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Article: Estimation of basic reproduction number (R

Mai, Nguyen Tuan Anh / Trinh, Thi Bich Ngoc / Nguyen, Van Tam / Lai, Thi Ngoc Ha / Le, Nam Phuong / Nguyen, Thi Thu Huyen / Nguyen, Thi Lan / Ambagala, Aruna / Do, Duc Luc / Le, Van Phan

Frontiers in veterinary science

2022 Volume 9, Page(s) 918438

Abstract: ... Basic reproduction number (R ...

Abstract	African swine fever (ASF) is a devastating disease affecting the global swine industry. Recently, it has spread to many countries in Africa, Europe, Asia, and the Caribbean, leaving severe damage to local, regional, national, and global economies. Due to its highly complex molecular characteristics and pathogenesis, the development of a successful vaccine has been an unmet challenge. Therefore, ASF control relies solely on biosecurity, rapid detection, and elimination. Epidemiological information obtained from natural ASF outbreaks is critical for designing and implementing ASF control measures. Basic reproduction number (R
Language	English
Publishing date	2022-09-29
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2834243-4
ISSN	2297-1769
ISSN	2297-1769
DOI	10.3389/fvets.2022.918438
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Article: Spatial Transcriptomic Analysis Using R-Based Computational Machine Learning Reveals the Genetic Profile of Yang or Yin Deficiency Syndrome in Chinese Medicine Theory.

Zhang, Cheng / Tam, Chi Wing / Tang, Guoyi / Chen, Yuanyuan / Wang, Ning / Feng, Yibin

Evidence-based complementary and alternative medicine : eCAM

2022 Volume 2022, Page(s) 5503181

Abstract: ... Yin deficiency by reanalyzing a transcriptomic data set retrieved from the GEO database using R-based ... of spatial transcriptomic analysis using R-based machine learning approaches to elucidate molecular profiles ... on peripheral blood mononuclear cells (PBMCs). The add-on functions in R including GEOquery, DESeq2, WGCNA ...

Abstract	Objectives: Yang and Yin are two main concepts responsible for harmonious balance reflecting health conditions based on Chinese medicine theory. Of note, deficiency of either Yang or Yin is associated with disease susceptibility. In this study, we aim to clarify the molecular feature of Yang and Yin deficiency by reanalyzing a transcriptomic data set retrieved from the GEO database using R-based machine learning analyses, which lays a foundation for medical diagnosis, prevention, and treatment of unbalanced Yang or Yin. Methods: Besides conventional methods for target mining, we took the advantage of spatial transcriptomic analysis using R-based machine learning approaches to elucidate molecular profiles of Yin and Yang deficiency by reanalyzing an RNA-Seq data set (GSE87474) in the GEO focusing on peripheral blood mononuclear cells (PBMCs). The add-on functions in R including GEOquery, DESeq2, WGCNA (target identification with a scale-free topological assumption), Scatterplot3d, Tidyverse, and UpsetR were used. For information in the selected GEO data set, PBMCs representing 20,740 expressed genes were collected from subjects with Yang or Yin deficiency ( Results: The symptomatic gene targets for Yang deficiency (KAT2B, NFKB2, CREBBP, GTF2H3) or Yin deficiency (JUNB, JUND, NGLY1, TNF, RAF1, PPP1R15A) were potentially discovered. CREBBP was identified as a shared key contributive gene regulating either the Yang or Yin deficiency group. The intrinsic molecular characteristics of these specific genes could link with clinical observations of Yang/Yin deficiency, in which Yang deficiency is associated with immune dysfunction tendency and energy deregulation, while Yin deficiency mainly contains oxidative stress, dysfunction of the immune system, and abnormal lipid/protein metabolism. Conclusion: Our study provides representative gene targets and modules for supporting clinical traits of Yang or Yin deficiency in Chinese medicine theory, which is beneficial for promoting the modernization of Chinese medicine theory. Besides, R-based machine learning approaches adopted in this study might be further applied for investigating the underlying genetic polymorphisms related to Chinese medicine theory.
Language	English
Publishing date	2022-03-16
Publishing country	United States
Document type	Journal Article
ZDB-ID	2171158-6
ISSN	1741-4288 ; 1741-427X
ISSN (online)	1741-4288
ISSN	1741-427X
DOI	10.1155/2022/5503181
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Article ; Online: Excellent outcomes in older patients with primary CNS lymphoma treated with R-MPV/cytarabine without whole brain radiotherapy or autologous stem cell transplantation therapy.

