Welcome to the HCV Advocate’s AASLD Conference coverage.  In an effort to best serve our readership, we will post all the important and interesting abstracts about HCV from the conference.  While attending the conference, we will update any abstracts that we personally cover at the conference. The updated abstracts will be marked with the date that they have been updated and posted.  The other abstracts posted to the web site are HCV related abstracts posted to www.aasld.org that we have not been able to report on or update.  

 

To locate specific abstracts on this page, click on “Edit” at the top of  your browser (Microsoft Internet Explorer) and then on Find (on this page).  In Netscape, click on “Search” and then on “Find in This Page.” Simply type in a word or term and the search engine will list the related abstracts.

 

Please click here to view our fact sheet on reading and understanding an abstract.

 

Thank You,

Alan Franciscus

Editor-in-Chief

 

 

 

 

 

Hepatitis C

 

 

Drugs in Development

Studies on the new therapies being investigated to treatment hepatitis C that have been studied in humans, but have not been approved by the FDA.

 

·       Albuferon

o      A PHASE 2 STUDY OF ALBUFERON IN COMBINATION WITH RIBAVIRIN INNON-RESPONDERS TO PRIOR INTERFERON THERAPY FOR CHRONIC HEPATITIS C. (updated November 16, 2005)

 

·       Amantadine

o      MUTATIONS IN THE HCV-P7 PROTEIN AND SENSITIVITY TO ANTIVIRAL THERAPY WITH AMANTADINE IN CHRONIC HEPATITIS C.

o      DOES AMANTADINE IMPROVE THE VIROLOGICAL SUSTAINED RESPONSE OF NAĎVE PATIENTS WITH CHRONIC HEPATITIS C IN ASSOCIATION WITH PEG-INTERFERON-RIBAVIRIN COMBINATION ? A PROSPECTIVE, RANDOMISED, MULTICENTER, DOUBLE-BLIND STUDY:PRELIMINARY RESULTS IN 200 PATIENTS. (updated November 26, 2005)

·       CPG 10101

o       IMMUNOPHENOTYPING PROFILE OF CPG 10101, A NEW TLR9 AGONIST ANTIVIRAL FOR HEPATITIS C.

 

·       GNS 037

o       ENTRY INHIBITOR GNS 037 EXHIBITS POTENT ANTI-HCV ACTIVITY IN VITRO

 

·       Gamma Interferon

o      ANALYSIS OF RESPONSES TO ALPHA AND GAMMA INTERFERONS IN HEPATITIS C VIRUS INFECTED CHIMPANZEES.

o      CONSENSUS INTERFERON IN COMBINATION WITH GAMMA INTERFERON AND/OR RIBAVIRIN LEADS TO A SIGNIFICANT RESPONSE IN TREATMENT-NAIVE HEPATITIS C GENOTYPE 1 PATIENTS. (updated November 28, 2005)

 

·       NM283

o      CHARACTERIZATION OF NM283 (VALOPICITABINE) RESISTANCE PROFILE USING BOVINE VIRAL DIARRHEA VIRUS.

o      ABSENCE OF EFFECT OF PEGYLATED INTERFERON ALFA-2B ON THE PHARMACOKINETICS OF VALOPICITABINE (NM283) IN PATIENTS WITH CHRONIC HEPATITIS C. (updated November 14, 2005)

o      RANDOMIZED TRIAL OF VALOPICITABINE (NM283), ALONE OR WITH PEG-INTERFERON, VS. RETREATMENT WITH PEG-INTERFERON PLUS RIBAVIRIN (PEGIFN/RBV) IN HEPATITIS C PATIENTS WITH PREVIOUS NON-RESPONSE TO PEGIFN/RBV: FIRST INTERIM RESULTS. (updated November 18, 2005)

 

·       R1479 

o      HIGH SELECTIVITY AND LOW CYTOTOXICITY ASSOCIATED WITH R1479, A NOVEL INHIBITOR OF HCV REPLICATION.

o      THE NOVEL NUCLEOSIDE ANALOG R1479 IS A POTENT INHIBITOR OF HCV POLYMERASE AND HCV REPLICATION IN CELL CULTURE.

