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Jiuhong Zha, Bifeng Ding, Haoyu Wang, Weihan Zhao, Chen Yu, Katia Alves, Niloufar Mobashery, Yan Luo, Rajeev M Menon
BACKGROUND/PURPOSE: The 3 direct-acting antiviral (3D) regimen of ombitasvir/paritaprevir/ritonavir plus dasabuvir has recently been approved in several Asian geographic regions for the treatment of hepatitis C virus (HCV) genotype (GT) 1 infection. The pharmacokinetics of the components of the 3D regimen with or without ribavirin were evaluated in healthy Chinese subjects and HCV GT1b-infected Chinese, South Korean, and Taiwanese patients, with or without cirrhosis, to determine how the drug exposures in Asian populations compare with historical data in Western populations...
June 16, 2018: European Journal of Drug Metabolism and Pharmacokinetics
Béla Hunyady, Margit Abonyi, Zsuzsanna Gerlei, Judit Gervain, Gábor Horváth, Viktor Jancsik, Gabriella Lengyel, Erzsébet Makkai, Alajos Pár, Zoltán Péter, Margit Pusztay, Pál Ribiczey, László Rókusz, Christoph Sarrazin, Ferenc Schneider, Simone Susser, Ferenc Szalay, István Tornai, Anna Tusnádi, Eszter Újhelyi, Klára Werling, Mihály Makara
Aim of the study: Combination of ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin (3DDA±RBV) therapy is shown to be effective in HCV genotype 1 (GT1) infected patients. However, sparse data exist in patients who failed previous boceprevir or telaprevir based therapies. Real life efficacy and safety of this combination were evaluated in HCV GT1b infected patients (mostly cirrhotics) with compensated liver disease who failed previous boceprevir or telaprevir based therapies more than a year before...
June 2018: Clinical and Experimental Hepatology
Imam Waked, Gamal Esmat, Rabab Fouad, Naglaa Allam, Mohamed Hassany, Mohammad Mohey, Gamal Shiha, Reham Soliman, Roula B Qaqish, Coleen Hall, Negar N Alami, Sarah Kopecky-Bromberg, Niloufar Mobashery
BACKGROUND: In AGATE-II, treatment with ombitasvir co-formulated with paritaprevir/ritonavir plus ribavirin (RBV) in Egyptians infected with hepatitis C virus genotype 4 (HCV GT4) resulted in high rates of sustained virologic response at Post-Treatment Week 12. This subanalysis examined the effects of treatment in AGATE-II on liver biomarkers in patients with compensated cirrhosis. METHODS: AGATE-II was a phase 3, open-label, partly randomized trial of once-daily ombitasvir/paritaprevir/ritonavir with weight-based RBV in treatment-naive or treatment-experienced patients...
June 13, 2018: Journal of Medical Virology
Robert Flisiak, Ewa Janczewska, Mariusz Łucejko, Ewa Karpińska, Dorota Zarębska-Michaluk, Khalil Nazzal, Beata Bolewska, Jolanta Białkowska, Hanna Berak, Katarzyna Fleischer-Stępniewska, Krzysztof Tomasiewicz, Kornelia Karwowska, Krzysztof Simon, Anna Piekarska, Olga Tronina, Ewelina Tuchendler, Aleksander Garlicki
We followed for 2 years patients treated with Direct Acting Agents (DAA) to assess long-term durability of virologic response, improvement of liver function, reduction of liver stiffness (LS), and risk of hepatocellular carcinoma (HCC).The study included patients from 16 hepatologic centers involved in the AMBER, investigators initiated study on treatment of chronic hepatitis C patients within a programme preceding EU registration of Ombitasvir/Paritaprevir/ritonavir±Dasabuvir±Ribavirin. A total of 204 patients among 209 from the primary study were enrolled; 200 with available testing at 2 years follow-up (2yFU) with undetectable HCV RNA (198 responders and 2 non-responders retreated)...
June 11, 2018: Journal of Viral Hepatitis
Grace Elizabeth Dolman, Paul Selby, William T Gelson
The era of direct acting antivirals has revolutionised the management of chronic hepatitis C infection and improved patient outcomes. The optimal management of patients who require liver transplantation remains a matter of ongoing discussion. Treatment in the post-transplantation setting may be complicated by significant drug-drug interactions between antiviral agents and standard immune suppressive treatment regimens. We describe what we believe to be the first reported case of a patient successfully treated for CHC with ombitasvir/paritaprevir/ritonavir plus dasabuvir, while taking sirolimus following liver transplantation...