Tatarczuch, Maciej / Paul, Erin / Gilberston, Michael / Gregory, Gareth P / Tam, Constantine / Quach, Hang / Bazargan, Ali / Filshie, Robin / Ku, Matthew / Tey, Amanda / Shortt, Jake / Opat, Stephen

Leukemia & lymphoma

2020 Volume 62, Issue 1, Page(s) 112–117

Abstract: ... intent using R-MPV/Ara-C with omission of consolidative radiotherapy in older patients. Outcomes ...

Abstract	Primary CNS lymphoma (PCNSL) in immunocompetent patients is a disease of older adults who are often unsuitable for the high dose therapy or experience substantial morbidity from whole brain radiotherapy. As therapeutic studies in older patients are limited, there is a need for real world data to guide patient care. Here we report a series of 38 consecutive immunocompetent patients with PCNSL treated with curative intent using R-MPV/Ara-C with omission of consolidative radiotherapy in older patients. Outcomes for patients aged < 60 years and > 60 years were similar with overall response rates of 100% vs 85%, (
MeSH term(s)	Aged ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Brain ; Central Nervous System Neoplasms/drug therapy ; Central Nervous System Neoplasms/therapy ; Combined Modality Therapy ; Cytarabine/therapeutic use ; Hematopoietic Stem Cell Transplantation ; Humans ; Methotrexate/therapeutic use ; Stem Cell Transplantation ; Transplantation, Autologous
Chemical Substances	Cytarabine (04079A1RDZ) ; Methotrexate (YL5FZ2Y5U1)
Language	English
Publishing date	2020-09-27
Publishing country	United States
Document type	Journal Article
ZDB-ID	1042374-6
ISSN	1029-2403 ; 1042-8194
ISSN (online)	1029-2403
ISSN	1042-8194
DOI	10.1080/10428194.2020.1821007
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Article ; Online: RECQ-like helicases Sgs1 and BLM regulate R-loop-associated genome instability.

Chang, Emily Yun-Chia / Novoa, Carolina A / Aristizabal, Maria J / Coulombe, Yan / Segovia, Romulo / Chaturvedi, Richa / Shen, Yaoqing / Keong, Christelle / Tam, Annie S / Jones, Steven J M / Masson, Jean-Yves / Kobor, Michael S / Stirling, Peter C

The Journal of cell biology

2017 Volume 216, Issue 12, Page(s) 3991–4005

Abstract: Sgs1, the orthologue of human Bloom's syndrome helicase BLM, is a yeast DNA helicase functioning in DNA replication and repair. We show ... ...

Abstract	Sgs1, the orthologue of human Bloom's syndrome helicase BLM, is a yeast DNA helicase functioning in DNA replication and repair. We show that
MeSH term(s)	Bloom Syndrome/genetics ; Bloom Syndrome/metabolism ; Bloom Syndrome/pathology ; Cell Line, Transformed ; Cell Line, Tumor ; DNA/chemistry ; DNA/genetics ; DNA/metabolism ; DNA Repair ; DNA Replication ; Fibroblasts/metabolism ; Fibroblasts/pathology ; Gene Dosage ; Gene Expression Regulation ; Genomic Instability ; Histones/genetics ; Histones/metabolism ; Humans ; Nucleic Acid Conformation ; Protein Binding ; RNA/genetics ; RNA/metabolism ; RecQ Helicases/genetics ; RecQ Helicases/metabolism ; Saccharomyces cerevisiae/genetics ; Saccharomyces cerevisiae/metabolism ; Saccharomyces cerevisiae/ultrastructure ; Saccharomyces cerevisiae Proteins/genetics ; Saccharomyces cerevisiae Proteins/metabolism
Chemical Substances	Histones ; Saccharomyces cerevisiae Proteins ; RNA (63231-63-0) ; DNA (9007-49-2) ; Bloom syndrome protein (EC 3.6.1.-) ; SGS1 protein, S cerevisiae (EC 3.6.1.-) ; RecQ Helicases (EC 3.6.4.12)
Language	English
Publishing date	2017-10-17
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	218154-x
ISSN	1540-8140 ; 0021-9525
ISSN (online)	1540-8140
ISSN	0021-9525
DOI	10.1083/jcb.201703168
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Article ; Online: ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV.