 

·       SCH 503034

o      ANTI-VIRAL ACTIVITY OF SCH 503034, A HCV PROTEASE INHIBITOR, ADMINISTERED AS MONOTHERAPY IN HEPATITIS C GENOTYPE-1 (HCV-1) PATIENTS REFRACTORY TO PEGYLATED INTERFERON (PEG-IFN-Á). (updated November 18, 2005)

o      COMBINATION THERAPY WITH THE HCV PROTEASE INHIBITOR, SCH 503034, PLUS PEG-INTRON INHEPATITIS C GENOTYPE-1 PEG-INTRON NON-RESPONDERS: PHASE IB RESULTS. (updated November 18, 2005)

 

·       VX-950

o      DECLINE IN SERUM NEOPTERIN CONCENTRATION CORRELATES WITH HCV RNA DECLINE DURING ADMINISTRATION OF VX-950, A HEPATITIS C VIRUS PROTEASE INHIBITOR.

o      PRECLINICAL AND EARLY CLINICAL DEVELOPMENT GENETIC HETEROGENEITY IN THE HCV NS3 PROTEASE OF UNTREATED GENOTYPE 1 PATIENTS HAS LITTLE EFFECT ON THE SENSITIVITY TO VX-950.

o      ITMN A AND B, NOVEL INHIBITORS OF THE HCV NS3/4 PROTEASE RETAIN THEIR POTENCY AGAINST VX-950 AND BILN-2016 RESISTANT NS3/4 PROTEASE MUTANTS AND AN IFN-A-2A RESISTANT HCV REPLICON. (updated November 14, 2005)

o      FINAL RESULTS OF A PHASE 1B, MULTIPLE-DOSE STUDY OF VX-950, A HEPATITIS C VIRUS PROTEASE INHIBITOR. (updated November 17, 2005)

o      PHARMACOKINETICS OF VX-950, AND ITS EFFECT ON HEPATITIS C VIRAL DYNAMIC (updated November 17, 2005)

 

Drugs in Development – Preclinical

Drugs that are being designed and tested to treat hepatitis C, but have not been studied in humans.

 

·       THERAPEUTIC VACCINATION FOR CHRONIC HEPATITIS C VIRUS INFECTION IN HCV TRIMERA MICE

·       DEMONSTRATION OF THE EFFICACY OF SMALL MOLECULE HCV INHIBITORS IN THE KMT MOUSEMODEL OF HEPATITIS C VIRUS (HCV) INFECTION.

·       PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF THE ISATORIBINE ORAL PRODRUG ANA975 IN APHASE 1 HEALTHY VOLUNTEER STUDY. (updated November 28, 2005)

·       REDIRECTING T LYMPHOCYTE SPECIFICITY USING HCV-SPECIFIC T CELL RECEPTOR GENES CONFERS RECOGNITION OF NATURALLY OCCURRINGVIRAL MUTANTS.

·       SINGLE DOSE PHARMACOKINETICS OF A NOVEL HEPATITIS C PROTEASE INHIBITOR, SCH 503034, IN AN ORAL CAPSULE FORMULATION.

·       DEVELOPMENT IDENTIFICATION OF A NOVEL SMALL MOLECULE HEPATITIS C VIRUS REPLICATION INHIBITOR THAT TARGETS HOST SPHINGOLIPID BIOSYNTHESIS.

·       DEVELOPMENT SCH 503034, A MECHANISM-BASED INHIBITOR OF HEPATITIS C VIRUS (HCV) NS3 PROTEASE SUPPRESSES POLYPROTEIN MATURATION AND ENHANCES THE ANTIVIRAL ACTIVITY OF INTERFERON-Á-2B (INF)

·       HCV REPLICATION IS INHIBITED BY CYCLOSPORIN A, MYCOPHENOLIC ACID AND IFN-ALPHA IN A SYNERGISTIC FASHION AND WITH DISTINCT ANTI-VIRAL KINETICS.

·       NIM811 EXHIBITS POTENT ANTI-HCV ACTIVITY IN VITRO AND REPRESENTS A NOVEL APPROACH FOR VIRAL HEPATITIS C THERAPY.

·       CANNABINOIDS BLOCK INTERFERON-MEDIATED SUPPRESSION OF HEPATITIS C VIRUS (HCV) REPLICATION. (updated November 14, 2005)

·       THE IMMUNOMODULATOR AS101 INHIBITS HCV REPLICATION. (updated November 14, 2005)

·       CHARACTERIZATION OF IN VITRO SELECTED CON 1 SUBGENOMIC REPLICONS RESISTANT TO 2’-CMETHYL-CYTIDINE, A POTENT INHIBITOR OF GENOTYPE 1A AND 1B HCV POLYMERASES.