June 6, 2018: BMJ Case Reports
Aparna Vasanthakumar, Justin W Davis, Manal Abunimeh, Jonas Söderholm, Jiuhong Zha, Emily O Dumas, Daniel E Cohen, Jeffrey F Waring, Martin Lagging
BACKGROUND: Genetic variants of inosine triphosphatase (ITPA) that confer reduced ITPase activity are associated with protection against ribavirin(RBV)-induced hemolytic anemia in peginterferon(IFN)/RBV-based treatment of hepatitis C virus (HCV). Patients with reduced ITPase activity showed improved treatment efficacy when treated with IFN/RBV. In addition, a genetic polymorphism near the IL28B gene is associated with an improved response to IFN/RBV treatment. RBV has been an important component of IFN-containing regimens, and is currently recommended in combination with several IFN-free regimens for treatment of harder to cure HCV infections...
2018: PloS One
Antonio Ascione, Massimo De Luca, Mario Melazzini, Simona Montilla, Maria Paola Trotta, Salvatore Petta, Massimo Puoti, Vincenzo Sangiovanni, Vincenzo Messina, Savino Bruno, Antonio Izzi, Erica Villa, Alessio Aghemo, Anna Linda Zignego, Alessandra Orlandini, Luca Fontanella, Antonio Gasbarrini, Marco Marzioni, Edoardo G Giannini, Antonio Craxì
PURPOSE: To analyse safety and efficacy of treatment based on ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in the sub-group of GT1 patients older than 65 years. METHODS: We collected data extracted from the ABACUS compassionate-use nationwide Italian programme, in patients with cirrhosis due to hepatitis C virus (HCV) Genotype-1 (GT1) or 4 and at high risk of decompensation. GT1-HCV-infected patients received once-daily ombitasvir/paritaprevir, with the pharmacokinetic enhancer ritonavir (25/150/100 mg) and twice-daily dasabuvir (250 mg) plus Ribavirin (RBV) (OBV/PTV/r + DSV + RBV) for 12 (GT1b) or 24 (GT1a) weeks...
May 28, 2018: Infection
A A Butt, Y Ren, A Puenpatom, J M Arduino, R Kumar, A-B Abou-Samra
BACKGROUND: Chronic kidney disease (CKD) was a relative contraindication to hepatitis C virus (HCV) treatment in the interferon/ribavirin era. AIM: To determine the efficacy, tolerability and safety of sofosbuvir/ledipasvir (SOF/LDV) and paritaprevir/ritonavir/ombitasvir/dasabuvir (PrOD) regimens in persons with CKD. METHODS: We identified persons initiated on a SOF/LDV or PrOD regimen from October 30, 2014 to April 30, 2016. We excluded those with missing HCV genotype or eGFR values...
May 24, 2018: Alimentary Pharmacology & Therapeutics
Lena A Mikolas, Kimberly Jacques, Mostaqul Huq, Charles Krasner, Scott E Mambourg
OBJECTIVES: To evaluate outcomes of a clinical pharmacist specialist (CPS)-managed hepatitis C virus (HCV) treatment clinic (HCVTC) in treating HCV-infected veterans with direct-acting antivirals (DAAs). METHODS: We established a CPS-managed HCVTC under a collaborative practice agreement with our infectious disease physician (IDP). A total of 132 veterans were treated between November 1, 2014, and November 30, 2015. The CPS engaged in pretreatment screening, drug selection, patient education, medication counseling, drug therapy monitoring, drug utilization review, addressing issues on drug adherence, and routine and posttreatment follow-up of patients to assess sustained virologic response (SVR) after 12 weeks of treatment...
January 1, 2018: Journal of Pharmacy Practice
Akio Miyasaka, Yuich Yoshida, Toshimi Yoshida, Akihiko Murakami, Koichi Abe, Ken Ohuchi, Tadashi Kawakami, Daisuke Watanebe, Takao Hoshino, Kei Sawara, Yasuhiro Takikawa
Objective There are few reports on the outcomes of 12-week paritaprevir, ombitasvir, and ritonavir (PTV/OBV/r) treatment in real-world clinical settings. We aimed to evaluate the efficacy and safety of 12-week treatment with ritonavir-boosted paritaprevir and ombitasvir in patients with hepatitis C virus (HCV) genotype 1 infection in a real-world setting. Methods Fifty-eight patients with chronic hepatitis or compensated hepatic cirrhosis and genotype-1 HCV infection were treated with PTV/OBV/r and followed for 24 weeks after the completion of treatment in 10 centers in northern Tohoku...
