Technivie(ombitasvir, paritaprevir, and ritonavir tablets)固定剂量组合片治疗基因型4慢性丙型肝炎已获美国FDA批准上市 Technivie是由翁比他韦（ombitasvir）、帕利普韦（paritaprevir）及利托那韦（ritonavir）固定剂量组合片剂,前者为HCV NS5A抑制剂,中间为HCV NS3/4A蛋白酶抑制剂,后者为CYP3A抑制剂。其与利巴韦林联合,专用于治疗无肝硬化的基因型4慢性丙型肝炎病毒（HCV）感染。 推荐剂量是每日早餐时口服1次,2片/次,持续12周，推荐与利巴韦林联合使用。 批准日期：2015年7月24日；公司：AbbVie Inc. Technivie(ombitasvir/paritaprevir/ritonavir)复方片，为口服使用 美国初次批准：2015 作用机制 TECHNIVIE结合了两种直接作用的丙型肝炎病毒抗病毒剂和不同的作用机制[参见微生物学]。 利托那韦对HCV无活性。 利托那韦是一种有效的CYP3A抑制剂，其增加了帕利匹韦的峰和谷血浆药物浓度和总体药物暴露（即，曲线下面积）。 适应证和用途 TECHNIVIE是一种固定剂量的ombitasvir，一种丙肝病毒NS5A抑制剂，paritaprevir，一种丙肝病毒NS3/4A蛋白酶抑制剂，和利托那韦，一种CYP3A抑制剂的组合和适用与利巴韦林[ribavirin]联用为有基因型4慢性丙型肝炎病毒(HCV)感染无硬化患者的治疗。 使用限制：建议TECHNIVIE不为在有中度肝受损患者(Child-Pugh B)使用。 剂量和给药方法 推荐剂量：两片每天1次口服(在早晨)与一餐不考虑脂肪或热量。建议TECHNIVIE与利巴韦林联用。 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。 剂型和规格 片：12.5mg ombitasvir，75mg paritaprevir，50mg利托那韦。 www.120ty.net TECHNIVIE™ (ombitasvir, paritaprevir, and ritonavir tablets) Receives FDA Approval as the First and Only All-Oral, Interferon-Free Treatment for Genotype 4 Chronic Hepatitis C in the U.S. - TECHNIVIE provides an opportunity to treat adults in the U.S. who have genotype 4 (GT4) chronic hepatitis C virus (HCV) infection without cirrhosis, a population historically considered difficult-to-treat - Approval is supported by a robust Phase II clinical trial of 135 chronic HCV GT4 patients, which demonstrated 100 percent sustained virologic response rates at 12 weeks post-treatment (SVR12) in patients who took TECHNIVIE with ribavirin (RBV) TECHNIVIE Rx Pharmacological Class: HCV NS5A inhibitor + HCV NS3/4A protease inhibitor + CYP3A inhibitor Active Ingredient(s): Ombitasvir 12.5mg, paritaprevir 75mg, ritonavir 50mg; tabs. Company AbbVie Indication(s): Chronic hepatitis C virus (HCV) genotype 4 infection without cirrhosis, in combination with ribavirin. Limitations of use: not for use in patients with moderate hepatic impairment. Pharmacology: Ombitasvir is a HCV NS5A inhibitor, which is essential for viral RNA replication and virion assembly. Paritaprevir is a HCV NS3/4A inhibitor, which is necessary for the proteolytic cleavage of the HCV encoded polyprotein and is essential for viral replication. Ritonavir is a CYP3A inhibitor that increases overall drug exposure. Clinical Trials: The efficacy and safety of Technivie was studied in a clinical trial (PEARL-I) in patients with genotype 4 chronic HCV infection without cirrhosis who were either treatment-naive or did not achieve virologic response with prior treatment with pegylated interferon/ribavirin (N=135). The primary endpoint was sustained virologic response defined as HCV RNA < LLOQ 12 weeks after the end of treatment (SVR12). Results showed 100% achieved overall SVR12 in the Technivie (with ribavirin) treated groups. Further, 91% of subjects who were treatment-naive achieved SVR12 after receiving Technivie (without ribavirin). For more clinical trial data, see full labeling. Legal Classification: Rx Adults: Take with a meal. ≥18 years: 2 tabs once daily in the AM for 12 weeks with ribavirin. Treatment-naive (or ribavirin intolerant): may consider administering without ribavirin for 12 weeks. Children: <18 years: not established. Contraindication(s): Severe hepatic impairment. Concomitant alfuzosin, carbamazepine, phenytoin, phenobarbital, rifampin, ergots, ethinyl estradiol, St. John’s wort, lovastatin, simvastatin, pimozide, efavirenz, sildenafil (as Revatio), triazolam, oral midazolam. When coadministered with ribavirin, its contraindications also apply to this combination regimen (eg, Pregnancy Category X). Warnings/Precautions: Monitor hepatic function prior to initiation, during the first 4 weeks, and as clinically indicated thereafter. Consider discontinuing if ALT persistently >10×ULN. Discontinue if ALT elevation is accompanied with liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or INR. HCV/HIV-1 co-infected: give suppressive antiretroviral regimen. Pregnancy (Category B). Use progestin-only contraception or non-hormonal methods during therapy. Nursing mothers. Interaction(s) See Contraindications. Increased risk of ALT elevations esp. in females using ethinyl estradiol-containing drugs; discontinue prior to starting; may resume 2 weeks after Technivie completion. May potentiate substrates of CYP3A, P-gp, BCRP, OATP1B1, or OATP1B3. Potentiated by strong CYP3A inhibitors or P-gp, BCRP, OATP1B1, or OATP1B3 inhibitors. Potentiates ketoconazole (limit max 200mg/day), pravastatin (max 40mg/day), cyclosporine (reduce to 1/5 of current dose and monitor renal function). Concomitant voriconazole, atazanavir, atazanavir/ritonavir, lopinavir/ritonavir, rilpivirine, salmeterol: not recommended. Concomitant tacrolimus (use reduced dose): do not administer on same day as initiating Technivie; monitor tacrolimus levels and renal function. Concomitant quetiapine: consider alternative anti-HCV therapy; if necessary, reduce quetiapine to 1/6 of current dose and monitor. Concomitant fluticasone may reduce serum cortisol; consider alternatives. Concomitant darunavir 800mg (without ritonavir): take at same time as Technivie. May decrease exposure to omeprazole; consider increasing omeprazole dose: max 40mg/day. Caution with antiarrhythmics (eg, amiodarone, bepridil, disopyramide, flecainide, systemic lidocaine, mexiletine, propafenone, quinidine); monitor. Monitor digoxin levels; decrease digoxin dose by 30–50%. Monitor with amlodipine, furosemide, buprenorphine/naloxone, alprazolam. Adverse Reaction(s) Asthenia, fatigue, nausea, insomnia, pruritus, skin reactions; ALT and bilirubin elevations. Notes: For ribavirin specific dosing and safety information, refer to the full prescribing information. How Supplied: Monthly carton—4 x 7 daily dose packs LAST UPDATED: 9/18/2015 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=85130606-e6a4-cf08-4bac-a460a30b0984