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1. Final Results of the Telaprevir Access Program: FibroScan Values Predict Safety and Efficacy in Hepatitis C Patients with Advanced Fibrosis or Cirrhosis.

Author

Antonia Lepida, Massimo Colombo, Inmaculada Fernandez, Djamal Abdurakhmanov, Paulo Abrao Ferreira, Simone I Strasser, Petr Urbanek, Alessandra Mangia, José L Calleja, Wafae Iraqi, Ralph DeMasi, Isabelle Lonjon-Domanec, Christophe Moreno, and Heiner Wedemeyer

Subjects
Medicine, Science
Abstract

Liver stiffness determined by transient elastography is correlated with hepatic fibrosis stage and has high accuracy for detecting severe fibrosis and cirrhosis in chronic hepatitis C patients. We evaluated the clinical value of baseline FibroScan values for the prediction of safety and efficacy of telaprevir-based therapy in patients with advanced fibrosis and cirrhosis in the telaprevir Early Access Program HEP3002.1,772 patients with HCV-1 and bridging fibrosis or cirrhosis were treated with telaprevir plus pegylated interferon-α and ribavirin (PR) for 12 weeks followed by PR alone, the total treatment duration depending on virological response and previous response type. Liver fibrosis stage was determined either by liver biopsy or by non-invasive markers. 1,282 patients (72%) had disease stage assessed by FibroScan; among those 46% were classified as Metavir F3 at baseline and 54% as F4.Overall, 1,139 patients (64%) achieved a sustained virological response (SVR) by intention-to-treat analysis. Baseline FibroScan values were tested for association with SVR and the occurrence of adverse events. By univariate analysis, higher baseline FibroScan values were predictive of lower sustained virological response rates and treatment-related anemia. By multivariate analysis, FibroScan was no longer statistically significant as an independent predictor, but higher FibroScan values were correlated with the occurrence of infections and serious adverse events.FibroScan has a limited utility as a predictor of safety and efficacy in patients treated with telaprevir-based triple therapy. Nevertheless it can be used in association with other clinical and biological parameters to help determine patients who will benefit from the triple regiments.ClinicalTrials.gov NCT01508286.

Published
2015
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2. The case for simplifying and using absolute targets for viral hepatitis elimination goals