May 18, 2018: Internal Medicine
Toru Ishikawa, Michitaka Imai, Takashi Owaki, Hiroki Sato, Yujiro Nozawa, Tomoe Sano, Akito Iwanaga, Keiichi Seki, Terasu Honma, Toshiaki Yoshida
The optimum retreatment strategy for chronic hepatitis C virus (HCV) patients who failed directly-acting antiviral agents (DAA)-based therapy is unknown. We herein report the outcomes of an HCV genotype (GT) 2a-infected patient with virologic failure following treatment with sofosbuvir plus ribavirin (SOF + RBV) who was successfully retreated with ombitasvir/paritaprevir/ritonavir plus ribavirin (OBV/PTV/r + RBV).
May 18, 2018: Internal Medicine
J C Del Rio-Valencia, R Asensi-Diez, L Villalobos-Torres, I Muñoz Castillo
OBJECTIVE: Hepatitis C virus (HCV) infection is a major cause of chronic liver disease. Six different genotypes (GT) of HCV (genotypes 1-6) have been identified. The genotype is clinically relevant since the majority of current direct antiviral agents (DAA´s) do not have pangenotypic efficacy. The purpose of this study was to describe the clinical characteristics of real world patients and evaluate the effectiveness of different treatment regimens. METHODS: Retrospective and observational study carried out in a third level hospital...
May 16, 2018: Revista Española de Quimioterapia: Publicación Oficial de la Sociedad Española de Quimioterapia
Vasily Isakov, Dzmitry Paduta, Rolando M Viani, Jeffrey V Enejosa, Viktor Pasechnikov, Olga Znoyko, Pavel Ogurtsov, Pavel O Bogomolov, Marina V Maevskaya, Xiaotian Chen, Nancy S Shulman
OBJECTIVE: An estimated 336 per 100 000 people in Russia are infected with hepatitis C virus, including up to 75% with genotype (GT) 1b. In the TURQUOISE-II/-III trials, a 12-week regimen of the direct-acting antiviral agents ombitasvir (OBV), paritaprevir (PTV), ritonavir, and dasabuvir (DSV) in GT1b-infected patients with compensated cirrhosis resulted in 12-week sustained virologic response (SVR) rates of 100%. PATIENTS AND METHODS: In TURQUOISE-IV, GT1b-infected patients (n=36) from Russia and Belarus with compensated cirrhosis, who were treatment naive or previously treated with pegylated interferon/ribavirin (RBV), received OBV/PTV/ritonavir+DSV+RBV for 12 weeks...
May 14, 2018: European Journal of Gastroenterology & Hepatology
Hironao Okubo, Hitoshi Ando, Yushi Sorin, Eisuke Nakadera, Hiroo Fukada, Junichi Morishige, Akihisa Miyazaki, Kenichi Ikejima
BACKGROUND: Paritaprevir inhibits organic anion-transporting polypeptide (OATP)1B1 and OATP1B3, which transport bilirubin. Hyperbilirubinemia is an adverse event reported during hepatitis C treatment. Gadoxetic acid is also transported by OATP1B1/1B3. We evaluated whether the enhancement effect in gadoxetic acid-enhanced magnetic resonance (MR) imaging could predict the plasma concentration of paritaprevir and might anticipate the development of hyperbilirubinemia. METHODS: This prospective study evaluated 27 patients with hepatitis C who underwent gadoxetic acid-enhanced MR imaging prior to treatment with ombitasvir, paritaprevir, and ritonavir...
2018: PloS One
Vijay Gayam, Mazin Khalid, Amrendra Kumar Mandal, Muhammad Rajib Hussain, Osama Mukhtar, Arshpal Gill, Pavani Garlapati, Binav Shrestha, Debra Guss, Jagannath Sherigar, Mohammed Mansour, Smruti Mohanty
Background: Limited data exists comparing the safety, tolerability, and efficacy of direct-acting antivirals (DAAs) in patients with chronic hepatitis C genotype 4 (HCV GT-4) in the community practice setting. We aim to evaluate the treatment response of DAAs in these patients. Methods: All the HCV GT-4 patients treated with DAAs between January 2014 and October 2017 in a community clinic setting were retrospectively analyzed. Pretreatment baseline patient characteristics, treatment efficacy with sustained virologic response (SVR) at 12 weeks post treatment (SVR12), and adverse reactions were assessed...