·       AN Á-GLUCOSIDASE INHIBITOR APPROVED FOR USE IN TYPE II DIABETES HAS ANTIVIRAL ACTIVITY AND DISPLAYS SYNERGY WITH IFN ALFACON-1 IN A SURROGATE SYSTEM FOR HCV.  (updated November 22, 2005)

·       TREATMENT OF HCV-ASSOCIATED PROGRESSIVE LIVER DISEASE WITH TACROLIMUS: TRIAL USING A MOUSE MODEL.’ (updated November 14, 2005)

·       CHARACTERIZATION OF A NOVEL APPROACH FOR HCV IMMUNIZATIONUSING SPLENIC DERIVED DENDRITIC CELLS WITH PHAGOCYTOSED HCVNS5 COATED MAGNETIC BEADS.

 

 

Drugs in Development – Phase 3, 4 Trials

Drugs that have been FDA approved to treat hepatitis C and have undergone additional testing in special populations and circumstances.

 

·       SHORT-TERM TREATMENT DURATION FOR HCV-2 AND HCV-3 INFECTED PATIENTS WITH CHRONIC HEPATITIS. (updated November 28, 2005

·       PEG-IFN ALPHA2B AND RIBAVIRIN IN DECOMPENSATED CIRRHOTIC PATIENTS WITH CHRONIC HCV INFECTION: A CONTROLLED STUDY.

·       SUSTAINED VIROLOGIC RESPONSE RATES FROM A RANDOMIZED TRIAL OF HCV GENOTYPE-1 SUBJECTS TREATED WITH EITHER CONSENSUS IFN AND RIBAVIRIN OR PEGYLATED INTERFERON ALFA-2B AND RIBAVIRIN.

·       A STUDY ON THE TREATMENT OF CHRONIC HCV HEPATITIS WITH PEGYLATED INTERFERON ALPHA-2A AND RIBAVIRIN IN HAEMODIALYZED PATIENTS WAITING FOR RENAL TRANSPLANT.

·       FIBROSIS STAGE IS NOT A PREDETERMINANT OF SIGNIFICANT ADVERSE EVENTS IN PREVIOUS INTERFERON (IFN)-RIBAVIRIN (RIBA) TREATMENT FAILURES RECEIVING PEG-INTERFERON-ALFA 2B/RIBA WEIGHT BASED DOSING: RESULTS FROM THE EPIC3 PROGRAM. (updated November 28, 2005

·       INTERFERON (IFN) INDUCED THROMBOCYTOPENIA IS INDEPENDENT OF LEVEL OF FIBROSIS IN PATIENTS WITH CHRONIC HEPATITIS C (CHC): RESULTS FROM THE EPIC3 PROGRAM.

·       MINIMAL IMPORTANT DIFFERENCE (MID) IN VITALITY SCORE; A NEW OUTCOME MEASURE IN HCV TREATMENT TRIALS.

·       INTERIM ANALYSIS OF THE SAFETY AND EFFICACY OF PEGINTERFERON ALFA-2A PLUS RIBAVIRIN IN CHRONIC HEPATITIS C PATIENTS UNABLE TO TOLERATE OR NONRESPONSIVE TO TREATMENT WITH PEGINTERFERON ALFA-2B PLUS RIBAVIRIN  (updated November 21, 2005)

·       WEIGHT-BASED RIBAVIRIN DOSING (WBD) INCREASES SUSTAINED VIRAL RESPONSE (SVR) INPATIENTS WITH CHRONIC HEPATITIS C (CHC): FINAL RESULTS OF THE WIN-R STUDY, A US COMMUNITY BASED TRIAL. (updated November 21, 2005)

 

 

HCV Medications Approved by the FDA

Studies about the medications approved or indicated to treat hepatitis C.  In addition, issues such as retreatment, refining treatment issues, and treatment in special populations are listed in this section. 

