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Jingjing Yu, Zhu Zhou, Jessica Tay-Sontheimer, Rene H Levy, Isabelle Ragueneau-Majlessi
A total of 103 drugs (including 14 combination drugs) were approved by the U.S. Food and Drug Administration from 2013 to 2016. Pharmacokinetic-based drug interaction profiles were analyzed using the University of Washington Drug Interaction Database and the clinical relevance of these observations was characterized based on information from New Drug Application reviews. CYP3A was identified as a major contributor to clinical drug-drug interactions (DDIs), involved in approximately 2/3 of all interactions. Transporters (alone or with enzymes) were found to participate in about half of all interactions, although most of these were weak-to-moderate interactions...
March 23, 2018: Drug Metabolism and Disposition: the Biological Fate of Chemicals
Audrey C Rosene, Jaymee L Gaspar
The warfarin management strategy for a mechanical mitral valve patient initiated on a ritonavir-based hepatitis C treatment regimen is described. A 62-year-old male with a past medical history of hepatitis C genotype 1a and stable warfarin dose history was initiated on a concomitant Viekira Pak® (VP) regimen containing ritonavir. Prior to initiation of the VP for hepatitis C treatment, the patient was stable on a warfarin dose of 40 mg/wk for 5 months. During treatment with VP, the patient experienced a markedly decreased international normalized ratio (INR) and warfarin requirements ultimately increased 125% from baseline (90 mg/wk)...
January 1, 2018: Journal of Pharmacy Practice
Debasis Das, Mayank Pandya
Hepatitis C virus (HCV) infection is a major health burden worldwide. Approximately, 170-200 million individuals are chronically infected worldwide and a quarter of these patients are at increased risk of developing liver cirrhosis, hepatocellular carcinoma and even liver failure. A complete eradication of the virus is one of the most important treatment goal for antiviral research. In 2011, the first-generation protease inhibitors boceprevir (BOC) telaprevir (TVR) have been approved by FDA as the direct-acting antiviral agents...
September 12, 2017: Mini Reviews in Medicinal Chemistry
V Arya, P Zhao, K S Reynolds, P Mishra, I R Younis
Dasabuvir, a component of VIEKIRA PAK, is a substrate of CYP2C8 enzymes. Prescribing information for VIEKIRA PAK contraindicates gemfibrozil, a strong CYP2C8 inhibitor, because coadministration significantly increases dasabuvir exposures, which may increase the risk of QT prolongation. Clopidogrel may increase dasabuvir exposures primarily due to CYP2C8 inhibition by clopidogrel-acyl-β-D-glucuronide. This commentary outlines the US Food and Drug Administration (FDA) interdisciplinary review team's scientific perspective to address the potential for a significant drug-drug interaction (DDI) between clopidogrel and VIEKIRA PAK...
October 2017: Clinical Pharmacology and Therapeutics
Shih Yea Sylvia Wu, Bridget Faire, Edward Gane
VIEKIRA PAK (ritonavir-boosted paritaprevir/ombitasvir and dasabuvir) is an approved treatment for compensated patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection. This oral regimen has minimal adverse effects and is well tolerated. Cure rates are 97% in patients infected with HCV GT 1a and 99% in those with HCV GT 1b. We report the first case of life-threatening allergic pneumonitis associated with VIEKIRA PAK. This unexpected serious adverse event occurred in a 68-year-old Chinese female with genotype 1b chronic hepatitis C and Child-Pugh A cirrhosis...
2017: Case Reports in Medicine
Nourah Zoman Al-Zoman, Hadir Mohamed Maher, Amal Al-Subaie
BACKGROUND: Ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira Pak(®)) are the newest medicines approved for use in the treatment of hepatitis C virus (HCV) and are available in tablet form as an oral combination. Specifically, these agents are indicated in the treatment of HCV in patients with genotype 1 infection. Due to the therapeutic importance and increased use of Viekira Pak, proper methods for its determination in bulk and pharmaceutical formulations must be developed. RESULTS: The present study describes the development and validation of a simple, rapid, selective and economical reverse phase high performance liquid chromatography-diode array detection (HPLC-DAD) method for the simultaneous determination of paritaprevir (PAR), ombitasvir (OMB), dasabuvir(DAS) and ritonavir (RIT) in bulk and pharmaceutical preparations...
2017: Chemistry Central Journal
A Suarez Benjumea, C Gonzalez-Corvillo, J M Sousa, G Bernal Blanco, M Suñer Poblet, M A Perez Valdivia, F M Gonzalez Roncero, P Acevedo, M A Gentil Govantez
BACKGROUND: Hepatitis C virus (HCV) still has significant prevalence in kidney transplant (KT) recipients and is related to poor recipient and graft survival. New direct-acting antivirals (DAA) are leading to a radical change in the problem. METHODS: We studied HCV prevalence at the time of transplantation and in follow-up patients, the way cases are handled, and the results of DAA. RESULTS: A total of 2,001 KT had been performed in our center since 1978...
November 2016: Transplantation Proceedings
Mary Choy
Calcifediol (Rayaldee) for secondary hyperparathyroidism in adults with chronic kidney disease; dasabuvir/ombitasvir/paritaprevir/ritonavir (Viekira XR) for hepatitis C virus infection; and lixisenatide (Adlyxin) for type-2 diabetes.
