Sofosbuvir: First Global Approval

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Gilead Sciences Inc. U.S. Food and Drug Administration approves Gileads Sovaldi™ (sofosbuvir) for the treatment of chronic hepatitis C. 2013. http://www.gilead.com. Accessed 6 Dec 2013.

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Gilead Sciences Inc. Gilead announces SVR12 rates from three phase 3 studies evaluating a once-daily fixed-dose combination of sofosbuvir and ledipasvir for genotype 1 hepatitis C patients [media release]. 2013. http://www.gilead.com. Accessed 8 Jan 2014.

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Jacobson IM, Gordon SC, Kowdley KV, et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med. 2013;368(20):1867–77.

Han B, Mo H, Wong KA. In vitro analyses of HCV NS5B S282T mutants in multiple HCV genotypes show low levels of reduced susceptibility to sofosbuvir (GS-7977), no cross resistance to other classes of direct-acting antivirals, and hypersensitivity to ribavirin [abstract no. 1078]. Hepatology. 2012;56(4 Suppl):711A–2A.

Rajyaguru S, Xu S, Hebner C, et al. Sofosbuvir selects the NS5B S282T mutation in vitro in genotype 1-6 replicons and is not cross-resistant to resistance associated variants selected by other classes of antiviral inhibitors [abstract no. 1094]. Hepatology. 2013;58(4 Suppl):739A.

Kirby B, Gordi T, Symonds WT, et al. Population pharmacokinetics of sofosbuvir and its major metabolite (GS-331007) in healthy and HCV infected adult subjects [abstract no. 1106]. Hepatology. 2013;58(4 Suppl):746A–7A.

Mogalian E, German P, Brainard DM, et al. Lack of a clinically significant pharmacokinetic drug-drug interaction between sofosbuvir and GS-5816 in healthy volunteers [abstract no. 465]. Hepatology. 2013;58(4 Suppl):431A.

German P, Mathias A, Pang PS, et al. Lack of a clinically significant pharmacokinetic drug-drug interaction between sofosbuvir (GS-7977) and GS-5885 or GS-9669 in healthy volunteers [abstract no. 1888]. Hepatology. 2012;56(4 Suppl):1072A–3A.

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Mathias A, Cornpropst M, Clemons D, et al. No clinically significant pharmacokinetic drug-drug interactions between sofosbuvir (GS-7977) and the immunosuppressants, cyclosporine A or tacrolimus in healthy volunteers [abstract no. 1869]. Hepatology. 2012;56(4 Suppl):1063A–4A.

German P, Moorehead L, Pang PS, et al. Lack of a clinically important pharmacokinetic interaction between norgestimate/ethinyl estradiol and sofosbuvir (SOF) or ledipasvir (LDV) in HCV-uninfected female subjects [abstract no. 469]. Hepatology. 2013;58(4 Suppl):433A.

Kowdley K, Shiffman M, Sheikh A, et al. Sofosbuvir + ribavirin with or without peginterferon is well-tolerated and associated with high SVR rates: integrated results from 4 phase 3 trials in HCV genotype 1-6 [abstract no. 412]. Am J Gastroenterol. 2013;108(Suppl 1):S123.

Lawitz E, Poordad F, Brainard DM, et al. Sofosbuvir in combination with PegIFN and ribavirin for 12 weeks provides high SVR rates in HCV-infected genotype 2 or 3 treatment-experienced patients with and without compensated cirrhosis: results from the LONESTAR-2 study [abstract no. LB-4]. Hepatology. 2013;58(6 Suppl):1380A.

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Curry MP, Forns X, Chung RT, et al. Pretransplant sofosbuvir and ribavirin to prevent recurrence of HCV infection after liver transplantation [abstract no. 213]. Hepatology. 2013;58(4 Suppl):314A–5A.

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Jacobsen IM, Ghalib RH, Rodriguez-Torres M, et al. SVR results of a once-daily regimen of simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in cirrhotic and non-cirrhotic HCV genotype 1 treatment-naive and prior null responder patients: the COSMOS study [abstract no. LB-3]. Hepatology. 2013;58(6 Suppl):1379A.

Sulkowski MS, Gardiner DF, Rodriguez-Torres M, et al. High rate of sustained virologic response with the all- oral combination of daclatasvir (NS5A inhibitor) plus sofosbuvir (nucleotide NS5B inhibitor), with or without ribavirin, in treatment-naive patients chronically infected with HCV genotype 1, 2, or 3 [abstract no. LB-2]. Hepatology. 2012;56(6):1516A–7A.

Sulkowski MS, Gardiner DF, Rodriguez-Torres M, et al. 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) [abstract]. J Gastroenterol Hepatol. 2013;28(Suppl 2):155.

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Gilead Sciences Inc. Gilead announces phase 2 results for sofosbuvir-based regimens in hepatitis C patients before and after liver transplantation [media release]. 2013. http://www.gilead.com. Accessed 8 Jan 2014.

Gilead Sciences. Sofosbuvir + RBV for 16 or 24 weeks and sofosbuvir + PEG + RBV for 12 weeks in subjects with genotype 2 or 3 chronic HCV infection [ClinicalTrials.gov identifier NCT01962441] US National Institutes of Health, ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov/ct2/show/NCT01962441. Accessed 17 Dec 2013.

Gilead Sciences. Open-label study of sofusbuvir + ribavirin with or without peginterferon alfa-2a in subjects with chronic HCV infection who participated in prior Gilead HCV studies [ClinicalTrials.gov identifier NCT01625338] US National Institutes of Health, ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov/ct2/show/NCT01625338. Accessed 17 Dec 2013.

Gilead Sciences. Safety and efficacy study of sofosbuvir plus ribavirin in treatment-naive adults with genotype 1 and 3 chronic HCV infection [ClinicalTrials.gov identifier NCT01896193] US National Institutes of Health, ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov/ct2/show/NCT01896193. Accessed 17 Dec 2013.

Gilead Sciences. Phase 3 study of sofosbuvir and ribavirin [ClinicalTrials.gov identifier NCT01910636] US National Institutes of Health, ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov/ct2/show/NCT01910636. Accessed 17 Dec 2013.

Gilead Sciences. A phase 3, open-label study to investigate the efficacy and safety of sofosbuvir plus ribavirin in chronic genotype 1, 2, 3 and 4 hepatitis C virus (HCV) and human immunodeficiency virus (HIV) co-infected subjects [ClinicalTrials.gov identifier NCT01783678] US National Institutes of Health, ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov/ct2/show/NCT01783678. Accessed 17 Dec 2013.

Gilead Sciences. Sofosbuvir plus ribavirin administered for either 12 or 24 weeks in treatment-naïve and treatment-experienced Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection [ClinicalTrials.gov identifier NCT01713283] US National Institutes of Health, ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov/ct2/show/NCT01713283. Accessed 17 Dec 2013.

Gilead Sciences. Sofosbuvir containing regimens for the treatment of chronic HCV infection in subjects with chronic genotype 1, 2, 3, or 6 HCV infection [ClinicalTrials.gov identifier NCT01826981] US National Institutes of Health, ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov/ct2/show/NCT01826981. Accessed 17 Dec 2013.

Gilead Sciences. GS-7977 and ribavirin in patients with chronic HCV with cirrhosis and portal hypertension with or without liver decompensation [ClinicalTrials.gov identifier NCT01687257] US National Institutes of Health, ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov/ct2/show/NCT01687257. Accessed 17 Dec 2013.

Gilead Sciences. Sofosbuvir plus ribavirin in subjects with HCV infection and renal insufficiency [ClinicalTrials.gov identifier NCT01958281] US National Institutes of Health, ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov/ct2/show/NCT01958281. Accessed 17 Dec 2013.

Gilead Sciences. Safety and efficacy of sofosbuvir plus GS-5816 with or without ribavirin in treatment-naive subjects with chronic HCV infection [ClinicalTrials.gov identifier NCT01858766] US National Institutes of Health, ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov/ct2/show/NCT01858766. Accessed 18 Dec 2013.

Gilead Sciences. Safety and efficacy of sofosbuvir plus GS-5816 with or without ribavirin in treatment-experienced subjects with chronic HCV infection [ClinicalTrials.gov identifier NCT01909804] US National Institutes of Health, ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov/ct2/show/NCT01909804. Accessed 17 Dec 2013.

Gilead Sciences. Expanded access program of sofosbuvir with ribavirin and with or without pegylated interferon in aggressive post-transplant hepatitis C [ClinicalTrials.gov identifier NCT01779518] US National Institutes of Health, ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov/ct2/show/NCT01779518. Accessed 17 Dec 2013.