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2. Characteristics associated with serological COVID-19 vaccine response and durability in an older population with significant comorbidity: the Danish Nationwide ENFORCE Study

Author

Søgaard, Ole Schmeltz, Reekie, Joanne, Johansen, Isik Somuncu, Nielsen, Henrik, Benfield, Thomas, Wiese, Lothar, Stærke, Nina Breinholt, Iversen, Kasper, Fogh, Kamille, Bodilsen, Jacob, Iversen, Mette, Knudsen, Lene Surland, Klastrup, Vibeke, Larsen, Fredrikke Dam, Andersen, Sidsel Dahl, Hvidt, Astrid Korning, Andreasen, Signe Rode, Madsen, Lone Wulff, Lindvig, Susan Olaf, Øvrehus, Anne, Ostrowski, Sisse Rye, Abildgaard, Christiane, Matthews, Charlotte, Jensen, Tomas O., Raben, Dorthe, Erikstrup, Christian, Fischer, Thea K., Tolstrup, Martin, Østergaard, Lars, and Lundgren, Jens

Published
2022
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3. Global change in hepatitis C virus prevalence and cascade of care between 2015 and 2020: a modelling study

Author

Blach, Sarah, Terrault, Norah A, Tacke, Frank, Gamkrelidze, Ivane, Craxi, Antonio, Tanaka, Junko, Waked, Imam, Dore, Gregory J, Abbas, Zaigham, Abdallah, Ayat R, Abdulla, Maheeba, Aghemo, Alessio, Aho, Inka, Akarca, Ulus S, Alalwan, Abduljaleel M, Alanko Blomé, Marianne, Al-Busafi, Said A, Aleman, Soo, Alghamdi, Abdullah S, Al-Hamoudi, Waleed K, Aljumah, Abdulrahman A, Al-Naamani, Khalid, Al Serkal, Yousif M, Altraif, Ibrahim H, Anand, Anil C, Anderson, Motswedi, Andersson, Monique I, Athanasakis, Kostas, Baatarkhuu, Oidov, Bakieva, Shokhista R, Ben-Ari, Ziv, Bessone, Fernando, Biondi, Mia J, Bizri, Abdul Rahman N, Brandão-Mello, Carlos E, Brigida, Krestina, Brown, Kimberly A, Brown, Jr, Robert S, Bruggmann, Philip, Brunetto, Maurizia R, Busschots, Dana, Buti, Maria, Butsashvili, Maia, Cabezas, Joaquin, Chae, Chungman, Chaloska Ivanova, Viktorija, Chan, Henry Lik Yuen, Cheinquer, Hugo, Cheng, Kent Jason, Cheon, Myeong-Eun, Chien, Cheng-Hung, Chien, Rong-Nan, Choudhuri, Gourdas, Christensen, Peer Brehm, Chuang, Wan-Long, Chulanov, Vladimir, Cisneros, Laura E, Coco, Barbara, Contreras, Fernando A, Cornberg, Markus, Cramp, Matthew E, Crespo, Javier, Cui, Fuqiang, Cunningham, Chris W, Dagher Abou, Lucy, Dalgard, Olav, Dao, Doan Y, De Ledinghen, Victor, Derbala, Moutaz F, Deuba, Keshab, Dhindsa, Karan, Djauzi, Samsuridjal, Drazilova, Sylvia, Duberg, Ann-Sofi, Elbadri, Mohammed, El-Sayed, Manal H, Esmat, Gamal, Estes, Chris, Ezzat, Sameera, Färkkilä, Martti A, Ferradini, Laurent, Ferraz, Maria Lucia G, Ferreira, Paulo R A, Filipec Kanizaj, Tajana, Flisiak, Robert, Frankova, Sona, Fung, James, Gamkrelidze, Amiran, Gane, Edward, Garcia, Virginia, García-Samaniego, Javier, Gemilyan, Manik, Genov, Jordan, Gheorghe, Liliana S, Gholam, Pierre M, Goldis, Adrian, Gottfredsson, Magnus, Gray, Richard T, Grebely, Jason, Gschwantler, Michael, Hajarizadeh, Behzad, Hamid, Saeed S, Hamoudi, Waseem, Hatzakis, Angelos, Hellard, Margaret E, Himatt, Sayed, Hofer, Harald, Hrstic, Irena, Hunyady, Bela, Husa, Petr, Husic-Selimovic, Azra, Jafri, Wasim S M, Janicko, Martin, Janjua, Naveed, Jarcuska, Peter, Jaroszewicz, Jerzy, Jerkeman, Anna, Jeruma, Agita, Jia, Jidong, Jonasson, Jon G, Kåberg, Martin, Kaita, Kelly D E, Kaliaskarova, Kulpash S, Kao, Jia-Horng, Kasymov, Omor T, Kelly-Hanku, Angela, Khamis, Faryal, Khamis, Jawad, Khan, Aamir G, Khandu, Lekey, Khoudri, Ibtissam, Kielland, Knut B, Kim, Do Young, Kodjoh, Nicolas, Kondili, Loreta A, Krajden, Mel, Krarup, Henrik Bygum, Kristian, Pavol, Kwon, Jisoo A, Lagging, Martin, Laleman, Wim, Lao, Wai Cheung, Lavanchy, Daniel, Lázaro, Pablo, Lazarus, Jeffrey V, Lee, Alice U, Lee, Mei-Hsuan, Li, Michael K K, Liakina, Valentina, Lim, Young-Suk, Löve, Arthur, Lukšić, Boris, Machekera, Shepherd Mufudzi, Malu, Abraham O, Marinho, Rui T, Maticic, Mojca, Mekonnen, Hailemichael D, Mendes-Correa, Maria Cássia, Mendez-Sanchez, Nahum, Merat, Shahin, Meshesha, Berhane Redae, Midgard, Håvard, Mills, Mike, Mohamed, Rosmawati, Mooneyhan, Ellen, Moreno, Christophe, Muljono, David H, Müllhaupt, Beat, Musabaev, Erkin, Muyldermans, Gaëtan, Nartey, Yvonne Ayerki, Naveira, Marcelo C M, Negro, Francesco, Nersesov, Alexander V, Njouom, Richard, Ntagirabiri, Rénovat, Nurmatov, Zuridin S, Obekpa, Solomon A, Oguche, Stephen, Olafsson, Sigurdur, Ong, Janus P, Opare-Sem, Ohene K, Orrego, Mauricio, Øvrehus, Anne L, Pan, Calvin Q, Papatheodoridis, George V, Peck-Radosavljevic, Markus, Pessoa, Mário G, Phillips, Richard O, Pimenov, Nikolay, Plaseska-Karanfilska, Dijana, Prabdial-Sing, Nishi N, Puri, Pankaj, Qureshi, Huma, Rahman, Aninda, Ramji, Alnoor, Razavi-Shearer, Devin M, Razavi-Shearer, Kathryn, Ridruejo, Ezequiel, Ríos-Hincapié, Cielo Y, Rizvi, S M Shahriar, Robaeys, Geert K M M, Roberts, Lewis R, Roberts, Stuart K, Ryder, Stephen D, Sadirova, Shakhlo, Saeed, Umar, Safadi, Rifaat, Sagalova, Olga, Said, Sanaa S, Salupere, Riina, Sanai, Faisal M, Sanchez-Avila, Juan F, Saraswat, Vivek A, Sarrazin, Christoph, Sarybayeva, Gulya, Seguin-Devaux, Carole, Sharara, Ala I, Sheikh, Mahdi, Shewaye, Abate B, Sievert, William, Simojoki, Kaarlo, Simonova, Marieta Y, Sonderup, Mark W, Spearman, C Wendy, Sperl, Jan, Stauber, Rudolf E, Stedman, Catherine A M, Su, Tung-Hung, Suleiman, Anita, Sypsa, Vana, Tamayo Antabak, Natalia, Tan, Soek-Siam, Tergast, Tammo L, Thurairajah, Prem H, Tolmane, Ieva, Tomasiewicz, Krzysztof, Tsereteli, Maia, Uzochukwu, Benjamin S C, Van De Vijver, David A M C, Van Santen, Daniela K, Van Vlierberghe, Hans, Van Welzen, Berend, Vanwolleghem, Thomas, Vélez-Möller, Patricia, Villamil, Federico, Vince, Adriana, Waheed, Yasir, Weis, Nina, Wong, Vincent W-S, Yaghi, Cesar G, Yesmembetov, Kakharman, Yosry, Ayman, Yuen, Man-Fung, Yunihastuti, Evy, Zeuzem, Stefan, Zuckerman, Eli, and Razavi, Homie A

