所属类别： (12.5毫克/75毫克/50毫克)/片 28片/盒
包装规格： (12.5毫克/75毫克/50毫克)/片 28片/盒
原产地英文商品名：technivie tab (12.5mg/75mg/50mg)/tab 28tabs/box
中文参考商品译名：technivie复方片 (12.5毫克/75毫克/50毫克)/片 28片/盒
肝受损：建议在有中度肝受损(Child-Pugh B)患者不用TECHNIVIE。在有严重肝受损(Child-Pugh C)患者禁忌TECHNIVIE。
12.5mg ombitasvir，75mg paritaprevir，50mg利托那韦.
Food and Drug Administration (FDA) approved TECHNIVIE (ombitasvir, paritaprevir, and ritonavir tablets) in combination with ribavirin (RBV) for the treatment of adults with genotype 4 (GT4) chronic hepatitis C virus (HCV) infection who do not have cirrhosis. TECHNIVIE is the first and only all-oral, interferon-free, direct-acting antiviral treatment approved in the U.S. for adult patients with GT4 chronic HCV infection. The approval of TECHNIVIE marks an important advancement in providing this historically difficult-to-treat population of HCV patients an opportunity for a cure. Virologic cure is defined as a sustained virologic response (SVR), which is when the virus is no longer detectable in the patient’s blood 12 weeks after treatment (SVR12).1 TECHNIVIE is not recommended for use in patients with moderate hepatic impairment (Child-Pugh B).”Physicians have previously had limited options when it comes to treating people living with GT4 chronic hepatitis C,” said Tarek Hassanein, M.D., professor of medicine, University of California San Diego School of Medicine. “The approval of TECHNIVIE in combination with ribavirin is important for these patients who now have an approved all-oral, interferon-free treatment option that provides a high probability of a cure.”The FDA granted priority review to AbbVie for TECHNIVIE, a designation granted to investigational therapies that treat a serious condition and provide a significant improvement in safety or effectiveness. This designation shortened the regulatory review period from the normal 10 months to six months. TECHNIVIE was also granted a Breakthrough Therapy designation by the FDA in 2014, a status given to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence that may demonstrate substantial improvement on at least one clinically significant endpoint compared to available therapy.2″As demonstrated by the PEARL-I study results, TECHNIVIE delivers on AbbVie’s ongoing commitment to provide curative therapies for HCV patients who have historically been considered difficult-to-treat,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie.About the PEARL-I StudyThis approval of TECHNIVIE is based on data from the PEARL-I study, which demonstrated 100 percent sustained virologic response rates at 12 weeks post-treatment (SVR12) in patients who received TECHNIVIE and RBV for 12 weeks. PEARL-I is an open-label Phase 2b study that eva luated the efficacy and safety of TECHNIVIE in GT4 chronic HCV patients without cirrhosis. The study included GT4 patients who were new to therapy (n=42/42) or who had failed previous treatment with pegylated interferon (pegIFN) and RBV (n=49/49). Additionally, 91 percent of patients who were new to therapy achieved SVR12 (n=40/44) after taking TECHNIVIE without RBV. In the treatment-naive group without RBV, on-treatment virologic breakthrough was reported in one patient (two percent), and two patients (five percent) experienced post-treatment relapse. There were no virologic failures in the other treatment arms.There were no discontinuations due to adverse events in these patients. The most commonly reported treatment-emergent adverse events (greater than 10 percent in any group) observed in patients receiving TECHNIVIE or TECHNIVIE with RBV, respectively, were asthenia (weakness) (25-29 percent), fatigue (7-15 percent), nausea (9-14 percent) and insomnia (5-13 percent). Four patients who received TECHNIVIE with RBV experienced decreased hemoglobin (anemia) which required RBV dose reductions; however, none of these patients required blood transfusions or medication to boost their red blood cell production. All patients treated with TECHNIVIE and RBV achieved SVR12.About AbbVie Patient Support ProgramsFor people living with chronic HCV infection who face financial difficulties, the AbbVie Patient Assistance Program provides AbbVie HCV medication at no cost to eligible patients. Additionally, AbbVie’s patient support program, called proCeed™, provides a broad range of patient support options. The proCeed program can be accessed at www.technivie.com or by calling 1-844-2-PROCEED.AbbVie also supports independent nonprofit organizations that assist eligible patients enrolled in federal and private insurance plans with their out-of-pocket medication costs.About TECHNIVIETECHNIVIE is an all-oral antiviral treatment consisting of the fixed-dose combination of paritaprevir/ritonavir (150/100mg) co-formulated with ombitasvir (25mg) dosed once daily and taken with a meal, which is co-administered with weight-based RBV (1000mg or 1200mg in divided doses, twice daily), taken with food. The combination of two direct-acting antivirals, each with distinct mechanisms of action, targets and inhibits specific HCV proteins in the viral replication process.About Hepatitis CHepatitis C is inflammation of the liver caused by an infection with the hepatitis C virus. It is transmitted when an infected person’s blood enters the bloodstream of another person. The Centers for Disease Control (CDC) estimates that 2.7 million people have chronic HCV infection in the U.S.4, which is more than two times as many people affected by the human immunodeficiency virus (HIV).5 There are six major HCV genotypes (GT1-6). While genotype 1 (GT1) is the most preva lent form of HCV in the U.S., accounting for approximately 74 percent of all cases6, GT4 infection is estimated to account for approximately 1.1 percent of HCV infections7, and was historically considered difficult-to-treat. It is estimated that more than one million people currently living with HCV will develop cirrhosis (scarring of the liver) by the year 2020,8 and with HCV-related liver transplants on the rise, it has become a critical public health issue. As the population ages and HCV progresses, it is projected that total annual direct medical costs of HCV in the U.S. will reach $85 billion over the next 20 years.9
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