Author

Razavi, H. Blach, S. Razavi-Shearer, D. Abaalkhail, F. Abbas, Z. Abdallah, A. Abrao Ferreira, P. Abu Raddad, L.J. Adda, D. Agarwal, K. Aghemo, A. Ahmed, A. Al-Busafi, S.A. Al-hamoudi, W. Al-Kaabi, S. Al-Romaihi, H. Aljarallah, B. AlNaamani, K. Alqahtani, S. Alswat, K. Altraif, I. Asselah, T. Bacon, B. Bessone, F. Bizri, A.R. Block, T. Bonino, F. Brandão-Mello, C.E. Brown, K. Bruggmann, P. Brunetto, M.R. Buti, M. Cabezas, J. Calleja, J.L. Castro Batänjer, E. Chan, H.L.-Y. Chang, H. Chen, C.-J. Christensen, P.B. Chuang, W.-L. Cisneros, L. Cohen, C. Colombo, M. Conway, B. Cooper, C. Craxi, A. Crespo, J. Croes, E. Cryer, D. Cupertino de Barros, F.P. Derbala, M. Dillon, J. Doss, W. Dou, X. Doyle, J. Duberg, A.-S. Dugan, E. Dunn, R. Dusheiko, G. El Khayat, H. El-Sayed, M.H. Eshraghian, A. Esmat, G. Esteban Mur, R. Ezzat, S. Falconer, K. Fassio, E. Ferrinho, P. Flamm, S. Flisiak, R. Foster, G. Fung, J. García-Samaniego, J. Gish, R.G. Gonçales, F. Halota, W. Hamoudi, W. Hassany, M. Hatzakis, A. Hay, S. Himatt, S. Hoepelman, I.M. Hsu, Y.-C. Hui, Y.T. Hunyady, B. Jacobson, I. Janjua, N. Janssen, H. Jarcuska, P. Kabagambe, K. Kanto, T. Kao, J.-H. Kaymakoglu, S. Kershenobich, D. Khamis, F. Kim, D.J. Kim, D.Y. Kondili, L.A. Kottilil, S. Kramvis, A. Kugelmas, M. Kurosaki, M. Lacombe, K. Lagging, M. Lao, W.-C. Lavanchy, D. Lazarus, J.V. Lee, A. Lee, S.S. Levy, M. Liakina, V. Lim, Y.-S. Liu, S. Maddrey, W. Malekzadeh, R. Marinho, R.T. Mathur, P. Maticic, M. Mendes Correa, M.C. Mera, J. Merat, S. Mogawer, S. Mohamed, R. Muellhaupt, B. Muljono, D. Mostafa, I. Nahum, M.S. Nawaz, A. Negro, F. Ninburg, M. Ning, Q. Ntiri- Reid, B. Nymadawa, P. Oevrehus, A. Ormeci, N. Orrego, M. Osman, A. Oyunsuren, T. Pan, C. Papaevangelou, V. Papatheodoridis, G. Popping, S. Prasad, P. Prithiviputh, R. Qureshi, H. Ramji, A. Razavi-Shearer, K. Reddy, R. Remak, W. Richter, C. Ridruejo, E. Robaeys, G. Roberts, S. Roberts, L. Roudot-Thoraval, F. Saab, S. Said, S. Salamat, A. Sanai, F. Sanchez-Avila, J.F. Schiff, E. Schinazi, R. Sebastiani, G. Seguin-Devaux, C. Shanmugam, R.P. Sharara, A. Shilton, S. Shouval, D. Sievert, W. Simonova, M. Sohrabpour, A.A. Sonderup, M. Soza, A. Wendy Spearman, C. Steinfurth, N. Sulkowski, M. Tan, S.-S. Tanaka, J. Tashi, D. Thein, H.-H. Thompson, P. Tolmane, I. Toy, M. Valantinas, J. Van de Vijver, D. Vélez-Möller, P. Vince, A. Waked, I. Wang, S. Wedemeyer, H. Wong, V. Xie, Q. Yamada, S. Yang, H.-I. Yesmembetov, K. Yilmaz, Y. Younossi, Z. Yu, M.-L. Yuen, M.-F. Yurdaydin, C. Yusuf, A. Zekry, A. Zeuzem, S. Polaris Observatory Collaborators

Subjects
digestive system diseases
Abstract

The 69th World Health Assembly endorsed the Global Health Sector Strategy for Viral Hepatitis, embracing a goal to eliminate hepatitis infection as a public health threat by 2030. This was followed by the World Health Organization's (WHO) global targets for the care and management of hepatitis B virus (HBV) and hepatitis C virus (HCV) infections. These announcements and targets were important in raising awareness and calling for action; however, tracking countries’ progress towards these elimination goals has provided insights to the limitations of these targets. The existing targets compare a country's progress relative to its 2015 values, penalizing countries who started their programmes prior to 2015, countries with a young population, or countries with a low prevalence. We recommend that (1) WHO simplify the hepatitis elimination targets, (2) change to absolute targets and (3) allow countries to achieve these disease targets with their own service coverage initiatives that will have the maximum impact. The recommended targets are as follows: reduce HCV new chronic cases to ≤5 per 100 000, reduce HBV prevalence among 1-year-olds to ≤0.1%, reduce HBV and HCV mortality to ≤5 per 100 000, and demonstrate HBV and HCV year-to-year decrease in new HCV- and HBV-related HCC cases. The objective of our recommendations is not to lower expectations or diminish the hepatitis elimination standards, but to provide clearer targets that recognize the past and current elimination efforts by countries, help measure progress towards true elimination, and motivate other countries to follow suit. © 2020 John Wiley & Sons Ltd

