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Edgar A Rivera-Leon, Iris M Llamas-Covarrubias, Raul A Soria-Rodriguez, Sergio Sanchez-Enriquez, Luz A González-Hernández, Jaime F Andrade-Villanueva, Mara A Llamas-Covarrubias
INTRODUCTION: Patients with HIV+ often present lipid disturbances. The role of ghrelin and obestatin in these lipid disturbances is not clear. The effect of antiretroviral (ART) drugs on those molecules is also unknown. This study measured ghrelin and obestatin levels, as well as metabolic markers, in patients with HIV+ before and after 36 weeks of ART. MATERIAL AND METHODS: Twenty HIV-positive, ART-naïve patients who started a scheme consisting of tenofovir/emtricitabine+lopinavir/ritonavir were enrolled...
October 10, 2018: Endocrinología, Diabetes y Nutrición
Chun-Ming Hong, Chen-Hua Liu, Tung-Hung Su, Hung-Chih Yang, Pei-Jer Chen, Yu-Wen Chen, Jia-Horng Kao, Chun-Jen Liu
BACKGROUND/PURPOSE: Treatment of chronic hepatitis C (CHC) has entered a new era since the introduction of direct-acting antiviral agents (DAAs). Numerous clinical trials have shown that treatment response as well as tolerability of DAAs are superior to those of conventional therapy with pegylated interferon and ribavirin. However, the results of clinical trials may not be directly applied to real-world practice. Therefore our study tried to investigate the effectiveness of various DAA regimens in Taiwanese patients with chronic hepatitis C...
September 26, 2018: Journal of Microbiology, Immunology, and Infection, Wei Mian Yu Gan Ran za Zhi
Norio Itokawa, Masanori Atsukawa, Akihito Tsubota, Tadashi Ikegami, Noritomo Shimada, Keizo Kato, Hiroshi Abe, Tomomi Okubo, Taeang Arai, Ai-Nakagawa Iwashita, Chisa Kondo, Shigeru Mikami, Toru Asano, Yasushi Matsuzaki, Hidenori Toyoda, Takashi Kumada, Etsuko Iio, Yasuhito Tanaka, Katsuhiko Iwakiri
AIM: Although the development of new direct-acting antivirals (DAA) for the treatment of chronic hepatitis C virus (HCV) infection has markedly advanced, how cirrhosis affects DAA treatment remains unclear. We aimed to clarify the impact of cirrhosis on DAA treatment of patients infected with HCV. METHODS: This large-scale, multicenter, retrospective study consisted of 2,130 HCV genotype 1b-infected patients who were treated with one of the following DAA combination therapies: asunaprevir/daclatasvir (ASV/DCV), ledipasvir/sofosbuvir (LDV/SOF) or paritaprevir/ombitasvir/ritonavir (PTV/OBV/r)...
October 11, 2018: Hepatology Research: the Official Journal of the Japan Society of Hepatology
Kevin Robertson, Paul Maruff, Lisa L Ross, David Wohl, Catherine B Small, Howard Edelstein, Mark S Shaefer
Human immunodeficiency virus (HIV)-associated neurocognitive disorders can persist in many patients despite achieving viral suppression while on antiretroviral therapy (ART). Neurocognitive function over 48 weeks was evaluated using a Cogstate test battery assessing psychomotor function, attention, learning, and working memory in 293 HIV-1-infected, ART-experienced, and virologically suppressed adults. The ASSURE study randomized participants 1:2 to remain on tenofovir/emtricitabine (TDF/FTC) and ritonavir-boosted atazanavir (ATV/r) or simplify to abacavir/lamivudine + atazanavir (ABC/3TC + ATV)...
October 8, 2018: Journal of Neurovirology
Gabriel Tremblay, Vasiliki Chounta, James Piercy, Tim Holbrook, Shan Ashton Garib, Evgeny K Bukin, Yogesh Suresh Punekar
OBJECTIVES: To evaluate the cost effectiveness of dolutegravir + abacavir/lamivudine (DTG + ABC/3TC) compared with raltegravir + abacavir/lamivudine (RAL + ABC/3TC) and ritonavir-boosted darunavir + abacavir/lamivudine (DRV/r + ABC/3TC) in HIV-1-infected treatment-naive patients in Russia. METHODS: A dynamic Markov model was developed with five response states and six CD4+ -based health states. Efficacy estimated as probability of viral suppression (HIV RNA <50 copies/ml) at 48 weeks was obtained from a published network meta-analysis...