 

·       Infergen (consensus interferon)

o      CONSENSUS INTERFERON AND RIBAVIRIN IN PATIENTS WITH CHRONIC HEPATITIS C WHO WERE NONRESPONDERS TO PRIOR THERAPY WITH EITHER INTERFERON ALFA AND RIBAVIRIN OR PEGYLATED INTERFERON AND RIBAVIRIN.

o      EARLY VIRAL RESPONSE TO CONSENSUS INTERFERON PLUS RIBAVIRIN THERAPY IN PATIENTS WHO ARE NONRESPONDERS OR RELAPSERS TO PRIOR PEG IFN PLUS RIBAVIRIN THERAPY.

o      EFFICACY OF DAILY CONSENSUS INTERFERON AND RIBAVIRIN COMPARED TO PEG-INTERFERON Á-2B AND RIBAVIRIN IN NON-RESPONDERS WITH CHRONIC HEPATITIS C.

o      PEGYLATED INTERFERONS (PEG-IFNS) DO NOT PRESENT VIRAL REBOUND AFTER SHORT-TERM ADMINISTRATION OF CONSENSUS INTERFERON (CIFN) TO IFN-NAIVE PATIENTS (PTS) WITH CHRONIC HEPATITES C (CHC), GENOTYPE 1.

o      EFFICACY AND COST-EFFECTIVENESS OF 24 WEEKS OF HIGH-DOSE INDUCTION THERAPY WITH CONSENSUS INTERFERON IN CHRONIC HEPATITIS C PATIENTS WITH GENOTYPE 2 INFECTION.

o      ANTIVIRAL RESPONSE OF HCV GENOTYPE-1 TO CONSENSUS INTERFERON AND RIBAVIRIN COMPARED WITH PEGYLATED INTERFERON AND RIBAVIRIN. (updated November 22, 2005

 

·       Pegasys (peginterferon alfa-2a)

o      SUSTAINED VIROLOGICAL RESPONSE (SVR) IS DURABLE AFTER TREATMENT WITH PEGINTERFERON ALFA-2A (40KD) (PEGASYS®) ALONE OR IN COMBINATION WITH RIBAVIRIN (COPEGUS®): RESULTS OF AN ONGOING LONG-TERM FOLLOW-UP STUDY. (updated November 16, 2005)

o      EFFECT OF ETHNICITY ON THE PHARMACOKINETICS OF RIBAVIRIN (COPEGUS®) AND PEGINTERFERON ALFA-2A (40KD) (PEGASYS®) IN PATIENTS WITH CHRONIC HEPATITIS C.

o      ASSOCIATION BETWEEN SUSTAINED VIROLOGICAL RESPONSE (SVR) AND ALT LEVELS IN HIV-HCV CO-INFECTED PATIENTS WHO RECEIVED PEGINTERFERON ALFA-2A (40KD) (PEGASYS®) PLUS RIBAVIRIN (COPEGUS®) IN THE AIDS PEGASYS RIBAVIRIN INTERNATIONAL CO-INFECTION TRIAL (APRICOT). (updated November 26, 2005) 

o      INTERIM SAFETY ANALYSIS OF PATIENTS ENROLLED IN THE RANDOMIZED, INTERNATIONAL RETREATMENT WITH PEGASYS® IN PATIENTS NOT RESPONDING TO PRIOR PEGINTERFERON ALFA-2B/RIBAVIRIN (RBV) COMBINATION THERAPY (REPEAT) STUDY.  (updated November 28, 2005)

o      PHARMACOKINETICS AND RESPONSE OF OBESE PATIENTS WITH CHRONIC HEPATITIS C TREATED WITH DIFFERENT DOSES OF PEG-IFN ALPHA2A(40KD) (PEGASYS®).  (updated November 26, 2005) 

o      VIRAL AND METABOLIC FACTORS INFLUENCING ALANINE AMINOTRANSFERASE (ALT) ACTIVITY IN PATIENTS WITH CHRONIC HEPATITIS C RECEIVING PEGINTERFERON ALFA-2A (40KD) (PEGASYS®) AND RIBAVIRIN (COPEGUS®) IN RANDOMIZED PHASE III TRIALS.  (updated November 26, 2005) 

o      ARE THERE DIFFERENCES IN SUSTAINED VIROLOGICAL RESPONSE (SVR)RATES IN PATIENTS WITH HCV GENOTYPE 2 OR 3 INFECTION AND PERSISTENTLY ‘NORMAL’ ALT ACTIVITY UNDERGOING TREATMENT WITH PEGINTERFERON ALFA-2A (40KD) (PEGASYS®) PLUS RIBAVIRIN (COPEGUS®)? 

