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1. Treatment with bulevirtide in HIV-infected patients with chronic hepatitis D: ANRS HD EP01 BuleDelta and compassionate cohort

Author

Victor de Lédinghen, Claire Fougerou-Leurent, Estelle Le Pabic, Stanislas Pol, Dulce Alfaiate, Karine Lacombe, Marie-Noëlle Hilleret, Caroline Lascoux-Combe, Anne Minello, Eric Billaud, Isabelle Rosa, Anne Gervais, Vlad Ratziu, Nathalie Ganne, Georges-Philippe Pageaux, Vincent Leroy, Véronique Loustaud-Ratti, Philippe Mathurin, Julie Chas, Caroline Jezequel, Sophie Métivier, Jérôme Dumortier, Jean-Pierre Arpurt, Tarik Asselah, Bruno Roche, Antonia Le Gruyer, Marc-Antoine Valantin, Caroline Scholtès, Emmanuel Gordien, Christelle Tual, Amel Kortebi, Fatoumata Coulibaly, Eric Rosenthal, Miroslava Subic-Levrero, Dominique Roulot, Fabien Zoulim, François Raffi, Laurent Alric, Patrick Miailhes, Albert Tran, Christiane Stern, Xavier Causse, Simona Tripon, Ghassan Riachi, Olivier Chazouillères, Armando Abergel, Louis d’Alteroche, Jérôme Gournay, Garance Lagadic, Patrizia Carrieri, Ségolène Brichler, Martin Siguier, Jessica Krause, Juliette Foucher, Souad Ben Ali, Magdalena Meszaros, Anne Varaut, and Valérie Canva

Subjects
Cirrhosis, HDV, HBV, Pegylated interferon, Hepatitis D, HDV RNA, Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Background & Aims: In France, bulevirtide (BLV) became available in September 2019 through an early access program to treat patients with HDV. The aim of this analysis was to evaluate the efficacy and safety of BLV in patients with HIV and HDV coinfection. Methods: Patients received BLV 2 mg ± pegylated interferon-α (pegIFNα) according to the physician’s decision. The primary endpoint (per-protocol analysis) was the virological response rate at Week 48, defined as the proportion of patients with undetectable serum HDV RNA or a HDV RNA decline >2 log10 IU/ml from baseline. Results: The characteristics of the 38 patients were as follows: 28 male, mean age 47.7 years, and mean baseline HDV RNA viral load 5.7 ± 1.2 log10 IU/ml. Median HIV viral load and mean CD4 count were 32 (30–65) copies/ml and 566 ± 307/mm3, respectively. Eight patients stopped treatment before Week 48. At Week 48, 10 of 19 patients (52.6%) in the 2 mg BLV group and five of seven patients (71.4%) in the 2 mg BLV + pegIFNɑ group had reached virological response (no HDV RNA available in four patients). At Week 48, seven of 19 patients in the 2 mg BLV group and three of six patients in the 2 mg BLV + pegIFNɑ group had a combined response (virological response and normal alanine aminotransferase level). Conclusions: Adults living with HIV coinfected with HDV can be treated by BLV with a virological response in more than 50% of patients. The combination of BLV and pegIFNɑ showed a strong virological response. Impact and implications: Bulevirtide is the only EMA-approved drug for HDV treatment, and we showed that it can be used in adults living with HIV, with an overall good tolerability. Bulevirtide induces a virological response in more than 50% of patients, suggesting that bulevirtide should be considered as a first-line therapy in this specific population. Bulevirtide in combination with pegIFNα could be used in patients without pegIFNα contraindication. No specific drug–drug interaction is reported. Bulevirtide is the only EMA-approved drug for HDV treatment, and we showed that it can be used in adults living with HIV, with an overall good tolerability. Bulevirtide induces a virological response in more than 50% of patients, suggesting that bulevirtide should be considered as a first-line therapy in this specific population. Bulevirtide in combination with pegIFNα could be used in patients without pegIFNα contraindication. No specific drug–drug interaction is reported. Bulevirtide is the only EMA-approved drug for HDV treatment, and we showed that it can be used in adults living with HIV, with an overall good tolerability. Bulevirtide induces a virological response in more than 50% of patients, suggesting that bulevirtide should be considered as a first-line therapy in this specific population. Bulevirtide in combination with pegIFNα could be used in patients without pegIFNα contraindication. No specific drug–drug interaction is reported.

Published
2024
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2. Treatment with bulevirtide in HIV-infected patients with chronic hepatitis D: ANRS HD EP01 BuleDelta and compassionate cohort

Author

Raffi, François, Alric, Laurent, Miailhes, Patrick, Tran, Albert, Stern, Christiane, Causse, Xavier, Tripon, Simona, Riachi, Ghassan, Chazouillères, Olivier, Abergel, Armando, d’Alteroche, Louis, Gournay, Jérôme, Lagadic, Garance, Carrieri, Patrizia, Brichler, Ségolène, Siguier, Martin, Krause, Jessica, Foucher, Juliette, Ben Ali, Souad, Meszaros, Magdalena, Varaut, Anne, Canva, Valérie, de Lédinghen, Victor, Fougerou-Leurent, Claire, Le Pabic, Estelle, Pol, Stanislas, Alfaiate, Dulce, Lacombe, Karine, Hilleret, Marie-Noëlle, Lascoux-Combe, Caroline, Minello, Anne, Billaud, Eric, Rosa, Isabelle, Gervais, Anne, Ratziu, Vlad, Ganne, Nathalie, Pageaux, Georges-Philippe, Leroy, Vincent, Loustaud-Ratti, Véronique, Mathurin, Philippe, Chas, Julie, Jezequel, Caroline, Métivier, Sophie, Dumortier, Jérôme, Arpurt, Jean-Pierre, Asselah, Tarik, Roche, Bruno, Le Gruyer, Antonia, Valantin, Marc-Antoine, Scholtès, Caroline, Gordien, Emmanuel, Tual, Christelle, Kortebi, Amel, Coulibaly, Fatoumata, Rosenthal, Eric, Subic-Levrero, Miroslava, Roulot, Dominique, and Zoulim, Fabien

