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1. Rare HCV subtypes and retreatment outcomes in a cohort of European DAA-experienced patients

Author

Antoni, C., Teufel, A., Vogelmann, R., Ebert, M., Balavoine, J., Giostra, E., Berning, M., Hampe, J., Boettler, T., Neumann-Haefelin, C., Thimme, R., De Gottardi, A., Rauch, A., Semmo, N., Ellenrieder, V., Gress, M., Herrmann, A., Stallmach, A., Hoffmann, D., Protzer, U., Kodal, A., Löbermann, M., Götze, T., Keitel-Anselmino, V., Lange, C.M., Zachoval, R., Mayerle, J., Maieron, A., Michl, P., Merle, U., Moradpour, D., Chave, J.-P., Muche, M., Epple, H.-J., Müller-Schilling, M., Kocheise, F., Müller, T., Tacke, F., Roeb, E., Rissland, J., Krawczyk, M., Schulze, P., Semela, D., Spengler, U., Rockstroh, J., Strassburg, C.P., Siebler, J., Schulze zur Wiesch, J., Piecha, F., von Felden, J., Jordan, S., Lohse, A., Sprinzl, M., Galle, P., Stauber, R., Strey, B., Steckstor, W., Schmiegel, W., Brockmeyer, N.H., Canbay, A., Trautwein, C., Uschner, F., Trebicka, J., Weber, T., Wedemeyer, H., Cornberg, M., Manns, M., Wietzke-Braun, P., Günther, R., Willuweit, K., Hilgard, G., Schmidt, H., Zizer, E., Backhus, J., Seufferlein, T., Al-Taie, O., Angeli, W., Beckebaum, S., Erhardt, A., Garrido-Lüneburg, A., Gattringer, H., Genné, D., Gschwantler, M., Gundling, F., Hametner, S., Schöfl, R., Haag, S., Heinzow, H., Heyer, T., Hirschi, C., Jussios, A., Kanzler, S., Kordecki, N., Kraus, M., Kullig, U., Wollschläger, S., Magenta, L., Beretta-Piccoli, B. Terziroli, Menges, M., Mohr, L., Muehlenberg, K., Niederau, C., Paulweber, B., Petrides, A., Pinkernell, M., Piso, R., Rambach, W., Reinhardt, L., Reiser, M., Riecken, B., Rieke, A., Roth, J., Schelling, M., Schlee, P., Schneider, A., Scholz, D., Schott, E., Schuchmann, M., Schulten-Baumer, U., Seelhoff, A., Stich, A., Stickel, F., Ungemach, J., Walter, E., Weber, A., Wege, H., Winzer, T., Abels, W., Adler, M., Audebert, F., Baermann, C., Bästlein, E., Barth, R., Barthel, K., Becker, W., Behrends, J., Benninger, J., Berger, F., Berzow, D., Beyer, T., Bierbaum, M., Blaukat, O., Bodtländer, A., Böhm, G., Börner, N., Bohr, U., Bokemeyer, B., Bruch, H.R., Bucholz, D., Buggisch, P., Matschenz, K., Petersen, J., Burkhard, O., Busch, N., Chirca, C., Delker, R., Diedrich, J., Frank, M., Diehl, M., Tal, A.O., Schneider, M., Dienethal, A., Dietel, P., Dikopoulos, N., Dreck, M., Dreher, F., Drude, L., Ende, K., Ehrle, U., Baumgartl, K., Emke, F., Glosemeyer, R., Felten, G., Hüppe, D., Fischer, J., Fischer, U., Frederking, D., Frick, B., Friese, G., Gantke, B., Geyer, P., Schwind, H.R., Glas, M., Glaunsinger, T., Goebel, F., Göbel, U., Görlitz, B., Graf, R., Gruber, H., Hartmann, C., Klag, C., Härter, G., Herder, M., Heuchel, T., Heuer, S., Hinrichsen, H., Seegers, B., Höffl, K.-H., Hörster, H., Sonne, J.-U., Hofmann, W.P., Holst, F., Hunstiger, M., Hurst, A., Jägel-Guedes, E., John, C., Jung, M., Kallinowski, B., Kapzan, B., Kerzel, W., Khaykin, P., Klarhof, M., Klüppelberg, U., Wolfratshausen, Klugewitz, K., Knapp, B., Knevels, U., Kochsiek, T., Körfer, A., Köster, A., Kuhn, M., Langekamp, A., Künzig, B., Link, R., Littman, M., Löhr, H., Lutz, T., Gute, P., Knecht, G., Lutz, U., Mainz, D., Mahle, I., Maurer, P., Mauss, S., Mayer, C., Möller, H., Heyne, R., Moritzen, D., Mroß, M., Mundlos, M., Naumann, U., Nehls, O., K, Ningel, R., Oelmann, A., Olejnik, H., Gadow, K., Pascher, E., Philipp, A., Pichler, M., Polzien, F., Raddant, R., Riedel, M., Rietzler, S., Rössle, M., Rufle, W., Rump, A., Schewe, C., Hoffmann, C., Schleehauf, D., Schmidt, W., Schmidt-Heinevetter, G., Fabris, J. Schmidtler-von, Schneider, L., Schober, A., Niehaus-Hahn, S., Schwenzer, J., Seidel, T., Seitel, G., Sick, C., Simon, K., Stähler, D., Stenschke, F., Steffens, H., Stein, K., Steinmüller, M., Sternfeld, T., Svensson, K., Tacke, W., Teuber, G., Teubner, K., Thieringer, J., Tomesch, A., Trappe, U., Ullrich, J., Urban, G., Usadel, S., von Lucadou, A., Weinberger, F., Werheid-Dobers, M., Werner, P., Winter, T., Zehnter, E., Zipf, A., Dietz, Julia, Graf, Christiana, Berg, Christoph P., Port, Kerstin, Deterding, Katja, Buggisch, Peter, Peiffer, Kai-Henrik, Vermehren, Johannes, Dultz, Georg, Geier, Andreas, Reiter, Florian P., Bruns, Tony, Schattenberg, Jörn M., Durmashkina, Elena, Gustot, Thierry, Moreno, Christophe, Trauth, Janina, Discher, Thomas, Fischer, Janett, Berg, Thomas, Kremer, Andreas E., Müllhaupt, Beat, Zeuzem, Stefan, and Sarrazin, Christoph

Published
2024
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2. Suppression of HBV by Tenofovir in HBV/HIV Coinfected Patients: A Systematic Review and Meta-Analysis

Author

Peters, Marion, Price, H, Dunn, D, Pillay, D, Bani-Sadr, F, de, T, Jain, MK, Kuzushita, N, Mauss, S, Núñez, M, and Nüesch, R

Abstract

Background:Hepatitis B coinfection is common in HIV-positive individuals and as antiretroviral therapy has made death due to AIDS less common, hepatitis has become increasingly important. Several drugs are available to treat hepatitis B. The most potent an

Published
2013

3. Real‐world experience with the all‐oral, interferon‐free regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir for the treatment of chronic hepatitis C virus infection in the German Hepatitis C Registry

Author

Welzel, T. M., Hinrichsen, H., Sarrazin, C., Buggisch, P., Baumgarten, A., Christensen, S., Berg, T., Mauss, S., Teuber, G., Stein, K., Deterding, K., van Bömmel, F., Heyne, R., John, C., Zimmermann, T., Lutz, T., Schott, E., Hettinger, J., Kleine, H., König, B., Hüppe, D., and Wedemeyer, H.

Published
2017
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7. Treatment with tenofovir disoproxil fumarate or entecavir in chronic hepatitis B virus-infected patients with renal impairment: results from a 7-year, multicentre retrospective cohort study