Ferenci, Peter / Bernstein, David / Lalezari, Jacob / Cohen, Daniel / Luo, Yan / Cooper, Curtis / Tam, Edward / Marinho, Rui T / Tsai, Naoky / Nyberg, Anders / Box, Terry D / Younes, Ziad / Enayati, Pedram / Green, Sinikka / Baruch, Yaacov / Bhandari, Bal Raj / Caruntu, Florin Alexandru / Sepe, Thomas / Chulanov, Vladimir /

Janczewska, Ewa / Rizzardini, Giuliano / Gervain, Judit / Planas, Ramon / Moreno, Christophe / Hassanein, Tarek / Xie, Wangang / King, Martin / Podsadecki, Thomas / Reddy, K Rajender

The New England journal of medicine

2014 Volume 370, Issue 21, Page(s) 1983–1992

Abstract: Background: The interferon-free regimen of ABT-450 with ritonavir (ABT-450/r), ombitasvir, and ... weeks of ABT-450/r-ombitasvir (at a once-daily dose of 150 mg of ABT-450, 100 mg of ritonavir, and 25 mg ... with ABT-450/r-ombitasvir and dasabuvir without ribavirin was associated with high rates of sustained ...

Abstract	Background: The interferon-free regimen of ABT-450 with ritonavir (ABT-450/r), ombitasvir, and dasabuvir with or without ribavirin has shown efficacy in inducing a sustained virologic response in a phase 2 study involving patients with hepatitis C virus (HCV) genotype 1 infection. We conducted two phase 3 trials to examine the efficacy and safety of this regimen in previously untreated patients with HCV genotype 1 infection and no cirrhosis. Methods: We randomly assigned 419 patients with HCV genotype 1b infection (PEARL-III study) and 305 patients with genotype 1a infection (PEARL-IV study) to 12 weeks of ABT-450/r-ombitasvir (at a once-daily dose of 150 mg of ABT-450, 100 mg of ritonavir, and 25 mg of ombitasvir), dasabuvir (250 mg twice daily), and ribavirin administered according to body weight or to matching placebo for ribavirin. The primary efficacy end point was a sustained virologic response (an HCV RNA level of <25 IU per milliliter) 12 weeks after the end of treatment. Results: The study regimen resulted in high rates of sustained virologic response among patients with HCV genotype 1b infection (99.5% with ribavirin and 99.0% without ribavirin) and among those with genotype 1a infection (97.0% and 90.2%, respectively). Of patients with genotype 1b infection, 1 had virologic failure, and 2 did not have data available at post-treatment week 12. Among patients with genotype 1a infection, the rate of virologic failure was higher in the ribavirin-free group than in the ribavirin group (7.8% vs. 2.0%). In both studies, decreases in the hemoglobin level were significantly more common in patients receiving ribavirin. Two patients (0.3%) discontinued the study drugs owing to adverse events. The most common adverse events were fatigue, headache, and nausea. Conclusions: Twelve weeks of treatment with ABT-450/r-ombitasvir and dasabuvir without ribavirin was associated with high rates of sustained virologic response among previously untreated patients with HCV genotype 1 infection. Rates of virologic failure were higher without ribavirin than with ribavirin among patients with genotype 1a infection but not among those with genotype 1b infection. (Funded by AbbVie; PEARL-III and PEARL-IV ClinicalTrials.gov numbers, NCT01767116 and NCT01833533.).
MeSH term(s)	Adult ; Aged ; