Sofosbuvir: first global approval.

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M.S. Sulkowski, D.F. Gardiner, M. Rodriguez-Torres, K.R. Reddy, T. Hassanein, I. Jacobson, E. Lawitz, A.S. Lok, F. Hinestrosa, P.J. Thuluvath, H. Schwartz, D.R. Nelson, G.T. Everson, T. Eley, M. Wind-Rotolo, S.-P. Huang, M. Gao, F. McPhee, D. Hernandez, D. Sherman, R. Hindes, W. Symonds, C. Pasquinelli, D.M. Grasela, 1417 SUSTAINED VIROLOGIC RESPONSE WITH DACLATASVIR PLUS SOFOSBUVIR ± RIBAVIRIN (RBV) IN CHRONIC HCV GENOTYPE (GT) 1-INFECTED PATIENTS WHO PREVIOUSLY FAILED TELAPREVIR (TVR) OR BOCEPREVIR (BOC) Journal of Hepatology. ,vol. 58, ,(2013) , 10.1016/S0168-8278(13)61416-6

J. Guedj, P.S. Pang, E. Lawitz, M. Rodriguez-Torres, B. Symonds, A.S. Perelson, 1196 ANALYSIS OF THE KINETICS OF VIRAL DECLINE DURING 14 DAYS OF ADMINISTRATION OF SOFOSBUVIR AND GS-0938 Journal of Hepatology. ,vol. 58, ,(2013) , 10.1016/S0168-8278(13)61197-6

Eric Lawitz, Alessandra Mangia, David Wyles, Maribel Rodriguez-Torres, Tarek Hassanein, Stuart C. Gordon, Michael Schultz, Mitchell N. Davis, Zeid Kayali, K. Rajender Reddy, Ira M. Jacobson, Kris V. Kowdley, Lisa Nyberg, G. Mani Subramanian, Robert H. Hyland, Sarah Arterburn, Deyuan Jiang, John McNally, Diana Brainard, William T. Symonds, John G. McHutchison, Aasim M. Sheikh, Zobair Younossi, Edward J. Gane, Sofosbuvir for previously untreated chronic hepatitis C infection The New England Journal of Medicine. ,vol. 368, pp. 1878- 1887 ,(2013) , 10.1056/NEJMOA1214853

P. German, L. Moorehead, Phillip Pang, M. Vimal, A. Mathias, Lack of a clinically important pharmacokinetic interaction between sofosbuvir or ledipasvir and hormonal oral contraceptives norgestimate/ethinyl estradiol in HCV-Uninfected female subjects The Journal of Clinical Pharmacology. ,vol. 54, pp. 1290- 1298 ,(2014) , 10.1002/JCPH.346

Tarik Asselah, Sofosbuvir-based interferon-free therapy for patients with HCV infection Journal of Hepatology. ,vol. 59, pp. 1342- 1345 ,(2013) , 10.1016/J.JHEP.2013.07.023

Kris V Kowdley, Eric Lawitz, Israel Crespo, Tarek Hassanein, Mitchell N Davis, Michael DeMicco, David E Bernstein, Nezam Afdhal, John M Vierling, Stuart C Gordon, Jane K Anderson, Robert H Hyland, Hadas Dvory-Sobol, Di An, Robert G Hindes, Efsevia Albanis, William T Symonds, M Michelle Berrey, David R Nelson, Ira M Jacobson, Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): An open-label, randomised, multicentre phase 2 trial The Lancet. ,vol. 381, pp. 2100- 2107 ,(2013) , 10.1016/S0140-6736(13)60247-0

Ira M Jacobson, Stuart C Gordon, Kris V Kowdley, Eric M Yoshida, Maribel Rodriguez-Torres, Mark S Sulkowski, Mitchell L Shiffman, Eric Lawitz, Gregory Everson, Michael Bennett, Eugene Schiff, M Tarek Al-Assi, G Mani Subramanian, Di An, Ming Lin, John McNally, Diana Brainard, William T Symonds, John G McHutchison, Keyur Patel, Jordan Feld, Stephen Pianko, David R Nelson, None, Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options The New England Journal of Medicine. ,vol. 368, pp. 1867- 1877 ,(2013) , 10.1056/NEJMOA1214854

Eric Lawitz, Jay P Lalezari, Tarek Hassanein, Kris V Kowdley, Fred F Poordad, Aasim M Sheikh, Nezam H Afdhal, David E Bernstein, Edwin DeJesus, Bradley Freilich, David R Nelson, Douglas T Dieterich, Ira M Jacobson, Donald Jensen, Gary A Abrams, Jama M Darling, Maribel Rodriguez-Torres, K Rajender Reddy, Mark S Sulkowski, Natalie H Bzowej, Robert H Hyland, Hongmei Mo, Ming Lin, Michael Mader, Robert Hindes, Efsevia Albanis, William T Symonds, Michelle M Berrey, Andrew Muir, Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-cirrhotic, treatment-naive patients with genotypes 1, 2, and 3 hepatitis C infection: a randomised, double-blind, phase 2 trial The Lancet Infectious Diseases. ,vol. 13, pp. 401- 408 ,(2013) , 10.1016/S1473-3099(13)70033-1

Anuoluwapo Osinusi, Eric G. Meissner, Yu-Jin Lee, Dimitra Bon, Laura Heytens, Amy Nelson, Michael Sneller, Anita Kohli, Lisa Barrett, Michael Proschan, Eva Herrmann, Bhavana Shivakumar, Wenjuan Gu, Richard Kwan, Geb Teferi, Rohit Talwani, Rachel Silk, Colleen Kotb, Susan Wroblewski, Dawn Fishbein, Robin Dewar, Helene Highbarger, Xiao Zhang, David Kleiner, Brad J. Wood, Jose Chavez, William T. Symonds, Mani Subramanian, John McHutchison, Michael A. Polis, Anthony S. Fauci, Henry Masur, Shyamasundaran Kottilil, Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial. JAMA. ,vol. 310, pp. 804- 811 ,(2013) , 10.1001/JAMA.2013.109309