Published
2021

3. The case for simplifying and using absolute targets for viral hepatitis elimination goals.

Author

Razavi H., Blach S., Razavi-Shearer D., Abaalkhail F., Abbas Z., Abdallah A., Abrao Ferreira P., Abu Raddad L.J., Adda D., Agarwal K., Aghemo A., Ahmed A., Al-Busafi S.A., Al-hamoudi W., Al-Kaabi S., Al-Romaihi H., Aljarallah B., AlNaamani K., Alqahtani S., Alswat K., Altraif I., Asselah T., Bacon B., Bessone F., Bizri A.R., Block T., Bonino F., Brandao-Mello C.E., Brown K., Bruggmann P., Brunetto M.R., Buti M., Cabezas J., Calleja J.L., Castro Batanjer E., Chan H.L.-Y., Chang H., Chen C.-J., Christensen P.B., Chuang W.-L., Cisneros L., Cohen C., Colombo M., Conway B., Cooper C., Craxi A., Crespo J., Croes E., Cryer D., Cupertino de Barros F.P., Derbala M., Dillon J., Doss W., Dou X., Doyle J., Duberg A.-S., Dugan E., Dunn R., Dusheiko G., El Khayat H., El-Sayed M.H., Eshraghian A., Esmat G., Esteban Mur R., Ezzat S., Falconer K., Fassio E., Ferrinho P., Flamm S., Flisiak R., Foster G., Fung J., Garcia-Samaniego J., Gish R.G., Goncales F., Halota W., Hamoudi W., Hassany M., Hatzakis A., Hay S., Himatt S., Hoepelman I.M., Hsu Y.-C., Hui Y.T., Hunyady B., Jacobson I., Janjua N., Janssen H., Jarcuska P., Kabagambe K., Kanto T., Kao J.-H., Kaymakoglu S., Kershenobich D., Khamis F., Kim D.J., Kim D.Y., Kondili L.A., Kottilil S., Kramvis A., Kugelmas M., Kurosaki M., Lacombe K., Lagging M., Lao W.-C., Lavanchy D., Lazarus J.V., Lee A., Lee S.S., Levy M., Liakina V., Lim Y.-S., Liu S., Maddrey W., Malekzadeh R., Marinho R.T., Mathur P., Maticic M., Mendes Correa M.C., Mera J., Merat S., Mogawer S., Mohamed R., Muellhaupt B., Muljono D., Mostafa I., Nahum M.S., Nawaz A., Negro F., Ninburg M., Ning Q., Ntiri- Reid B., Nymadawa P., Oevrehus A., Ormeci N., Orrego M., Osman A., Oyunsuren T., Pan C., Papaevangelou V., Papatheodoridis G., Popping S., Prasad P., Prithiviputh R., Qureshi H., Ramji A., Razavi-Shearer K., Reddy R., Remak W., Richter C., Ridruejo E., Robaeys G., Roberts S., Roberts L., Roudot-Thoraval F., Saab S., Said S., Salamat A., Sanai F., Sanchez-Avila J.F., Schiff E., Schinazi R., Sebastiani G., Seguin-Devaux C., Shanmugam R.P., Sharara A., Shilton S., Shouval D., Sievert W., Simonova M., Sohrabpour A.A., Sonderup M., Soza A., Wendy Spearman C., Steinfurth N., Sulkowski M., Tan S.-S., Tanaka J., Tashi D., Thein H.-H., Thompson P., Tolmane I., Toy M., Valantinas J., Van de Vijver D., Velez-Moller P., Vince A., Waked I., Wang S., Wedemeyer H., Wong V., Xie Q., Yamada S., Yang H.-I., Yesmembetov K., Yilmaz Y., Younossi Z., Yu M.-L., Yuen M.-F., Yurdaydin C., Yusuf A., Zekry A., Zeuzem S., Razavi H., Blach S., Razavi-Shearer D., Abaalkhail F., Abbas Z., Abdallah A., Abrao Ferreira P., Abu Raddad L.J., Adda D., Agarwal K., Aghemo A., Ahmed A., Al-Busafi S.A., Al-hamoudi W., Al-Kaabi S., Al-Romaihi H., Aljarallah B., AlNaamani K., Alqahtani S., Alswat K., Altraif I., Asselah T., Bacon B., Bessone F., Bizri A.R., Block T., Bonino F., Brandao-Mello C.E., Brown K., Bruggmann P., Brunetto M.R., Buti M., Cabezas J., Calleja J.L., Castro Batanjer E., Chan H.L.-Y., Chang H., Chen C.-J., Christensen P.B., Chuang W.-L., Cisneros L., Cohen C., Colombo M., Conway B., Cooper C., Craxi A., Crespo J., Croes E., Cryer D., Cupertino de Barros F.P., Derbala M., Dillon J., Doss W., Dou X., Doyle J., Duberg A.-S., Dugan E., Dunn R., Dusheiko G., El Khayat H., El-Sayed M.H., Eshraghian A., Esmat G., Esteban Mur R., Ezzat S., Falconer K., Fassio E., Ferrinho P., Flamm S., Flisiak R., Foster G., Fung J., Garcia-Samaniego J., Gish R.G., Goncales F., Halota W., Hamoudi W., Hassany M., Hatzakis A., Hay S., Himatt S., Hoepelman I.M., Hsu Y.-C., Hui Y.T., Hunyady B., Jacobson I., Janjua N., Janssen H., Jarcuska P., Kabagambe K., Kanto T., Kao J.-H., Kaymakoglu S., Kershenobich D., Khamis F., Kim D.J., Kim D.Y., Kondili L.A., Kottilil S., Kramvis A., Kugelmas M., Kurosaki M., Lacombe K., Lagging M., Lao W.-C., Lavanchy D., Lazarus J.V., Lee A., Lee S.S., Levy M., Liakina V., Lim Y.-S., Liu S., Maddrey W., Malekzadeh R., Marinho R.T., Mathur P., Maticic M., Mendes Correa M.C., Mera J., Merat S., Mogawer S., Mohamed R., Muellhaupt B., Muljono D., Mostafa I., Nahum M.S., Nawaz A., Negro F., Ninburg M., Ning Q., Ntiri- Reid B., Nymadawa P., Oevrehus A., Ormeci N., Orrego M., Osman A., Oyunsuren T., Pan C., Papaevangelou V., Papatheodoridis G., Popping S., Prasad P., Prithiviputh R., Qureshi H., Ramji A., Razavi-Shearer K., Reddy R., Remak W., Richter C., Ridruejo E., Robaeys G., Roberts S., Roberts L., Roudot-Thoraval F., Saab S., Said S., Salamat A., Sanai F., Sanchez-Avila J.F., Schiff E., Schinazi R., Sebastiani G., Seguin-Devaux C., Shanmugam R.P., Sharara A., Shilton S., Shouval D., Sievert W., Simonova M., Sohrabpour A.A., Sonderup M., Soza A., Wendy Spearman C., Steinfurth N., Sulkowski M., Tan S.-S., Tanaka J., Tashi D., Thein H.-H., Thompson P., Tolmane I., Toy M., Valantinas J., Van de Vijver D., Velez-Moller P., Vince A., Waked I., Wang S., Wedemeyer H., Wong V., Xie Q., Yamada S., Yang H.-I., Yesmembetov K., Yilmaz Y., Younossi Z., Yu M.-L., Yuen M.-F., Yurdaydin C., Yusuf A., Zekry A., and Zeuzem S.