October 5, 2018: Value in Health Regional Issues
Diana L Shuster, Rajeev M Menon, Bifeng Ding, Amit Khatri, Hong Li, Eric Cohen, Melissa Jewett, Daniel E Cohen, Jiuhong Zha
PURPOSE: To characterize the pharmacokinetics of ombitasvir, paritaprevir, ritonavir, dasabuvir, and ribavirin in hepatitis C virus (HCV)-infected patients with chronic kidney disease stage 4 (CKD4) or end-stage renal disease (ESRD), including those on dialysis, in the open-label phase 3 RUBY-I and RUBY-II studies. METHODS: Patients (n = 18 CKD4, n = 68 ESRD) received ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily ± dasabuvir 250 mg twice daily ± ribavirin 200 mg once daily for 12 or 24 weeks...
October 5, 2018: European Journal of Clinical Pharmacology
Akarin Hiransuthikul, Narukjaporn Thammajaruk, Isariya Techatanawat, Busarat Karachot, Bancha Chuasuwan, Chutima Manamuti, Mariam Duereh, Mathus Sawpitiporn, Jiratchaya Sophonphan, Sivaporn Gatechompol, Anchalee Avihingsanon, Chureeratana Bowonwattanuwong, Kiat Ruxrungtham
BACKGROUND: Ritonavir (RTV) tablet was not available in Thailand until it was manufactured by Government Pharmaceutical Organization of Thailand. We assessed pharmacokinetics (PK), safety and efficacy of generic RTV-boosted atazanavir (ATV) in virologically suppressed HIV-1 infected Thai adults. METHODS: Virologically suppressed HIV-1 infected Thai adults who currently use ATV (either 200 or 300 mg) with Norvir® soft gel capsule (SGC) 100 mg-based regimen were enrolled into this prospective, 48-week single-arm study...
September 28, 2018: Antiviral Therapy
Pere Domingo, Mª Gracia Mateo, Mª Del Mar Gutierrez, Francesc Vidal
The advent of protease inhibitors (PI) in the mid-nineties and its use as part of triple combinations revolutionized the management of HIV infection. Since then, progression to AIDS and AIDS-related deaths can be prevented. However, antiretroviral therapy based on PI has been discouraged for a while given its lower tolerability compared to alternative options; and only recent improvements in pharmacotherapy have renewed the interest for the newest agents within this class. First, the tolerability of the latest PI darunavir (DRV) and atazanavir is much better than for older PI, such as indinavir or lopinavir...
2018: AIDS Reviews
Linna Xie, Zichan Dai, Chunxiu Pang, Dexin Lin, Min Zheng
Water-soluble tetrazolium (WST) dyes, such as WST-1 and WST-8, are widely used in cell proliferation and anti-cell-growth drug screen assays. However, the underlying determinants for WST reduction are still largely unknown. In addition, application of tetrazolium-based assays to cellular glucose metabolism studies has not been fully explored. In the present study, we show here that WST-8 reduction is dependent on cellular glucose metabolism. In order to minimize the variance of live cell number during stimulation, we treated cells with different stimuli and performed tetrazolium-based assays within 6 hours...
2018: International Journal of Biological Sciences
Jincheng Yang, Mina Nikanjam, Brookie M Best, Jorge Pinto, Ellen G Chadwick, Eric S Daar, Peter L Havens, Natella Rakhmanina, Edmund V Capparelli
Lopinavir/ritonavir (LPV/r) is recommended by the World Health Organization as first-line treatment for HIV-infected infants and young children. We performed a composite population pharmacokinetic (PK) analysis on LPV plasma concentration data from 6 pediatric and adult studies to determine maturation and formulation effects from infancy to adulthood. Intensive PK data were available for infants, children, adolescents, and adults (297 intensive profiles/1662 LPV concentrations). LPV PK data included 1 adult, 1 combined pediatric-adult, and 4 pediatric studies (age 6 weeks to 63 years) with 3 formulations (gel-capsule, liquid, melt-extrusion tablets)...