Published
2024
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3. Prevalence of liver fibrosis and risk factors in a general population using non-invasive biomarkers (FibroTest)

Author

Bismut Françoise, Messous Djamila, Drane Fabienne, Munteanu Mona, Norha Pascal, Ngo Yen, Varsat Brigitte, Varaut Anne, Ingiliz Patrick, Lebray Pascal, Poynard Thierry, Carrau Jean, Massard Julien, Ratziu Vlad, and Giordanella Jean

Subjects
Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Abstract Background FibroTest and elastography have been validated as biomarkers of liver fibrosis in the most frequent chronic liver diseases and in the fibrosis screening of patients with diabetes. One challenge was to use them for estimating the prevalence of fibrosis, identifying independent risk factors and to propose screening strategies in the general population. Methods We prospectively studied 7,463 consecutive subjects aged 40 years or older. Subjects with presumed advanced fibrosis (FibroTest greater than 0.48) were re-investigated in a tertiary center. Results The sample characteristics were similar to those of the French population. FibroTest was interpretable in 99.6%. The prevalence of presumed fibrosis was 2.8%, (209/7,463), including cirrhosis in 0.3% (25/7,463); 105/209 (50%) subjects with presumed fibrosis accepted re-investigation. Fibrosis was confirmed in 50, still suspected in 27, indeterminate in 25 and not confirmed with false positive FibroTest or false negative elastography in 3 subjects. False negative rate of FibroTest estimated using elastography was 0.4% (3/766). The attributable causes for confirmed fibrosis were both alcoholic and nonalcoholic fatty liver disease (NAFLD) in 66%, NAFLD in 13%, alcohol in 9%, HCV in 6%, and other in 6%. Factors independently associated (all P < 0.003) with confirmed fibrosis were age, male gender, waist circumference, HCV antibody and alcohol consumption estimated using carbohydrate-deficient transferrin, enabling efficient screening-oriented strategies to be compared and proposed. Conclusions Biomarkers have permitted to estimate prevalence of advanced fibrosis around 2.8% in a general population aged 40 years or older, and several risk factors which may be used for the validation of selective or non-selective screening strategies.

Published
2010
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4. FRI-425 Hepatitis B core-related antigen (HBcrAg) in a prospective French hospital database on chronic hepatitis B (HBVbiomark)

Author

Quang, Erwan Vo, primary, Chevaliez, Stéphane, additional, Giovanna, Scoazec, additional, Anne, Varaut, additional, Amaddeo, Giuliana, additional, Boukraa, Amal, additional, Simoes, Mélanie, additional, Mazialivoua, Anne Laure, additional, Soulier, Alexandre, additional, Ortonne, Valérie, additional, Garrigou, Olivia, additional, Pawlotsky, Jean-Michel, additional, Leroy, Vincent, additional, and Ingiliz, Patrick, additional

Published
2024
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6. Cannabis use as a factor of lower corpulence in hepatitis C-infected patients: results from the ANRS CO22 Hepather cohort

