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    Summary
    EudraCT Number:2016-001125-13
    Sponsor's Protocol Code Number:SAHIV-IMEA50
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-06-16
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2016-001125-13
    A.3Full title of the trial
    Pilot study - Short duration therapy of acute hepatitis C genotypes 1 or 4 in HIV-infected patients: efficacy and tolerability of grazoprevir 100mg/elbasvir 50mg during 8 weeks
    Etude pilote SAHIV - Essai thérapeutique de traitement court de l’infection aigue par le virus de l’hépatite C de génotypes 1 ou 4 chez les patients infectés par le VIH : efficacité et tolérance de l’association combinée grazoprevir 100mg/elbasvir 50mg pendant 8 semaines.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study assessing the efficacy and tolerability of a new oral treatment containing grazoprevir (100mg) and elbasvir (50mg) used during 8 weeks in patients presenting acute hepatitis C (genotypes 1 or 4) and co-infected with human immunodeficiency virus (HIV).
    Etude évaluant l'efficacité et la tolérance d'un nouveau traitement oral contenant du grazoprevir (100mg) and elbasvir (50mg), utilisé pendant 8 semaines chez des patients présentant une hépatite C aigue (génotypes 1 ou 4) et co-infectés par le virus de l’immunodéficience humaine (VIH).
    A.3.2Name or abbreviated title of the trial where available
    SAHIV
    SAHIV
    A.4.1Sponsor's protocol code numberSAHIV-IMEA50
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIMEA (Institut de Médecine et d’Epidémiologie Appliquée)–Fondation Léon M’Ba
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMSD
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIMEA (Institut de Médecine et d’Epidémiologie Appliquée – Fondation Léon M’Ba
    B.5.2Functional name of contact pointROUGIER Hayette
    B.5.3 Address:
    B.5.3.1Street AddressHôpital Saint-Antoine, SMIT, Bât Mayer, Porte 2, 184 rue du Faubourg Saint-Antoine
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75012
    B.5.3.4CountryFrance
    B.5.4Telephone number+33149282405
    B.5.5Fax number+33149282595
    B.5.6E-mailhayette.rougier.sat@aphp.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ZEPATIER
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameZEPATIER
    D.3.2Product code GRAZOPREVIR
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ZEPATIER
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameZEPATIER
    D.3.2Product code ELBASVIR
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute hepatitis C (genotypes 1 or 4)
    Hépatite C aigue (génotypes 1 ou 4)
    E.1.1.1Medical condition in easily understood language
    Acute hepatitis C (genotypes 1 or 4)
    Hépatite C aigue (génotypes 1 ou 4)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10065051
    E.1.2Term Acute hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the rate of substained virological response (SVR) 12 weeks after 8 weeks of oral treatment with grazoprevir 100mg/elbasvir 50mg (MRK-combo) in patients with acute hepatitis C genotype1 or 4 and co-infected with HIV
    Evaluer le taux de réponse virologique soutenue (RVS) 12 semaines après l’arrêt du traitement oral combiné avec grazoprevir 100mg / elbasvir 50mg (MRK-combo) administré pendant 8 semaines à des patients présentant une hépatite C aigue de génotype 1 ou 4 et co-infecté par le VIH.
    E.2.2Secondary objectives of the trial
    HCV virological assessment
    - To describe the HCV virological response at W4, W8, PT4 (=W12) and PT12(=W20) as a whole and according to genotypes (PT = post-treatment visit)
    - To study the prognostic factors associated with SVR12 (PT 12).
    - To assess the emergence of resistance in case of virological failure (HCV RNA ≥12 IU/mL).
    - To describe treatment adherence and quality of life during the course of the study.
    - To evaluate the incidence of HCV reinfection at 1 year (W56).
    - To evaluate the sensitivity of HCV rapid testing (using the Oraquick HCV rapid antibody test) in co-infected patients with HIV and first acute Hepatitis C.

    HIV virological assessment
    - To describe the evolution of HIV parameter during treatment (CD4 count and HIV-RNA).

    Safety assessment
    - To describe all the clinical events occurred during the study course
    Evaluation virologique VHC
    - Décrire la réponse virologique VHC à S4, S8, PT4 et PT 12, dans son ensemble et selon le génotype (PT = visite post-traitement)
    - Étudier les facteurs pronostiques associés à la réponse virologique soutenue 12 semaines après l’arrêt du traitement (PT12).
    - Décrire les résistances associées au traitement en cas d’échec virologique (ARN-VHC ≥12 UI/mL).
    - Décrire l’observance au traitement de l’étude et la qualité de vie pendant la durée de l’essai.
    - Evaluer la sensibilité du TROD Oraquick HCV, chez les patients VIH présentant une hépatite C aiguë pour la première fois.