September 25, 2018: Journal of Clinical Pharmacology
Richard E Nelson, Junjie Ma, Jacob Crook, Kristin Knippenberg, Heather Nyman, Damemarie Paul, Stephen Esker, Joanne LaFleur
BACKGROUND: Tenofovir disoproxil fumarate (TDF), a key component in many human immunodeficiency virus (HIV) treatment regimens, is associated with increased renal and bone toxicities. The contributions of such toxicities to treatment costs, as well as the relative differences in treatment costs for various TDF/emtricitabine (FTC) regimens, remains unexplored. OBJECTIVE: To estimate and compare mean overall and renal- and bone-specific costs, including total, inpatient, outpatient, and pharmacy costs in patients treated with TDF/FTC+efavirenz (EFV) compared with several non-EFV-containing TDF/FTC regimens...
October 2018: Journal of Managed Care & Specialty Pharmacy
Monkez M Yousif, Ahmed Elsadek Fakhr, Emad A Morad, Hesham Kelani, Emad F Hamed, Hany M Elsadek, Mahmoud H Zahran, Afify Fahmy Afify, Waleed A Ismail, Ahmed I Elagrody, Nevin F Ibrahim, Fatma A Amer, Ayman M Zaki, Ayman M E M Sadek, Ali M Shendi, George Emad, Hesham A Farrag
The reappearance of HCV infection months or years after sustained virologic response (SVR) may be due to the persistence of HCV in tissue cells in spite of being undetected in serum. This situation is known as occult hepatitis C infection (OCI). We aimed to assess the prevalence of OCI in Egyptian patients with chronic hepatitis C (CHC) who achieved SVR after treatment with direct-acting antiviral agents (DAA). We carried out a cross-sectional study at the Advanced Center for Liver Diseases of Zagazig University Hospitals and Al-Ahrar Viral Hepatitis Treatment Center, Sharkia Governorate, Egypt...
September 1, 2018: Le Infezioni in Medicina
Huda Ansari
BACKGROUND: Lopinavir is specific reversible inhibitors of the enzyme HIV protease with mean oral bioavailability of less than 20% due to extensive hepatic metabolism by cytochrome P450 3A4. The reported half-life of Lopinavir is 5-6 hours and the maximum recommended daily dose is 400 mg/day. All the marketed tablet and capsule formulations of lopinavir are generally combined with Ritonavir, a potent inhibitor of cytochrome P450 3A4, to minimize presystemic metabolism of lopinavir. Hence, to overcome limitations associated with oral administration of lopinavir and to promote single drug administration, utilization of vesicular nanocarriers through topical route could prove to be effective, as the approach combines the inherent advantages of topical route and the drug carrying potential of vesicular nanocarriers across the tough and otherwise impervious skin barrier layer, i...
September 23, 2018: Current HIV Research
Shontreal Cooper, Hyacinth Norris, Joy Lander-Roe, Gregg Alleyne
We report a case of a 22-year-old G1P0010 African-American female with poorly controlled perinatally acquired HIV/AIDS and recent diagnosis of progressive multifocal leukoencephalopathy (PML) by magnetic resonance imaging (MRI). She presented to a tertiary care facility for prenatal care and direct observation therapy after poor medication adherence during pregnancy. After multiple attempts at outpatient ART management, the patient was admitted at 35 weeks' gestation for direct observation therapy for both antiretroviral therapy and anti-seizure medication...
2018: IDCases
So Yeon Park, Jin Seo Lee, Jun Seong Son, Jae-Hoon Ko, Kyong Ran Peck, Younghee Jung, Heung Jeong Woo, Young Soo Joo, Joong Sik Eom, Hyejin Shi
An effective post-exposure prophylaxis (PEP) strategy may limit the spread of infection. However, there is no consensus regarding PEP for Middle East respiratory syndrome coronavirus (MERS-CoV) infection. We assessed the efficacy of ribavirin and lopinavir/ritonavir as PEP for healthcare workers (HCWs) exposed to patients with severe MERS-CoV pre-isolation pneumonia. We assessed the safety of PEP regimen. We retrospectively enrolled HCWs with high-risk exposure to MERS-CoV pre-isolation pneumonia. HCWs who received PEP therapy were classified into the PEP group...
September 18, 2018: Journal of Hospital Infection
Alicia Gutierrez-Valencia, Coral García, Pompeyo Viciana, Yusnelkis Milanés-Guisado, Tamara Fernandez-Magdaleno, Nuria Espinosa, Juan Pasquau, Luis Fernando López-Cortés
BACKGROUND: Simplification strategies of antiretroviral treatment represent effective tools for the reduction of drug-induced toxicity, resistance mutations in case of virological failure and costs. OBJECTIVES: To assess the effectiveness of simplification to atazanavir/ritonavir (ATVrtv) or unboosted atazanavir (ATV400) plus lamivudine, and if low plasma or intracellular ATV Ctrough influence virological outcomes. METHODS: Ambispective observational study in patients with undetectable HIV-RNA who were switched to ATVrtv or ATV400 plus lamivudine once daily...