Author

Barré, Tangui, Carrat, Fabrice, Ramier, Clémence, Fontaine, Hélène, Di Beo, Vincent, Bureau, Morgane, Dorival, Céline, Larrey, Dominique, Delarocque-Astagneau, Elisabeth, Mathurin, Philippe, Marcellin, Fabienne, Petrov-Sanchez, Ventzislava, Cagnot, Carole, Carrieri, Patrizia, Pol, Stanislas, Protopopescu, Camelia, Alric, Laurent, Pomes, Chloe, Zoulim, Fabien, Maynard, Marianne, Bai, Roxane, Hucault, Lucie, Bailly, François, Raffi, François, Billaud, Eric, Boutoille, David, Lefebvre, Maeva, André-Garnier, Elisabeth, Cales, Paul, Hubert, Isabelle, Lannes, Adrien, Lunel, Françoise, Boursier, Jérôme, Asselah, Tarik, Boyer, Nathalie, Giuily, Nathalie, Castelnau, Corinne, Scoazec, Giovanna, Rousseaud, Emilie, Vallet-Pichard, Anaïs, Sogni, Philippe, de Ledinghen, Victor, Foucher, Juliette, Hiriart, Jean-Baptiste, M’bouyou, Jancell, Irlès-Depé, Marie, Bourlière, Marc, Ahmed, Si Nafa Si, Oules, Valérie, Tran, Albert, Anty, Rodolphe, Gelsi, Eve, Truchi, Régine, Thabut, Dominique, Hammeche, Saloua, Moussali, Joseph, Causse, Xavier, de Dieuleveult, Barbara, Ouarani, Brahim, Labarrière, Damien, Ganne, Nathalie, Grando-Lemaire, Véronique, Nahon, Pierre, Brulé, Séverine, Ulker, Betul, Guyader, Dominique, Jezequel, Caroline, Brener, Audrey, Laligant, Anne, Rabot, Aline, Renard, Isabelle, Habersetzer, François, Baumert, Thomas, Doffoel, Michel, Mutter, Catherine, Simo-Noumbissie, Pauline, Razi, Esma, Bronowicki, Jean-Pierre, Barraud, Hélène, Bensenane, Mouni, Nani, Abdelbasset, Hassani-Nani, Sarah, Bernard, Marie-Albertine, Pageaux, Georges-Philippe, Meszaros, Magda, Metivier, Sophie, Bureau, Christophe, Morales, Thibault, Peron, Jean Marie, Robic, Marie Angèle, Decaens, Thomas, Faure, Marine, Froissart, Bruno, Hilleret, Marie-Noelle, Zarski, Jean-Pierre, Riachi, Ghassan, Goria, Odile, Paris, Fatima, Montialoux, Hélène, Leroy, Vincent, Amaddeo, Giuliana, Varaut, Anne, Simoes, Mélanie, Amzal, Rachida, Chazouillières, Olivier, Andreani, Tony, Angoulevant, Bénédicte, Chevance, Azeline, Serfaty, Lawrence, Samuel, Didier, Antonini, Teresa, Coilly, Audrey, Duclos-Vallée, Jean-Charles, Tateo, Mariagrazia, Abergel, Armand, Reymond, Maud, Brigitte, Chanteranne, Benjamin, Buchard, Muti, Léon, Geist, Claire, Conroy, Guillaume, Riffault, Raphaëlle, Rosa, Isabelle, Barrault, Camille, Costes, Laurent, Hagège, Hervé, Loustaud-Ratti, Véronique, Carrier, Paul, Debette-Gratien, Maryline, Lassailly, Guillaume, Lemaitre, Elise, Canva, Valérie, Dharancy, Sébastien, Louvet, Alexandre, Minello, Anne, Latournerie, Marianne, Bardou, Marc, Mouillot, Thomas, D’alteroche, Louis, Barbereau, Didier, Nicolas, Charlotte, Elkrief, Laure, Jaillais, Anaïs, Gournay, Jérôme, Chevalier, Caroline, Archambeaud, Isabelle, Habes, Sarah, Portal, Isabelle, Gelu-Simeon, Moana, Saillard, Eric, Lafrance, Marie-Josée, Catherine, Lucie, Chau, Frederic, Goderel, Isabelle, Lusivika-Nzinga, Clovis, Bellance, Marc-Antoine, Bellet, Jonathan, Monfalet, Priscilla, Chane-Teng, Jessica, Bijaoui, Sephora, Pannetier, Grégory, Téoulé, François, Nicol, Jérôme, Sebal, Florian, Bekhti, Rafika, Boston, Anaïs, Nailler, Laura, Le Meut, Guillaume, Diallo, Alpha, Fourati, Slim, Housset, Chantal, Bruyand, Mathias, Wittkop, Linda, Zucman-Rossi, Jessica, L’hennaff, Marianne, Sizorn, Michèle, Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Département d'hépatologie [CHU Cochin], Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM), Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Hôpital Raymond Poincaré [Garches], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service des Maladies de l'Appareil Digestif et de la Nutrition [CHRU Lille], Hôpital Claude Huriez [Lille], CHU Lille-CHU Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), and Agence Nationale de Recherches sur le Sida et les Hépatites Virales (ANRS)

Subjects
Endocannabinoid system, Behaviors, Δ9-Tetrahydrocannabinol, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Obesity, Sciences du Vivant [q-bio]/Médecine humaine et pathologie, Chronic, Body weight, Hepatitis C, Fibrosis, Corpulence, Cannabis, Marijuana
Abstract

Background Patients with chronic hepatitis C virus (HCV) infection are at greater risk of developing metabolic disorders. Obesity is a major risk factor for these disorders, and therefore, managing body weight is crucial. Cannabis use, which is common in these patients, has been associated with lower corpulence in various populations. However, this relationship has not yet been studied in persons with chronic HCV infection. Methods Using baseline data from the French ANRS CO22 Hepather cohort, we used binary logistic and multinomial logistic regression models to test for an inverse relationship between cannabis use (former/current) and (i) central obesity (i.e., large waist circumference) and (ii) overweight and obesity (i.e., elevated body mass index (BMI)) in patients from the cohort who had chronic HCV infection. We also tested for relationships between cannabis use and both waist circumference and BMI as continuous variables, using linear regression models. Results Among the 6348 participants in the study population, 55% had central obesity, 13.7% had obesity according to their BMI, and 12.4% were current cannabis users. After multivariable adjustment, current cannabis use was associated with lower risk of central obesity (adjusted odds ratio, aOR [95% confidence interval, CI]: 0.45 [0.37–0.55]), BMI-based obesity (adjusted relative risk ratio (aRRR) [95% CI]: 0.27 [0.19–0.39]), and overweight (aRRR [95% CI]: 0.47 [0.38–0.59]). This was also true for former use, but to a lesser extent. Former and current cannabis use were inversely associated with waist circumference and BMI. Conclusions We found that former and, to a greater extent, current cannabis use were consistently associated with smaller waist circumference, lower BMI, and lower risks of overweight, obesity, and central obesity in patients with chronic HCV infection. Longitudinal studies are needed to confirm these relationships and to assess the effect of cannabis use on corpulence and liver outcomes after HCV cure. Trial registration ClinicalTrials.gov identifier: NCT01953458.