o      IMPACT OF BASELINE HEPATITIS C VIRUS (HCV) RNA AND GENOTYPE ON THE EFFICACY OF PEGINTERFERON ALFA-2A (40KD) (PEGASYS®) PLUS RIBAVIRIN (COPEGUS®) IN PATIENTS WITH COMPENSATED CIRRHOSIS/BRIDGING FIBROSIS. (updated November 17, 2005) 

o      FASTING TRIGLYCERIDE LEVELS BEFORE, DURING AND AFTER TREATMENT WITH PEGINTERFERON ALFA-2A (40KD) (PEGASYS®) PLUS RIBAVIRIN (RBV, COPEGUS®) IN PATIENTS INFECTED WITH HCV GENOTYPE 2 OR 3: THE ACCELERATE SERUM TRIGLYCERIDE SUBSTUDY. (updated November 21, 2005)   

o      CLUSTERING OF POOR PROGNOSTIC FACTORS IN HEAVIER PATIENTS WITH CHRONIC HEPATITIS C (CHC): BASELINE CHARACTERISTICS AND OUTCOMES WITH PEGINTERFERON ALFA-2A (40KD) (PEGASYS®) PLUS RIBAVIRIN (RBV, COPEGUS®) IN RANDOMIZED, INTERNATIONAL, PHASE III TRIALS. (updated November 15, 2005)  

o      PREDICTED OUTCOMES IN PATIENTS WITH PERSISTENTLY ‘NORMAL’ ALT LEVELS AND HCV GENOTYPE 1 TREATED WITH PEGINTERFERON ALFA-2A (40KD) (PEGASYS®) PLUS RIBAVIRIN (RBV, COPEGUS®) 1000/1200 MG/DAY FOR 48 WEEKS.  (updated November 17, 2005)

o      EFFICACY OF PEGINTERFERON ALFA-2A (40KD) AND RIBAVIRIN IN PATIENTS WITH CHRONIC HEPATITIS C IN GERMANY – A CONTRIBUTION TO HEALTH CARE RESEARCH.  (updated November 18, 2005)

o      WEEK 4 VIROLOGICAL RESPONSE WITH PEGINTERFERON ALFA-2A (40KD) (PEGASYS®) PLUS RIBAVIRIN (RBV, COPEGUS®) PORTENDS A SUSTAINED VIROLOGICAL RESPONSE (SVR) AFTER 24 WEEKS IN GENOTYPE 1 CHRONIC HEPATITIS C PATIENTS WITH PERSISTENTLY ‘NORMAL’ ALT ACTIVITY. (updated November 26, 2005)

o      AN EVALUATION OF THE COST-EFFECTIVENESS OF PEGINTERFERON ALFA-2A (40KD) (PEGASYS®) PLUS RIBAVIRIN (COPEGUS®) FOR THE FIRST TREATMENT OF MILD CHRONIC HEPATITIS C (CHC). (updated November 26, 2005)

o      LOW BODY WEIGHT PREDICTS PEG-INTERFERON ALFA-2A (PEGASYS) INDUCED NEUTROPENIA IN CHRONIC HEPATITIS C PATIENTS.

o      IS SHORTER TREATMENT WITH PEGINTERFERON ALFA-2A (40KD) (PEGASYS®) PLUS RIBAVIRIN (COPEGUS®) POSSIBLE IN HCV GENOTYPE 1 ‘SUPER-RESPONDERS’? PRELIMINARY RESULTS OF A PROSPECTIVE RANDOMIZED CLINICAL TRIAL.

o      RAPID VIROLOGICAL RESPONSE AT WEEK 4 (RVR) OF PEGINTERFERON ALFA-2A (40KD) (PEGASYS®) PLUS RIBAVIRIN (RBV, COPEGUS®) TREATMENT PREDICTS SUSTAINED VIROLOGICAL RESPONSE (SVR) AFTER 24 WEEKS IN GENOTYPE 1 PATIENTS. (updated November 15, 2005)

 

·       Peg-Intron (peginterferon alfa-2b)

o      PEG-IFN ALPHA 2B (1.5 MCG/KG/WK) + RIB (800-1400 MG DAILY) IS SIGNIFICANTLY MORE EFFECTIVE THAN PEG-IFN ALPHA 2B (1.0 MCG/KG/WK) + RIB (800-1400 MG DAILY) IN MEN WITH GT 1 AND WOMEN WITH GT 2/3: FINAL RESULTS OF A PROSPECTIVE, RANDOMIZED, CONTROLLED TRIAL. 

