoglobin less than 11 gm/dl
      >WBC <3,000
      >HIV+platelet count <80,000
      >Recipient of an organ or tissue transplant
      >
      >RESULTS:
      >This study found that SVR was improved by use of EPO only in the high dose
      >RBV group and not in the standard weight-based dose RBV group when both
      >groups receiving EPO were compared to standard RBV weight-based dosing group
      >who did NOT receive EPO, despite a reduction in anemia in the standard RBV
      >dose group who received EPO. This appeared to be due to a great reduction in
      >the relapse rate in the high dose RBV group only.
      >
      >AUTHOR SUMMARY
      >The use of EPO at the initiation of HCV therapy significantly reduced:
      >--Frequency of anemia
      >--The need for RBV dose reduction
      >--The mean dose by which RBV was reduced
      >HOWEVER, this did not significantly effect:
      >--overall mean RBV dose
      >--early viraologic response
      >--sustained virologic response
      >The use of higher dose weight-based RBV (1,000-1,600 mg/d) with EPO at the
      >start of HCV therapy significantly increased SVR in patients with HCV
      >genotype 1:
      >-across all body weights
      >-in both whites and blacks
      >The increase in SVR was achieved:
      >-despite the need to dose reduce ribavirin in 31 percent of patients
      >-significant reduction in relapse occurred.
      >
      >
      >PATIENT POPULATION
      > Group 1 Group 2 Group 3
      >N 48 49 49
      >Age (yrs) 48 48 45
      >Male 55% 63% 61%
      >AAs 36% 43% 39%
      >Body weight(kg) 82 82 82
      >Serum ALT 101 90 114
      >Log HCV RNA (IU/ml) 5.6 5.5 5.5
      >Inflammation
      >Score 7.1 6.6 6.8
      >% cirrhosis 4% 8% 2%
      >
      >HEMOGLOBIN RESPONSE
      > Group 1 Group 2 Group 3
      >Baseline 15.1 15.2 15.7
      >Maximal Hb decline 4.1 3.0* 3.7
      >Hb <19g/dL 34% 9% 6%*
      >Hb <8.6 g/dl 2% 2% 0%
      >
      > Group 1 Group 2 Group 3
      >EVR 68% 65% 63%
      >ETR 46% 31% 53%
      >SVR 29% 19% 49%*
      >Relapse 36% 40% 8%*
      >Rate
      >*p<0.05 versus groups 1 and 2
      >
      >RIBAVIRIN DOSE
      > Group 1 Group 2 Group
      >3
      >Initial dose(mg/d) 1079 1104 1273
      >Mean dose(mg/d) 1016 1102 1224
      >Pts w/dose reduction 40% 10% 31%
      >mean dose reduction(mg/d) 179 27 102
      ><80% maximal dose 19% 12% 7%
      >
      >EFFECT OF RACE
      >The SVR rate was improved in the 51 African-American study patients who
      >received high-dose RBV with EPO, although AAs still had a lower SVR than
      >Caucasians.
      >
      >Standard WB RBV
      > AA C
      >EVR 29% 78%
      >SVR 19% 27%
      >
      >HD RBV
      > AA C
      >EVR 38% 31%
      >SVR 72% 56%
      >
      >
      >EFFECT OF BODY WEIGHT
      >In all body weight groups, the SVR rates were better in the patients who
      >received HD RBV than in the patients who received WB RBV.
      ><65 kg: 15% vs 36%
      >65-85 kg: 29% vs 61%
      >86-105 kg: 25% vs 47%
      >>105 kg: 10% vs 33%
      >
      >REASONS FOR DISCONTINUATION
      > Group 1 Group 2
      >Group 3
      >Non-response 14(29%) 16(33%) 14(29%)
      >Systemic side effects 12(25%) 17(35%) 9(18%)
      >Anemia 2(4%) 1(2%)
      >0(0%)
      >Other hematologic 0(0%) 1(2%) 1(2%)
      >Other 1(2%) 1(2%)
      >0(0%)
      >HCV RNA(-) when stopped 7(15%) 7(15%) 3(6%)
      >
      >
      >SENSORED RESPONSE ANALYSIS
      >Patients who were HCV RNA negative at the time of discontinuation. Of course
      >these patients could have gone onto relapse.
      > Group 1 group 2 Group 3
      >ETR 51% 37% 54%
      >SVR 34% 22% 49%*
      >
      >
      >
      >
      > ----------
      >
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