Abstract

The 69th World Health Assembly endorsed the Global Health Sector Strategy for Viral Hepatitis, embracing a goal to eliminate hepatitis infection as a public health threat by 2030. This was followed by the World Health Organization's (WHO) global targets for the care and management of hepatitis B virus (HBV) and hepatitis C virus (HCV) infections. These announcements and targets were important in raising awareness and calling for action; however, tracking countries' progress towards these elimination goals has provided insights to the limitations of these targets. The existing targets compare a country's progress relative to its 2015 values, penalizing countries who started their programmes prior to 2015, countries with a young population, or countries with a low prevalence. We recommend that (1) WHO simplify the hepatitis elimination targets, (2) change to absolute targets and (3) allow countries to achieve these disease targets with their own service coverage initiatives that will have the maximum impact. The recommended targets are as follows: reduce HCV new chronic cases to <=5 per 100 000, reduce HBV prevalence among 1-year-olds to <=0.1%, reduce HBV and HCV mortality to <=5 per 100 000, and demonstrate HBV and HCV year-to-year decrease in new HCV- and HBV-related HCC cases. The objective of our recommendations is not to lower expectations or diminish the hepatitis elimination standards, but to provide clearer targets that recognize the past and current elimination efforts by countries, help measure progress towards true elimination, and motivate other countries to follow suit.Copyright © 2020 John Wiley & Sons Ltd

