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Ewelina Marciniewicz, Przemysław Podgórski, Tomasz Pawłowski, Krzysztof Małyszczak, Katarzyna Fleischer-Stępniewska, Brygida Knysz, Marta Waliszewska-Prosół, Agnieszka Żelwetro, Weronika Rymer, Małgorzata Inglot, Maria Ejma, Marek Sąsiadek, Joanna Bladowska
The study was performed to evaluate cerebral volume changes in HCV-infected subjects before and after interferon-free therapy with direct-acting antiviral agents (DAA). We aimed also to estimate the impact of successful DAA therapy on the neuropsychological state of patients. Eleven HCV genotype 1 (GT1) patients treated with ombitasvir/paritaprevir (boosted with ritonavir) and dasabuvir, with or without ribavirin underwent brain magnetic resonance (MR) before and 24 weeks after completion of therapy. All patients achieved sustained viral response...
February 7, 2019: Journal of the Neurological Sciences
Dilek Torun, Baris Soydas, Nihan Tekkarismaz, Ruya Ozelsancak, Hasan Micozkadioglu, Mehmet Haberal
INTRODUCTION: Hepatitis C virus (HCV) infection is associated with increased mortality and morbidity in kidney transplant patients. The ability to establish a sustained viral response before renal transplant is important for these patients. Direct-acting antiviral agents can increase the sustained viral response in most patients with HCV infection. In this case series, we aimed to determine the efficacy and safety of a combined therapy of ombitasvir, paritaprevir, ritonavir, and dasabuvir with or without ribavirin in patients with HCV genotype 1 infection without cirrhosis and on hemodialysis who were awaiting deceased-donor kidney transplant...
February 14, 2019: Hemodialysis International
D Podzamczer, N Rozas, P Domingo, C Miralles, E Van den Eynde, A Romero, E Deig, H Knobel, J Pasquau, A Antela, B Clotet, P Geijo, E Rodríguez de Castro, M A Casado, A Muñoz, A Casado, For The Pro-Str Study Group
BACKGROUND: To investigate the impact of switching from stable Combined Antiretroviral Therapy (cART) to single-tablet regimen (RPV/FTC/TDF=EVIPLERA®/COMPLERA®) on patient-reported outcomes in HIV-infected adults who cannot tolerate previous cART, in a real-world setting. METHODS: PRO-STR is a 48-week observational, prospective, multicenter study. Presence and magnitude of symptoms (main end point), health-related quality-of-life (HRQoL), adherence, satisfaction with treatment and patient preferences were assessed...
February 12, 2019: Current HIV Research
Inmaculada Jarrin, Ines Suarez-Garcia, Cristina Moreno, Maria Tasias, Jorge Del Romero, Rosario Palacios, Joaquim Peraire, Miguel Gorgolas, Santiago Moreno
BACKGROUND: We compared time to treatment change (TC), viral suppression (VS) and change in CD4+ T-cell counts of first-line antiretroviral regimens (ART). METHODS: We analyzed HIV treatment-naïve adults from the Cohort of the Spanish HIV/AIDS Research Network (CoRIS) initiating the most commonly used ART regimens from September 2014 to November 2015. We used proportional hazards models on the sub-distribution hazard to estimate sub-distribution hazard ratios (sHR) for time to TC, logistic regression to estimate odds ratios (ORs) for VS (viral load<50 copies/ml), and linear regression to assess mean differences in CD4 changes from ART initiation...
February 12, 2019: Antiviral Therapy
Myosotys Rodriguez, Jessica Lapierre, Chet Raj Ojha, Shashank Pawitwar, Mohan Kumar Muthu Karuppan, Fatah Kashanchi, Nazira El-Hage
Accelerated neurological disorders are increasingly prominent among the HIV-infected population and are likely driven by the toxicity from long-term use of antiretroviral drugs. We explored potential side effects of antiretroviral drugs in HIV-infected primary human astrocytes and whether opioid co-exposure exacerbates the response. HIV-infected human astrocytes were exposed to the reverse transcriptase inhibitor, emtricitabine, alone or in combination with two protease inhibitors ritonavir and atazanavir (ERA) with and without morphine co-exposure...