    Evaluation virologique VIH
    Décrire l’évolution des paramètres VIH (ARN-VIH et typage lymphocytaire)

    Evaluation de la tolérance
    Décrire tous les événements cliniques apparus pendant l’étude
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult ≥18 years
    2. A recent acute HCV infection or reinfection (see definition below) occurred within 6 months prior screening:
    An acute HCV infection is defined by:
    a. HCV RNA was detectable within 6 months after a negative HCV RNA or HCV serology test.
    OR
    b. Detectable HCV RNA and an acute clinical hepatitis occurred within 5 months prior to the screening visit.

    Clinical Hepatitis is defined by:
    - ALT ≥ 250 IU/L with normal ALT within the preceding 8 months,
    or
    - ALT ≥ 500 IU/L with either no measured ALT or with abnormal ALT within the preceding 8 months.

    HCV reinfection is defined by:
    a. Documented de novo infection after prior clearance after treatment or spontaneously,
    - After-treatment clearance is defined by one negative HCV RNA ≥ 6 months after end of treatment.
    - Spontaneous clearance is defined by two negative HCV RNA a minimum of 6 months apart.
    OR
    b. Documented infection with a new viral strain, confirmed by phylogenetic or genotypic analysis.

    3. Infection with HCV genotype 1 or 4 (confirmed at screening visit or by using a previous biological test performed 1 to 4 weeks before D0)
    4. Plasma HCV-RNA ≥ 1000 UI/mL (confirmed at screening visit or by using a previous biological test performed 1 to 4 weeks before D0)
    5. Confirmed HIV infection
    6. Without HIV treatment or with an acceptable stable HIV treatment for at least two weeks (See section 8.3 of the protocol)
    7. Body weight ≥40 kg and ≤125 kg
    8. Female patients with child-bearing potential and their heterosexual partners must use adequate contraception from the date of screening until 30 days after administration of the last dose of study drug. Male participants must agree to consistently and correctly use a condom, while their female partner must use adequate contraception from the date of screening until 30 days after administration of the last dose of study drug
    9. Informed and signed consent
    10. Patients with Health insurance (Sécurité Sociale or Couverture Médicale Universelle)
    1. Adulte ≥18 ans
    2. Infection récente ou réinfection aigue par le virus de l’hépatite C dans les 6 derniers mois avant la visite de sélection, selon les définitions suivantes :
    Infection aigue par le virus de l’hépatite C
    a. Charge virale ARN-VHC détectable avec une sérologie VHC antérieure négative ou une charge virale ARN-VHC indétectable dans les 6 derniers mois.
    OU
    b. Charge virale ARN-VHC détectable et présence d’une cytolyse hépatique dans les 5 derniers mois précédent la visite de sélection de l’étude.

    La cytolyse hépatique est définie par :
    - ALAT ≥ 250 IU/L avec un taux d’ALAT normal dans les 8 mois précédents,
    ou
    - ALAT ≥ 500 IU/L avec aucun taux antérieur ou présence d’un taux d’ALAT anormal dans les 8 mois précédents.

    Réinfection par le virus de l’hépatite C:
    a. Preuve d’une nouvelle infection après traitement ou guérison spontanée :
    - Après traitement : guérison documentée par une charge virale ARN-VHC indétectable ≥ 6 mois après la fin du traitement,
    - Après guérison spontanée : définie par deux charges virales ARN-VHC indétectables espacées ‘au moins 6 mois
    OU
    Infection documentée par la présence d’une nouvelle souche de virus, confirmée par une analyse génotypique ou phylogénétique.