Author

Lampertico, P, Berg, T, Buti, M, Pathil, A, Petersen, J, Ryder, S, Zoulim, F, Botros, I, Flaherty, J, Jump, B, Op den Brouw, M, van Troostenburg, A, Ramroth, H, Bourliere, M, De Ledinghen, V, Riachi, G, Loustaud-Ratti, V, Tran, A, Larrey, D, Dumortier, J, Leroy, V, Metivier, S, Sellier, P, Mauss, S, Peterson, J, Schiefke, I, Niederau, C, Teuber, G, Goeser, T, Jung, M, Grambihler, A, Pathil-Warth, A, Sprinzl, K, Von der Ohe, M, Antoni, C, Weigand, K, Andreone, P, Di Marco, V, Madonia, S, Puoti, M, Santantonio, T, Vigano, M, Ciancio, A, D'Offizi, G, Pirisi, M, Suarez Garcia, E, Pascasio Acevedo, J, Andrade, R, Gea, F, Serra Desfilis, M, Molina Perez, E, Manzano Alonso, M, Carrion, J, Aoufi Rabih, S, Planas, M, Agarwal, K, Ustianowski, A, Aspinall, R, Kennedy, P, Geretti, A, Mccorry, R, Foxton, M, Healy, B, Lampertico P., Berg T., Buti M., Pathil A., Petersen J., Ryder S. D., Zoulim F., Botros I., Flaherty J. F., Jump B., Op den Brouw M. L., van Troostenburg A., Ramroth H., Bourliere M., De Ledinghen V., Riachi G., Loustaud-Ratti V., Tran A., Larrey D., Dumortier J., Leroy V., Metivier S., Sellier P., Mauss S., Peterson J., Schiefke I., Niederau C., Teuber G., Goeser T., Jung M. C., Grambihler A., Pathil-Warth A., Sprinzl K., Von der Ohe M., Antoni C., Weigand K., Andreone P., Di Marco V., Madonia S., Puoti M., Santantonio T., Vigano M., Ciancio A., D'Offizi G., Pirisi M., Suarez Garcia E., Pascasio Acevedo J. M., Andrade R., Gea F., Serra Desfilis M. A., Molina Perez E., Manzano Alonso M., Carrion J. A., Aoufi Rabih S., Planas M. M., Ryder S., Agarwal K., Ustianowski A., Aspinall R., Kennedy P., Geretti A. M., McCorry R., Foxton M., Healy B., Lampertico, P, Berg, T, Buti, M, Pathil, A, Petersen, J, Ryder, S, Zoulim, F, Botros, I, Flaherty, J, Jump, B, Op den Brouw, M, van Troostenburg, A, Ramroth, H, Bourliere, M, De Ledinghen, V, Riachi, G, Loustaud-Ratti, V, Tran, A, Larrey, D, Dumortier, J, Leroy, V, Metivier, S, Sellier, P, Mauss, S, Peterson, J, Schiefke, I, Niederau, C, Teuber, G, Goeser, T, Jung, M, Grambihler, A, Pathil-Warth, A, Sprinzl, K, Von der Ohe, M, Antoni, C, Weigand, K, Andreone, P, Di Marco, V, Madonia, S, Puoti, M, Santantonio, T, Vigano, M, Ciancio, A, D'Offizi, G, Pirisi, M, Suarez Garcia, E, Pascasio Acevedo, J, Andrade, R, Gea, F, Serra Desfilis, M, Molina Perez, E, Manzano Alonso, M, Carrion, J, Aoufi Rabih, S, Planas, M, Agarwal, K, Ustianowski, A, Aspinall, R, Kennedy, P, Geretti, A, Mccorry, R, Foxton, M, Healy, B, Lampertico P., Berg T., Buti M., Pathil A., Petersen J., Ryder S. D., Zoulim F., Botros I., Flaherty J. F., Jump B., Op den Brouw M. L., van Troostenburg A., Ramroth H., Bourliere M., De Ledinghen V., Riachi G., Loustaud-Ratti V., Tran A., Larrey D., Dumortier J., Leroy V., Metivier S., Sellier P., Mauss S., Peterson J., Schiefke I., Niederau C., Teuber G., Goeser T., Jung M. C., Grambihler A., Pathil-Warth A., Sprinzl K., Von der Ohe M., Antoni C., Weigand K., Andreone P., Di Marco V., Madonia S., Puoti M., Santantonio T., Vigano M., Ciancio A., D'Offizi G., Pirisi M., Suarez Garcia E., Pascasio Acevedo J. M., Andrade R., Gea F., Serra Desfilis M. A., Molina Perez E., Manzano Alonso M., Carrion J. A., Aoufi Rabih S., Planas M. M., Ryder S., Agarwal K., Ustianowski A., Aspinall R., Kennedy P., Geretti A. M., McCorry R., Foxton M., and Healy B.

Abstract

Background: Limited data exist regarding tenofovir disoproxil fumarate (TDF) safety and effectiveness in chronic hepatitis B virus–infected (CHB) patients with renal impairment (RI). Aims: To compare real-world data on renal safety and effectiveness of TDF vs entecavir (ETV) in CHB patients with moderate-to-severe RI. Methods: Retrospective, non-interventional, cohort study analysing medical records for TDF/ETV-treated CHB patients (54 European centres). Included patients experienced moderate-to-severe RI (creatinine clearance 20-60 mL/min [Cockcroft-Gault]) either before TDF/ETV initiation (‘before’ subgroup [baseline = treatment initiation]) or after TDF/ETV initiation (‘after’ subgroup [baseline = first RI occurrence]). The primary objective was TDF safety, particularly renal-related adverse events of special interest (AESI). TDF and ETV safety and effectiveness were compared and multivariate analyses were performed using inverse probability treatment weighting. Results: ‘Before’ subgroup included 107 TDF- and 91 ETV-treated patients; ‘after’ subgroup included 212 TDF- and 77 ETV-treated patients. Mean baseline creatinine clearance was higher for TDF- vs ETV-treated patients (both subgroups). Median follow-up was 3.1 years (both treatments). AESI were more frequent with TDF vs ETV (‘before’: 18.7% vs 8.8%; ‘after’: 9.9% vs 3.9%); however, differences were not significant by multivariate analysis. Only TDF-treated patients experienced renal tubular dysfunction (6.5% ‘before’; 1.9% ‘after’) as well as renal adverse events leading to treatment discontinuation (8.4% ‘before’; 7.1% ‘after’). Effectiveness was similar between treatments. Conclusions: Overall safety was similar for TDF vs ETV (both subgroups). Given that renal tubular dysfunction occurred with TDF and not with ETV, renal safety concerns may be greater with TDF in CHB patients with RI.

Published
2020

8. 2019 update of the European AIDS Clinical Society Guidelines for treatment of people living with HIV version 10.0

Author

Ryom, L, Cotter, A, De Miguel, R, Beguelin, C, Podlekareva, D, Arribas, J, Marzolini, C, Mallon, P, Rauch, A, Kirk, O, Molina, J, Guaraldi, G, Winston, A, Bhagani, S, Cinque, P, Kowalska, J, Collins, S, Battegay, M, De Miguel Buckley, R, D'Arminio Monforte, A, Bracchi, M, Dedes, N, Horban, A, Katlama, C, Latysheva, I, Lundgren, J, Mccormack, S, Mussini, C, Pozniak, A, Pulido, F, Raffi, F, Reiss, P, Stellbrink, H, Vasylyev, M, Gibbons, S, Livio, F, Behrens, G, Bower, M, Compston, J, De Wit, S, Fabbri, L, Fux, C, Gisslen, M, Martinez, E, Miro, J, Negredo, E, Poulter, N, Sebastiani, G, Berenguer, J, Boesecke, C, Bruno, R, Konov, S, Lacombe, K, Mauss, S, Mendao, L, Peters, L, Puoti, M, Rockstroh, J, Ambrosioni, J, De Castro, N, Fatkenheuer, G, Furrer, H, Oprea, C, Volny-Anne, A, Sullivan, A, Mulcahy, F, Wensing, A, Ryom L., Cotter A., De Miguel R., Beguelin C., Podlekareva D., Arribas J. R., Marzolini C., Mallon P. G. M., Rauch A., Kirk O., Molina J. M., Guaraldi G., Winston A., Bhagani S., Cinque P., Kowalska J. D., Collins S., Battegay M., De Miguel Buckley R., D'Arminio Monforte A., Bracchi M., Dedes N., Horban A., Katlama C., Latysheva I., Lundgren J. D., McCormack S., Mussini C., Pozniak A., Pulido F., Raffi F., Reiss P., Stellbrink H. -J., Vasylyev M., Gibbons S., Livio F., Behrens G., Bower M., Compston J., De Wit S., Fabbri L. M., Fux C. A., Gisslen M., Martinez E., Miro J. M., Negredo E., Poulter N., Sebastiani G., Berenguer J., Boesecke C., Bruno R., Konov S., Lacombe K., Mauss S., Mendao L., Peters L., Puoti M., Rockstroh J. K., Ambrosioni J., De Castro N., Fatkenheuer G., Furrer H., Oprea C., Volny-Anne A., Sullivan A., Mulcahy F., Wensing A., Ryom, L, Cotter, A, De Miguel, R, Beguelin, C, Podlekareva, D, Arribas, J, Marzolini, C, Mallon, P, Rauch, A, Kirk, O, Molina, J, Guaraldi, G, Winston, A, Bhagani, S, Cinque, P, Kowalska, J, Collins, S, Battegay, M, De Miguel Buckley, R, D'Arminio Monforte, A, Bracchi, M, Dedes, N, Horban, A, Katlama, C, Latysheva, I, Lundgren, J, Mccormack, S, Mussini, C, Pozniak, A, Pulido, F, Raffi, F, Reiss, P, Stellbrink, H, Vasylyev, M, Gibbons, S, Livio, F, Behrens, G, Bower, M, Compston, J, De Wit, S, Fabbri, L, Fux, C, Gisslen, M, Martinez, E, Miro, J, Negredo, E, Poulter, N, Sebastiani, G, Berenguer, J, Boesecke, C, Bruno, R, Konov, S, Lacombe, K, Mauss, S, Mendao, L, Peters, L, Puoti, M, Rockstroh, J, Ambrosioni, J, De Castro, N, Fatkenheuer, G, Furrer, H, Oprea, C, Volny-Anne, A, Sullivan, A, Mulcahy, F, Wensing, A, Ryom L., Cotter A., De Miguel R., Beguelin C., Podlekareva D., Arribas J. R., Marzolini C., Mallon P. G. M., Rauch A., Kirk O., Molina J. M., Guaraldi G., Winston A., Bhagani S., Cinque P., Kowalska J. D., Collins S., Battegay M., De Miguel Buckley R., D'Arminio Monforte A., Bracchi M., Dedes N., Horban A., Katlama C., Latysheva I., Lundgren J. D., McCormack S., Mussini C., Pozniak A., Pulido F., Raffi F., Reiss P., Stellbrink H. -J., Vasylyev M., Gibbons S., Livio F., Behrens G., Bower M., Compston J., De Wit S., Fabbri L. M., Fux C. A., Gisslen M., Martinez E., Miro J. M., Negredo E., Poulter N., Sebastiani G., Berenguer J., Boesecke C., Bruno R., Konov S., Lacombe K., Mauss S., Mendao L., Peters L., Puoti M., Rockstroh J. K., Ambrosioni J., De Castro N., Fatkenheuer G., Furrer H., Oprea C., Volny-Anne A., Sullivan A., Mulcahy F., and Wensing A.