Published
2022
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4. Levels of SARS-CoV-2 antibodies among fully vaccinated individuals with Delta or Omicron variant breakthrough infections

Author

Stærke, Nina Breinholt, Reekie, Joanne, Nielsen, Henrik, Benfield, Thomas, Wiese, Lothar, Knudsen, Lene Surland, Iversen, Mette Brouw, Iversen, Kasper, Fogh, Kamille, Bodilsen, Jacob, Juhl, Maria Ruwald, Lindvig, Susan Olaf, Øvrehus, Anne, Madsen, Lone Wulff, Klastrup, Vibeke, Andersen, Sidsel Dahl, Juhl, Anna Karina, Andreasen, Signe Rode, Ostrowski, Sisse Rye, Erikstrup, Christian, Fischer, Thea K., Tolstrup, Martin, Østergaard, Lars, Johansen, Isik Somuncu, Lundgren, Jens, and Søgaard, Ole Schmeltz

Published
2022
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9. Combining cross-sectional survey and register data improved the estimate of hepatitis C prevalence among patients attending a psychiatric emergency department in Denmark

Author

Rose, Thomas Vemmelund, primary, Christensen, Peer Brehm, additional, Hjorth, Peter, additional, Madsen, Lone Wulff, additional, Hansen, Janne Fuglsang, additional, Dröse, Sandra, additional, Harvald, Gustav Bang, additional, Røge, Birgit Thorup, additional, and Øvrehus, Anne Lindebo Holm, additional

Published
2023
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12. Model projections on the impact of HCV treatment in the prevention of HCV transmission among people who inject drugs in Europe

Author

Fraser, Hannah, Martin, Natasha K., Brummer-Korvenkontio, Henrikki, Carrieri, Patrizia, Dalgard, Olav, Dillon, John, Goldberg, David, Hutchinson, Sharon, Jauffret-Roustide, Marie, Kåberg, Martin, Matser, Amy A., Matičič, Mojca, Midgard, Havard, Mravcik, Viktor, Øvrehus, Anne, Prins, Maria, Reimer, Jens, Robaeys, Geert, Schulte, Bernd, van Santen, Daniela K., Zimmermann, Ruth, Vickerman, Peter, and Hickman, Matthew

Published
2018
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13. Hepatitis C virus prevalence and level of intervention required to achieve the WHO targets for elimination in the European Union by 2030: a modelling study

Author

Razavi, Homie, Robbins, Sarah, Zeuzem, Stefan, Negro, Francesco, Buti, Maria, Duberg, Ann-Sofi, Roudot-Thoraval, Françoise, Craxi, Antonio, Manns, Michael, Marinho, Rui T, Hunyady, Bela, Colombo, Massimo, Aleman, Soo, Antonov, Krasimir, Arkkila, Perttu, Athanasakis, Kostas, Blach, Sarah, Blachier, Martin, Blasco, Antonio J, Calinas, Filipe, Calleja, Jose L, Christensen, Peer B, Cramp, Matthew E, Croes, Esther, de Knegt, Robert J, de Ledinghen, Victor, Delile, Jean-Michel, Estes, Chris, Falconer, Karolin, Färkkilä, Martti, Flisiak, Robert, Frankova, Sona, Gamkrelidze, Ivane, García-Samaniego, Javier, Genov, Jordan, Gerstoft, Jan, Gheorghe, Liana, Goldis, Adrian, Gountas, Ilias, Gregorčič, Sergeja, Gschwantler, Michael, Gunter, Jessie, Halota, Waldemar, Harcouet, Laura, Hézode, Christophe, Hoffmann, Patrick, Horvath, Gabor, Hrstic, Irena, Jarčuška, Peter, Jelev, Deian, Jeruma, Agita, Kåberg, Martin, Kieran, Jennifer, Kondili, Loreta A, Kotzev, Iskren, Krarup, Henrik, Kristian, Pavol, Lagging, Martin, Laleman, Wim, Lázaro, Pablo, Liakina, Valentina, Lukšić, Boris, Maimets, Matti, Makara, Mihály, Mateva, Lyudmila, Maticic, Mojca, Mennini, Francesco S, Mitova, Rumiana, Moreno, Christophe, Mossong, Joel, Murphy, Kimberly, Nde, Helen, Nemecek, Vratislav, Nonkovic, Dijana, Norris, Suzanne, Oltman, Marian, Øvrehus, Anne L H, Papatheodoridis, George, Pasini, Ken, Razavi-Shearer, Devin, Razavi-Shearer, Kathryn, Reesink, Henk W, Reic, Tatjana, Rozentale, Baiba, Ryder, Stephen D, Salupere, Riina, Sarmento-Castro, Rui, Sarrazin, Christoph, Schmelzer, Jonathan D, Schréter, Ivan, Seguin-Devaux, Carole, Simojoki, Kaarlo, Simonova, Marietta, Smit, Peter J, Souliotis, Kyriakos, Speiciene, Danute, Sperl, Jan, Stärkel, Peter, Struck, Daniel, Sypsa, Vana, Thornton, Lelia, Tolmane, Ieva, Tomasiewicz, Krzysztof, Valantinas, Jonas, Van Damme, Pierre, van de Vijver, David, van der Meer, Adriaan J, van Santen, Daniela, Van Vlierberghe, Hans, Vandijck, Dominique, Vella, Stefano, Videčnik-Zorman, Jerneja, Vogel, Wolfgang, Weis, Nina, and Hatzakis, Angelos

Published
2017
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14. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study