Published
2022

12. Cannabis Use Is Inversely Associated with Overweight and Obesity in Hepatitis B Virus-Infected Patients (ANRS CO22 Hepather Cohort)

Author

Barré, Tangui, Pol, Stanislas, Ramier, Clémence, Di Beo, Vincent, Carrat, Fabrice, Bureau, Morgane, Bourlière, Marc, Dorival, Céline, Serfaty, Lawrence, Asselah, Tarik, Boursier, Jérôme, Marcellin, Fabienne, Carrieri, Patrizia, Fontaine, Hélène, Protopopescu, Camelia, Alric, Laurent, Bonnet, Delphine, Payssan-Sicart, Virginie, Pomes, Chloe, Zoulim, Fabien, Maynard, Marianne, Bai, Roxane, Hucault, Lucie, Bailly, François, Raffi, François, Billaud, Eric, Boutoille, David, Lefebvre, Maeva, André-Garnier, Elisabeth, Cales, Paul, Hubert, Isabelle, Lannes, Adrien, Lunel, Françoise, Boyer, Nathalie, Giuily, Nathalie, Castelnau, Corinne, Scoazec, Giovanna, Rousseaud, Emilie, Vallet-Pichard, Anaïs, Sogni, Philippe, Ledinghen, Victor De, Foucher, Juliette, Hiriart, Jean-Baptiste, M'Bouyou, Jancell, Irlès-Depé, Marie, Si Ahmed, Si Nafa, Oules, Valérie, Tran, Albert, Anty, Rodolphe, Gelsi, Eve, Truchi, Régine, Thabut, Dominique, Hammeche, Saloua, Moussali, Joseph, Causse, Xavier, Dieuleveult, Barbara De, Ouarani, Brahim, Labarrière, Damien, Ganne, Nathalie, Grando-Lemaire, Véronique, Nahon, Pierre, Brulé, Séverine, Ulker, Betul, Guyader, Dominique, Jezequel, Caroline, Brener, Audrey, Laligant, Anne, Rabot, Aline, Renard, Isabelle, Habersetzer, François, Baumert, Thomas, Doffoel, Michel, Mutter, Catherine, Simo-Noumbissie, Pauline, Razi, Esma, Bronowicki, Jean-Pierre, Barraud, Hélène, Bensenane, Mouni, Nani, Abdelbasset, Hassani-Nani, Sarah, Bernard, Marie-Albertine, Pageaux, Georges-Philippe, Larrey, Dominique, Meszaros, Magda, Metivier, Sophie, Bureau, Christophe, Morales, Thibault, Peron, Jean Marie, Robic, Marie Angèle, Decaens, Thomas, Faure, Marine, Froissart, Bruno, Hilleret, Marie-Noelle, Zarski, Jean-Pierre, Riachi, Ghassan, Goria, Odile, Paris, Fatima, Montialoux, Hélène, Leroy, Vincent, Amaddeo, Giuliana, Varaut, Anne, Simoes, Mélanie, Amzal, Rachida, Chazouillières, Olivier, Andreani, Tony, Angoulevant, Bénédicte, Chevance, Azeline, Samuel, Didier, Antonini, Teresa, Coilly, Audrey, Duclos Vallée, Jean-Charles, Tateo, Mariagrazia, Abergel, Armand, Reymond, Maud, Brigitte, Chanteranne, Benjamin, Buchard, Muti, Léon, Geist, Claire, Conroy, Guillaume, Riffault, Raphaëlle, Rosa, Isabelle, Barrault, Camille, Costes, Laurent, Hagège, Hervé, Loustaud-Ratti, Véronique, Carrier, Paul, Debette-Gratien, Maryline, Mathurin, Philippe, Lassailly, Guillaume, Lemaitre, Elise, Canva, Valérie, Dharancy, Sébastien, Louvet, Alexandre, Minello, Anne, Latournerie, Marianne, Bardou, Marc, Mouillot, Thomas, d'Alteroche, Louis, Barbereau, Didier, Nicolas, Charlotte, Elkrief, Laure, Jaillais, Anaïs, Gournay, Jérôme, Chevalier, Caroline, Archambeaud, Isabelle, Habes, Sarah, Portal, Isabelle, Gelu-Simeon, Moana, Saillard, Eric, Lafrance, Marie-Josée, Catherine, Lucie, Nutrition, obésité et risque thrombotique (NORT), Institut National de la Recherche Agronomique (INRA)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'hépatologie médicale [CHU Cochin], Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), ESIM - Déterminants Sociaux de la Santé et du Recours aux Soins (DS3), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'hépato-gastro-entérologie, Assistance Publique - Hôpitaux de Marseille (APHM), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Hôpital de Hautepierre [Strasbourg], Service d’Hépatologie [Hôpital Beaujon], Hôpital Beaujon [AP-HP], Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC), and BOURGEAIS, Véronique

Subjects
Hepatitis B virus, medicine.medical_specialty, Cirrhosis, [SDV]Life Sciences [q-bio], Aucun, Overweight, medicine.disease_cause, Virus, 03 medical and health sciences, Hepatitis B, Chronic, 0302 clinical medicine, Internal medicine, medicine, Humans, Pharmacology (medical), Obesity, ComputingMilieux_MISCELLANEOUS, Cannabis, 030304 developmental biology, Pharmacology, 0303 health sciences, biology, Cannabinoids, business.industry, Liver Neoplasms, Hepatitis B, biology.organism_classification, medicine.disease, digestive system diseases, 3. Good health, [SDV] Life Sciences [q-bio], Complementary and alternative medicine, Hepatocellular carcinoma, Cohort, cannabis, obesity, overweight, socioeconomic status, 030211 gastroenterology & hepatology, medicine.symptom, business
Abstract

International audience; Background: Chronic hepatitis B virus (HBV) infection may evolve into cirrhosis and hepatocellular carcinoma, and this progression may be accelerated by specific risk factors, including overweight and obesity. Although evidence for a protective effect of cannabis use on elevated body weight has been found for other populations, no data are available for HBV-infected patients.Aims: We aimed to identify risk factors (including cannabis use) for overweight and obesity in patients with HBV chronic infection.Methods: Using baseline data from the French ANRS CO22 Hepather cohort, we performed two separate analyses, one using “central obesity” (based on waist circumference) and the other “overweight” and “obesity” (based on body mass index) as outcomes. Logistic and multinomial regressions were used to model central obesity and overweight/obesity, respectively.Results: Among the 3706 patients in the study population, 50.8% had central obesity, 34.7% overweight, and 14.4% obesity. After multivariable adjustment, current cannabis use was associated with a 59% lower risk of central obesity compared with no lifetime use (adjusted odds ratio [95% CI]: 0.41 [0.24 to 0.70]). It was also associated with a 54% and 84% lower risk of overweight (adjusted relative risk ratio [95% CI]: 0.46 [0.27 to 0.76]) and obesity (0.16 [0.04 to 0.67]), respectively.Conclusions: Cannabis use was associated with lower risks of overweight and obesity in patients with HBV chronic infection. Future studies should test whether these potential benefits of cannabis and cannabinoid use translate into reduced liver disease progression in this high-risk population.