Published
2021

4. The case for simplifying and using absolute targets for viral hepatitis elimination goals

Author

Tsendsuren S. Oyunsuren, Chari Cohen, Waseem Hamoudi, Yao‐Chun Hsu, Harry L.A. Janssen, Hisham El Khayat, Manal H El-Sayed, Wan-Long Chuang, Young-Suk Lim, Mohamed Hassany, Fernando Passos Cupertino de Barros, Faisal Abaalkhail, Stefan Zeuzem, Samual S Lee, Miriam T. Levy, Imam Waked, Vassiliki Papaevangelou, James Fung, Erika Castro Batänjer, Kathryn Razavi-Shearer, Boatemaa Ntiri‐ Reid, Rosmawati Mohamed, Pagbajabyn Nymadawa, Robert Flisiak, Alnoor Ramji, Carole Seguin-Devaux, Sherif Mogawer, Béla Hunyady, Huma Qureshi, Mojca Matičič, Martin Lagging, Mark W. Sonderup, Xiaoguang Dou, Anne Oevrehus, William Sievert, Ezequiel Ridruejo, Ann-Sofi Duberg, Ahad Eshraghian, R. P. Shanmugam, Arif Nawaz, Qing Xie, Rick Dunn, Sayed Himatt, Daniel Shouval, Mendez Sanchez Nahum, Sabahattin Kaymakoglu, Vincent Wai-Sun Wong, Soek-Siam Tan, Willis Maddrey, Papu Prasad, Amjad Salamat, Stephanie Popping, Alice Lee, Maurizia Rossana Brunetto, Khalid Alswat, Peyton Thompson, Dong Joon Kim, Henry Chang, Amir Ali Sohrabpour, Ellen Dugan, Peer Brehm Christensen, David A. M. C. van de Vijver, Joaquín Cabezas, Su Wang, Ala I. Sharara, Peter Jarcuska, Karine Lacombe, Danjuma Adda, Sammy Saab, Chien-Jen Chen, Hwai I. Yang, Sanaa Said, Raymond F. Schinazi, Shyamasundaran Kottilil, Graham R. Foster, Qing Ning, Mehlika Toy, Ira M. Jacobson, Ayat R. Abdallah, Laura Cisneros, Dhondup Tashi, Naveed Z. Janjua, Moutaz Derbala, Marcelo Kugelmas, Steven L. Flamm, Angelos Hatzakis, Yusuf Yilmaz, Mark S. Sulkowski, Eugene R. Schiff, Kakharman Yesmembetov, John F. Dillon, Rittoo Prithiviputh, Carlos Eduardo Brandão-Mello, Rajender Reddy, Françoise Roudot-Thoraval, Lewis R. Roberts, Javier Crespo, Massimo Colombo, Nancy Steinfurth, I. M. Hoepelman, Kosh Agarwal, Faisal M. Sanai, Waleed Al-Hamoudi, Shuang Liu, Beat Muellhaupt, Sonjelle Shilton, Curtis Cooper, Calvin Q. Pan, Aijaz Ahmed, Wai-cheung C Lao, Alejandro Soza, Patricia Vélez‐Möller, Ibrahim Altraif, Tarik Asselah, Junko Tanaka, Badr Aljarallah, Adriana Vince, Faryal Khamis, Juan Francisco Sánchez-Ávila, Rafael Esteban Mur, Kimberly A. Brown, Saad Al-Kaabi, Ming-Lung Yu, Jonas Valantinas, Marieta Simonova, Javier García-Samaniego, Do Young Kim, Ieva Tolmane, Valentina Liakina, Antonio Craxì, Devin Razavi-Shearer, Waldemar Halota, Stuart K. Roberts, Donna Cryer, Kenneth Kabagambe, William Remak, Jeffrey V. Lazarus, Brian Conway, Sameera Ezzat, C Wendy Spearman, Karolin Falconer, Maria C Mendes Correa, Poonam Mathur, Ferruccio Bonino, Jose Luis Calleja, Said A. Al-Busafi, E. A. Croes, Tim Block, Shahin Merat, Francesco Negro, Reza Malekzadeh, Fernando L. Gonçales, Amany Zekry, Wahid Doss, Michael Ninburg, Philip Bruggmann, Man-Fung Yuen, George V. Papatheodoridis, Aasim Yusuf, David Kershenobich, Bruce R. Bacon, Abdul Rahman Bizri, Gamal Esmat, Sarah Blach, Hamad Al-Romaihi, Tatsuya Kanto, Ibrahim Mostafa, Homie Razavi, Alessio Aghemo, Mauricio Orrego, Jia-Horng Kao, Daniel Lavanchy, Zobair M. Younossi, Henry Lik-Yuen