Author

Blach, Sarah, Zeuzem, Stefan, Manns, Michael, Altraif, Ibrahim, Duberg, Ann-Sofi, Muljono, David H, Waked, Imam, Alavian, Seyed M, Lee, Mei-Hsuan, Negro, Francesco, Abaalkhail, Faisal, Abdou, Ahmed, Abdulla, Maheeba, Rached, Antoine Abou, Aho, Inka, Akarca, Ulus, Al Ghazzawi, Imad, Al Kaabi, Saad, Al Lawati, Faryal, Al Namaani, Khalid, Al Serkal, Youssif, Al-Busafi, Said A, Al-Dabal, Layla, Aleman, Soo, Alghamdi, Abdullah S, Aljumah, Abdulrahman A, Al-Romaihi, Hamad E, Andersson, Monique I, Arendt, Vic, Arkkila, Perttu, Assiri, Abdullah M, Baatarkhuu, Oidov, Bane, Abate, Ben-Ari, Ziv, Bergin, Colm, Bessone, Fernando, Bihl, Florian, Bizri, Abdul R, Blachier, Martin, Blasco, Antonio J, Mello, Carlos E Brandão, Bruggmann, Philip, Brunton, Cheryl R, Calinas, Filipe, Chan, Henry L Y, Chaudhry, Asad, Cheinquer, Hugo, Chen, Chien-Jen, Chien, Rong-Nan, Choi, Moon Seok, Christensen, Peer B, Chuang, Wan-Long, Chulanov, Vladimir, Cisneros, Laura, Clausen, Mette R, Cramp, Matthew E, Craxi, Antonio, Croes, Esther A, Dalgard, Olav, Daruich, Jorge R, de Ledinghen, Victor, Dore, Gregory J, El-Sayed, Manal H, Ergör, Gul, Esmat, Gamal, Estes, Chris, Falconer, Karolin, Farag, Elmoubashar, Ferraz, Maria L G, Ferreira, Paulo R, Flisiak, Robert, Frankova, Sona, Gamkrelidze, Ivane, Gane, Ed, García-Samaniego, Javier, Khan, Amir Ghafoor, Gountas, Ilias, Goldis, Adrian, Gottfredsson, Magnús, Grebely, Jason, Gschwantler, Michael, Pessôa, Mário Guimarães, Gunter, Jessie, Hajarizadeh, Behzad, Hajelssedig, Omer, Hamid, Saeed, Hamoudi, Waseem, Hatzakis, Angelos, Himatt, Sayed M, Hofer, Harald, Hrstic, Irena, Hui, Yee-Tak, Hunyady, Bela, Idilman, Ramazan, Jafri, Wasim, Jahis, Rohani, Janjua, Naveed Z, Jarčuška, Peter, Jeruma, Agita, Jonasson, Jón G, Kamel, Yasser, Kao, Jia-Horng, Kaymakoglu, Sabahattin, Kershenobich, David, Khamis, Jawad, Kim, Young S, Kondili, Loreta, Koutoubi, Zaher, Krajden, Mel, Krarup, Henrik, Lai, Moon-sing, Laleman, Wim, Lao, Wai-cheung, Lavanchy, Daniel, Lázaro, Pablo, Leleu, Henri, Lesi, Olufunmilayo, Lesmana, Laurentius A, Li, Michael, Liakina, Valentina, Lim, Young-Suk, Luksic, Boris, Mahomed, Adam, Maimets, Matti, Makara, Mihály, Malu, Abraham O, Marinho, Rui T, Marotta, Paul, Mauss, Stefan, Memon, Muhammad S, Correa, Maria C Mendes, Mendez-Sanchez, Nahum, Merat, Shahin, Metwally, Ammal M, Mohamed, Rosmawati, Moreno, Christophe, Mourad, Fadi H, Müllhaupt, Beat, Murphy, Kimberly, Nde, Helen, Njouom, Richard, Nonkovic, Diana, Norris, Suzanne, Obekpa, Solomon, Oguche, Stephen, Olafsson, Sigurður, Oltman, Marian, Omede, Ogu, Omuemu, Casimir, Opare-Sem, Ohene, Øvrehus, Anne L H, Owusu-Ofori, Shirley, Oyunsuren, Tsendsuren S, Papatheodoridis, George, Pasini, Ken, Peltekian, Kevork M, Phillips, Richard O, Pimenov, Nikolay, Poustchi, Hossein, Prabdial-Sing, Nishi, Qureshi, Huma, Ramji, Alnoor, Razavi-Shearer, Devin, Razavi-Shearer, Kathryn, Redae, Berhane, Reesink, Henk W, Ridruejo, Ezequiel, Robbins, Sarah, Roberts, Lewis R, Roberts, Stuart K, Rosenberg, William M, Roudot-Thoraval, Françoise, Ryder, Stephen D, Safadi, Rifaat, Sagalova, Olga, Salupere, Riina, Sanai, Faisal M, Avila, Juan F Sanchez, Saraswat, Vivek, Sarmento-Castro, Rui, Sarrazin, Christoph, Schmelzer, Jonathan D, Schréter, Ivan, Seguin-Devaux, Carole, Shah, Samir R, Sharara, Ala I, Sharma, Manik, Shevaldin, Anatoly, Shiha, Gamal E, Sievert, William, Sonderup, Mark, Souliotis, Kyriakos, Speiciene, Danute, Sperl, Jan, Stärkel, Peter, Stauber, Rudolf E, Stedman, Catherine, Struck, Daniel, Su, Tung-Hung, Sypsa, Vana, Tan, Soek-Siam, Tanaka, Junko, Thompson, Alexander J, Tolmane, Ieva, Tomasiewicz, Krzysztof, Valantinas, Jonas, Van Damme, Pierre, van der Meer, Adriaan J, van Thiel, Ingo, Van Vlierberghe, Hans, Vince, Adriana, Vogel, Wolfgang, Wedemeyer, Heiner, Weis, Nina, Wong, Vincent WS, Yaghi, Cesar, Yosry, Ayman, Yuen, Man-fung, Yunihastuti, Evy, Yusuf, Aasim, Zuckerman, Eli, and Razavi, Homie

Published
2017
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15. Combining cross-sectional survey and register data improved the estimate of hepatitis C prevalence among patients attending a psychiatric emergency department in Denmark.

Author

Rose, Thomas Vemmelund, Christensen, Peer Brehm, Hjorth, Peter, Madsen, Lone Wulff, Hansen, Janne Fuglsang, Dröse, Sandra, Harvald, Gustav Bang, Røge, Birgit Thorup, and Øvrehus, Anne Lindebo Holm

Subjects
HEPATITIS C, PEOPLE with mental illness, HOSPITAL emergency services, POINT-of-care testing, PSYCHIATRIC emergencies, DATABASES
Abstract

The prevalence of hepatitis C (HCV) among psychiatric patients is elevated compared to the background population in many studies, but the prevalence among Danish psychiatric patients is unknown. The aim of the study was to determine the HCV prevalence and the proportion of the psychiatric patient population that remains to be diagnosed and treated in a Danish setting. During a 5-month period, patients attending the psychiatric emergency room in Vejle, Denmark, were offered point-of-care anti-HCV testing. Previous hepatitis C tests for all patients attending the Psychiatric Department in the study period were extracted from the national laboratory database (DANVIR). We combined the survey and register data in a capture–recapture estimate of undiagnosed patients with HCV. During the study 24.9% (589 of 2364) patients seen at the psychiatric department attended the emergency room. The prevalence of anti-HCV among those tested in the emergency room was 1.6%. The laboratory register identified 595/2364 patients previously tested for anti-HCV with a positive prevalence of 6.1%. The undiagnosed anti-HCV positives among the 1483 never tested was estimated to 1.1%. Thus the total estimated prevalence of anti-HCV was 2.3% (54/2364, 95% CI 1.7%–3.0%) in the population, of whom 70.4% had been diagnosed, and 72.2% of diagnosed patients had received treatment or cleared HCV. Combining survey and register data showed that the WHO target of 90% diagnosed and 80% treated was not met. To eliminate HCV in the psychiatric population, both undiagnosed and untreated patients must be targeted. [ABSTRACT FROM AUTHOR]

Published
2024
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16. Experience with sotrovimab treatment of SARS-CoV-2-infected patients in Denmark

Author

Rasmussen, Line Dahlerup, Lebech, Anne Mette, Øvrehus, Anne, Poulsen, Birgitte Klindt, Christensen, Hanne Rolighed, Nielsen, Henrik, Johansen, Isik Somuncu, Omland, Lars Haukali, Wiese, Lothar, Helleberg, Marie, Storgaard, Merete, Dalager-Pedersen, Michael, Rasmussen, Thomas A., Benfield, Thomas, Petersen, Tonny Studsgaard, Andersen, Åse Bengård, Gram, Mie Agermose, Stegger, Marc, Edslev, Sofie Marie, Obel, Niels, Rasmussen, Line Dahlerup, Lebech, Anne Mette, Øvrehus, Anne, Poulsen, Birgitte Klindt, Christensen, Hanne Rolighed, Nielsen, Henrik, Johansen, Isik Somuncu, Omland, Lars Haukali, Wiese, Lothar, Helleberg, Marie, Storgaard, Merete, Dalager-Pedersen, Michael, Rasmussen, Thomas A., Benfield, Thomas, Petersen, Tonny Studsgaard, Andersen, Åse Bengård, Gram, Mie Agermose, Stegger, Marc, Edslev, Sofie Marie, and Obel, Niels

Abstract

Aims: To evaluate the experience with use of sotrovimab following severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection in high-risk groups. Methods: In a nationwide, population-based cohort study, we identified all individuals treated with sotrovimab (N = 2933) and stratified them by 4 high-risk groups: (A) malignant haematological disease, (B) solid organ transplantation, (C) anti-CD20 therapy ≤1 year and (D) other risks. Cox regression analysis was used to calculate hazard ratios for hospitalization, death and associated prognostic factors. Results: Of 2933 sotrovimab-treated individuals, 83% belonged to high-risk groups (37.6% haematological malignancy, 27.4% solid organ transplantation and 17.5% treatment with anti-CD20 ≤1 year). Only 17.8% had other risks (11.8% were pregnant, 10.7% primary immunodeficiency, 21.2% other malignancy, 4.3% received anti-CD20 >1 year and 52.0% other/unknown causes). Within 90 days of infusion, 30.2% were hospitalized and 5.3% died. The main prognostic factors were the predefined high-risk groups, mainly malignant haematological disease and age ≥65 years. Number of COVID-19 vaccines (≥3) was associated with a decreased risk of hospitalization. The Delta but not the Omicron BA.2 variant was associated with a higher risk of death compared to the BA.1 variant. Conclusion: More than 90% of the patients treated with sotrovimab belonged to the very high-risk groups as described in the Danish guidelines. Sotrovimab-treated individuals remained at a high risk of hospitalization and death which was strongly associated with the underlying immunocompromised state and age. Having received >3 COVID-19 vaccines was association with decreased risk of death and hospitalization.