o      PEGINTERFERON A-2B 1 MCG/KG DOSE PLUS RIBAVIRIN 800-1200MG FOR 24-48 WEEKS, ACCORDING TO GENOTYPE, IN NAIVE PATIENTS WITH CHRONIC HEPATITIS C: EFFICACY AND COST-EFFECTIVENESS EVALUATION. (updated November 15, 2005)

o      COST-EFFECTIVENESS OF PEGINTERFERON ALFA-2B PLUS RIBAVIRIN FOR CHRONIC HEPATITIS C IN HIV-HCV CO-INFECTED PATIENTS. 

o      THE TARGET TRIAL: FINAL RESULTS USING 3.0ΜG/KG PEGYLATED INTERFERON ALFA 2-B (PEG;PEG-INTRON®) PLUS RIBAVIRIN (RBV;REBETOL®) FOR CHRONIC HEPATITIS C PATIENTS WHO WERE NONRESPONDERS (NR) AND RELAPSERS (R) TO PREVIOUS THERAPY. 

o      DIFFERING IMMUNE EFFECTS OF PEG-IFN-ALPHA 2B AND IFN-ALPHA 2B COMBINED WITH RIBAVIRIN FOR CHRONIC HEPATITIS C. 

o      PEGINTERFERON-A 2B AND RIBAVIRIN TREATMENT IN PATIENTS WITH HEPATITIS C VIRUS-RELATED SYSTEMIC VASCULITIS.

o      DOUBLE-DOSE PEGINTERFERON ALFA-2B WITH WEIGHT-BASED RIBAVIRIN IMPROVES RESPONSE FOR INTERFERON/RIBAVIRIN NON-RESPONDERS WITH HEPATITIS C: FINAL RESULTS OF “RENEW”.

o      CLINICAL AND ECONOMIC IMPLICATIONS OF A 4-WEEK VIRAL NEGATIVE RESPONSE TO PEGINTERFERON ALFA-2B PLUS RIBAVIRIN FOR CHRONIC HEPATITIS C AND GENOTYPE 1 WITH LOW VIRAL LOAD. 

o      THE ANTIVIRAL EFFECTS ASSESSED BY INTERFERON INDUCED ENZYME, 2_F-5F OLIGOADENYLATE SYNTHETASE (2-5AS) ACTIVITY DURING INTERFERON ALPHA 2B+RIBAVIRAN, PEGINTERFERON ALPHA 2A ALONE, AND PEGINTERFERON ALPHA 2B+RIBAVIRIN THERAPIES FOR CHRONIC HEPATITIS C.

o      TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1 WITH PEGINTERFERON ALFA-2B (PEGIFN), HIGH WEIGHT BASED DOSE RIBAVIRIN (RVN) AND EPOETIN ALFA (EPO) ENHANCES SUSTAINED VIROLOGIC RESPONSE (SVR). (updated November 26, 2005)

o      PEGINTERFERON A-2B 1 MCG/KG DOSE PLUS RIBAVIRIN 800-1200MG FOR 24-48 WEEKS, ACCORDINGTO GENOTYPE, IN NAIVE PATIENTS WITH CHRONIC HEPATITIS C: EFFICACY AND COST-EFFECTIVENESS EVALUATION. (updated November 26, 2005)

o      INTERFERON (IFN) INDUCED THROMBOCYTOPENIA IS INDEPENDENT OF LEVEL OF FIBROSIS IN PATIENTS WITH CHRONIC HEPATITIS C (CHC): RESULTS FROM THE EPIC3 PROGRAM. (updated November 28, 2005)

o      PEGETRON PROSPECTIVE OPTIMAL WEIGHT-BASED DOSING RESPONSE PROGRAM (POWER): PRELIMINARY RESULTS. (updated November 28, 2005) 

 

·        Ribavirin

o      TOTAL CLEARANCE OF RIBAVIRIN (CL/F) BASED RIBAVIRIN DOSAGE IMPROVES THE SAFETY AND EFFECT OF INTERFERON AND RIBAVIRIN COMBINATION THERAPY FOR CHRONIC HEPATITIS C.