Chan, Anna Kramvis, David H. Muljono, Clemens Richter, Hla-Hla Thein, Fernando Bessone, Paulo Roberto Abrão Ferreira, Geoffrey Dusheiko, Susan Hay, Geert Robaeys, Eduardo Fassio, Loreta A. Kondili, Jorge Mera, Khalid Al-Naamani, Alaa Osman, Saleh A. Alqahtani, Joseph Doyle, Necati Örmeci, Yee Tak Hui, Heiner Wedemeyer, Laith Jamal Abu Raddad, Masayuki Kurosaki, Rui Tato Marinho, Robert G. Gish, Zaigham Abbas, Seiji Yamada, Giada Sebastiani, Cihan Yurdaydin, Maria Buti, Paulo Ferrinho, Razavi H., Blach S., Razavi-Shearer D., Abaalkhail F., Abbas Z., Abdallah A., Abrao Ferreira P., Abu Raddad L.J., Adda D., Agarwal K., Aghemo A., Ahmed A., Al-Busafi S.A., Al-hamoudi W., Al-Kaabi S., Al-Romaihi H., Aljarallah B., AlNaamani K., Alqahtani S., Alswat K., Altraif I., Asselah T., Bacon B., Bessone F., Bizri A.R., Block T., Bonino F., Brandao-Mello C.E., Brown K., Bruggmann P., Brunetto M.R., Buti M., Cabezas J., Calleja J.L., Castro Batanjer E., Chan H.L.-Y., Chang H., Chen C.-J., Christensen P.B., Chuang W.-L., Cisneros L., Cohen C., Colombo M., Conway B., Cooper C., Craxi A., Crespo J., Croes E., Cryer D., Cupertino de Barros F.P., Derbala M., Dillon J., Doss W., Dou X., Doyle J., Duberg A.-S., Dugan E., Dunn R., Dusheiko G., El Khayat H., El-Sayed M.H., Eshraghian A., Esmat G., Esteban Mur R., Ezzat S., Falconer K., Fassio E., Ferrinho P., Flamm S., Flisiak R., Foster G., Fung J., Garcia-Samaniego J., Gish R.G., Goncales F., Halota W., Hamoudi W., Hassany M., Hatzakis A., Hay S., Himatt S., Hoepelman I.M., Hsu Y.-C., Hui Y.T., Hunyady B., Jacobson I., Janjua N., Janssen H., Jarcuska P., Kabagambe K., Kanto T., Kao J.-H., Kaymakoglu S., Kershenobich D., Khamis F., Kim D.J., Kim D.Y., Kondili L.A., Kottilil S., Kramvis A., Kugelmas M., Kurosaki M., Lacombe K., Lagging M., Lao W.-C., Lavanchy D., Lazarus J.V., Lee A., Lee S.S., Levy M., Liakina V., Lim Y.-S., Liu S., Maddrey W., Malekzadeh R., Marinho R.T., Mathur P., Maticic M., Mendes Correa M.C., Mera J., Merat S., Mogawer S., Mohamed R., Muellhaupt B., Muljono D., Mostafa I., Nahum M.S., Nawaz A., Negro F., Ninburg M., Ning Q., Ntiri- Reid B., Nymadawa P., Oevrehus A., Ormeci N., Orrego M., Osman A., Oyunsuren T., Pan C., Papaevangelou V., Papatheodoridis G., Popping S., Prasad P., Prithiviputh R., Qureshi H., Ramji A., Razavi-Shearer K., Reddy R., Remak W., Richter C., Ridruejo E., Robaeys G., Roberts S., Roberts L., Roudot-Thoraval F., Saab S., Said S., Salamat A., Sanai F., Sanchez-Avila J.F., Schiff E., Schinazi R., Sebastiani G., Seguin-Devaux C., Shanmugam R.P., Sharara A., Shilton S., Shouval D., Sievert W., Simonova M., Sohrabpour A.A., Sonderup M., Soza A., Wendy Spearman C., Steinfurth N., Sulkowski M., Tan S.-S., Tanaka J., Tashi D., Thein H.-H., Thompson P., Tolmane I., Toy M., Valantinas J., Van de Vijver D., Velez-Moller P., Vince A., Waked I., Wang S., Wedemeyer H., Wong V., Xie Q., Yamada S., Yang H.-I., Yesmembetov K., Yilmaz Y., Younossi Z., Yu M.-L., Yuen M.-F., Yurdaydin C., Yusuf A., Zekry A., Zeuzem S., Medical Microbiology & Infectious Diseases, Virology, and Negro, Francesco