Abstract

Background: The European AIDS Clinical Society (EACS) Guidelines cover key aspects of HIV management with major updates every two years. Guideline highlights: The 2019 Guidelines were extended with a new section focusing on drug–drug interactions and other prescribing issues in people living with HIV (PLWH). The recommendations for treatment-naïve PLWH were updated with four preferred regimens favouring unboosted integrase inhibitors. A two-drug regimen with dolutegravir and lamivudine, and a three-drug regimen including doravirine were also added to the recommended initial regimens. Lower thresholds for hypertension were expanded to all PLWH and for cardiovascular disease prevention, the 10-year predicted risk threshold for consideration of antiretroviral therapy (ART) modification was lowered from 20% to 10%. Frailty and obesity were added as new topics. It was specified to use urine albumin to creatinine ratio to screen for glomerular disease and urine protein to creatinine ratio for tubular diseases, and thresholds were streamlined with the Kidney Disease: Improving Global Outcomes (KDIGO) recommendations. Hepatitis C virus (HCV) treatment recommendations were split into preferred and alternative treatment options. The algorithm for management of recently acquired HCV infection was updated and includes recommendations for early chronic infection management. Treatment of resistant tuberculosis (TB) was streamlined with the World Health Organization (WHO) recommendations, and new tables on immune reconstitution inflammatory syndrome, on when to start ART in the presence of opportunistic infections and on TB drug dosing were included. Conclusions: The EACS Guidelines underwent major revisions of all sections in 2019. They are available in four different formats including a new interactive web-based version and are translated into Chinese, French, German, Japanese, Portuguese, Russian and Spanish.

Published
2020

9. Treatment with tenofovir disoproxil fumarate or entecavir in chronic hepatitis B virus-infected patients with renal impairment: results from a 7-year, multicentre retrospective cohort study

Author

Lampertico P., Berg T., Buti M., Pathil A., Petersen J., Ryder S. D., Zoulim F., Botros I., Flaherty J. F., Jump B., Op den Brouw M. L., van Troostenburg A., Ramroth H., Bourliere M., De Ledinghen V., Riachi G., Loustaud-Ratti V., Tran A., Larrey D., Dumortier J., Leroy V., Metivier S., Sellier P., Mauss S., Peterson J., Schiefke I., Niederau C., Teuber G., Goeser T., Jung M. C., Grambihler A., Pathil-Warth A., Sprinzl K., Von der Ohe M., Antoni C., Weigand K., Andreone P., Di Marco V., Madonia S., Puoti M., Santantonio T., Vigano M., Ciancio A., D'Offizi G., Pirisi M., Suarez Garcia E., Pascasio Acevedo J. M., Andrade R., Gea F., Serra Desfilis M. A., Molina Perez E., Manzano Alonso M., Carrion J. A., Aoufi Rabih S., Planas M. M., Ryder S., Agarwal K., Ustianowski A., Aspinall R., Kennedy P., Geretti A. M., McCorry R., Foxton M., Healy B., Lampertico P., Berg T., Buti M., Pathil A., Petersen J., Ryder S.D., Zoulim F., Botros I., Flaherty J.F., Jump B., Op den Brouw M.L., van Troostenburg A., Ramroth H., Bourliere M., De Ledinghen V., Riachi G., Loustaud-Ratti V., Tran A., Larrey D., Dumortier J., Leroy V., Metivier S., Sellier P., Mauss S., Peterson J., Schiefke I., Niederau C., Teuber G., Goeser T., Jung M.C., Grambihler A., Pathil-Warth A., Sprinzl K., Von der Ohe M., Antoni C., Weigand K., Andreone P., Di Marco V., Madonia S., Puoti M., Santantonio T., Vigano M., Ciancio A., D'Offizi G., Pirisi M., Suarez Garcia E., Pascasio Acevedo J.M., Andrade R., Gea F., Serra Desfilis M.A., Molina Perez E., Manzano Alonso M., Carrion J.A., Aoufi Rabih S., Planas M.M., Ryder S., Agarwal K., Ustianowski A., Aspinall R., Kennedy P., Geretti A.M., McCorry R., Foxton M., Healy B., Lampertico, P, Berg, T, Buti, M, Pathil, A, Petersen, J, Ryder, S, Zoulim, F, Botros, I, Flaherty, J, Jump, B, Op den Brouw, M, van Troostenburg, A, Ramroth, H, Bourliere, M, De Ledinghen, V, Riachi, G, Loustaud-Ratti, V, Tran, A, Larrey, D, Dumortier, J, Leroy, V, Metivier, S, Sellier, P, Mauss, S, Peterson, J, Schiefke, I, Niederau, C, Teuber, G, Goeser, T, Jung, M, Grambihler, A, Pathil-Warth, A, Sprinzl, K, Von der Ohe, M, Antoni, C, Weigand, K, Andreone, P, Di Marco, V, Madonia, S, Puoti, M, Santantonio, T, Vigano, M, Ciancio, A, D'Offizi, G, Pirisi, M, Suarez Garcia, E, Pascasio Acevedo, J, Andrade, R, Gea, F, Serra Desfilis, M, Molina Perez, E, Manzano Alonso, M, Carrion, J, Aoufi Rabih, S, Planas, M, Agarwal, K, Ustianowski, A, Aspinall, R, Kennedy, P, Geretti, A, Mccorry, R, Foxton, M, and Healy, B

Subjects
Male, Adult, medicine.medical_specialty, Guanine, Tenofovir, MEDLINE, Antiviral Agents, Virus, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Hepatitis B, Chronic, Retrospective Studie, Internal medicine, 80 and over, HBV, Medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Renal Insufficiency, Young adult, Aged, Aged, 80 and over, Female, Middle Aged, Retrospective Studies, Treatment Outcome, Chronic, Antiviral Agent, Hepatology, business.industry, Gastroenterology, virus diseases, Retrospective cohort study, Entecavir, Hepatitis B, medicine.disease, Cohort, 030211 gastroenterology & hepatology, business, medicine.drug, Human
Abstract

BackgroundLimited data exist regarding tenofovir disoproxil fumarate (TDF) safety and effectiveness in chronic hepatitis B virus-infected (CHB) patients with renal impairment (RI).AimsTo compare real-world data on renal safety and effectiveness of TDF vs entecavir (ETV) in CHB patients with moderate-to-severe RI.MethodsRetrospective, non-interventional, cohort study analysing medical records for TDF/ETV-treated CHB patients (54 European centres). Included patients experienced moderate-to-severe RI (creatinine clearance 20-60 mL/min [Cockcroft-Gault]) either before TDF/ETV initiation ('before' subgroup [baseline = treatment initiation]) or after TDF/ETV initiation ('after' subgroup [baseline = first RI occurrence]). The primary objective was TDF safety, particularly renal-related adverse events of special interest (AESI). TDF and ETV safety and effectiveness were compared and multivariate analyses were performed using inverse probability treatment weighting.Results'Before' subgroup included 107 TDF- and 91 ETV-treated patients; 'after' subgroup included 212 TDF- and 77 ETV-treated patients. Mean baseline creatinine clearance was higher for TDF- vs ETV-treated patients (both subgroups). Median follow-up was 3.1 years (both treatments). AESI were more frequent with TDF vs ETV ('before': 18.7% vs 8.8%; 'after': 9.9% vs 3.9%); however, differences were not significant by multivariate analysis. Only TDF-treated patients experienced renal tubular dysfunction (6.5% 'before'; 1.9% 'after') as well as renal adverse events leading to treatment discontinuation (8.4% 'before'; 7.1% 'after'). Effectiveness was similar between treatments.ConclusionsOverall safety was similar for TDF vs ETV (both subgroups). Given that renal tubular dysfunction occurred with TDF and not with ETV, renal safety concerns may be greater with TDF in CHB patients with RI.