April 2018: Gastroenterology Research
Kimberly L Garrison, Polina German, Erik Mogalian, Anita Mathias
Several safe and highly-effective directly-acting antiviral drugs for chronic hepatitis C virus (HCV) have been developed and greatly increase the number of treatment options available to successfully treat HCV infection. However, as treatment regimens contain at least two drugs (e.g., sofosbuvir with daclatasvir, simeprevir, ledipasvir, or velpatasvir; elbasvir and grazoprevir) and up to five drugs (ombitasvir/paritaprevir/ritonavir+dasabuvir+ribavirin), the potential for drug-drug interactions (DDI) becomes an important consideration for HCV-infected individuals with comorbidities that require concomitant medications, such as HIV/HCV co-infection or immunosuppression following liver transplantation...
April 25, 2018: Drug Metabolism and Disposition: the Biological Fate of Chemicals
Leigh Cervino, Lauren M Hynicka
OBJECTIVE: To describe the most current evidence for the use of direct-acting antivirals (DAAs) to treat hepatitis C along the pregnancy-pediatric continuum in the United States. DATA SOURCES: The MEDLINE/PubMed databases were searched (January 1995 to February 2018) for articles in English using the terms: hepatitis C, vertical transmission, pregnancy, pediatrics, ribavirin, interferon, direct acting antivirals, daclatasvir, dasabuvir, elbasvir, glecaprevir, grazoprevir, ledipasvir, ombitasvir, paritaprevir, pibrentasvir, simeprevir, sofosbuvir, and velpatasvir...
April 1, 2018: Annals of Pharmacotherapy
Jan Sperl, Miluse Kreidlova, Dusan Merta, Klara Chmelova, Renata Senkerikova, Sona Frankova
BACKGROUND/AIMS: Chronic hepatitis C (HCV) virus infection reactivates under immunosuppressive drugs and therefore has a negative impact on long-term survival of kidney transplant recipients. Treatment-induced clearance of hepatitis C virus (HCV) in kidney transplant candidates prevents virus reactivation after transplantation. Paritaprevir/Ritonavir/Ombitasvir with Dasabuvir (PrOD) represents a highly effective treatment regimen for HCV genotype 1 (GT1), also suitable for patients with end-stage renal disease (ESRD)...
2018: Kidney & Blood Pressure Research
Kazuhisa Murai, Tetsuro Shimakami, Christoph Welsch, Takayoshi Shirasaki, Fanwei Liu, Juria Kitabayashi, Shiho Tanaka, Masaya Funaki, Hitoshi Omura, Tomoki Nishikawa, Ariunaa Suminyadorj, Masao Honda, Shuichi Kaneko
Simeprevir is a novel NS3/4A protease inhibitor (PI) of hepatitis C virus (HCV). The baseline polymorphism NS3-Q80K is frequently observed in genotype (gt) 1a HCV and often associated with treatment failure in simeprevir-containing regimens. We aimed to elucidate mechanisms of treatment failure due to NS3-Q80K. We included a Q80R mutation in our study and generated a series of Huh-7.5 cells, each of which harbored either wild-type gt 1a H77S.3 or one of the variants, Q80K or Q80R. The cells were cultured with increasing concentrations of simeprevir, and NS3 domain sequences were determined...
April 16, 2018: Antimicrobial Agents and Chemotherapy
S Takeuchi, M Takamura, T Yoshida, K Takahashi, K Hayashi, S Hashimoto, S Yamagiwa, M Tasaki, Y Nakagawa, K Saito, Y Tanabe, Y Tomita, S Terai
A 74-year-old Japanese man with a history of chronic hepatitis C and kidney transplant (KT) was administered pegylated-interferon plus ribavirin therapy. However, this therapy was ineffective. The patient was then hospitalized to receive ombitasvir (OBV) plus paritaprevir (PTV) plus ritonavir (r) antiviral combination therapy. He tested negative for the virus after 4 weeks, and completed 12 weeks of treatment. The patient ultimately achieved a sustained virological response after the 12 weeks of treatment. Cyclosporine (CyA) trough levels, during the OBV-PTV-r therapy, reached a peak within 5 days of initiating therapy, and increases in serum creatinine and total bilirubin were also observed...
April 2018: Transplantation Proceedings
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