Published
2023

17. Full-length sequence analysis of hepatitis C virus genotype 3b strains and development of an in vivo infectious 3b cDNA clone

Author

Bajpai, Priyanka Shukla, Collignon, Laura, Sølund, Christina, Madsen, Lone Wulff, Christensen, Peer Brehm, Øvrehus, Anne, Weis, Nina, Holmbeck, Kenn, Fahnøe, Ulrik, Bukh, Jens, Bajpai, Priyanka Shukla, Collignon, Laura, Sølund, Christina, Madsen, Lone Wulff, Christensen, Peer Brehm, Øvrehus, Anne, Weis, Nina, Holmbeck, Kenn, Fahnøe, Ulrik, and Bukh, Jens

Abstract

Worldwide, genotype 3 is the second most prevalent major variant among patients with chronic hepatitis C virus (HCV) infection and the most difficult to treat with direct-acting antivirals (DAAs). Further, subtype 3b, which is highly prevalent in Southeast Asia with increasing transmission in high-risk populations, carries paired NS5A resistance-associated substitutions (RAS), NS5A-A30K+L31M, conferring resistance to DAA therapy and lowering cure rates with pan-genotypic regimens. However, no complete genomic sequence or infectious clone exists for HCV genotype 3b. We determined the entire genome sequences, including 5′ and 3′ termini, of HCV genotype 3b isolates from three treatment naïve chronic hepatitis C patients, and by clonal analysis of the entire coding sequence demonstrated heterogeneous genome population compositions all carrying RAS A30K+L31M in NS5A. We generated a full-length HCV genotype 3b cDNA clone (pODN) and transfected Huh7.5 and Huh-Lunet/SEC14L2 cells with derived RNA transcripts without detecting HCV antigens by immunofluorescence staining. In contrast, intrahepatic transfection with RNA transcripts from pODN, and subsequent virus passages, in human-liver chimeric mice resulted in robust infection with serum HCV RNA titers of up to 7.9 log10 genome equivalents/mL. Consensus HCV sequences of virus recovered from the transfected mouse contained no coding mutations exceeding 5% frequency, and sequences from the passage-infected mice likewise had no consensus changes. Thus, we developed the first HCV genotype 3b full-length cDNA clone which by its infectivity and genetic stability in human-liver chimeric mice proved functionality, and potential utility in future development of infectious cell culture systems needed for this DAA treatment-resistant subtype. IMPORTANCE HCV genotype 3b is a difficult-to-treat subtype, associated with accelerated progression of liver disease and resistance to antivirals. Moreover, its prevalence has sign

Published
2023

18. Use of molnupiravir: A Danish nationwide drug utilization study.

Author

Ladebo, Louise, Rasmussen, Lotte, Jensen, Peter Bjødstrup, Lindahl, Mette, Øvrehus, Anne, Hallas, Jesper, and Reilev, Mette

Abstract

Purpose: To describe utilization patterns, characteristics of users and prescribers of the new oral antiviral medication, molnupiravir, indicated for mild‐to‐moderate COVID‐19. Methods: Using nationwide registries, we identified all Danish adults who filled a prescription for molnupiravir from December 16th, 2021, to August 31st, 2022. We described weekly incidence rates and patient characteristics over time, prescriber characteristics as well as time between molnupiravir initiation and a positive SARs‐CoV‐2 test. Patient characteristics were compared to matched, untreated SARS‐CoV‐2 positive reference groups. Results: By August 31st, 2022, 5847 individuals had filled a prescription for molnupiravir. The incidence rate gradually increased to 16 weekly prescriptions per 1000 RT‐PCR SARS‐CoV‐2 positives. Users of molnupiravir were most often men (55% vs. 45% women). The majority (81%) had a positive RT‐PCR SARS‐CoV‐2 test and few (2.9%) redeemed molnupiravir outside the recommended window of 5 days from the positive test result. Compared to matched, untreated SARS‐CoV‐2 positive reference groups, users of molnupiravir had a median age of 74 years versus 49 years, a higher proportion resided in a nursing home (12% vs. 1.5%) and had a higher number of comorbidities (median of 3 vs. 0); most commonly hypertension (38%), chronic lung disease (35%), diabetes (20%) and mood disorders (20%). General practitioners were the primary prescribers of molnupiravir (91%). Conclusions: Molnupiravir was mainly prescribed by general practitioners to RT‐PCR SARS‐CoV‐2 positive individuals who had a potentially increased risk of severe COVID‐19. Though some off‐label prescribing occurred, our study indicates a high level of adherence to contemporary guidelines. [ABSTRACT FROM AUTHOR]

Published
2024
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21. Experience with sotrovimab treatment of SARS‐CoV‐2‐infected patients in Denmark

Author

Rasmussen, Line Dahlerup, primary, Lebech, Anne‐Mette, additional, Øvrehus, Anne, additional, Poulsen, Birgitte Klindt, additional, Christensen, Hanne Rolighed, additional, Nielsen, Henrik, additional, Johansen, Isik Somuncu, additional, Omland, Lars Haukali, additional, Wiese, Lothar, additional, Helleberg, Marie, additional, Storgaard, Merete, additional, Dalager‐Pedersen, Michael, additional, Rasmussen, Thomas A., additional, Benfield, Thomas, additional, Petersen, Tonny Studsgaard, additional, Andersen, Åse Bengård, additional, Gram, Mie Agermose, additional, Stegger, Marc, additional, Edslev, Sofie Marie, additional, and Obel, Niels, additional

Published
2023
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23. A multinational Delphi consensus to end the COVID-19 public health threat