Published
2020

11. Therapy and prophylaxis of opportunistic infections in HIV-infected patients: a guideline by the German and Austrian AIDS societies (DAIG/ÖAG) (AWMF 055/066)

Author

Thoden, J., Potthoff, A., Bogner, J. R., Brockmeyer, N. H., Esser, S., Grabmeier-Pfistershammer, K., Haas, B., Hahn, K., Härter, G., Hartmann, M., Herzmann, C., Hutterer, J., Jordan, A. R., Lange, C., Mauss, S., Meyer-Olson, D., Mosthaf, F., Oette, M., Reuter, S., Rieger, A., Rosenkranz, T., Ruhnke, M., Schaaf, B., Schwarze, S., Stellbrink, H. J., Stocker, H., Stoehr, A., Stoll, M., Träder, C., Vogel, M., Wagner, D., Wyen, C., and Hoffmann, C.

Published
2013
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13. How do generic quotas work? An analysis using HIV infection as an example

Author

Rüsenberg, R, Baumgarten, A, Mauss, S, Gradl, G, Schulz, M, Bartmeyer, B, Kollan, C, and Schmidt, D

Subjects
Berlin, Germany, Drugs, Generic, Humans, HIV Infections, Biosimilar Pharmaceuticals, Drug Prescriptions, Environmental & Occupational Health
Abstract

BACKGROUND: Instruments controlling statutory healthcare medical supply have long been a topic of debate in health policy reform discussions. Over the years, a variety of tools have been developed, most of which are aimed at controlling drug expenditure. The instruments controlling regional prescriptions primarily focus on controlling behavioural patterns of the prescribing physicians. Important to note is the increased use of indication-directed quotas, primarily of drug leads and/or generics/biosimilars. These are now also available in the area of the human immunodeficiency virus (HIV), such as the generic quotas for HIV medications introduced in Bavaria and Berlin in 2020. OBJECTIVE: The aim of this article is to analyse the benefits and limitations of generic quota solutions in HIV care using statutory health insurance drug prescription data and to outline recommendations for action. RESULTS: It was observed that the quota potential for generics in the area of patent-free drugs in HIV care has already been largely exhausted. This can be explained by HIV prescribers supporting product exchange on the prescription. DISCUSSION: The best-case scenario in terms of regulation has almost been reached. This is due to a suitable set of instruments, including the framework agreement for medical supply as well as prescribing according to guidelines - in conjunction with the Pharmaceuticals Market Reorganisation Act (AMNOG) and reference prices for drugs. Conforming with guidelines and (existing) single-tablet regimens play an integral role in maintaining good quality of care.

Published
2021

14. Strategies to manage hepatitis C virus (HCV) disease burden

Author

Wedemeyer, H., Duberg, A. S., Buti, M., Rosenberg, W. M., Frankova, S., Esmat, G., Örmeci, N., Van Vlierberghe, H., Gschwantler, M., Akarca, U., Aleman, S., Balk, İ., Berg, T., Bihl, F., Bilodeau, M., Blasco, A. J., Brandão Mello, C. E., Bruggmann, P., Calinas, F., Calleja, J. L., Cheinquer, H., Christensen, P. B., Clausen, M., Coelho, H. S. M., Cornberg, M., Cramp, M. E., Dore, G. J., Doss, W., El-Sayed, M. H., Ergör, G., Estes, C., Falconer, K., Félix, J., Ferraz, M. L. G., Ferreira, P. R., García-Samaniego, J., Gerstoft, J., Giria, J. A., Gonçales, F. L., Jr, Guimarães Pessôa, M., Hézode, C., Hindman, S. J., Hofer, H., Husa, P., Idilman, R., Kåberg, M., Kaita, K. D. E., Kautz, A., Kaymakoglu, S., Krajden, M., Krarup, H., Laleman, W., Lavanchy, D., Lázaro, P., Marinho, R. T., Marotta, P., Mauss, S., Mendes Correa, M. C., Moreno, C., Müllhaupt, B., Myers, R. P., Nemecek, V., vrehus, A. L. H., Parkes, J., Peltekian, K. M., Ramji, A., Razavi, H., Reis, N., Roberts, S. K., Roudot-Thoraval, F., Ryder, S. D., Sarmento-Castro, R., Sarrazin, C., Semela, D., Sherman, M., Shiha, G. E., Sperl, J., Stärkel, P., Stauber, R. E., Thompson, A. J., Urbanek, P., Van Damme, P., van Thiel, I., Vandijck, D., Vogel, W., Waked, I., Weis, N., Wiegand, J., Yosry, A., Zekry, A., Negro, F., Sievert, W., and Gower, E.

Published
2014
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15. The present and future disease burden of hepatitis C virus (HCV) infection with todayʼs treatment paradigm

Author

Razavi, H., Waked, I., Sarrazin, C., Myers, R. P., Idilman, R., Calinas, F., Vogel, W., Mendes Correa, M. C., Hézode, C., Lázaro, P., Akarca, U., Aleman, S., Balk, İ., Berg, T., Bihl, F., Bilodeau, M., Blasco, A. J., Brandão Mello, C. E., Bruggmann, P., Buti, M., Calleja, J. L., Cheinquer, H., Christensen, P. B., Clausen, M., Coelho, H. S. M., Cramp, M. E., Dore, G. J., Doss, W., Duberg, A. S., El-Sayed, M. H., Ergör, G., Esmat, G., Falconer, K., Félix, J., Ferraz, M. L. G., Ferreira, P. R., Frankova, S., García-Samaniego, J., Gerstoft, J., Giria, J. A., Gonçales, F. L., Jr, Gower, E., Gschwantler, M., Guimarães Pessôa, M., Hindman, S. J., Hofer, H., Husa, P., Kåberg, M., Kaita, K. D. E., Kautz, A., Kaymakoglu, S., Krajden, M., Krarup, H., Laleman, W., Lavanchy, D., Marinho, R. T., Marotta, P., Mauss, S., Moreno, C., Murphy, K., Negro, F., Nemecek, V., Örmeci, N., vrehus, A. L. H., Parkes, J., Pasini, K., Peltekian, K. M., Ramji, A., Reis, N., Roberts, S. K., Rosenberg, W. M., Roudot-Thoraval, F., Ryder, S. D., Sarmento-Castro, R., Semela, D., Sherman, M., Shiha, G. E., Sievert, W., Sperl, J., Stärkel, P., Stauber, R. E., Thompson, A. J., Urbanek, P., Van Damme, P., van Thiel, I., Van Vlierberghe, H., Vandijck, D., Wedemeyer, H., Weis, N., Wiegand, J., Yosry, A., Zekry, A., Cornberg, M., Müllhaupt, B., and Estes, C.

Published
2014
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16. Historical epidemiology of hepatitis C virus (HCV) in selected countries

Author

Bruggmann, P., Berg, T., vrehus, A. L. H., Moreno, C., Brandão Mello, C. E., Roudot-Thoraval, F., Marinho, R. T., Sherman, M., Ryder, S. D., Sperl, J., Akarca, U., Balk, İ., Bihl, F., Bilodeau, M., Blasco, A. J., Buti, M., Calinas, F., Calleja, J. L., Cheinquer, H., Christensen, P. B., Clausen, M., Coelho, H. S. M., Cornberg, M., Cramp, M. E., Dore, G. J., Doss, W., Duberg, A. S., El-Sayed, M. H., Ergör, G., Esmat, G., Estes, C., Falconer, K., Félix, J., Ferraz, M. L. G., Ferreira, P. R., Frankova, S., García-Samaniego, J., Gerstoft, J., Giria, J. A., Gonçales, F. L., Jr, Gower, E., Gschwantler, M., Guimarães Pessôa, M., Hézode, C., Hofer, H., Husa, P., Idilman, R., Kåberg, M., Kaita, K. D. E., Kautz, A., Kaymakoglu, S., Krajden, M., Krarup, H., Laleman, W., Lavanchy, D., Lázaro, P., Marotta, P., Mauss, S., Mendes Correa, M. C., Müllhaupt, B., Myers, R. P., Negro, F., Nemecek, V., Örmeci, N., Parkes, J., Peltekian, K. M., Ramji, A., Razavi, H., Reis, N., Roberts, S. K., Rosenberg, W. M., Sarmento-Castro, R., Sarrazin, C., Semela, D., Shiha, G. E., Sievert, W., Stärkel, P., Stauber, R. E., Thompson, A. J., Urbanek, P., van Thiel, I., Van Vlierberghe, H., Vandijck, D., Vogel, W., Waked, I., Wedemeyer, H., Weis, N., Wiegand, J., Yosry, A., Zekry, A., Van Damme, P., Aleman, S., and Hindman, S. J.

Published
2014
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23. Barrieren der Hepatitis-C-Virus (HCV) Elimination in Deutschland: warum erhalten diagnostizierte Patienten keine Therapie?