    3. Hépatite C de génotype 1 ou 4 (confirmée à la visite de sélection ou en utilisant une analyse précédente réalisée dans les 4 semaines avant le jour 0).
    4. Charge virale ARN-VHC ≥ 1000 UI/mL (confirmée à la visite de sélection ou en utilisant un bilan biologique précédent réalisé dans les 4 semaines avant le jour 0).
    5. Etre co-infecté par le VIH.
    6. Sans traitement anti-VIH ou avec un traitement anti-VIH stable depuis au moins deux semaines et compatible avec l’étude (Cf. section 8.3 du protocole).
    7. Poids ≥40 kg and ≤125 kg
    8. Les femmes en âge d’avoir des enfants et leur(s) partenaire(s) sexuel(s) doivent accepter d’utiliser un moyen de contraception efficace à partir de la visite de sélection et jusqu’à 30 jours après la dernière prise du traitement de l’étude.
    Les hommes doivent accepter d’utiliser systématiquement et correctement le préservatif. Leur(s) partenaire(s) féminine(s) doit (doivent) utiliser une méthode de contraception adéquate, de la visite de sélection et jusqu’à 30 jours après la dernière prise du traitement de l’étude.
    9. Avoir signé le consentement de l’étude.
    10. Etre affilié à un régime de sécurité sociale (Sécurité Sociale ou Couverture Médicale Universelle).
    E.4Principal exclusion criteria
    Current condition
    1. Opportunistic infections (stage C), active or occurred within 6 months prior to baseline.
    2. Primary HIV infection.
    3. Co-infection with Hepatitis B virus (AgHBs +) without appropriate treatment (TDF or TAF) for at least 2 weeks.
    4. Confirmed cirrhosis (before acute HCV diagnosis).
    5. Any other causes of acute hepatitis.
    6. Pregnant or breast-feeding women.
    7. Transplant recipients.
    8. Evolutive malignancy.
    9. Patients with a history of non-adherence, who will be at risk of being unable to respect the study follow-up timetable.
    10. Patients participating in another clinical trial (with an experimental treatment) or within an exclusion period of a previous clinical trial at screening.
    11. Patients under legal gardianship or incarcerated.
    Biological criteria
    12. Hb < 10 g/dL (female) or < 11g/dL (male).
    13. Platelets < 50 000/mm3.
    14. Neutrophil count < 750/mm3.
    Criteria related to study drugs
    15. Other antiretroviral drugs than those allowed in the study (please refer to section 8.3 of the protocol).
    16. Contra-indications to Grazoprevir and/or Elbasvir or to any of the excipients listed in the summary of the product characteristics.
    17. Contra-indicated treatment likely to interfere with the study drugs as listed in the summary of the product characteristics.
    Etat en cours
    1. Avoir ou avoir eu dans les 6 derniers mois avant la visite de sélection une maladie opportuniste (stade C).
    2. Etre en primo-infection VIH.
    3. Co-infection active par le virus de l’hépatite B (Ag HBs+) sans traitement approprié (TDF ou TAF) commencé au moins depuis deux semaines
    4. Cirrhose confirmée (avant le diagnostic d’hépatite C aigue)
    5. Toute autre cause d’hépatite aigue
    6. Femme enceinte ou allaitante
    7. Avoir eu une transplantation hépatique
    8. Avoir un cancer en cours
    9. Antécédent de non-observance, patient qui pourrait être susceptible d’être incapable de respecter le calendrier de suivi de l’étude
    10. Participer simultanément à une autre étude clinique (comportant un traitement expérimental) ou être en période d’exclusion pour une étude précédente
    11. Etre sous curatelle, tutelle ou sauvegarde de justice
    Critères biologiques
    12. Hémoglobine < 10 g/dL (femme) or < 11g/dL (homme).
    13. Plaquettes < 50 000/mm3
    14. Neutrophiles < 750/mm3
    Critères relatifs au traitement de l’étude
    15. Traitements antirétroviraux autres que ceux autorisés par l’étude (Cf. section 8.3 du protocole)
    16. Contre-indications au Grazoprevir et/ou à l’Elbasvir ou à tout excipient listé dans le résumé des caractéristiques du produit
    17. Traitement contre-indiqué susceptible d’interférer avec le traitement de l’étude comme défini dans le résumé des caractéristiques du produit
    E.5 End points
    E.5.1Primary end point(s)
    SVR rate defined by an undetectable plasma HCV RNA (<12 IU/mL) 12 weeks post-treatment (SVR12).
    Taux de réponse virologique soutenue (ARN-VHC < 12 UI/mL) 12 semaines après l’arrêt du traitement de l’étude
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks post end of treatment
    12 semaines après l'arrêt du traitement
    E.5.2Secondary end point(s)
    Please refer to the protocol
    Cf. protocole
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to the protocol
    Cf. protocole
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of the last patient
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Care after patient participation in the trial will be the normal treatment/follow up of that condition.
    Après leur participation, les patients seront pris en charge selon les soins/suivis habituels pour cette pathologie.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-14
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