Author

Lazarus, Jeffrey V., Romero, Diana, Kopka, Christopher J., Karim, Salim Abdool, Abu-Raddad, Laith J., Almeida, Gisele, Baptista-Leite, Ricardo, Barocas, Joshua A., Barreto, Mauricio L., Bar-Yam, Yaneer, Bassat, Quique, Batista, Carolina, Bazilian, Morgan, Chiou, Shu-Ti, del Rio, Carlos, Dore, Gregory J., Gao, George F., Gostin, Lawrence O., Hellard, Margaret, Jimenez, Jose L., Kang, Gagandeep, Lee, Nancy, Matičič, Mojca, McKee, Martin, Nsanzimana, Sabin, Oliu-Barton, Miquel, Pradelski, Bary, Pyzik, Oksana, Rabin, Kenneth, Raina, Sunil, Rashid, Sabina Faiz, Rathe, Magdalena, Saenz, Rocio, Singh, Sudhvir, Trock-Hempler, Malene, Villapol, Sonia, Yap, Peiling, Binagwaho, Agnes, Kamarulzaman, Adeeba, El-Mohandes, Ayman, Barreto, Mauricio, Abdulla, Salim, Addleman, Sarah, Aghayeva, Gulnara, Agius, Raymond, Ahmed, Mohammed, Ramy, Mohamed Ahmed, Aide, Pedro, Aleman, Soo, Alfred, Jean-Patrick, Ali, Shamim, Aliaga, Jorge, Aloudat, Tammam, Alqahtani, Saleh A., Al-Salman, Jameela, Amuasi, John H., Agrawal, Anurag, Anwar, Wagida, Araujo-Jorge, Tania, Artaza, Osvaldo, Asadi, Leyla, Awuku, Yaw, Baker, Michael, Barberia, Lorena, Bascolo, Ernesto, Belcher, Paul, Bell, Lizett, Benzaken, Adele, Bergholtz, Emil, Bhadelia, Nahid, Bhan, Anant, Bilodeau, Stephane, Bitrán, Ricardo, Bluyssen, Philomena, Bosman, Arnold, Bozza, Fernando A., Brinkmann, Melanie M., Brown, Andrew, Mellado, Bruce, Bukusi, Elizabeth, Bullen, Chris, Buonanno, Giorgio, Burgess, Rochelle, Butler, Matthew, Byakika-Kibwika, Pauline, Cabieses, Baltica, Carlsson, Gunilla, Cascini, Fidelia, Chabala, Chishala, Chakroun, Mohamed, Cheng, null, Chetty, Agnes, Chumachenko, Dmytro, Consalves, Gregg, Conway Morris, Andrew, Cordie, Ahmed, Corrah, Tumani, Crabtree-Ramírez, Brenda, Dashdorj, Naranjargal, Davidovitch, Nadav, de Souza, Luis Eugenio, Dhariwal, Akshay Chand, Druică, Elena, Ergonul, Onder, Erondu, Ngozi A., Essar, Mohammad Yasir, Ewing, Andrew, Fanjul, Gonzalo, Feierstein, Daniel, Feigl-Ding, Eric, Figueroa, Ramon, Figueroa, John Peter, Fisher, Dale, Flores, Walter, Forero-Peña, David A., Frumkin, Howard, Gamkrelidze, Amiran, Gandhi, Monica, Garcia, Patricia, Garcia-Basteiro, Alberto L., García-Sastre, Adolfo, Garg, Suneela, Gbeasor-Komlanvi, null, Gershenson, Carlos, Gilada, Ishwar, Giovanella, Ligia, González, Marino, Green, Manfred S., Greenhalgh, Trisha, Griffin, Paul, Griffin, Stephen, Grinsztejn, Beatriz, Anand, Tanu, Guerra, Germán, Guinto, Renzo, Gujski, Mariusz, Guner, Rahmet, Hamdy, Adam, Hâncean, Marian-Gabriel, Haniffa, Abusayeed, Hartigan-Go, Kenneth Y., Hassan, Hoda K., Hay, Simon I., Heino, Matti T. J., Hel, Zdenek, Hotez, Peter, Hu, Jia, Hukić, Mirsada, IJsselmuiden, Carel, Iroko, Davidson, Iskarous, Maged, Izugbara, Chimaraoke, Jacobs, Choolwe, Jadad, Alejandro R., Jehan, Fyezah, Jordan, Ayana, Jroundi, Imane, Kain, Kevin, Kamberi, Fatjona, Karamov, Eduard, Karan, Abraar, Katz, Rebecca, Katzourakis, Aris, Kazembe, Abigail, Khamis, Faryal, Khamzayev, Komiljon, Khanyola, Judy, Khunti, Kamlesh, Kiguli-Malwadde, Elsie, Kim, Woo Joo, Kirenga, Bruce J., Klimovský, Daniel, Kmush, Brittany L., Knaul, Felicia, Kogevinas, Manolis, Kristensen, Frederik, Kumar, Dinesh, Kumar, Raman, Kvalsvig, Amanda, Lacerda, Marcus V., Lal, Arush, Lawton, Tom, Lemery, Jay, Leonardi, Anthony J., Li, Yuguo, Löttvall, Jan, Lounis, Mohamed, Maceira, Daniel, MacIntyre, C. Raina, Madani, Azzeddine, Magiorkinis, Gkikas, Malekzadeh, Reza, Choisy, Marc, Marcelin, Jasmine R., Marks, Guy B., Marr, Linsey, Marrazzo, Jeanne, Martina, Antonieta, Martín-Moreno, José M., Mateos, Carlos, Mayxay, Mayfong, Mazarati, Jean Bapiste, Mboup, Souleymane, McDonald, Jennifer, McMillan, Faye, Mechili, Enkeleint, Medici, Andre, Davis, Sarah L. M., Meier, Petra, Memish, Ziad A., Menon, Jaideep, Menon, Purnima, Mesiano-Crookston, Jonathan, Michie, Susan, Mikolasevic, Ivana, Milicevic, Ognjen, Mishra, Asit Kumar, Mohamed, Rahma, Mokdad, Ali H., Monroy-Valle, Michele, Morawska, Lidia, Moschos, Sterghios A., Motawea, Karam, Mousavi, Sayed Hamid, Mumtaz, Ghina, Munene, Peter K., Muñoz Almagro, Carmen, Muriuki, Janet, Muyingo, Sylvia, Naniche, Denise, Naylor, C. David, Ndembi, Nicaise, Nemec, Juraj, Nesteruk, Igor, Ngaruiya, Christine, Nguyen, Hung, Nikolova, Dafina, Nitzan, Dorit, Norheim, Ole, Noushad, Mohammed, Ntoumi, Francine, Nyborg, Gunhild Alvik, Ochodo, Eleanor, Odabasi, Zekaver, Okwen, Mbah Patrick, Olivia, Keiser, Ong, David S. Y., Opara, Ijeoma, Orozco, Miguel, Oshitani, Hitoshi, Pagel, Christina, Pai, Madhukar, Pálsdóttir, Björg, Papatheodoridis, Georgios, Paraskevis, Dimitrios, Leigh, Jeanna Parsons, Pécoul, Bernard, Peichl, Andreas, Perez-Then, Eddy, Duc, Phuc Pham, Philippe, Cécile, Pineda Rojas, Andrea, Pladsen, Courtney, Pozniak, Anton, Quiroga, Rodrigo, Qureshi, Huma, Rampal, Sanjay, Ranney, Megan, Rathe, Laura, Ratzan, Scott, Raventos, Henriette, Rees, Helen, Reis, Renata, Ricciardi, Walter, Rizk, Nesrine, Robalo, Magda, Robertson, Eleanor, Robinson, Leanne, Rokx, Casper, Ros, Tamsin, Røttingen, John-Arne, Rubin, Meir, Ruxrungtam, Kiat, Sadirova, Shakhlo, Saha, Senjuti, Salgado, Nelly, Sanchez, Lizet, Sangaramoorthy, Thurka, Santamaria-Ulloa, Carolina, Santos, Renata, Sawaf, Bisher, Schneider, Matthias F., Schooley, Robert T., Sener, Alper, Sepulveda, Jaime, Shah, Jaffer, Shibani, Mosa, Shoib, Sheikh, Sikazwe, Izukanji, Šimaitis, Aistis, Gill, Amandeep Singh, Skhvitaridze, Natia, Sokolović, Milka, Solomon, Roma, Solórzano, Xavier, Springer, Sandra A., Šrol, Jakub, Staines, Anthony, Stelfox, Henry T., Strathdee, Steffanie, Sulaiman, Lokman Hakim, Sutton, Brett, Svanæs, Dag, Swed, Sarya, Sypsa, Vana, Sørensen, Kristine, Tajudeen, Raji, Tan, Amy, Tang, Julian, Tanner, Marcel, Sethi, Tavpritesh, Temmerman, Marleen, Than, Kyu Kyu, Tinto, Halidou, Tomètissi, Sênoudé Pacôme, Torres, Irene, Tshering, null, Tsiodras, Sotirios, Tsofa, Benjamin, Vahlne, Anders, Vargas, Juan Rafael, Bernal, Ivan Dario Velez, Ventura, Deisy, Vilasanjuan, Rafael, Vipond, Joe, Wamala-Andersson, Sarah, Wargocki, Pawel, West, Robert, Weyand, Angela, White, Trenton M., Wolff, Guntram, Yao, Maosheng, Yates, Christian A., Yeboah, Georgina, Yee-Sin, Leo, Yi, Siyan, Teo, Yik-Ying, Yong, Poovorawan, Zamora-Mesía, Victor, Øvrehus, Anne, 0000-0001-9618-2299, 0000-0002-4832-9564, 0000-0002-4986-2133, 0000-0003-0790-0506, 0000-0003-0875-7596, 0000-0002-6994-1891, 0000-0002-3869-615X, 0000-0001-5286-4044, 0000-0001-6203-1847, 0000-0002-0121-9683, 0000-0003-1793-6350, 0000-0003-2418-0037, 0000-0002-5095-748X, 0000-0003-4492-3256, 0000-0002-5964-8210, 0000-0002-6779-3151, 0000-0002-8074-4450, Lazarus, Jeffrey V [0000-0001-9618-2299], Romero, Diana [0000-0002-4832-9564], Karim, Salim Abdool [0000-0002-4986-2133], Abu-Raddad, Laith J [0000-0003-0790-0506], Bassat, Quique [0000-0003-0875-7596], Chiou, Shu-Ti [0000-0002-6994-1891], Gao, George F [0000-0002-3869-615X], Gostin, Lawrence O [0000-0001-5286-4044], Jimenez, Jose L [0000-0001-6203-1847], McKee, Martin [0000-0002-0121-9683], Oliu-Barton, Miquel [0000-0003-1793-6350], Pradelski, Bary [0000-0003-2418-0037], Rathe, Magdalena [0000-0002-5095-748X], Trock-Hempler, Malene [0000-0003-4492-3256], Yap, Peiling [0000-0002-5964-8210], Binagwaho, Agnes [0000-0002-6779-3151], Kamarulzaman, Adeeba [0000-0002-8074-4450], Apollo - University of Cambridge Repository, Helsinki Collegium for Advanced Studies, Research Group of Nelli Hankonen, Doctoral Programme in Social Sciences, Academic Disciplines of the Faculty of Social Sciences, RS: CAPHRI - R2 - Creating Value-Based Health Care, International Health, Performance analysis and optimization of LARge Infrastructures and Systems (POLARIS), Inria Grenoble - Rhône-Alpes, Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Laboratoire d'Informatique de Grenoble (LIG), Université Pierre Mendès France - Grenoble 2 (UPMF)-Université Joseph Fourier - Grenoble 1 (UJF)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-Institut National Polytechnique de Grenoble (INPG)-Centre National de la Recherche Scientifique (CNRS)-Université Pierre Mendès France - Grenoble 2 (UPMF)-Université Joseph Fourier - Grenoble 1 (UJF)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-Institut National Polytechnique de Grenoble (INPG)-Centre National de la Recherche Scientifique (CNRS), Internal Medicine, Medical Microbiology & Infectious Diseases, Veritati - Repositório Institucional da Universidade Católica Portuguesa, and Lazarus J. V., Romero D., Kopka C. J., Karim S. A., Abu-Raddad L. J., Almeida G., Baptista-Leite R., Barocas J. A., Barreto M. L., Bar-Yam Y., et al.