Author

Buggisch, P, additional, Heiken, H, additional, Mauss, S, additional, Weber, B, additional, Jung, MC, additional, Görne, H, additional, Heyne, R, additional, Hinrichsen, H, additional, Hidde, D, additional, König, B, additional, Pires dos Santos, AG, additional, Niederau, C, additional, Wedemeyer, H, additional, and Berg, T, additional

Published
2020
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24. Evolution of hepatitis C virus genotype 1a vs. 1b distribution reflects profound changes of HCV epidemiology in Germany between 2004 and 2018 - Analysis of 17,093 patients from five consecutive registries including the German Hepatitis C-Registry (DHC-R)

Author

KG, Simon, additional, Serfert, Y, additional, Buggisch, P, additional, Mauss, S, additional, KH, Böker, additional, Klinker, H, additional, Müller, T, additional, Merle, U, additional, Hüppe, D, additional, MP, Manns, additional, Wedemeyer, H, additional, and Hepatitis C-Register, D, additional

Published
2020
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25. Highlights of the 2017 European AIDS Clinical Society (EACS) Guidelines for the treatment of adult HIV-positive persons version 9.0

Author

Ryom, L, Boesecke, C, Bracchi, M, Ambrosioni, J, Pozniak, A, Arribas, J, Behrens, G, Mallon, P, Puoti, M, Rauch, A, Miro, J, Kirk, O, Marzolini, C, Lundgren, J, Battegay, M, d'Arminio Monforte, A, Clumeck, N, Dedes, N, Gatell, J, Horban, A, Katlama, C, Mccormack, S, Molina, J, Mussini, C, Raffi, F, Reiss, P, Stellbrink, H, Bower, M, Cinque, P, Collins, S, Compston, J, De Wit, S, Fabbri, L, Fux, C, Guaraldi, G, Martinez, E, Papapoulos, S, du Pasquier, R, Poulter, N, Williams, I, Winston, A, Berenguer, J, Bhagani, S, Bruno, R, Konov, S, Lacombe, K, Mauss, S, Mendao, L, Peters, L, Rockstroh, J, Fatkenheuer, G, Furrer, H, Mocroft, A, Morlat, P, Volny-Anne, A, Ryom L., Boesecke C., Bracchi M., Ambrosioni J., Pozniak A., Arribas J., Behrens G., Mallon P. G. M., Puoti M., Rauch A., Miro J. M., Kirk O., Marzolini C., Lundgren J. D., Battegay M., d'Arminio Monforte A., Clumeck N., Dedes N., Gatell J. M., Horban A., Katlama C., McCormack S., Molina J. -M., Mussini C., Raffi F., Reiss P., Stellbrink H. -J., Bower M., Cinque P., Collins S., Compston J., De Wit S., Fabbri L. M., Fux C. A., Guaraldi G., Martinez E., Papapoulos S., du Pasquier R., Poulter N., Williams I., Winston A., Berenguer J., Bhagani S., Bruno R., Konov S., Lacombe K., Mauss S., Mendao L., Peters L., Rockstroh J. K., Fatkenheuer G., Furrer H., Mocroft A., Morlat P., Volny-Anne A., Ryom, L, Boesecke, C, Bracchi, M, Ambrosioni, J, Pozniak, A, Arribas, J, Behrens, G, Mallon, P, Puoti, M, Rauch, A, Miro, J, Kirk, O, Marzolini, C, Lundgren, J, Battegay, M, d'Arminio Monforte, A, Clumeck, N, Dedes, N, Gatell, J, Horban, A, Katlama, C, Mccormack, S, Molina, J, Mussini, C, Raffi, F, Reiss, P, Stellbrink, H, Bower, M, Cinque, P, Collins, S, Compston, J, De Wit, S, Fabbri, L, Fux, C, Guaraldi, G, Martinez, E, Papapoulos, S, du Pasquier, R, Poulter, N, Williams, I, Winston, A, Berenguer, J, Bhagani, S, Bruno, R, Konov, S, Lacombe, K, Mauss, S, Mendao, L, Peters, L, Rockstroh, J, Fatkenheuer, G, Furrer, H, Mocroft, A, Morlat, P, Volny-Anne, A, Ryom L., Boesecke C., Bracchi M., Ambrosioni J., Pozniak A., Arribas J., Behrens G., Mallon P. G. M., Puoti M., Rauch A., Miro J. M., Kirk O., Marzolini C., Lundgren J. D., Battegay M., d'Arminio Monforte A., Clumeck N., Dedes N., Gatell J. M., Horban A., Katlama C., McCormack S., Molina J. -M., Mussini C., Raffi F., Reiss P., Stellbrink H. -J., Bower M., Cinque P., Collins S., Compston J., De Wit S., Fabbri L. M., Fux C. A., Guaraldi G., Martinez E., Papapoulos S., du Pasquier R., Poulter N., Williams I., Winston A., Berenguer J., Bhagani S., Bruno R., Konov S., Lacombe K., Mauss S., Mendao L., Peters L., Rockstroh J. K., Fatkenheuer G., Furrer H., Mocroft A., Morlat P., and Volny-Anne A.

Abstract

Background: The European AIDS Clinical Society (EACS) Guidelines have since 2005 provided multidisciplinary recommendations for the care of HIV-positive persons in geographically diverse areas. Guideline highlights: Major revisions have been made in all sections of the 2017 Guidelines: antiretroviral treatment (ART), comorbidities, coinfections and opportunistic diseases. Newly added are also a summary of the main changes made, and direct video links to the EACS online course on HIV Management. Recommendations on the clinical situations in which tenofovir alafenamide may be considered over tenofovir disoproxil fumarate are provided, and recommendations on which antiretrovirals can be used safely during pregnancy have been revised. Renal and bone toxicity and hepatitis C virus (HCV) treatment have been added as potential reasons for ART switches in fully virologically suppressed individuals, and dolutegravir/rilpivirine has been included as a treatment option. In contrast, dolutegravir monotherapy is not recommended. New recommendations on non-alcoholic fatty liver disease, chronic lung disease, solid organ transplantation, and prescribing in elderly are included, and human papilloma virus (HPV) vaccination recommendations have been expanded. All drug–drug interaction tables have been updated and new tables are included. Treatment options for direct-acting antivirals (DAAs) have been updated and include the latest combinations of sofosbuvir/velpatasvir/voxilaprevir and glecaprevir/pibrentasvir. Recommendations on management of DAA failure and acute HCV infection have been expanded. For treatment of tuberculosis (TB), it is underlined that intermittent treatment is contraindicated, and for resistant TB new data suggest that using a three-drug combination may be as effective as a five-drug regimen, and may reduce treatment duration from 18-24 to 6-10 months. Conclusions: Version 9.0 of the EACS Guidelines provides a holistic approach to HIV care and is translated

Published
2018

31. Diagnostic accuracy of noninvasive markers of steatosis, NASH, and liver fibrosis in HIV-monoinfected individuals at risk of Nonalcoholic Fatty Liver Disease (NAFLD): Results from the ECHAM study

Author

Lemoine, M, Assoumou, L, De Wit, S, Girard, P-M, Valantin, MA, Katlama, C, Necsoi, C, Campa, P, Huefner, AD, Schulze Zur Wiesch, J, Rougier, H, Bastard, J-P, Stocker, H, Mauss, S, Serfaty, L, Ratziu, V, Menu, Y, Schlue, J, Behrens, G, Bedossa, P, Capeau, J, Ingiliz, P, Costagliola, D, and ANRS-ECHAM Group

Subjects
Liver Cirrhosis, Male, medicine.medical_specialty, Liver fibrosis, ANRS-ECHAM Group, Population, Diagnostic accuracy, HIV Infections, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Adipokines, Belgium, Fibrosis, Non-alcoholic Fatty Liver Disease, Internal medicine, Germany, Virology, Nonalcoholic fatty liver disease, Medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Prospective Studies, Prospective cohort study, education, Aged, Ultrasonography, 2. Zero hunger, education.field_of_study, medicine.diagnostic_test, business.industry, 1103 Clinical Sciences, Middle Aged, medicine.disease, Magnetic Resonance Imaging, 3. Good health, Infectious Diseases, Anti-Retroviral Agents, Liver biopsy, Elasticity Imaging Techniques, 030211 gastroenterology & hepatology, Female, France, Steatosis, business
Abstract

BACKGROUND: HIV-monoinfected individuals are at high risk of nonalcoholic fatty liver disease. Noninvasive tests of steatosis, nonalcoholic steatohepatitis (NASH), and fibrosis have been poorly assessed in this population. Using liver biopsy (LB) as a reference, we assessed the accuracy of noninvasive methods for their respective diagnosis: magnetic resonance imaging proton-density-fat-fraction (MRI-PDFF), FibroScan/controlled attenuation parameter (CAP), and biochemical tests. METHODS: We enrolled antiretroviral therapy-controlled participants with persistently elevated transaminases and/or metabolic syndrome, and/or lipodystrophy. All had hepatic MRI-PDFF, FibroScan/CAP, FibroTest/NashTest/SteatoTest, APRI, FIB-4, and nonalcoholic fatty liver disease-fibrosis score. A LB was indicated if suspected significant fibrosis (FibroScan ≥7.1 kPa and/or FibroTest ≥0.49). Performance was considered as good if area under a receiver operating characteristic curves (AUROCs) was >0.80. RESULTS: Among the 140 patients with suspected significant fibrosis out of the 402 eligible patients, 49 had had a LB: median age of 54 years (53-65), body mass index: 26 kg/m (24-30), steatosis in 37 (76%), NASH in 23 (47%), and fibrosis in 31 (63%) patients [F2: 7 (14%); F3: 6 (12%); and F4: 2 (4%)]. Regarding steatosis, MRI-PDFF had excellent and CAP good performances with AUROCs at 0.98 (95% confidence interval: 0.96 to 1.00) and 0.88 (0.76 to 0.99), respectively, whereas the AUROCs of SteatoTest was 0.68 (0.51 to 0.85). Regarding fibrosis (≥F2), APRI and FIB-4 had good performance with AUROCs at 0.86 (0.74 to 0.98) and 0.81 (0.67 to 0.95). By contrast, FibroScan and FibroTest had poor AUROCs [0.61 (0.43 to 0.79) and 0.61 (0.44 to 0.78)], with very low specificity. Regarding NASH, alanine aminotransferase ≥36 IU/L had good performance with AUROCs of 0.83 (0.71 to 0.94), whereas the NashTest had an AUROC of 0.60 (0.44 to 0.76). CONCLUSIONS: In HIV-monoinfected patients, MRI-PDFF and FibroScan/CAP are highly accurate for the diagnosis of steatosis. The alanine aminotransferase level and APRI should be considered for the detection of NASH and fibrosis.