Published
2021

13. Sofosbuvir-Daclatasvir-Simeprevir Plus Ribavirin in Direct-Acting Antiviral–Experienced Patients With Hepatitis C

Author

Giovanna Scoazec, Isaac Ruiz, Alexandre Soulier, Ariane Mallat, Anne Varaut, Murielle François, Françoise Roudot-Thoraval, Christophe Hézode, Slim Fourati, Stéphane Chevaliez, and Jean-Michel Pawlotsky

Subjects
0301 basic medicine, Microbiology (medical), Simeprevir, medicine.medical_specialty, Daclatasvir, Sofosbuvir, business.industry, Ribavirin, 030106 microbiology, Hepatitis C, medicine.disease, Gastroenterology, Virological response, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Infectious Diseases, chemistry, Internal medicine, medicine, 030211 gastroenterology & hepatology, Adverse effect, business, Direct acting, medicine.drug
Abstract

We assessed the broadly used, off-label combination of sofosbuvir, daclatasvir, simeprevir, and ribavirin in direct-acting antiviral-experienced patients, as recommended in current guidelines despite scarce data. After 24 weeks' treatment, sustained virological response 12 weeks after the end of treatment was achieved in 6 patients (60%). Two cirrhotic patients relapsed and 2 discontinued treatment due to serious adverse events.

Published
2017

15. Retreatment with sofosbuvir and simeprevir of patients with hepatitis C virus genotype 1 or 4 who previously failed a daclatasvir‐containing regimen

Author

Magali Bouvier-Alias, Ariane Mallat, Isaac Ruiz, Françoise Roudot-Thoraval, Alexandre Soulier, Stéphane Chevaliez, Jean-Michel Pawlotsky, Giovanna Scoazec, Anne Varaut, Cyrille Feray, and Christophe Hézode

Subjects
Male, 0301 basic medicine, Simeprevir, medicine.medical_specialty, Pyrrolidines, Daclatasvir, Sustained Virologic Response, Sofosbuvir, Hepatitis C virus, Pilot Projects, medicine.disease_cause, Antiviral Agents, Gastroenterology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Pegylated interferon, Internal medicine, medicine, Humans, Treatment Failure, NS5A, Hepatology, business.industry, Ribavirin, Imidazoles, Valine, Hepatitis C, Chronic, Middle Aged, Surgery, 030104 developmental biology, chemistry, Asunaprevir, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, Carbamates, business, medicine.drug
Abstract

UNLABELLED Failure to achieve sustained virological response (SVR) with hepatitis C virus (HCV) direct-acting antiviral-based regimens is commonly associated with emergence of resistance-associated variants (RAVs). To avoid cross-resistance, recent guidelines recommend that patients who have failed on nonstructural protein 5A (NS5A) inhibitors should be retreated with sofosbuvir (SOF; NS5B inhibitor) combined with simeprevir (SIM; protease inhibitor [PI]); however, supporting evidence is lacking. This "real-world" study comprised patients who had failed to achieve SVR on previous NS5A-based therapy with daclatasvir (DCV) plus pegylated interferon (Peg-IFN) and ribavirin (RBV), with (n = 3) or without (n = 13) asunaprevir (ASV; PI). All 16 patients were retreated for 12 weeks with SOF plus SIM, without RBV. Antiviral efficacy was evaluated using the primary endpoint of SVR12 (SVR 12 weeks post-treatment); on-treatment response was also assessed. Patients (N = 16; 13 male; mean age: 54 years [range, 43-73]) were chronically infected with HCV genotype (GT) 1 (1a, n = 11; 1b, n = 3) or 4 (n = 2); they had advanced fibrosis or compensated cirrhosis (FibroScan, 9.6-70 kPa; cirrhosis, n = 9); median baseline HCV-RNA level was 1.38 × 10(6) IU/mL. No patient discontinued treatment because of adverse events or virological failure. All patients achieved HCV RNA below lower limit of quantification (

Published
2016

16. Viral kinetics analysis and virological characterization of treatment failures in patients with chronic hepatitis C treated with sofosbuvir and an NS5A inhibitor

Author

A. Varaut, M. Francois, J. Guedj, Lila Poiteau, Alexandre Soulier, Thi Huyen Tram Nguyen, Stéphane Chevaliez, Jean-Michel Pawlotsky, G. Scoazec, Christophe Hézode, A. Mallat, Isaac Ruiz, Slim Fourati, and F. Roudot-Thoraval

Subjects
0301 basic medicine, Male, Pyrrolidines, Sofosbuvir, Sustained Virologic Response, Hepacivirus, Viral Nonstructural Proteins, Gastroenterology, Cohort Studies, chemistry.chemical_compound, 0302 clinical medicine, Medicine, Pharmacology (medical), Treatment Failure, Aged, 80 and over, Standard treatment, Imidazoles, virus diseases, Valine, Middle Aged, Viral Load, Cohort, 030211 gastroenterology & hepatology, Drug Therapy, Combination, Female, Uridine Monophosphate, medicine.drug, Ledipasvir, Adult, medicine.medical_specialty, Daclatasvir, Genotype, Antiviral Agents, 03 medical and health sciences, Internal medicine, Humans, In patient, NS5A, Aged, Fluorenes, Hepatology, business.industry, Hepatitis C, Chronic, digestive system diseases, Clinical trial, Kinetics, 030104 developmental biology, chemistry, Benzimidazoles, Carbamates, business
Abstract