February 11, 2019: Journal of Neurovirology
Hwa-Ping Feng, Luzelena Caro, Christine Fandozzi, Xiaoyan Chu, Zifang Guo, Jennifer Talaty, Deborah Panebianco, Katherine Dunnington, Lihong Du, William D Hanley, Iain P Fraser, Anna Mitselos, Jean-Francois Denef, Inge De Lepeleire, Jan N de Hoon, Corinne Vandermeulen, William L Marshall, Patricia Jumes, Xiaobi Huang, Monika Martinho, Robert Valesky, Joan R Butterton, Marian Iwamoto, Wendy W Yeh
The combination of the hepatitis C virus (HCV) NS5A inhibitor elbasvir and NS3/4A protease inhibitor grazoprevir is a potent, once-daily therapy indicated for the treatment of chronic HCV infection in individuals coinfected with human immunodeficiency virus-1 (HIV). We explored the pharmacokinetic interactions of elbasvir and grazoprevir with ritonavir and ritonavir-boosted HIV protease inhibitors in three phase 1 trials. Drug-drug interaction trials in healthy participants were conducted to evaluate the effect of ritonavir on the pharmacokinetics of grazoprevir ( N = 10) and the potential 2-way pharmacokinetic interaction of elbasvir ( N = 30) or grazoprevir ( N = 39) when coadministered with ritonavir-boosted atazanavir, lopinavir, or darunavir...
February 11, 2019: Antimicrobial Agents and Chemotherapy
Bart G J Dekkers, Wouter F W Bierman, Daan J Touw, Jan-Willem C Alffenaar
No abstract text is available yet for this article.
February 7, 2019: AIDS
Peter Ferenci, Stefan Bourgeois, Peter Buggisch, Suzanne Norris, Manuela Curescu, Dominique Larrey, Fiona Marra, Henning Kleine, Patrick Dorr, Mariem Charafeddine, Eric Crown, Mark Bondin, David Back, Robert Flisiak
Ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin (OBV/PTV/r±DSV±RBV) regimens show high efficacy and good tolerability in clinical trials for chronic hepatitis C virus (HCV) genotypes (GT) 1 or 4. To evaluate whether these results translate to clinical practice, data were pooled from observational studies across 13 countries. Treatment-naïve or -experienced patients, with or without cirrhosis, received OBV/PTV/r±DSV±RBV according to approved local labels and clinical practice. Sustained virologic response at post-treatment Week 12 (SVR12), adverse events (AEs) and comedication management were assessed for patients initiating treatment before June 1, 2017...
February 10, 2019: Journal of Viral Hepatitis
R Karahoda, M Ceckova, F Staud
In spite of remarkable reduction in the number of children born with HIV due to antiretroviral therapy, concerns remain on the short- and long-term effects of antiretroviral drugs at the feto-placental unit. Cardio- and skeletal myopathies have been reported in children exposed to antiretroviral drugs prenatally. These conditions have also been described in perturbed placental transfer of l-carnitine, an essential co-factor in fatty acid oxidation. Due to limited fetal and placental synthesis, carnitine supply is maintained through the placental carnitine uptake from maternal blood by the organic cation/carnitine transporters OCTN1 and OCTN2 (SLC22A4 and SLC22A5, respectively)...
February 5, 2019: Toxicology and Applied Pharmacology
Michael Aboud, Richard Kaplan, Johannes Lombaard, Fujie Zhang, José A Hidalgo, Elmira Mamedova, Marcelo H Losso, Ploenchan Chetchotisakd, Carlos Brites, Jörg Sievers, Dannae Brown, Judy Hopking, Mark Underwood, Maria Claudia Nascimento, Yogesh Punekar, Martin Gartland, Kimberly Smith
BACKGROUND: Doubts exist regarding optimal second-line treatment options for HIV-1-infected patients in resource-limited settings. We assessed safety and efficacy of dolutegravir compared with ritonavir-boosted lopinavir, plus two nucleoside reverse transcriptase inhibitors (NRTIs) in adults in whom previous first-line antiretroviral therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI) plus two NRTIs has failed. METHODS: DAWNING is a phase 3b, open-label, parallel-group, non-inferiority, active-controlled trial done at 58 sites in 13 countries...