Subjects
Pandemics/economics, BIOMEDICINE AND HEALTHCARE. Clinical Medical Sciences, COVID-19 Vaccines, Delphi Technique, General Science & Technology, International Cooperation, Temel Bilimler (SCI), ÇOK DİSİPLİNLİ BİLİMLER, Public Health/economics, [SHS]Humanities and Social Sciences, SDG 3 - Good Health and Well-being, RA0421 Public health. Hygiene. Preventive Medicine, Medicine and Health Sciences, Humans, prevention and control, human, Settore MED/42 - IGIENE GENERALE E APPLICATA, Health Education, Pandemics, Multidisipliner, Organizations, Multidisciplinary, MULTIDISCIPLINARY SCIENCES, COVID-19/economics, Temel Bilimler, pandemic, Communication, Health Policy, BIOMEDICINA I ZDRAVSTVO. Kliničke medicinske znanosti, Doğa Bilimleri Genel, COVID-19, 3142 Public health care science, environmental and occupational health, Delphi study, NATURAL SCIENCES, GENERAL, N/A, Public Opinion, Government, Natural Sciences (SCI), Public Health, Natural Sciences
Abstract

Despite notable scientific and medical advances, broader political, socioeconomic and behavioural factors continue to undercut the response to the COVID-19 pandemic . Here we convened, as part of this Delphi study, a diverse, multidisciplinary panel of 386 academic, health, non-governmental organization, government and other experts in COVID-19 response from 112 countries and territories to recommend specific actions to end this persistent global threat to public health. The panel developed a set of 41 consensus statements and 57 recommendations to governments, health systems, industry and other key stakeholders across six domains: communication; health systems; vaccination; prevention; treatment and care; and inequities. In the wake of nearly three years of fragmented global and national responses, it is instructive to note that three of the highest-ranked recommendations call for the adoption of whole-of-society and whole-of-government approaches , while maintaining proven prevention measures using a vaccines-plus approach that employs a range of public health and financial support measures to complement vaccination. Other recommendations with at least 99% combined agreement advise governments and other stakeholders to improve communication, rebuild public trust and engage communities in the management of pandemic responses. The findings of the study, which have been further endorsed by 184 organizations globally, include points of unanimous agreement, as well as six recommendations with >5% disagreement, that provide health and social policy actions to address inadequacies in the pandemic response and help to bring this public health threat to an end.

Published
2022
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28. Characteristics associated with serological COVID-19 vaccine response and durability in an older population with significant comorbidity:the Danish Nationwide ENFORCE Study

Author

Søgaard, Ole Schmeltz, Reekie, Joanne, Johansen, Isik Somuncu, Nielsen, Henrik, Benfield, Thomas, Wiese, Lothar, Stærke, Nina Breinholt, Iversen, Kasper, Fogh, Kamille, Bodilsen, Jacob, Iversen, Mette, Knudsen, Lene Surland, Klastrup, Vibeke, Larsen, Fredrikke Dam, Andersen, Sidsel Dahl, Hvidt, Astrid Korning, Andreasen, Signe Rode, Madsen, Lone Wulff, Lindvig, Susan Olaf, Øvrehus, Anne, Ostrowski, Sisse Rye, Abildgaard, Christiane, Matthews, Charlotte, Jensen, Tomas O., Raben, Dorthe, Erikstrup, Christian, Fischer, Thea K., Tolstrup, Martin, Østergaard, Lars, Lundgren, Jens, Søgaard, Ole Schmeltz, Reekie, Joanne, Johansen, Isik Somuncu, Nielsen, Henrik, Benfield, Thomas, Wiese, Lothar, Stærke, Nina Breinholt, Iversen, Kasper, Fogh, Kamille, Bodilsen, Jacob, Iversen, Mette, Knudsen, Lene Surland, Klastrup, Vibeke, Larsen, Fredrikke Dam, Andersen, Sidsel Dahl, Hvidt, Astrid Korning, Andreasen, Signe Rode, Madsen, Lone Wulff, Lindvig, Susan Olaf, Øvrehus, Anne, Ostrowski, Sisse Rye, Abildgaard, Christiane, Matthews, Charlotte, Jensen, Tomas O., Raben, Dorthe, Erikstrup, Christian, Fischer, Thea K., Tolstrup, Martin, Østergaard, Lars, and Lundgren, Jens

Abstract

Objectives: To identify individual characteristics associated with serological COVID-19 vaccine responsiveness and the durability of vaccine-induced antibodies. Methods: Adults without history of SARS-CoV-2 infection from the Danish population scheduled for SARS-CoV-2 vaccination were enrolled in this parallel group, phase 4 study. SARS-CoV-2 Spike IgG and Spike-ACE2-receptor-blocking antibodies were measured at days 0, 21, 90, and 180. Vaccine responsiveness was categorized according to Spike IgG and Spike-ACE2-receptor-blocking levels at day 90 after first vaccination. Nondurable vaccine response was defined as day-90 responders who no longer had significant responses by day 180. Results: Of 6544 participants completing two vaccine doses (median age 64 years; interquartile range: 54–75), 3654 (55.8%) received BTN162b2, 2472 (37.8%) mRNA-1273, and 418 (6.4%) ChAdOx1 followed by an mRNA vaccine. Levels of both types of antibodies increased from baseline to day 90 and then decreased to day 180. The decrease was more pronounced for levels of Spike-ACE2-receptor-blocking antibodies than for Spike IgG. Proportions with vaccine hyporesponsiveness and lack of durable response were 5.0% and 12.1% for Spike IgG and 12.7% and 39.6% for Spike-ACE2-receptor-blocking antibody levels, respectively. Male sex, vaccine type, and number of comorbidities were associated with all four outcomes. Additionally, age ≥75 years was associated with hyporesponsiveness for Spike-ACE2-receptor-blocking antibodies (adjusted odds ratio: 1.59; 95% confidence interval: 1.25–2.01) but not for Spike IgG. Discussion: Comorbidity, male sex, and vaccine type were risk factors for hyporesponsiveness and nondurable response to COVID-19 vaccination. The functional activity of vaccine-induced antibodies declined with increasing age and had waned to pre-second-vaccination levels for most individuals after 6 months.