Subjects
ddc:616, Carcinoma, Hepatocellular, Hepatology, Hepatitis, Viral, Human, business.industry, Liver Neoplasms, ddc:616.07, medicine.disease, World Health Organization, Virology, digestive system diseases, Goal, Infectious Diseases, Absolute (philosophy), SDG 3 - Good Health and Well-being, medicine, Humans, Viral hepatitis, business, Goals, Human
Abstract

The 69th World Health Assembly endorsed the Global Health Sector Strategy for Viral Hepatitis, embracing a goal to eliminate hepatitis infection as a public health threat by 2030. This was followed by the World Health Organization's (WHO) global targets for the care and management of hepatitis B virus (HBV) and hepatitis C virus (HCV) infections. These announcements and targets were important in raising awareness and calling for action; however, tracking countries’ progress towards these elimination goals has provided insights to the limitations of these targets. The existing targets compare a country's progress relative to its 2015 values, penalizing countries who started their programmes prior to 2015, countries with a young population, or countries with a low prevalence. We recommend that (1) WHO simplify the hepatitis elimination targets, (2) change to absolute targets and (3) allow countries to achieve these disease targets with their own service coverage initiatives that will have the maximum impact. The recommended targets are as follows: reduce HCV new chronic cases to ≤5 per 100000, reduce HBV prevalence among 1-year-olds to ≤0.1%, reduce HBV and HCV mortality to ≤5 per 100000, and demonstrate HBV and HCV year-to-year decrease in new HCV- and HBV-related HCC cases. The objective of our recommendations is not to lower expectations or diminish the hepatitis elimination standards, but to provide clearer targets that recognize the past and current elimination efforts by countries, help measure progress towards true elimination, and motivate other countries to follow suit.