BACKGROUND The combination of sofosbuvir (SOF) plus an NS5A inhibitor for 12 weeks is highly efficacious in patients with chronic hepatitis C. As the costs of generic production of sofosbuvir and NS5A inhibitor are rapidly decreasing, the combination of these DAAs will be the standard treatment in most low- to middle-income countries in the future. AIM To identify key predictors of response that can be used to tailor treatment decisions. METHODS A cohort of 216 consecutive patients infected with HCV genotype 1 (1a: n = 57; 1b: n = 77), 2 (n = 4), 3 (n = 33) or 4 (n = 44) were treated with sofosbuvir (SOF) + daclatasvir (n = 176) or SOF + ledipasvir (n = 40) for 12 weeks. The viral kinetics was analysed using the biphasic model and the cure boundary was used to predict time to clear HCV. RESULTS The overall SVR rate was high (94.4%; n = 204), regardless of the time to viral suppression or low-level viraemia at the end of treatment. The model-based predicted HCV RNA levels at the end of treatment could not differentiate patients who did from those who did not achieve SVR. The presence of NS5A resistance-associated substitutions [position 28 (OR = 70.3, P

Published
2017

17. Anti-HBV DNA vaccination does not prevent relapse after discontinuation of analogues in the treatment of chronic hepatitis B: a randomised trial—ANRS HB02 VAC-ADN

Author

H, Fontaine, S, Kahi, C, Chazallon, M, Bourgine, A, Varaut, C, Buffet, O, Godon, J F, Meritet, Y, Saïdi, M L, Michel, D, Scott-Algara, J P, Aboulker, S, Pol, A, Vallet-Pichard, Institut Cochin (IC UM3 (UMR 8104 / U1016)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPC), Essais Thérapeutiques et Maladies Infectieuses, Université Paris-Sud - Paris 11 (UP11)-Institut National de la Santé et de la Recherche Médicale (INSERM), Pathogenèse des Virus de l'Hépatite B (PVHB), Institut Pasteur [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'Hépato-Gastro-Entérologie [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Service de Virologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Régulation des Infections Rétrovirales, Institut Pasteur [Paris], The trial was sponsored and funded by The National Agency for Research on Aids and Viral Hepatitis., Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), Institut Pasteur [Paris] (IP)-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut Pasteur [Paris] (IP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Paris (UP), and Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)

Subjects
Male, MESH: Treatment Failure, Gastroenterology, law.invention, 0302 clinical medicine, Randomized controlled trial, Recurrence, law, Vaccines, DNA, Prospective Studies, Treatment Failure, Prospective cohort study, Anti hbv, 0303 health sciences, MESH: Middle Aged, virus diseases, Middle Aged, Hepatitis B, 3. Good health, Female, 030211 gastroenterology & hepatology, MESH: Antiviral Agents, Adult, medicine.medical_specialty, MESH: Hepatitis B, Chronic, Antiviral Agents, DNA vaccination, 03 medical and health sciences, Hepatitis B, Chronic, Immune system, Internal medicine, medicine, Humans, Hepatitis B Vaccines, 030304 developmental biology, MESH: Hepatitis B Vaccines, MESH: Humans, business.industry, MESH: Adult, medicine.disease, MESH: Prospective Studies, MESH: Male, MESH: Recurrence, MESH: Vaccines, DNA, Discontinuation, Clinical trial, Immunology, [SDV.IMM.VAC]Life Sciences [q-bio]/Immunology/Vaccinology, business, MESH: Female
Abstract

International audience; Objective: The antiviral efficacy of nucleos(t)ide analogues whose main limitation is relapse after discontinuation requires long-term therapy. To overcome the risk of relapse and virological breakthrough during long-term therapy, we performed a phase I/II, open, prospective, multicentre trial using a HBV envelope-expressing DNA vaccine.Design: 70 patients treated effectively with nucleos(t)ide analogues for a median of 3 years (HBV DNA 120 IU/mL) or impossibility of stopping treatment at week 48.Results: Reactivation occurred in 97% of each group after a median 28 days without liver failure but with an HBV DNA

Published
2014

19. 719 - Sofosbuvir + Glecaprevir/Pibrentasvir (G/P) in Patients with Difficult to Treat HCV Infection. Final Results of the French Compassionate Use

Author

de Ledinghen, Victor, primary, Varaut, Anne, additional, Ursic-Bedoya, Jose, additional, Parlati, Lucia, additional, Hiriart, Jean-Baptiste, additional, Scoazec, Giovanna, additional, Merrouche, Wassil, additional, Pageaux, Georges, additional, Fontaine, Helene, additional, Alric, Laurent, additional, and Hezode, Christophe, additional

Published
2018
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21. Viral kinetics analysis and virological characterization of treatment failures in patients with chronic hepatitis C treated with sofosbuvir and an NS5A inhibitor

Author

Fourati, S., primary, Guedj, J., additional, Chevaliez, S., additional, Nguyen, T. H. T., additional, Roudot-Thoraval, F., additional, Ruiz, I., additional, Soulier, A., additional, Scoazec, G., additional, Varaut, A., additional, Poiteau, L., additional, Francois, M., additional, Mallat, A., additional, Hézode, C., additional, and Pawlotsky, J.-M., additional

Published
2017
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29. 719 - Sofosbuvir + Glecaprevir/Pibrentasvir (G/P) in Patients with Difficult to Treat HCV Infection. Final Results of the French Compassionate Use