Published
2019

33. Simplified monitoring for hepatitis C virus treatment with glecaprevir plus pibrentasvir, a randomised non-inferiority trial

Author

Dore, GJ, Feld, JJ, Thompson, A, Martinello, M, Muir, AJ, Agarwal, K, Mullhaupt, B, Wedemeyer, H, Lacombe, K, Matthews, GV, Schultz, M, Klein, M, Hezode, C, Mercade, GE, Kho, D, Petoumenos, K, Marks, P, Tatsch, F, Dos Santos, AGP, Gane, E, Trinh, R, Erratt, A, Quiene, S, Shaw, I, Filep, E, Roberts, S, Foster, G, Curry, M, Warlow, J, Mauss, S, Stedman, C, Vachon, M-L, Christensen, S, Muir, A, Baker, D, Ramji, A, Cornberg, M, Bloch, M, Bourliere, M, Semmo, N, Cannon, M, Tam, E, Jacobson, I, Shaw, D, Levin, J, Tsoi, K, Cooke, G, Matthews, G, Feld, J, Borgia, SM, Baumgarten, A, Dore, GJ, Feld, JJ, Thompson, A, Martinello, M, Muir, AJ, Agarwal, K, Mullhaupt, B, Wedemeyer, H, Lacombe, K, Matthews, GV, Schultz, M, Klein, M, Hezode, C, Mercade, GE, Kho, D, Petoumenos, K, Marks, P, Tatsch, F, Dos Santos, AGP, Gane, E, Trinh, R, Erratt, A, Quiene, S, Shaw, I, Filep, E, Roberts, S, Foster, G, Curry, M, Warlow, J, Mauss, S, Stedman, C, Vachon, M-L, Christensen, S, Muir, A, Baker, D, Ramji, A, Cornberg, M, Bloch, M, Bourliere, M, Semmo, N, Cannon, M, Tam, E, Jacobson, I, Shaw, D, Levin, J, Tsoi, K, Cooke, G, Matthews, G, Feld, J, Borgia, SM, and Baumgarten, A

Abstract

BACKGROUND & AIMS: Direct-acting antiviral (DAA) therapy for HCV has high efficacy and limited toxicity. We hypothesised that the efficacy of glecaprevir-pibrentasvir for chronic HCV with a simplified treatment monitoring schedule would be non-inferior to a standard treatment monitoring schedule. METHODS: In this open-label multicentre phase IIIb trial, treatment-naïve adults with chronic HCV without cirrhosis were randomly assigned (2:1) to receive glecaprevir-pibrentasvir 300 mg-120 mg daily for 8 weeks administered with a simplified or standard monitoring strategy. Clinic visits occurred at baseline and post-treatment week 12 in the simplified arm, and at baseline, week 4, week 8, and post-treatment week 12 in the standard arm. Study nurse phone contact occurred at week 4 and week 8 in both arms. Participants requiring adherence support were not eligible, including those reporting recent injecting drug use. The primary endpoint was sustained virological response at post-treatment week 12 (SVR12), with a non-inferiority margin of 6%. RESULTS: Overall, 380 participants (60% male, 47% genotype 1, 32% genotype 3) with chronic HCV were randomised and treated with glecaprevir-pibrentasvir in the simplified (n = 253) and standard (n = 127) arms. In the intention-to-treat population, SVR12 was 92% (95% CI 89%-95%) in the simplified and 95% (95% CI 92%-99%) in the standard arm (difference between arms -3.2%; 95% CI -8.2% to 1.8%) and did not reach non-inferiority. In the per-protocol population, SVR12 was 97% (95% CI 96%-99%) in the simplified and 98% (95% CI 96%-100%) in the standard arm. No treatment-related serious adverse events were reported. CONCLUSIONS: In patients with chronic HCV infection without cirrhosis, treatment with glecaprevir-pibrentasvir was safe and effective. In comparison to standard monitoring, a simplified monitoring schedule did not achieve non-inferiority. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT03117569. LAY SUMMARY: Direct-acting

Published
2020

38. Highlights of the 2017 European AIDS Clinical Society (EACS) Guidelines for the treatment of adult HIV-positive persons version 9.0

Author

Ryom L., Boesecke C., Bracchi M., Ambrosioni J., Pozniak A., Arribas J., Behrens G., Mallon P. G. M., Puoti M., Rauch A., Miro J. M., Kirk O., Marzolini C., Lundgren J. D., Battegay M., d'Arminio Monforte A., Clumeck N., Dedes N., Gatell J. M., Horban A., Katlama C., McCormack S., Molina J. -M., Mussini C., Raffi F., Reiss P., Stellbrink H. -J., Bower M., Cinque P., Collins S., Compston J., De Wit S., Fabbri L. M., Fux C. A., Guaraldi G., Martinez E., Papapoulos S., du Pasquier R., Poulter N., Williams I., Winston A., Berenguer J., Bhagani S., Bruno R., Konov S., Lacombe K., Mauss S., Mendao L., Peters L., Rockstroh J. K., Fatkenheuer G., Furrer H., Mocroft A., Morlat P., Volny-Anne A., Ryom, L, Boesecke, C, Bracchi, M, Ambrosioni, J, Pozniak, A, Arribas, J, Behrens, G, Mallon, P, Puoti, M, Rauch, A, Miro, J, Kirk, O, Marzolini, C, Lundgren, J, Battegay, M, d'Arminio Monforte, A, Clumeck, N, Dedes, N, Gatell, J, Horban, A, Katlama, C, Mccormack, S, Molina, J, Mussini, C, Raffi, F, Reiss, P, Stellbrink, H, Bower, M, Cinque, P, Collins, S, Compston, J, De Wit, S, Fabbri, L, Fux, C, Guaraldi, G, Martinez, E, Papapoulos, S, du Pasquier, R, Poulter, N, Williams, I, Winston, A, Berenguer, J, Bhagani, S, Bruno, R, Konov, S, Lacombe, K, Mauss, S, Mendao, L, Peters, L, Rockstroh, J, Fatkenheuer, G, Furrer, H, Mocroft, A, Morlat, P, Volny-Anne, A, AII - Infectious diseases, APH - Aging & Later Life, Infectious diseases, Global Health, and AII - Amsterdam institute for Infection and Immunity

Subjects
0301 basic medicine, antiretroviral treatment, Male, Sofosbuvir, HIV Infections, chemistry.chemical_compound, 0302 clinical medicine, Pregnancy, Antiretroviral Therapy, Highly Active, HBV, Pharmacology (medical), Drug Interactions, 030212 general & internal medicine, Pregnancy Complications, Infectious, 610 Medicine & health, Coinfection, Health Policy, EACS Governing Board, Pibrentasvir, Europe, Infectious Diseases, coinfections, Anti-Retroviral Agents, Dolutegravir, HCV, Practice Guidelines as Topic, Female, ART, European AIDS Clinical Society (EACS) Guideline, medicine.drug, Adult, Societies, Scientific, medicine.medical_specialty, comorbiditie, comorbidities, European AIDS Clinical Society guidelines, HIV, opportunistic diseases, AIDS-Related Opportunistic Infections, Humans, Voxilaprevir, 030106 microbiology, Tenofovir alafenamide, 03 medical and health sciences, Acquired immunodeficiency syndrome (AIDS), Virology, medicine, opportunistic disease, Intensive care medicine, business.industry, 1103 Clinical Sciences, Glecaprevir, medicine.disease, Transplantation, European AIDS Clinical Society guideline, chemistry, business, human activities
Abstract

BACKGROUND The European AIDS Clinical Society (EACS) Guidelines have since 2005 provided multidisciplinary recommendations for the care of HIV-positive persons in geographically diverse areas. GUIDELINE HIGHLIGHTS Major revisions have been made in all sections of the 2017 Guidelines: antiretroviral treatment (ART), comorbidities, coinfections and opportunistic diseases. Newly added are also a summary of the main changes made, and direct video links to the EACS online course on HIV Management. Recommendations on the clinical situations in which tenofovir alafenamide may be considered over tenofovir disoproxil fumarate are provided, and recommendations on which antiretrovirals can be used safely during pregnancy have been revised. Renal and bone toxicity and hepatitis C virus (HCV) treatment have been added as potential reasons for ART switches in fully virologically suppressed individuals, and dolutegravir/rilpivirine has been included as a treatment option. In contrast, dolutegravir monotherapy is not recommended. New recommendations on non-alcoholic fatty liver disease, chronic lung disease, solid organ transplantation, and prescribing in elderly are included, and human papilloma virus (HPV) vaccination recommendations have been expanded. All drug-drug interaction tables have been updated and new tables are included. Treatment options for direct-acting antivirals (DAAs) have been updated and include the latest combinations of sofosbuvir/velpatasvir/voxilaprevir and glecaprevir/pibrentasvir. Recommendations on management of DAA failure and acute HCV infection have been expanded. For treatment of tuberculosis (TB), it is underlined that intermittent treatment is contraindicated, and for resistant TB new data suggest that using a three-drug combination may be as effective as a five-drug regimen, and may reduce treatment duration from 18-24 to 6-10 months. CONCLUSIONS Version 9.0 of the EACS Guidelines provides a holistic approach to HIV care and is translated into the six most commonly spoken languages.