Published
2022

30. Levels of SARS-CoV-2 Antibodies Among Fully-Vaccinated Individuals With Delta or Omicron Variant Breakthrough Infections: A Prospective Cohort Study

Author

Stærke, Nina Breinholt, primary, Reekie, Joanne, additional, Nielsen, Henrik, additional, Benfield, Thomas, additional, Wiese, Lothar, additional, Knudsen, Lene Surland, additional, Iversen, Mette Brouw, additional, Iversen, Kasper Karmark, additional, Fogh, Kamille, additional, Bodilsen, Jacob, additional, Juhl, Maria Ruwald, additional, Lindvig, Susan Olaf, additional, Øvrehus, Anne, additional, Madsen, Lone Wulff, additional, Klastrup, Vibeke, additional, Andersen, Sidsel Dahl, additional, Juhl, Anna Karina, additional, Andreasen, Signe Rode, additional, Ostrowski, Sisse Rye, additional, Erikstrup, Christian, additional, Fischer, Thea K., additional, Tolstrup, Martin, additional, Østergaard, Lars Jørgen, additional, Johansen, Isik S., additional, Lundgren, Jens, additional, and Søgaard, Ole S., additional

Published
2022
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35. Characterization of a novel hepatitis C virus genotype 1 subtype from a patient failing 4 weeks of glecaprevir-pibrentasvir treatment

Author

Pedersen, Martin S., Fahnøe, Ulrik, Madsen, Lone W., Christensen, Peer B., Øvrehus, Anne, Bukh, Jens, Pedersen, Martin S., Fahnøe, Ulrik, Madsen, Lone W., Christensen, Peer B., Øvrehus, Anne, and Bukh, Jens

Abstract

Limited information is available in relation to surveillance, genotyping, genome sequences, and treatment outcomes for rare hepatitis C virus variants. Here, we have characterized a novel subtype of major hepatitis C virus genotype 1, which was deep sequenced before and after treatment failure with 4 weeks of glecaprevir and pibrentasvir.

Published
2021

36. Inferior cure rate in pilot study of 4-week glecaprevir/pibrentasvir treatment with or without ribavirin of chronic hepatitis C

Author

Madsen, Lone W., Christensen, Peer B., Fahnøe, Ulrik, Pedersen, Martin S., Bukh, Jens, Øvrehus, Anne, Madsen, Lone W., Christensen, Peer B., Fahnøe, Ulrik, Pedersen, Martin S., Bukh, Jens, and Øvrehus, Anne

Abstract

Background & Aims: Shortening the treatment duration for chronic hepatitis C may increase feasibility and reduce the cost of cure. The aims of this study were to compare 4 weeks of glecaprevir/pibrentasvir (GLE/PIB) treatment with and without ribavirin for patients with chronic hepatitis C and favourable baseline characteristics and to monitor the development of resistance-associated substitutions (RAS) and re-treatment outcomes if treatment failed. Methods: We performed an open-label single-centre randomized controlled trial, in which patients with chronic hepatitis C were randomized 1:1 to GLE/PIB ± ribavirin, stratified by genotype 3. The main inclusion criteria were treatment-naive patients, aged 18-49 with all genotypes accepted, and absence of liver fibrosis, determined by liver stiffness measurement less than 8 kPa. Viral genome sequences were determined by deep sequencing at baseline and at the time of relapse. Results: A total of 32 patients started treatment. Sustained virological response at week 12 (SVR12) was 59% (10/17) for GLE/PIB without ribavirin and 73% (11/15) for GLE/PIB with ribavirin. Drug target-specific NS5A RAS were detected at baseline for 45% (5/11) of patients with treatment failure and for 14% (3/21) of patients who achieved SVR12. Ten failure patients were retreated 12 weeks with sofosbuvir-based regimens; all have been cured. Conclusions: In this pilot study of 4-week treatment with GLE/PIB with and without ribavirin, we found that baseline RAS were more frequent in patients with virological failure. Development of RAS did occur after short treatment but did not result in retreatment failure with a different regimen. EudraCT no: 2017-005179-21.

Published
2021

37. Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe

Author

Marshall, Alison D., Cunningham, Evan B., Nielsen, Stine, Aghemo, Alessio, Alho, Hannu, Backmund, Markus, Bruggmann, Philip, Dalgard, Olav, Seguin-Devaux, Carole, Flisiak, Robert, Foster, Graham R., Gheorghe, Liana, Goldberg, David, Goulis, Ioannis, Hickman, Matthew, Hoffmann, Patrick, Jancorienė, Ligita, Jarcuska, Peter, Kåberg, Martin, Kostrikis, Leondios G., Makara, Mihály, Maimets, Matti, Marinho, Rui Tato, Matičič, Mojca, Norris, Suzanne, Ólafsson, Sigurður, Øvrehus, Anne, Pawlotsky, Jean-Michel, Pocock, James, Robaeys, Geert, Roncero, Carlos, Simonova, Marieta, Sperl, Jan, Tait, Michele, Tolmane, Ieva, Tomaselli, Stefan, van der Valk, Marc, Vince, Adriana, Dore, Gregory J., Lazarus, Jeffrey V., Grebely, Jason, International Network on Hepatitis in Substance Users (INHSU), Kostrikis, Leondios G. [0000-0002-5340-7109], Infectious diseases, AII - Infectious diseases, AII - Amsterdam institute for Infection and Immunity, APH - Digital Health, APH - Personalized Medicine, and APH - Global Health

Subjects
hepatitis C virus, HIV Infections, chemistry.chemical_compound, 0302 clinical medicine, Antiviral Agents/economics, HIV-HCV co-infection, 030212 general & internal medicine, Reimbursement, liver fibrosis, media_common, Dasabuvir, Coinfection, Health Policy, Gastroenterology, Hepatitis C, 3. Good health, Europe, Hepatitis C, Chronic/complications, Insurance, Health, Reimbursement, 030211 gastroenterology & hepatology, Switzerland, medicine.drug, medicine.medical_specialty, HIV Infections/complications, Antiviral Agents, Drug Costs, 03 medical and health sciences, hepatitis C treatment, medicine, Humans, media_common.cataloged_instance, European Union, European union, PWID, Intensive care medicine, Hepatitis, direct-acting antiviral, Hepatology, business.industry, Hepatitis C, Chronic, alcohol use, medicine.disease, reimbursement, Virology, Ombitasvir, chemistry, Paritaprevir, Ritonavir, business, treatment restrictions
Abstract

All-oral direct-acting antiviral drugs (DAAs) for hepatitis C virus, which have response rates of 95% or more, represent a major clinical advance. However, the high list price of DAAs has led many governments to restrict their reimbursement. We reviewed the availability of, and national criteria for, interferon-free DAA reimbursement among countries in the European Union and European Economic Area, and Switzerland. Reimbursement documentation was reviewed between Nov 18, 2016, and Aug 1, 2017. Primary outcomes were fibrosis stage, drug or alcohol use, prescriber type, and HIV co-infection restrictions. Among the 35 European countries and jurisdictions included, the most commonly reimbursed DAA was ombitasvir, paritaprevir, and ritonavir, with dasabuvir, and with or without ribavirin (33 [94%] countries and jurisdictions). 16 (46%) countries and jurisdictions required patients to have fibrosis at stage F2 or higher, 29 (83%) had no listed restrictions based on drug or alcohol use, 33 (94%) required a specialist prescriber, and 34 (97%) had no additional restrictions for people co-infected with HIV and hepatitis C virus. These findings have implications for meeting WHO targets, with evidence of some countries not following the 2016 hepatitis C virus treatment guidelines by the European Association for the Study of Liver. 3 2 125 133