November 2016: P & T: a Peer-reviewed Journal for Formulary Management
Catherine L Oberg, Robert J Hiensch, Hooman D Poor
OBJECTIVE: To report a case series of three patients with hepatitis C virus infection who all presented with severe type B lactic acidosis shortly after starting treatment with ombitasvir-paritaprevir-ritonavir-dasabuvir. DESIGN: Case series. SETTING: ICU. PATIENTS: Three patients, all who had HCV cirrhosis with mild hepatic impairment (Child-Pugh A) and had started taking ombitasvir-paritaprevir-ritonavir-dasabuvir within the preceding 2 weeks, presented with similar nonspecific symptoms of lethargy, fatigue, and nausea...
March 2017: Critical Care Medicine
Jerika T Lam, Laura Salazar
PURPOSE: The pharmacology, pharmacokinetics, clinical efficacy, and safety of Viekira, as well as its place in hepatitis C virus (HCV) therapy, are reviewed. SUMMARY: Ombitasvir 25 mg-paritaprevir 150 mg-ritonavir 100 mg plus dasabuvir 250 mg (Viekira) is approved in the United States as a combination direct-acting antiviral agent for treatment-naive or treatment-experienced patients with HCV genotype 1 infection, including those with compensated cirrhosis. It is the first coformulated direct-acting antiviral that targets different stages of the virus's life cycle...
July 15, 2016: American Journal of Health-system Pharmacy: AJHP
Xingquan Zhang
Unlike human immunodeficiency virus (HIV) and hepatitis B virus (HBV), hepatitis C virus (HCV) infection is a curable disease. Current direct antiviral agent (DAA) targets are focused on HCV NS3/4A protein (protease), NS5B protein (polymerase) and NS5A protein. The first generation of DAAs includes boceprevir and telaprevir, which are protease inhibitors and were approved for clinical use in 2011. The cure rate for genotype 1 patients increased from 45% to 70% when boceprevir or telaprevir was added to standard PEG-IFN/ribavirin...
January 2016: Acta Pharmaceutica Sinica. B
Lisa A Raedler
No abstract text is available yet for this article.
March 2015: American Health & Drug Benefits
Parvez S Mantry, Lakshmikant Pathak
Hepatitis C virus (HCV) affects nearly 1.3% of US population and around 2% of people worldwide. It is associated with serious complication of Cirrhosis and Hepatocellular carcinoma leading to significant morbidity and mortality. Until now the only treatment option for this serious disease was interferon based therapy which had poor tolerance and at best SVR (Sustained virological response) in only 50% of cases. With the introduction of other direct - acting antiviral agents the treatment of HCV has been revolutionized with significantly high rates of cure...
2016: Expert Review of Anti-infective Therapy
Brian P Lam, Thomas Jeffers, Zahra Younoszai, Yousef Fazel, Zobair M Younossi
Chronic hepatitis C (CHC) affects over 185 million individuals worldwide, approximately 3% of the world's population. CHC can lead to quality of life impairment, cirrhosis, hepatocellular carcinoma (HCC), liver failure and liver-related death. While CHC has been associated with increases in HCC, liver-related mortality and all-cause mortality, being cured of CHC is associated with improvement in these outcomes. Older interferon-based regimens were complex and toxic and required 6-12 months of therapy, with cure rates averaging around 40-45% for HCV genotype 1...
September 2015: Therapeutic Advances in Gastroenterology
Sai Zhang, Nathaniel D Bastian, Paul M Griffin
BACKGROUND: The standard care of treatment of interferon plus ribavirin (plus protease inhibitor for genotype 1) are effective in 50 % to 70 % of patients with CHC. Several new treatments including Harvoni, Olysio + Sovaldi, Viekira Pak, Sofosbuvir-based regimens characterized with potent inhibitors have been approved by the Food and Drug Administration (FDA) providing more options for CHC patients. Trials have shown that the new treatments increased the rate to 80% to 95%, though with a substantial increase in cost...
August 5, 2015: BMC Gastroenterology
Emma D Deeks
A fixed-dose tablet comprising ombitasvir (an NS5A replication complex inhibitor), paritaprevir (an NS3/4A protease inhibitor) and ritonavir (a cytochrome P450 inhibitor) taken in combination with dasabuvir (an NS5B polymerase inhibitor) is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection in several countries, including the USA (copackaged as Viekira Pak(™)) and those of the EU (Viekirax(®) and Exviera(®)). In phase II and III trials, this interferon-free regimen, taken ± ribavirin, provided high rates of sustained virological response 12 weeks post-treatment in adults with chronic HCV genotype 1a or 1b infection, including those with compensated cirrhosis, liver transplants or HIV-1 co-infection...
June 2015: Drugs
(no author information available yet)
No abstract text is available yet for this article.
May 12, 2015: JAMA: the Journal of the American Medical Association
Kunj Gohil
Nivolumab (Opdivo) for unresectable or metastatic melanoma; ombitasvir/paritaprevir/ritonavir with dasabuvir (Viekira Pak) for hepatitis C virus infection; and olaparib (Lynparza) for ovarian cancer.
March 2015: P & T: a Peer-reviewed Journal for Formulary Management
David B Rein, John S Wittenborn, Bryce D Smith, Danielle K Liffmann, John W Ward
BACKGROUND: New hepatitis C virus (HCV) treatments deliver higher cure rates with fewer contraindications, increasing demand for treatment and healthcare costs. The cost-effectiveness of new treatments is unknown. METHODS: We conducted a microsimulation of guideline testing followed by alternative treatment regimens for HCV among the US population aged 20 and older to estimate cases identified, treated, sustained viral response, deaths, medical costs, quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio (ICER) of different treatment options expressed as discounted lifetime costs and benefits from the healthcare perspective...
July 15, 2015: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
(no author information available yet)
No abstract text is available yet for this article.
February 2, 2015: Medical Letter on Drugs and Therapeutics
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