Published
2018
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41. Baseline risk factors determine lack of biochemical response after SVR in chronic hepatitis C treated with DAAs – Results from the German Hepatitis C-Registry (DHC-R)

Author

Mauss, S, additional, Böker, KH, additional, Klinker, H, additional, Heyne, R, additional, Buggisch, P, additional, Pathil, A, additional, Wiegand, J, additional, Cornberg, M, additional, Lange, C, additional, Berg, T, additional, Zeuzem, S, additional, Tacke, F, additional, and Hepatitis CRegister, D, additional

Published
2019
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42. Persistenz von HCV Resistenz-assoziierten Substitutionen in NS3, NS5A und NS5B nach einem DAA Therapieversagen

Author

Dietz, J, additional, Vermehren, J, additional, Peiffer, KH, additional, Müllhaupt, B, additional, Buggisch, P, additional, Matschenz, K, additional, Schattenberg, J, additional, Antoni, C, additional, Mauss, S, additional, Durmashkina, E, additional, Niederau, C, additional, Discher, T, additional, Trauth, J, additional, Schulze zur Wiesch, J, additional, Piecha, F, additional, Müller, T, additional, Berg, T, additional, Neumann-Haefelin, C, additional, Berg, C, additional, Zeuzem, S, additional, and Sarrazin, C, additional

Published
2019
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44. Der Einfluss des Alanin-Aminotransferase (ALT)-Verlaufs auf die Krankheitsprogression bei Patienten mit chronischer Hepatitis B e Antigen (HBeAg)-negativer Infektion: 4 Jahres-Daten einer prospektiven longitudinalen Studie (ALBATROS Studie)

Author

Knop, V, additional, Vermehren, J, additional, Graf, C, additional, Petersen, J, additional, Buggisch, P, additional, Wedemeyer, H, additional, Cornberg, M, additional, Mauss, S, additional, Sprinzl, M, additional, Berg, T, additional, van Bömmel, F, additional, Klinker, H, additional, Hüppe, D, additional, Bronowicki, JP, additional, Bickel, M, additional, Welzel, T, additional, Vermehren, A, additional, Zeuzem, S, additional, and Sarrazin, C, additional

Published
2019
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45. Serielle Messung der Lebersteifigkeit mittels transienter Elastografie vor und nach Therapie mit direkt wirksamen antiviralen Medikamenten bei Patienten mit chronischer Hepatitis C – Ergebnisse aus dem Deutschen Hepatitis C-Register (DHC-R)

Author

Knop, V, additional, Mauss, S, additional, Goeser, T, additional, Geier, A, additional, Zimmermann, T, additional, Herzer, K, additional, Postel, N, additional, Friedrich-Rust, M, additional, Hofmann, WP, additional, and Hepatitis CRegister, D, additional

Published
2019
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46. Impact of eradicating hepatitis C virus on the work productivity of chronic hepatitis C (CH-C) patients: An economic model from five European countries

Author

Younossi, Z, Brown, A, Buti, M, Fagiuoli, S, Mauss, S, Rosenberg, W, Serfaty, L, Srivastava, A, Smith, N, Stepanova, M, Beckerman, R, Younossi Z., Brown A., Buti M., Fagiuoli S., Mauss S., Rosenberg W., Serfaty L., Srivastava A., Smith N., Stepanova M., Beckerman R., Younossi, Z, Brown, A, Buti, M, Fagiuoli, S, Mauss, S, Rosenberg, W, Serfaty, L, Srivastava, A, Smith, N, Stepanova, M, Beckerman, R, Younossi Z., Brown A., Buti M., Fagiuoli S., Mauss S., Rosenberg W., Serfaty L., Srivastava A., Smith N., Stepanova M., and Beckerman R.

Abstract

CH-C negatively affects work productivity (WP), creating a large economic burden. The aim of this study was to model the impact of sustained virologic response (SVR) on WP in CHC genotype 1 (GT1) patients in five European countries (EU5). Work Productivity and Activity Index-Specific Health Problem questionnaire was administered to patients across the ION clinical trials (n = 629 European patients). The analysis modelled a population of GT1 CHC patients over one year, who had been either not treated or treated with LDV/SOF. Sensitivity analyses assessed the possibility that CHC patients' labour costs were lower than the general population's and presented results by fibrosis stage. Before initiation of treatment, EU patients with CHC GT1 exhibited absenteeism and presenteeism impairments of 3.54% and 9.12%, respectively. About 91.8% of EU patients in the ION trials achieved SVR and improved absenteeism and presenteeism impairments by 16.3% and 19.5%, respectively. Monetizing these data, treatment with LDV/SOF resulted in an annual productivity gain of €435 million and a weighted average per-employed patient (PEP) gain of €900 in the EU5. PEP gains from treatment are projected to be higher in cirrhotic than in noncirrhotic patients. If CHC patients are assumed to earn 20% less than the general population, gains of €348 million (€720 PEP) annually are projected. CHC results in a significant economic burden to European society. Due to improvements in WP, SVR with treatment could provide substantial economic gains, partly offsetting the direct costs related to its widespread use.

Published
2016

47. Essentials from the 2015 European AIDS Clinical Society (EACS) guidelines for the treatment of adult HIV-positive persons

Author

Ryom, L, Boesecke, C, Gisler, V, Manzardo, C, Rockstroh, J, Puoti, M, Furrer, H, Miro, J, Gatell, J, Pozniak, A, Behrens, G, Battegay, M, Lundgren, J, Monforte, A, Arribas, J, Clumeck, N, Dedes, N, Geretti, A, Horban, A, Katlama, C, Mccormack, S, Molina, J, Mussini, C, Raffi, F, Reiss, P, Stellbrink, H, Bower, M, Cinque, P, Collins, S, Compston, J, Deray, G, De Wit, S, Fux, C, Guraldi, G, Mallon, P, Martinez, E, Marzolini, C, Papapoulos, S, du Pasquier, R, Poulter, N, Williams, I, Winston, A, Bhagani, S, Bruno, R, Konov, S, Lacombe, K, Mauss, S, Mendao, L, Peters, L, Rauch, A, Tural, C, Fatkenheuer, G, Kirk, O, Mocroft, A, Morlat, P, Volny-Anne, A, Mulcahy, F, Oprea, C, Youle, M, Ryom L., Boesecke C., Gisler V., Manzardo C., Rockstroh J. K., Puoti M., Furrer H., Miro J. M., Gatell J. M., Pozniak A., Behrens G., Battegay M., Lundgren J. D., Monforte A. D., Arribas J., Clumeck N., Dedes N., Geretti A. M., Horban A., Katlama C., McCormack S., Molina J. M., Mussini C., Raffi F., Reiss P., Stellbrink H. J., Bower M., Cinque P., Collins S., Compston J., Deray G., De Wit S., Fux C. A., Guraldi G., Mallon P., Martinez E., Marzolini C., Papapoulos S., du Pasquier R., Poulter N., Williams I., Winston A., Bhagani S., Bruno R., Konov S., Lacombe K., Mauss S., Mendao L., Peters L., Rauch A., Tural C., Fatkenheuer G., Kirk O., Mocroft A., Morlat P., Volny-Anne A., Mulcahy F., Oprea C., Youle M., Ryom, L, Boesecke, C, Gisler, V, Manzardo, C, Rockstroh, J, Puoti, M, Furrer, H, Miro, J, Gatell, J, Pozniak, A, Behrens, G, Battegay, M, Lundgren, J, Monforte, A, Arribas, J, Clumeck, N, Dedes, N, Geretti, A, Horban, A, Katlama, C, Mccormack, S, Molina, J, Mussini, C, Raffi, F, Reiss, P, Stellbrink, H, Bower, M, Cinque, P, Collins, S, Compston, J, Deray, G, De Wit, S, Fux, C, Guraldi, G, Mallon, P, Martinez, E, Marzolini, C, Papapoulos, S, du Pasquier, R, Poulter, N, Williams, I, Winston, A, Bhagani, S, Bruno, R, Konov, S, Lacombe, K, Mauss, S, Mendao, L, Peters, L, Rauch, A, Tural, C, Fatkenheuer, G, Kirk, O, Mocroft, A, Morlat, P, Volny-Anne, A, Mulcahy, F, Oprea, C, Youle, M, Ryom L., Boesecke C., Gisler V., Manzardo C., Rockstroh J. K., Puoti M., Furrer H., Miro J. M., Gatell J. M., Pozniak A., Behrens G., Battegay M., Lundgren J. D., Monforte A. D., Arribas J., Clumeck N., Dedes N., Geretti A. M., Horban A., Katlama C., McCormack S., Molina J. M., Mussini C., Raffi F., Reiss P., Stellbrink H. J., Bower M., Cinque P., Collins S., Compston J., Deray G., De Wit S., Fux C. A., Guraldi G., Mallon P., Martinez E., Marzolini C., Papapoulos S., du Pasquier R., Poulter N., Williams I., Winston A., Bhagani S., Bruno R., Konov S., Lacombe K., Mauss S., Mendao L., Peters L., Rauch A., Tural C., Fatkenheuer G., Kirk O., Mocroft A., Morlat P., Volny-Anne A., Mulcahy F., Oprea C., and Youle M.