Author

Christophe Hézode, Giovanna Scoazec, José Ursic-Bedoya, Lucia Parlati, Anne Varaut, Jean-Baptiste Hiriart, Wassil Merrouche, Hélène Fontaine, Laurent Alric, Georges Philippe Pageaux, and Victor de Ledinghen

Subjects
medicine.medical_specialty, Hepatology, Sofosbuvir, business.industry, Gastroenterology, medicine, Compassionate Use, In patient, Glecaprevir / pibrentasvir, Intensive care medicine, business, medicine.drug
Published
2018

30. Diagnostic Accuracy of the Fibrotest in Hemodialysis and Renal Transplant Patients with Chronic Hepatitis C Virus

Author

Anaïs Vallet-Pichard, Pascal Lebray, Virginie Verkarre, Francoise Imbertbismuth, Bertrand Nalpas, Stanislas Pol, Jeanne Serpaggi, Hélène Fontaine, and Anne Varaut

Subjects
Adult, Male, Nephrology, medicine.medical_specialty, medicine.medical_treatment, Population, Gastroenterology, Automation, Liver Function Tests, Nephelometry and Turbidimetry, Predictive Value of Tests, Renal Dialysis, Internal medicine, medicine, Humans, education, Kidney transplantation, Transplantation, education.field_of_study, Kidney, medicine.diagnostic_test, FibroTest, business.industry, Reproducibility of Results, Hepatitis C Antibodies, Hepatitis C, Chronic, Middle Aged, medicine.disease, Kidney Transplantation, Surgery, medicine.anatomical_structure, Liver biopsy, Female, Hemodialysis, business, Biomarkers
Abstract

An accurate diagnosis of hepatitis C virus (HCV)-related liver lesions is mandatory in dialysis patients and kidney recipients to better define the treatment of and contraindications to kidney transplantation. The aim of this study was to assess the diagnostic accuracy of the fibrotest (a noninvasive method to assess liver fibrosis in HCV on a scale from 0 to 1) in hemodialysis and renal transplant patients infected by chronic HCV.In all, 110 patients with biopsy-proven HCV (60 renal transplant recipients and 50 hemodialysis patients), determined using the METAVIR scoring system, were studied.Forty-six percent of patients had fibrosisor =F2. A positive predictive value of a score0.6 for the presence of significant fibrosis by comparison with liver biopsy was 71%, and an negative predictive value of0.2 for excluding significant fibrosis was 77%, respectively. The areas under the ROC curves for the diagnosis of significant fibrosis were 0.66, 0.47, and 0.71 in the global population, hemodialysis patients, and renal transplant patients, respectively. In all, 75% of patients were correctly classified using the fibrotest. If biopsy was restricted to scores in the intermediate range (0.6 and0.2), the index could reduce the indication for biopsy by 47%. The results did not differ significantly in hemodialysis and renal transplant patients.The fibrotest has a diagnostic value in hemodialysis and renal transplant patients which is similar to that reported in the general population (75%) and its use could avoid 32% of liver biopsies if it were interpreted in detail in nephrology patients.

Published
2005

31. Tubulointerstitial Nephritis and Fanconi Syndrome in Primary Biliary Cirrhosis

Author

Pierre Rustin, Fadi Fakhouri, Jeanne Serpaggi, Raynald Binaut, Natacha Patey, Jean-Pierre Grünfeld, Marie Lino, Laurent Daniel, Anne Varaut, Bertrand Knebelmann, Philippe Vanhille, and Laure-Hélène Noël

Subjects
medicine.medical_specialty, Biopsy, Mitochondria, Liver, Pyruvate Dehydrogenase Complex, Mitochondrion, Kidney, Autoantigens, Gastroenterology, Autoimmune Diseases, Phosphates, Primary biliary cirrhosis, Calcitriol, Adrenal Cortex Hormones, Internal medicine, Humans, Medicine, Ketoglutarate Dehydrogenase Complex, Aged, Autoantibodies, medicine.diagnostic_test, biology, Liver Cirrhosis, Biliary, business.industry, Ursodeoxycholic Acid, Fanconi syndrome, Acidosis, Renal Tubular, Middle Aged, Fanconi Syndrome, medicine.disease, Pyruvate dehydrogenase complex, Mitochondria, Bone Diseases, Metabolic, Liver, Nephrology, Antibodies, Antinuclear, biology.protein, Kidney Failure, Chronic, Nephritis, Interstitial, Female, Antibody, business, Complication, Nephritis
Abstract

Primary biliary cirrhosis is a chronic cholestatic liver disease of unknown cause that predominantly affects middle-aged women. Distal tubular acidosis is the main renal complication of primary biliary cirrhosis. Tubulointerstitial nephritis and Fanconi syndrome have been reported more rarely. We report on 2 patients with primary biliary cirrhosis who presented with tubulointerstitial nephritis and Fanconi syndrome and review similar cases published previously. Serum from 1 patient exerted an inhibitory effect on pyruvate dehydrogenase and alpha-ketoglutarate dehydrogenase, 2 mitochondrial enzymes that are the main targets of antimitochondrial antibodies in primary biliary cirrhosis. Antimitochondrial antibodies may have a role in the genesis of tubulointerstitial nephritis and Fanconi syndrome, 2 typical renal features of mitochondrial cytopathies. Tubulointerstitial nephritis and Fanconi syndrome have to be added to the spectrum of renal diseases associated with primary biliary cirrhosis.