o      ASSESSMENT OF RIBAVIRIN MUTAGENIC PROPERTIES IN VIVO AND THE INFLUENCE OF INTERFERON ALPHA-INDUCED REDUCTION OF HEPATITIS C VIRUS RNA LOAD UPON THERAPY.

o      EVIDENCE OF SATURABLE RIBAVIRIN ABSORPTION.

o      RIBAVIRIN PLASMA CONCENTRATION IS PREDICTIVE OF SUSTAINED VIROLOGICAL RESPONSE IN HCV INFECTED PATIENTS. A PROSPECTIVE STUDY.

o      WEIGHT BASED RIBAVIRIN IN COMBINATION WITH PEGYLATED INTERFERON ALPHA 2-B DOES NOT IMPROVE SVR IN HCV INFECTED PATIENTS WHO FAILED PRIOR THERAPY: RESULTS IN 454 PATIENTS.

 

 

Treatment Issues

Other treatment related issues such as side effect management, the use of adjunct or supportive therapies, predictors of treatment response  and so forth

 

·       General

o      PATHOGENETIC SIGNIFICANCE OF NEUTRALIZING ANTI-HCV ANTIBODIES IN ACUTE AND CHRONIC HEPATITIS C VIRUS (HCV) INFECTION OFCHIMPANZEES TREATED WITH HYPERIMMUNE ANTI-HCV (CIVACIR™).

o      ASSOCIATION OF A SINGLE NUCLEOTIDE POLYMORPHISM OF THE CTLA-4 GENE WITH RESPONSE TO INTERFERON-BASED TREATMENT IN PATIENTS WITH CHRONIC HEPATITIS C VIRUS INFECTION.

o      SPECIFIC MECHANISMS OF HCV-3 ON HYPOCHOLESTEROLEMIA. LONG-TERM EFFECT OF SUSTAINED VIROLOGICAL RESPONSE.

o      SOLUBLE INTERLEUKIN 2 RECEPTORS PLASMA LEVELS AMONG RESPONDER AND NON-RESPONDER PATIENTS WITH CHRONIC HEPATITIS C.

o      A SIGNIFICANT ASSOCIATION OF THE SUBSTITUTION IN POSITION 2209 OF NS5A OF HEPATITIS C VIRUS 1B INFECTION AND THE RESPONSE TO STANDARD, CONSENSUS, OR PEGYLATED INTERFERON PLUS RIBAVIRIN THERAPY.

o      PRIMARY CARE BASED HEPATITIS C TREATMENT: COLLABORATING TO IMPROVE ACCESS, ADHERENCE AND OUTCOMES.

o      THE ASSOCIATION OF FATIGUE WITH POOR VIROLOGIC RESPONSE IN PATIENTS RECEIVING INTERFERON ALPHA PLUS RIBAVIRIN FOR THE TREATMENT OF HEPATITIS C.

o      INCIDENCE OF INFECTIONS DURING COMBINATION TREATMENT OF CHRONIC HEPATITIS C WITH PEGYLATED INTERFERONS ALFA 2B and 2A.

o      BASELINE NEUTRALIZING RESPONSES PREDICT THE VIROLOGICAL RESPONSE TO PEGYLATED INTERFERON ALPHA-RIBAVIRIN COMBINATION THERAPY.

o      EXPECTANT MANAGEMENT OF CHRONIC HEPATITIS C INFECTION – THE PATIENT PERSPECTIVE.

o      PERIPHERAL INSULIN RESISTANCE DURING THE TREATMENT OF CHRONIC C HEPATITIS WITH PEGYLATED INTERFERON PLUS RIBAVIRIN.

o      INFLUENCE OF APOLIPOPROTEIN E GENOTYPE ON VIROLOGIC RESPONSE IN HCV TYPE 1-INFECTED PATIENTS TREATED WITH PEG-IFNA PLUS RIBAVIRIN

o      PREDICTIVE FACTORS FOR HISTOLOGICAL RESPONSE TO LONG-TERM PHLEBOTOMY IN PATIENTS WITH CHRONIC HEPATITIS C.

o      SOLUBLE INTERLEUKIN 2 RECEPTORS PLASMA LEVELS AMONG RESPONDER AND NON-RESPONDER PATIENTS WITH CHRONIC HEPATITIS C.

o      THE ROLE OF ANTIVIRAL THERAPY AFTER CHEMOTHERAPY ON THE CLINICAL OUTCOME OF HCV RELATED NON-HODGKIN LYMPHOMA (NHL).