2018: PloS One
Elizabeth C George, Raffaella Bucciardini, Laura Richert, Nikos Dedes, Vincenzo Fragola, Pythia Nieuwkerk, Bruno Spire, Alain Volny-Anne, Brian West, Jean-Michel Molina, Andrzej Horban, Julie Fox, Anton Pozniak, Stefano Vella, Monique Termote, François Raffi
BACKGROUND: There are few data comparing patient reported outcomes (PROs) in randomized trials of initial antiretroviral therapy (ART). We present results from a substudy of the NEAT001/ANRS143 trial. METHODS: The randomized trial compared first-line DRV/r 800/100mg once daily plus RAL 400mg twice daily and DRV/r plus TDF/FTC 245/200mg once daily. Changes in PROs were assessed with 3 questionnaires: EuroQoL 5 domains (EQ-5D), Centre for Epidemiologic Studies Depression scale (CES-D), and HIV Treatment Satisfaction (HIVTSQ)...
September 3, 2018: Journal of Acquired Immune Deficiency Syndromes: JAIDS
Fuu-Jen Tsai, Mao-Wang Ho, Chih-Ho Lai, Chen-Hsing Chou, Ju-Pi Li, Chi-Fung Cheng, Yang-Chang Wu, Xiang Liu, Hsinyi Tsang, Ting-Hsu Lin, Chiu-Chu Liao, Shao-Mei Huang, Jung-Chun Lin, Chih-Chien Lin, Ching-Liang Hsieh, Wen-Miin Liang, Ying-Ju Lin
Antiretroviral (ART) drugs has previously been associated with lipodystrophic syndrome, metabolic consequences, and neuropsychiatric complications. ART drugs include three main classes of protease inhibitors (PIs), nucleoside analog reverse transcriptase inhibitors (NRTIs), and non-nucleoside reverse transcriptase inhibitors (NNRTIs). Our previous work demonstrated that a high risk of hyperlipidemia was observed in HIV-1-infected patients who received ART drugs in Taiwan. Patients receiving ART drugs containing either Abacavir/Lamivudine (Aba/Lam; NRTI/NRTI), Lamivudine/Zidovudine (Lam/Zido; NRTI/NRTI), or Lopinavir/Ritonavir (Lop/Rit; PI) have the highest risk of hyperlipidemia...
2018: Frontiers in Pharmacology
Su Nwe San, Jun Matsumoto, Yumi Saito, Masako Koike, Hiroaki Sakaue, Yoshinori Kato, Masachika Fujiyoshi, Noritaka Ariyoshi, Harumi Yamada
1. Paritaprevir (PTV) is a non-structural protein 3/4A protease inhibitor developed for the treatment of hepatitis C disease as a fixed dose combination of ombitasvir (OBV) and ritonavir (RTV) with or without dasabuvir. 2. The aim of this study was to evaluate the effects of cytochrome P450 (CYP) 3A5 on in vitro PTV metabolism using human recombinant CYP3A4, CYP3A5 (rCYP3A4, rCYP3A5), and human liver microsomes (HLMs) genotyped as either CYP3A5*1/*1, CYP3A5*1/*3, or CYP3A5*3/*3. 3. The intrinsic clearance (CLint , Vmax /Km ) for the production of a metabolite from PTV in rCYP3A4 was 1...
September 19, 2018: Xenobiotica; the Fate of Foreign Compounds in Biological Systems
Ariel Porcalla, Nella Barshteyn, Scott Snyder, Mondira Bhattacharya
BACKGROUND: Drug-drug interaction (DDIs) are evaluated using pharmacokinetic (PK) simulation models, clinical studies, and scientific publications throughout drug development. DDIs with Norvir (ritonavir) and combination products (eg, Kaletra [lopinavir/ritonavir]) containing ritonavir as a PK enhancer are relevant, because these drugs could affect exposures of CYP3A4 substrates. Application of algorithms proactively identified recently approved drugs, which potentially cause adverse outcomes when given with drugs containing ritonavir...
November 2017: Therapeutic Innovation & Regulatory Science
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