February 4, 2019: Lancet Infectious Diseases
Diğdem Özer Etik, Nuretdin Suna, Serkan Öcal, Haldun Selçuk, Ülkü Dağlı, Turan Çolak, Fatih Hilmioğlu, Ahmet Sedat Boyacıoğlu, Mehmet Haberal
OBJECTIVES: The introduction of direct-acting antiviral agents has allowed significant chances for treatment for difficult-to-treat populations. This study aimed to investigate the efficacy, tolerability, and safety of these therapies in both patients with end-stage renal disease and kidney transplant recipients with chronic hepatitis C virus infection. MATERIALS AND METHODS: This study was a retrospective analysis with prospective follow-up of patients. The antiviral combination of ombitasvir 25 mg, paritaprevir 75 mg, ritonavir 50 mg, and dasabuvir 50 mg was prescribed to patients with end-stage renal disease or kidney transplant recipients with noncirrhotic or compensated cirrhotic liver disease...
February 2019: Experimental and Clinical Transplantation
Stein Schalkwijk, Rob Ter Heine, Angela Colbers, Edmund Capparelli, Brookie M Best, Tim R Cressey, Rick Greupink, Frans G M Russel, José Moltó, Mark Mirochnick, Mats O Karlsson, David M Burger
Background: Darunavir 800 mg once (q24h) or 600 mg twice (q12h) daily combined with low-dose ritonavir is used to treat HIV-positive pregnant women. Decreased total darunavir exposure (17%-50%) has been reported during pregnancy, but limited data on unbound exposure are available. Objectives: To evaluate total and unbound darunavir exposures following standard darunavir/ritonavir dosing and to explore the value of potential optimized darunavir/ritonavir dosing regimens for HIV-positive pregnant women...
January 30, 2019: Journal of Antimicrobial Chemotherapy
Ignacio Pérez-Valero, Ronald Ellis, Robert Heaton, Reena Deutsch, Donald Franklin, David B Clifford, Ann Collier, Benjamin Gelman, Christina Marra, John Allen McCutchan, Allison Navis, Ned Sacktor, David Simpson, Igor Grant, Scott Letendre
BACKGROUND: During antiretroviral therapy, HIV RNA can be detected in cerebrospinal fluid (CSF) when it is undetectable in plasma, a condition termed 'CSF viral escape'. The aim of the current study was to determine the prevalence and risk factors for CSF viral escape in two large cohorts in the USA. METHODS: A total of 1264 HIV-infected volunteers enrolled in two US cohorts at their most recent visit between 2003 and 2011 were included in this cross-sectional analysis if their HIV RNA level in plasma was less than 50 copies/ml while receiving stable antiretroviral therapy (ART) (>6 months) and if they had HIV RNA measured in CSF at their most recent visit between 2003 and 2011...
March 1, 2019: AIDS
Joanna Bladowska, Tomasz Pawłowski, Katarzyna Fleischer-Stępniewska, Brygida Knysz, Krzysztof Małyszczak, Agnieszka Żelwetro, Weronika Rymer, Małgorzata Inglot, Marta Waliszewska-Prosół, Maria Ejma, Przemysław Podgórski, Anna Zimny, Marek Sąsiadek
The purpose of this study was to assess cerebral microstructural and perfusion changes in patients with chronic hepatitis C virus (HCV) infection before and after interferon-free therapy, using advanced magnetic resonance (MR) techniques. Eleven HCV-positive patients underwent diffusion tensor imaging (DTI) and perfusion weighted imaging (PWI) using a 1.5T MR unit, before and 24 weeks after completion of interferon-free therapy. DTI fractional anisotropy (FA) and apparent diffusion coefficient (ADC) values were obtained from 14 white matter tracts...
January 31, 2019: Journal of Viral Hepatitis
Jose I Bernardino, Amanda Mocroft, Cedrick Wallet, Stéphane de Wit, Christine Katlama, Peter Reiss, Patrick W Mallon, Laura Richert, Jean-Michel Molina, Hernando Knobel, Philippe Morlat, Abdel Babiker, Anton Pozniac, Francois Raffi, Jose R Arribas
BACKGROUND: Comparison of changes in body composition, adipokines and inflammatory markers after initial therapy with a nucleos(t)ide reverse transcriptase inhibitor (N(t)RTI)- sparing or containing regimen are scarce. DESIGN: Randomised Clinical Trial. METHODS: This is the body composition substudy of NEAT 001/ANRS 143, a randomised trial comparing darunavir/ritonavir (DRV/r) plus either raltegravir (RAL) or tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in 805 ART naïve HIV-infected adults...
