In Studies Clause Samples
The "In Studies" clause defines the terms and conditions under which certain activities, data, or materials are used or referenced within the context of research studies. Typically, this clause outlines the scope of permitted use, such as allowing access to data or materials solely for the purposes of conducting specified studies, and may set requirements for confidentiality, reporting, or publication. Its core practical function is to ensure that all parties understand the boundaries and obligations related to the use of resources in research, thereby protecting proprietary interests and maintaining compliance with ethical or legal standards.
In Studies. Persons who were genotype 1 with decompensated (severe) cirrhosis who were treated with daclatasvir and sofosbuvir with ribavirin for 12 weeks had a response rate of 83%. The response rate in those who were Child-▇▇▇▇ B was 94% and in those whose cirrhosis was Child-▇▇▇▇ C the response was 56%. Those who had Genotype 3 with decompensated cirrhosis had an 83% response. Persons with genotype 3 who had compensated (mild) cirrhosis were treated with daclatasvir and sofosbuvir for 12 weeks and had a 58% response. The European compassionate-use program treated persons with genotype 3 and cirrhosis for 24 weeks with daclatasvir and sofosbuvir and had an 86% response. Pending further data treatment extension and the addition of ribavirin is recommended. Persons with genotype 3 without cirrhosis who had previous treatment with sofosbuvir plus ribavirin that failed were treated with daclatasvir and sofosbuvir for 12 weeks and had a 71% response. Based on this limited data it is recommended to extend treatment duration to 24 weeks and add ribavirin. There is limited data for retreating persons with genotype 3 and cirrhosis whose previous treatment has failed. Genotype 3 cirrhotic patients given daclatasvir and sofosbuvir with ribavirin for 12 or 16 weeks had an 88% and 89% response rate. Therefore, it is recommended that persons with genotype 3 and compensated (mild) cirrhosis whose previous treatment with sofosbuvir plus ribavirin or peginterferon and ribavirin failed receive daclatasvir plus sofosbuvir and ribavirin for 24 weeks pending additional data.
In Studies. Persons with genotype 1 without cirrhosis who previously failed treatment with a sofosbuvir plus ribavirin containing regimen with or without peginterferon alfa were treated with Harvoni® & ribavirin for 12 weeks and had a 100% response (cure) rate. Persons with genotype 1 who had cirrhosis and previously failed treatment were treated with Harvoni® and ribavirin for 12 weeks and had a 96% response (cure) rate. Persons who had decompensated cirrhosis and were treated with Harvoni® and ribavirin for 12 weeks had an 86% or better response (cure) rate. Persons with genotype 1 or 4 who had a recurrence of hepatitis C infection after transplant had a 95% or better response rate if they had mild to advanced fibrosis or mild cirrhosis. Those with genotype 1 who had moderate cirrhosis (Childs-▇▇▇▇ B) had an 87% response rate. Those with genotype 1 who had advanced cirrhosis (severe/Childs-▇▇▇▇ C) had an 88% response rate after a 12-week treatment course of Harvoni® and ribavirin.
In Studies. Persons with genotype 1 who did not have cirrhosis were treated with daclatasvir and sofosbuvir for 12 weeks and had a 96% response (cure) rate. Those with cirrhosis had a 91% response. Persons with genotype 3 without cirrhosis had a 96% response rate after taking daclatasvir and sofosbuvir for 12 weeks. Those with cirrhosis had a 63% response rate after taking daclatasvir and sofosbuvir for 12 weeks. The European compassionate use program reported an 86% sustained virologic response rate (cure) in persons with genotype 3 with cirrhosis who were treated for 24 weeks. Those with severe cirrhosis (Childs ▇▇▇▇ B or C) had a 70.6% response.
In Studies. Persons with genotype 1 or 4 who had decompensated cirrhosis and were treated with Harvoni® and ribavirin for 12 weeks had an 86% or better response (cure) rate (SOLAR-1). Persons with genotype 1 or 4 who had a recurrence of hepatitis C infection after transplant had a 95% or better response rate if they had mild to advanced fibrosis or mild cirrhosis. Those with genotype 1 who had moderate cirrhosis (Child-▇▇▇▇ B) had an 86% response rate. Those with genotype 1 who had advanced cirrhosis (severe/Child-▇▇▇▇ C) had a 60% response rate after a 12-week treatment course of Harvoni® and ribavirin (SOLAR-1). There is no available data for persons with genotype 5 or 6. Do not share needles or other drug works, toothbrushes, razors, or nail clippers. Cover cuts to prevent blood exposure. Only get a tattoo if the equipment and ink used is sterile (such as at a commercial, regulated tattoo studio). Practice safe sex. Do not drink alcohol or use drugs because these hurt the liver. WHOM TO CALL If you have any questions, contact your primary care provider.
In Studies. In the Optimist-2 study in which patients with cirrhosis were treated with simeprevir and sofosbuvir, sustained virologic response (cure) was achieved by 25 of 34 (74%) patients with HCV genotype 1a and the Q80K mutation and in 35 of 38 (92%) of patients with genotype 1a without the Q80K mutation. Ribavirin is recommended as part of all retreatment regimens for patients in whom prior treatment with NS5A inhibitors has failed.
In Studies. Persons with genotype 1 without cirrhosis who were treated with simeprevir and sofosbuvir for 12 weeks had a 95% response rate. Those who were previously treated with pegylated interferon and ribavirin were treated with simeprevir and sofosbuvir for 12 weeks and had a 95% response rate.
In Studies. Six persons with genotype 1a with baseline NS5A polymorphisms (mutations in the hepatitis C virus that can decrease response to treatment) treated with Zepatier™ and ribavirin for 16 weeks had a 100% response (cure) rate. Persons who had genotype 1a or 1b previously treated with Peg-interferon, ribavirin and a protease inhibitor (boceprevir, simeprevir, or telaprevir) and took Zepatier™ and ribavirin for 12 weeks had an overall 96% response (cure) rate. Five persons with genotype 4 whose previous treatment with peginterferon and ribavirin failed, took Zepatier™ and ribavirin for 16 weeks and had a 100% response (cure) rate.