o      ANTIVIRAL THERAPY IN PATIENTS WITH OCCULT HCV INFECTION.

o      RELATIONSHIP BETWEEN SUSTAINED VIRAL RESPONSE AND LEUKOCYTE INTERFERON RECEPTOR (IFNAR-2) EXPRESSION ON IN CHRONIC HEPATITIS C PATIENTS TREATED WITH SEVERAL INTERFERONS.

o      REDUCTION IN HEMOGLOBIN A1C VALUES IN DIABETIC PATIENTS DURING HEPATITIS C COMBINATION THERAPY: A COMBINED EFFECT OF RIBAVIRIN-INDUCED HEMOLYSIS AND DECREASED GLUCOSE LEVELS.

o      ANTIVIRAL COMBINATION THERAPY MODULATES SERUM LEVELS OF MARKERS OF HEPATIC ANGIOGENESIS IN CHRONIC HEPATITIS C (CHC) PATIENTS.

o      PEGYLATED INTERFERON PLUS RIBAVIRIN VERSUS NON-PEGYLATED INTERFERON PLUS RIBAVIRIN FOR CHRONIC HEPATITIS C – A COCHRANE SYSTEMATIC REVIEW.

o      CYTOKINE RESPONSE IN CHRONIC HEPATITIS C (CHC) PATIENTS TREATED WITH PEGYLATED INTERFERON PLUS RIBAVIRIN.

o      ERYTHROPOIETIN INCREASES PLATELETS COUNT DURING ANTIVIRAL THERAPY WITH INTERFERON AND RIBAVIRIN FOR CHRONIC HEPATITIS C VIRUS INFECTION.

o      THE INCREASE OF VON WILLEBRAND FACTOR AS A NEW PREDICTOR OF RESPONSE TO COMBINATION ANTIVIRAL THERAPY IN PATIENTS WITH CHRONIC HEPATITIS C.

o      ALTERATIONS OF LEPTIN LEVELS DURING IFN-Á TREATMENT IN PATIENTS WITH CHRONIC VIRAL HEPATITIS B AND C: EVIDENCE OF AN IFN-Á-MEDIATED SUPPRESSION OF LEPTIN PRODUCTION.

o      RELIABILITY AND VALIDITY OF THE BECK DEPRESSION INVENTORY (BDI-II) IN A CHRONIC HEPATITIS C POPULATION UNDERGOING PEG IFN PLUS RIBAVIRIN THERAPY

o      EFFECT OF SERTRALINE ON PRURITUS IN CHOLESTATIC LIVER DISEASE: A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED CROSSOVER STUDY

o      TUMOR NECROSIS FACTOR ALPHA PROMOTER POLYMORPHISM AT POSITION ˇV308 PREDICTS HEPATITIS C VIRUS RESPONSE TO COMBINATION THERAPY WITH HIGH DOSE INTERFERON AND RIBAVIRIN.

o      SUSTAINED VIROLOGICAL RESPONSE TO TREATMENT IN 100% OF PATIENTS RECENTLY INFECTED, NOSOCOMIALLY, WITH HCV GENOTYPE 2.

 

·       African-Americans

o      PEGINTERFERON ALFA-2A AND RIBAVIRIN IN AFRICAN AMERICAN AND CAUCASIAN PATIENTS WITHCHRONIC HEPATITIS C, GENOTYPE 1.

o      PERSISTENCE WITH HEPATITIS C THERAPY IN AFRICAN AMERICANS AND PATIENTS WITH DEPRESSION IN THE DEPARTMENT OF VETERANS AFFAIRS (VA). (updated November 21, 2005)

o      COMPARISON OF AFRICAN AMERICAN AND NON-AFRICAN AMERICAN PATIENT SUSTAINED VIROLOGICRESPONSE IN PEG-IFN ALPHA 2 + WEIGHT-BASED RIBAVIRIN NONRESPONDERS RETREATED WITH IFN ALFACON-1 + IFN GAMMA-1B. (updated November 21, 2005)

 

·       Cirrhosis

o      VIRAL FACTORS INFLUENCE SVR IN PTS WITH HCV-RELATED BRIDGING FIBROSIS BUT NOT CIRRHOSIS.

o      PEG-INTERFERON ± RIBAVIRIN IN ADVANCED HCV CIRRHOSIS.