Published
2005

35. Retreatment of HCV DAA Failures: HCV Infection may be Incurable

Author

G. Scoazec, J.-M. Pawlotsky, A. Varaut, Isaac Ruiz, Stéphane Chevaliez, A. Mallat, Slim Fourati, Christophe Hézode, Alexandre Soulier, and M. Francois

Subjects
03 medical and health sciences, 0302 clinical medicine, 030228 respiratory system, Hepatology, business.industry, Medicine, 030211 gastroenterology & hepatology, business, Virology
Published
2016

36. Efficacy and safety of adefovir dipivoxil in kidney recipients, hemodialysis patients, and patients with renal insufficiency

Author

Anne Varaut, Hélène Fontaine, Jeanne Serpaggi, Carol L. Brosgart, Bertrand Nalpas, Anaïs Vallet-Pichard, Eugenia Morales, Stanislas Pol, Virginie Verkarre, Graham Currie, and Marie-Laure Chaix

Subjects
Adult, Male, medicine.medical_specialty, Hepatitis B virus, medicine.medical_treatment, Population, Organophosphonates, Renal function, medicine.disease_cause, Gastroenterology, Antiviral Agents, chemistry.chemical_compound, Hepatitis B, Chronic, Renal Dialysis, Internal medicine, Drug Resistance, Viral, medicine, Adefovir, Humans, Renal Insufficiency, Viremia, education, Aged, Transplantation, Creatinine, education.field_of_study, business.industry, Adenine, virus diseases, Middle Aged, medicine.disease, Kidney Transplantation, digestive system diseases, Endocrinology, chemistry, Female, Hemodialysis, business, Kidney disease, medicine.drug
Abstract

Background. This study analyzes the biochemical, serological, and virological efficacy and the safety of adefovir dipivoxil in patients with renal disturbances. Methods. Twelve patients with lamivudine-resistant hepatitis B virus (HBV) chronic infection were treated for a median time of 15 (3–19) months. The daily dosage was 10 mg initially and then adjusted according to renal function. Results. Median (range) ALT values remained stable: 55 (13–117) and 37 (17–266) UI/L. After the 12th month, the median decline in serum HBV DNA was from 8.76 (6.3–9.7) to 2.97 (1.15–5.65) log10 Eq/ml (median decline of –5.5 log10). No virologic breakthrough was observed. One of the six HBeAg-positive patients lost HBe Ag but without HBe seroconversion; none had HBs Ag loss. There were no significant clinical and biochemical adverse effects. In the 11 nonhemodialysed patients, the creatinine clearance significantly improved from 70 (30–100) to 88 (38–125) ml/mn (P=0.01) and the mean serum creatinine levels increased only slightly from 114 (91–839) to 130 (81–561) μmol/ml (NS). Serum phosphorus remained stable. The urinary level of protein decreased from 0.16 (0.08–8.63) to 0.12 (0.01–0.74) g/day (NS). Conclusions. Adefovir dipivoxil is safe for the treatment of chronic hepatitis B in patients with varying degrees of renal dysfunction and lamivudine-resistant HBV and results in biochemical and virological efficacy similar to that reported in the general population.

Published
2005

37. Anti-HBV DNA vaccination does not prevent relapse after discontinuation of analogues in the treatment of chronic hepatitis B: a randomised trial—ANRS HB02 VAC-ADN

Author

Fontaine, H, primary, Kahi, S, additional, Chazallon, C, additional, Bourgine, M, additional, Varaut, A, additional, Buffet, C, additional, Godon, O, additional, Meritet, J F, additional, Saïdi, Y, additional, Michel, M L, additional, Scott-Algara, D, additional, Aboulker, J P, additional, and Pol, S, additional

Published
2014
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38. [The penalization of the medical domain]

Author

J M, Varaut

Subjects
Legislation, Medical, Liability, Legal, France, Delivery of Health Care
Abstract

The increasing penalisation of caring professions in France has not spared the medical and paramedical worlds. The growing number of classified offences, the ever-increasing recourse to associations to present claims, and society's need to identify a culprit rather than a cause for each dysfunction, all contribute to the development of this trend. A phenomenon that is dangerous because it blurs the distinction between criminal liability, normally used only to designate dangerous behaviour, and civil liability, which can result in damage payment. The new and somewhat vague notion of the "precautionary principle" could lead to an even greater range of legal proceedings and thus bring about a standstill situation characterised by abstention. It is proposed to reserve legal action only for those cases that arouse moral disapproval. This would mean modifying the articles of criminal law that sanction the crimes of manslaughter and accidental bodily harm by introducing the notions of a direct link and serious or deliberate offence in order to facilitate the instigation of proceedings.

Published
2000

44. Prevalence of liver fibrosis and risk factors in a general population using non-invasive biomarkers (FibroTest)

Author

Poynard, Thierry, primary, Lebray, Pascal, additional, Ingiliz, Patrick, additional, Varaut, Anne, additional, Varsat, Brigitte, additional, Ngo, Yen, additional, Norha, Pascal, additional, Munteanu, Mona, additional, Drane, Fabienne, additional, Messous, Djamila, additional, Bismut, Françoise Imbert, additional, Carrau, Jean Pierre, additional, Massard, Julien, additional, Ratziu, Vlad, additional, and Giordanella, Jean Pierre, additional

Published
2010
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49. Faut-il avoir peur des juges ? / Jean-Marc Varaut,...

Author

Varaut, Jean-Marc (1933-2005). Auteur du texte and Varaut, Jean-Marc (1933-2005). Auteur du texte

Abstract

Collection : Tribune libre, Collection : Tribune libre, Contient une table des matières, Avec mode texte

Published
2000

50. Pour la nation / Jean-Marc Varaut,...

Author

Varaut, Jean-Marc (1933-2005). Auteur du texte and Varaut, Jean-Marc (1933-2005). Auteur du texte

Abstract

Contient une table des matières, Avec mode texte

Published
1999

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