2019: PloS One
Necati Örmeci, Orhan Sezgin, Ridvan Karaali, Bilgehan Aygen, Dilara Turan, Serkan Yaras, İlknur Erdem, Orhan Yildiz, Fatih Karakaya, Kenan Ateş, Özgün Ö Asiller
INTRODUCTION: Both hepatitis C virus infection (HCV) and chronic kidney disease (CKD) have been comorbid illnesses with increasing morbidity and mortality. The present study was conducted to present real-life experiences about treatment of HCV and CKD with a fixed-dose combination of paritaprevir 150 mg/day, ritonavir 100 mg/day as a booster, ombitasvir 25 mg/day, and dasabuvir 250 mg twice/day, the PROD regimen. PATIENTS AND METHODS: This was a multicenter, retrospective cohort study...
January 21, 2019: European Journal of Gastroenterology & Hepatology
Anura S Indulkar, Xiaochun Lou, Geoff G Z Zhang, Lynne S Taylor
The aim of this study was to probe the dissolution mechanisms of amorphous solid dispersions (ASDs) of a poorly water soluble drug formulated with a hydrophilic polymer. Ritonavir (RTV) and polyvinylpyrrolidone/vinyl acetate (PVPVA) were used as model drug and polymer respectively. ASDs with drug loadings (DLs) from 10 to 50 wt.% were prepared by solvent evaporation. Surface normalized dissolution experiments were carried out using Wood's intrinsic dissolution apparatus, and both drug and polymer release were quantified...
January 22, 2019: Molecular Pharmaceutics
J P Liu, Y Q Cheng, J M Zhang, H M Jin, H B Ning, K Li, M Y Ma, Y N Wu, Z Peng, H Yin, C P Liu, J Shang
Objective: To recognize the efficacy and safety of paritaprevir/ritonavir-ombitasvir combined with dasabuvir (OBV/PTV/RTV+DSV) in the treatment of genotype 1b chronic hepatitis C. Methods: Patients with genotype 1b chronic hepatitis C who were admitted to the People's Hospital of Henan Province, Huashan Hospital of Shanghai and the Fifth Medical Center of the General Hospital of the People's Liberation Army of China between November 2017 to August 2018 were enlisted. All patients received OBV/PTV/RTV+DSV antiviral therapy...
December 20, 2018: Zhonghua Gan Zang Bing za Zhi, Zhonghua Ganzangbing Zazhi, Chinese Journal of Hepatology
Lama ElZohary, William B Weglicki, Joanna J Chmielinska, Jay H Kramer, I Tong Mak
We determined if HIV-1 expression in transgenic (HIV-1-Tg) rats enhanced hepatic genomic changes related to oxidative/nitrosative stress and lipogenesis during cART-treatment, and assessed effects of Mg-supplementation. A clinically used cART (atazanavir-ritonavir+Truvada) was given orally to control and HIV-1-Tg rats (18 weeks) with normal or 6-fold dietary-Mg. Oxidative/nitrosative and lipogenic genes were determined by real-time RT-PCR. cART induced a 4-fold upregulation of sterol regulatory element-binding protein-1 (SREBP-1) in HIV-1-Tg-rats, but not in controls; Tg rats displayed a 2...
2019: PloS One
Serkan Yaraş, Enver Üçbilek, Osman Özdoğan, Fehmi Ateş, Engin Altıntaş, Orhan Sezgin
BACKGROUND/AIMS: As the most common liver disease in hemodialysis patients, chronic hepatitis C (CHC) can cause cirrhosis and hepatocellular carcinoma, even increase in renal-related mortality. In Turkey, the frequency of anti-hepatitis C virus (HCV) antibodies in hemodialysis patients ranged from 31.4% to 51%. Until recently, the mainstay of the CHC treatment for these patients was pegylated interferon with potential toxicities and low sustained virological response. The 3D regimen, a combination of four drugs (ombitasvir, paritaprevir, dasabuvir, and ritonavir), has recently been used for patients with chronic kidney disease infected with genotype 1a and 1b HCV...
January 22, 2019: Turkish Journal of Gastroenterology: the Official Journal of Turkish Society of Gastroenterology
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