In Clinical Trials Sample Clauses

In Clinical Trials. Persons with genotype 3 who were treatment-naïve and were given sofosbuvir in combination with peginterferon and ribavirin had a 95% response rate. Persons with genotype 4 who were treatment-naïve had a 96% response rate to sofosbuvir in combination with peginterferon and ribavirin for 12 weeks. Note, the number of genotype 4 patients in clinical trials was small (28 patients studied). For those with genotypes 5 and 6, sofosbuvir in combination with peginterferon and ribavirin for 12 weeks is an alternative treatment. In one clinical trial all 6 subjects with genotype 6 and the 1 subject with genotype 5 responded to treatment.
Sample 1
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In Clinical Trials. The treatment response (cure) rate for Epclusa® given for 12 weeks was 99% overall for persons with genotypes 1, 2, 4, 5, and 6 who were never treated before or were treated in the past with peginterferon and ribavirin with or without a protease inhibitor, who did not have cirrhosis, or had compensated (mild) cirrhosis (ASTRAL-1). Persons with genotype 1a had a 98% response rate (ASTRAL -1). Persons with genotype 1b had a 99% response rate (ASTRAL -1). Persons with genotype 2 had a 99% response rate (ASTRAL-2). Persons who were genotype 4 had a 100% response rate (ASTRAL -1). Persons with genotype 5 had a 97% response rate (ASTRAL -1). Persons with genotype 6 had a 100% response rate (ASTRAL -1). The treatment response rate for Epclusa® given for 12 weeks was 95% overall for persons with genotype 3 (ASTRAL-3). For persons with genotype 3 who were treatment naïve without cirrhosis, the response rate was 98% (ASTRAL -3). Persons with genotype 3 who were treatment experienced without cirrhosis had a response rate of 94% (ASTRAL -3). Persons with genotype 3 who were treatment naïve (never before treated) and had compensated (mild) cirrhosis had a 93% response rate (ASTRAL -3). Persons with genotype 3 who were treatment experienced with compensated (mild) cirrhosis had an 89% response rate (ASTRAL -3).
Sample 1
In Clinical Trials. Persons with genotype 1 who were treatment-naïve (never treated before), did not have cirrhosis, and were treated with Harvoni® for 12 weeks had a 99% response (cure) rate. In persons with a baseline viral load of less than 6 million who did not have cirrhosis, the response rate was 97% with 8-week treatment and 96% with 12-week treatment. Persons with cirrhosis who were treatment-naïve had a 94% response rate. Persons without cirrhosis in whom prior treatment with peginterferon, ribavirin and/or a protease inhibitor failed were treated for 12 and 24 weeks with Harvoni®. The response in those who took 12 weeks was 95% and for those who received 24 weeks the response was 99%. Persons with cirrhosis in whom prior treatment with peginterferon, ribavirin, and/or a protease inhibitor failed had an 86% response to 12 weeks and 100% response rate to 24 weeks of Harvoni®. There are no data available on the use of Harvoni for 24 weeks in decompensated cirrhosis. However, in one study of this regimen in persons with genotype 1 with compensated cirrhosis the response was 71%. Persons with genotypes 4, 5, or 6 regardless of prior treatment experience or the presence or absence of compensated cirrhosis took Harvoni® for 12 weeks. Persons who were genotype 4 or 5 had a 93% or better treatment response (cure) rate. Those who were genotype 6 had a 96% response rate.
Sample 1
In Clinical Trials. Persons with genotype 1 who were treatment-naïve (never treated before) and did not have cirrhosis and were treated with sofosbuvir in combination with peginterferon and ribavirin for 12 weeks had a 90% response (cure) rate. Persons who were treatment-naïve genotype 1 with cirrhosis, had an 80% response rate. Those with multiple factors that affect treatment (advanced fibrosis, IL-28b CT or TT genotype (see explanation of test page 2), virus > 800,000 IU/ml) had a 71% response rate. Those who failed previous peginterferon/ribavirin therapy are expected to have approximately this same rate of cure (71%) based on computer modeling. Persons with genotype 1 who were treatment-naïve and were given sofosbuvir plus ribavirin (no peginterferon) for up to 24 weeks had response rates from 50-84% in clinical trials with an overall response rate of 72%. Persons with genotype 2 who were treatment naïve had a ≥ 95% chance of achieving a sustained virologic response from sofosbuvir and ribavirin for 12 weeks. Those with cirrhosis had a response rate of 83% in clinical trials. Persons with genotype 3 who were treatment-naïve, regardless of cirrhosis status had a ≥ 92% response rate to sofosbuvir in combination with ribavirin for 24 weeks. For those who were treatment-experienced, the response rate was 77% and treatment-experienced with cirrhosis, the response rate was 60%. Persons with genotype 3 who were treatment-naïve and were given sofosbuvir in combination with peginterferon and ribavirin (4 to 12 weeks) had a 97% response rate (39 patients studied). Persons with genotype 4 who were treatment-naïve had a 96% response rate to sofosbuvir in combination with peginterferon and ribavirin for 12 weeks. Note, the number of genotype 4 patients in clinical trials was small (28 patients studied). Few data from clinical trials are available for genotypes 5 and 6. Therefore if patients with genotype 5 or 6 need immediate treatment, daily sofosbuvir in combination with peginterferon and ribavirin therapy for 12 weeks is recommended by the American Association for the Study of Liver Diseases (AASLD) and Infectious Disease Society of America (IDSA). No data supports use of a peginterferon-free treatment regimen for those with genotype 5 or 6.
Sample 1
In Clinical Trials. The overall treatment response (cure) rate for Epclusa® and ribavirin given for 12 weeks was 94% for persons with hepatitis C genotypes 1, 2, 3, and 4 with decompensated cirrhosis (Child- Xxxx B or C) who were never treated before or were treated in the past with peginterferon and ribavirin with or without a protease inhibitor (ASTRAL-4). Persons with genotype 1a had a 94% (51/54) response rate. Those with genotype 1b had a 100% (14/14) response rate. Persons with genotype 2 had a 100% (4/4) response rate. Those with genotype 3 had an 85% (11/13) response rate. Persons with genotype 4 had a 100% (2/2) response rate. Genotype 3 subjects with pretreatment Y93H resistance associated polymorphisms (RAPs) treated for 12 weeks with Epclusa® had an 80% response rate. Those with compensated cirrhosis and pretreatment RAPs had a 67% response rate. It is expected that the sustained virologic response rate will improve with the addition of ribavirin.
Sample 1
In Clinical Trials. Persons with genotype 3 who were treatment-naïve and were given sofosbuvir in combination with peginterferon and ribavirin had a 97% response rate (39 patients studied). Persons with genotype 4 who were treatment-naïve had a 96% response rate to sofosbuvir in combination with peginterferon and ribavirin for 12 weeks. Note, the number of genotype 4 patients in clinical trials was small (28 patients studied). Few data from clinical trials are available for genotypes 5 and 6. Therefore if persons with genotype 5 or 6 need immediate treatment, daily sofosbuvir in combination with peginterferon and ribavirin therapy for 12 weeks is recommended by the AASLD and IDSA. No data supports use of a peginterferon-free treatment regimen for those with genotype 5 or 6.
Sample 1

Related to In Clinical Trials

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

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  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

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