Published
2018
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39. Low incidence of HCC in chronic hepatitis C patients with pretreatment liver stiffness measurements below 17.5 kilopascal who achieve SVR following DAAs

Author

Søholm, Jacob, primary, Hansen, Janne Fuglsang, additional, Mössner, Belinda, additional, Røge, Birgit Thorup, additional, Lauersen, Alex, additional, Hansen, Jesper Bach, additional, Weis, Nina, additional, Barfod, Toke Seierøe, additional, Lunding, Suzanne, additional, Øvrehus, Anne, additional, Mohey, Rajesh, additional, Thielsen, Peter, additional, and Christensen, Peer Brehm, additional

Published
2020
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41. Hepatitis C prevalence in Denmark in 2016—An updated estimate using multiple national registers

Author

Nielsen, Stine, primary, Hansen, Janne Fuglsang, additional, Hay, Gordon, additional, Cowan, Susan, additional, Jepsen, Peter, additional, Omland, Lars Haukali, additional, Krarup, Henrik Bygum, additional, Søholm, Jacob, additional, Lazarus, Jeffrey V., additional, Weis, Nina, additional, Øvrehus, Anne, additional, and Christensen, Peer Brehm, additional

Published
2020
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43. Low incidence of HCC in chronic hepatitis C patients with pretreatment liver stiffness measurements below 17.5 kilopascal who achieve SVR following DAAs

Author

Søholm, Jacob, Hansen, Janne Fuglsang, Mössner, Belinda, Røge, Birgit Thorup, Lauersen, Alex, Hansen, Jesper Bach, Weis, Nina, Barfod, Toke Seierøe, Lunding, Suzanne, Øvrehus, Anne, Mohey, Rajesh, Thielsen, Peter, Christensen, Peer Brehm, Søholm, Jacob, Hansen, Janne Fuglsang, Mössner, Belinda, Røge, Birgit Thorup, Lauersen, Alex, Hansen, Jesper Bach, Weis, Nina, Barfod, Toke Seierøe, Lunding, Suzanne, Øvrehus, Anne, Mohey, Rajesh, Thielsen, Peter, and Christensen, Peer Brehm

Abstract

Background and aims To evaluate the ability of pretreatment liver stiffness measurements (pLSM) to predict hepatocellular carcinoma (HCC), incident decompensation and all-cause mortality in chronic hepatitis C (CHC) patients who achieved sustained virological response (SVR) after treatment with direct-acting antivirals (DAAs). Methods 773 CHC patients with SVR after DAA treatment and no prior liver complications were identified retrospectively. Optimized cut-off of 17.5 kPa for incident HCC was selected by maximum Youden’s index. Patients were grouped by pLSM: <10 kPa [reference], 10–17.4 kPa and ≥17.5 kPa. Primary outcomes were incident hepatocellular carcinoma and secondary outcomes were incident decompensated cirrhosis and all-cause mortality, analyzed using cox-regression. Results Median follow-up was 36 months and 43.5% (336) had cirrhosis (LSM>12.5 kPa). The median pLSM was 11.6 kPa (IQR 6.7–17.8, range 2.5–75) and pLSM of <10 kPa, 10–17.4 kPa and 17.5–75 kPa was seen in 41.5%, 32.2% and 26.3%. During a median follow-up time of 36 months, 11 (1.4%) developed HCC, 14 (1.5%) developed decompensated cirrhosis, and 38 (4.9%) patients died. A pLSM of 17.5 kPa identified patients with a high risk of HCC with a negative predictive value of 98.9% and incidence rate of HCC in the 17.5–75 kPa group of 1.40/100 person years compared to 0.14/100 person years and 0.12/100 person years in the 10–17.4 kPa and <10 kPa groups, p<0.001. Conclusion Pretreatment LSM predicts risk of HCC, decompensation and all-cause mortality in patients with SVR after DAA treatment. Patients with a pLSM <17.5 kPa and no other risk factors for chronic liver disease appear not to benefit from HCC surveillance for the first 3 years after treatment. Longer follow-up is needed to clarify if they can be safely excluded from post treatment HCC screening hereafter.

Published
2020

44. The Copenhagen test and treat hepatitis C in a mobile clinic study:A protocol for an intervention study to enhance the HCV cascade of care for people who inject drugs (T'N'T HepC)

Author

Lazarus, Jeffrey Victor, Øvrehus, Anne, Demant, Jonas, Krohn-Dehli, Louise, Weis, Nina, Lazarus, Jeffrey Victor, Øvrehus, Anne, Demant, Jonas, Krohn-Dehli, Louise, and Weis, Nina

Abstract

Introduction: Injecting drug use is the primary driver of hepatitis C virus (HCV) infection in Europe. Despite the need for more engagement with care, people who inject drugs (PWID) are hard to reach with HCV testing and treatment. We initiated a study to evaluate the efficacy for testing and linkage to care among PWID consulting peer-based testing at a mobile clinic in Copenhagen, Denmark. Methods and analysis: In this intervention study, we will recruit participants at a single community-based, peer-run mobile clinic. In a single visit, we will first offer participants a point-of-care HCV antibody test, and if they test positive, then they will receive an HCV RNA test. If they are HCV-RNA+, we will administer facilitated referrals to designated 'fast-track' clinics at a hospital or an addiction centre for treatment. The primary outcomes for this study are the number of tested and treated individuals. Secondary outcomes include individuals lost at each step in the care cascade. Ethics and dissemination: The results of this study could provide a model for targeting PWID for HCV testing and treatment in Demark and other settings, which could help achieve WHO HCV elimination targets. The Health Research Ethics Committee of Denmark and the Danish Data Protection Agency confirmed (December 2018/January 2019) that this study did not require their approval. Study findings will be disseminated through peer-reviewed publications, conference presentations and social media.

Published
2020

45. Hepatitis C prevalence in Denmark in 2016—An updated estimate using multiple national registers

Author

Nielsen, Stine, Hansen, Janne Fuglsang, Hay, Gordon, Cowan, Susan, Jepsen, Peter, Omland, Lars Haukali, Krarup, Henrik Bygum, Søholm, Jacob, Lazarus, Jeffrey V., Weis, Nina, Øvrehus, Anne, Christensen, Peer Brehm, Nielsen, Stine, Hansen, Janne Fuglsang, Hay, Gordon, Cowan, Susan, Jepsen, Peter, Omland, Lars Haukali, Krarup, Henrik Bygum, Søholm, Jacob, Lazarus, Jeffrey V., Weis, Nina, Øvrehus, Anne, and Christensen, Peer Brehm

Abstract

Background Chronic hepatitis C (CHC) can be eliminated as a public health threat by meeting the WHO targets: 90% of patients diagnosed and 80% treated by 2030. To achieve and monitor progress towards elimination, an updated estimate of the size of the CHC population is needed, but Denmark has no complete national CHC register. By combining existing registers in 2007, we estimated the population living with CHC to be 16,888 (0.38% of the adult population). Aim To estimate the population living with diagnosed and undiagnosed CHC in Denmark on 31 December 2016. Among additional aims were to estimate the proportion of patients attending specialised clinical care. Methods People with diagnosed CHC were identified from four national registers. The total diagnosed population was estimated by capture-recapture analysis. The undiagnosed population was estimated by comparing the register data with data from two cross-sectional surveys. Results The population living with diagnosed CHC in Denmark was 7,581 persons (95%CI: 7,416–12,661) of which 6,116 (81%) were identified in the four registers. The estimated undiagnosed fraction was 24%, so the total CHC infected population was 9,975 corresponding to 0.21% of the adult population (95%CI: 9,758–16,659; 0.21%-0.36%). Only 48% of diagnosed patients had received specialised clinical care. Conclusion CHC prevalence in Denmark is declining and 76% of patients have been diagnosed. Linking diagnosed patients to care and increasing efforts to test people with former or current drug use will be necessary to achieve CHC elimination.

Published
2020

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