Abstract

Background: The European AIDS Clinical Society (EACS) guidelines are intended for all clinicians involved in the care of HIV-positive persons, and are available in print, online, and as a free App for download for iPhone and Android. Guideline highlights: The 2015 version of the EACS guidelines contains major revisions in all sections; antiretroviral treatment (ART), comorbidities, coinfections and opportunistic diseases. Among the key revisions is the recommendation of ART for all HIV-positive persons, irrespectively of CD4 count, based on the Strategic Timing of AntiRetroviral Treatment (START) study results. The recommendations for the preferred and the alternative ART options have also been revised, and a new section on the use of pre-exposure prophylaxis (PrEP) has been added. A number of new antiretroviral drugs/drug combinations have been added to the updated tables on drug-drug interactions, adverse drug effects, dose adjustment for renal/liver insufficiency and for ART administration in persons with swallowing difficulties. The revisions of the coinfection section reflect the major advances in anti-hepatitis C virus (HCV) treatment with direct-acting antivirals with earlier start of treatment in individuals at increased risk of liver disease progression, and a phasing out of interferon-containing treatment regimens. The section on opportunistic diseases has been restructured according to individual pathogens/diseases and a new overview table has been added on CD4 count thresholds for different primary prophylaxes. Conclusions: The diagnosis and management of HIV infection and related coinfections, opportunistic diseases and comorbidities continue to require a multidisciplinary effort for which the 2015 version of the EACS guidelines provides an easily accessable and updated overview.

Published
2016

50. Global prevalence, treatment, and prevention of hepatitis B virus infection in 2016: a modelling study

Author

Razavi-Shearer, D. Gamkrelidze, I. Nguyen, M.H. Chen, D.-S. Van Damme, P. Abbas, Z. Abdulla, M. Abou Rached, A. Adda, D. Aho, I. Akarca, U. Al Ali, F.H. Lawati, F.A.L. Naamani, K.A.L. Alashgar, H.I. Alavian, S.M. Alawadhi, S. Albillos, A. Al-Busafi, S.A. Aleman, S. Alfaleh, F.Z. Aljumah, A.A. Anand, A.C. Anh, N.T. Arends, J.E. Arkkila, P. Athanasakis, K. Bane, A. Ben-Ari, Z. Berg, T. Bizri, A.R. Blach, S. Brandão Mello, C.E. Brandon, S.M. Bright, B. Bruggmann, P. Brunetto, M. Buti, M. Chan, H.L.Y. Chaudhry, A. Chien, R.-N. Choi, M.S. Christensen, P.B. Chuang, W.-L. Chulanov, V. Clausen, M.R. Colombo, M. Cornberg, M. Cowie, B. Craxi, A. Croes, E.A. Cuellar, D.A. Cunningham, C. Desalegn, H. Drazilova, S. Duberg, A.-S. Egeonu, S.S. El-Sayed, M.H. Estes, C. Falconer, K. Ferraz, M.L.G. Ferreira, P.R. Flisiak, R. Frankova, S. Gaeta, G.B. García-Samaniego, J. Genov, J. Gerstoft, J. Goldis, A. Gountas, I. Gray, R. Guimarães Pessôa, M. Hajarizadeh, B. Hatzakis, A. Hézode, C. Himatt, S.M. Hoepelman, A. Hrstic, I. Hui, Y.-T.T. Husa, P. Jahis, R. Janjua, N.Z. Jarcuška, P. Jaroszewicz, J. Kaymakoglu, S. Kershenobich, D. Kondili, L.A. Konysbekova, A. Krajden, M. Kristian, P. Laleman, W. Lao, W.-C.C. Layden, J. Lazarus, J.V. Lee, M.-H. Liakina, V. Lim, Y.-S.S. Loo, C.-K.K. Lukšic, B. Malekzadeh, R. Malu, A.O. Mamatkulov, A. Manns, M. Marinho, R.T. Maticic, M. Mauss, S. Memon, M.S. Mendes Correa, M.C. Mendez-Sanchez, N. Merat, S. Metwally, A.M. Mohamed, R. Mokhbat, J.E. Moreno, C. Mossong, J. Mourad, F.H. Müllhaupt, B. Murphy, K. Musabaev, E. Nawaz, A. Nde, H.M. Negro, F. Nersesov, A. Nguyen, V.T.T. Njouom, R. Ntagirabiri, R. Nurmatov, Z. Obekpa, S. Ocama, P. Oguche, S. Omede, O. Omuemu, C. Opare-Sem, O. Opio, C.K. Örmeci, N. Papatheodoridis, G. Pasini, K. Pimenov, N. Poustchi, H. Quang, T.D. Qureshi, H. Ramji, A. Razavi-Shearer, K. Redae, B. Reesink, H.W. Rios, C.Y. Rjaskova, G. Robbins, S. Roberts, L.R. Roberts, S.K. Ryder, S.D. Safadi, R. Sagalova, O. Salupere, R. Sanai, F.M. Sanchez-Avila, J.F. Saraswat, V. Sarrazin, C. Schmelzer, J.D. Schréter, I. Scott, J. Seguin-Devaux, C. Shah, S.R. Sharara, A.I. Sharma, M. Shiha, G.E. Shin, T. Sievert, W. Sperl, J. Stärkel, P. Stedman, C. Sypsa, V. Tacke, F. Tan, S.S. Tanaka, J. Tomasiewicz, K. Urbanek, P. van der Meer, A.J. Van Vlierberghe, H. Vella, S. Vince, A. Waheed, Y. Waked, I. Walsh, N. Weis, N. Wong, V.W. Woodring, J. Yaghi, C. Yang, H.-I. Yang, C.-L. Yesmembetov, K. Yosry, A. Yuen, M.-F. Yusuf, M.A.M. Zeuzem, S. Razavi, H. The Polaris Observatory Collaborators

Abstract

Background: The 69th World Health Assembly approved the Global Health Sector Strategy to eliminate viral hepatitis by 2030. Although no virological cure exists for hepatitis B virus (HBV) infection, existing therapies to control viral replication and prophylaxis to minimise mother-to-child transmission make elimination of HBV feasible. We aimed to estimate the national, regional, and global prevalence of HBsAg in the general population and in the population aged 5 years in 2016, as well as coverage of prophylaxis, diagnosis, and treatment. Methods: In this modelling study, we used a Delphi process that included a literature review in PubMed and Embase, followed by interviews with experts, to quantify the historical epidemiology of HBV infection. We then used a dynamic HBV transmission and progression model to estimate the country-level and regional-level prevalence of HBsAg in 2016 and the effect of prophylaxis and treatment on disease burden. Findings: We developed models for 120 countries, 78 of which were populated with data approved by experts. Using these models, we estimated that the global prevalence of HBsAg in 2016 was 3·9% (95% uncertainty interval [UI] 3·4–4·6), corresponding to 291 992 000 (251 513 000–341 114 000) infections. Of these infections, around 29 million (10%) were diagnosed, and only 4·8 million (5%) of 94 million individuals eligible for treatment actually received antiviral therapy. Around 1·8 (1·6–2·2) million infections were in children aged 5 years, with a prevalence of 1·4% (1·2–1·6). We estimated that 87% of infants had received the three-dose HBV vaccination in the first year of life, 46% had received timely birth-dose vaccination, and 13% had received hepatitis B immunoglobulin along with the full vaccination regimen. Less than 1% of mothers with a high viral load had received antiviral therapy to reduce mother-to-child transmission. Interpretation: Our estimate of HBV prevalence in 2016 differs from previous studies, potentially because we took into account the effect of infant prophylaxis and early childhood vaccination, as well as changing prevalence over time. Although some regions are well on their way to meeting prophylaxis and prevalence targets, all regions must substantially scale-up access to diagnosis and treatment to meet the global targets. Funding: John C Martin Foundation. © 2018 Elsevier Ltd

Published
2018

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