Published
2021

5. Sustained virological response with telaprevir in 1,078 patients with advanced hepatitis C: the international telaprevir access program.

Author

Colombo M, Strasser S, Moreno C, Abrao Ferreira P, Urbanek P, Fernández I, Abdurakmonov D, Streinu-Cercel A, Verheyen A, Iraqi W, DeMasi R, Hill A, Lonjon-Domanec I, and Wedemeyer H

Subjects
Adult, Aged, Antiviral Agents administration & dosage, Drug Therapy, Combination, Female, Hepacivirus classification, Hepacivirus drug effects, Hepacivirus genetics, Humans, Interferon alpha-2, Interferon-alpha administration & dosage, Liver Cirrhosis drug therapy, Liver Cirrhosis virology, Male, Middle Aged, Oligopeptides administration & dosage, Polyethylene Glycols administration & dosage, Recombinant Proteins administration & dosage, Ribavirin administration & dosage, Treatment Outcome, Young Adult, Antiviral Agents therapeutic use, Hepatitis C, Chronic drug therapy, Hepatitis C, Chronic virology, Oligopeptides therapeutic use
Abstract

Background & Aims: There is little information regarding the extent to which difficult to cure patients with advanced liver fibrosis, due to hepatitis C virus genotype-1 (HCV-1) can successfully and safely be treated with triple therapy with telaprevir (TVR), pegylated interferon alpha (P) and ribavirin (R). In the TVR early access program HEP3002 we aimed to explore treatment safety and efficacy, and identify predictors of sustained virological response at week 24 (SVR24)., Methods: 1078 patients with bridging fibrosis (n=552) or cirrhosis (n=526) diagnosed by either liver biopsy or non-invasive markers, with compensated bone marrow (neutrophils >1500/mm(3), Hb >12/13 g/dl) and liver function (Albumin >3.3g/dl, Platelets >90,000/ml) received TVR PR for 12 weeks, followed by a PR tail according to label., Results: Overall, 614 (57%) achieved SVR24 by intention-to-treat analysis. The SVR24 rate was 68% in 221 treatment naïve patients (62.8% F4), 72% in 356 prior relapsers (64.4% F4), 55% in 139 partial responders (53.2% F4), and 34% in 294 null responders (28.6% F4). The SVR24 rate to response-guided therapy (24 weeks treatment duration if undetectable viremia at weeks 4 and 12) was 84% in 222 naïve/relapser F3 patients. Independent predictors of response were: (A) F3 (odds ratio (OR)=1.51, 95% CI 1.31-2.00, p=0.005), (B) subtype 1b (OR=1.63, 95% CI 1.18-2.24, p=0.0029), (C) alpha-fetoprotein <10 ng/ml (OR=2.50, 95% CI 1.87-3.36, p<0.0001) and (D) any prior response other than null (OR=3.29, 95% CI 2.40-4.52, p<0.0001). SVR24 rose for patients who had more of these predictive factors: 6/32 (19%) for none, 38/139 (27%) for 1, 129/260 (50%) for 2, 202/329 (61%) for 3, and 194/235 (83%) for 4 factors. Grade 2-4 treatment-related adverse events (AE) were experienced by 719 (67%) patients; 169 (16%) discontinued therapy for AE and 7 (0.6%) died during the PR tail., Conclusions: Naïve and experienced patients with advanced fibrosis or cirrhosis due to HCV-1 who have compensated bone marrow and liver function, can effectively and safely be treated by TVR triple therapy. Baseline predictors of outcome have been identified to optimize pre-treatment counselling., (Copyright © 2014 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.)

Published
2014
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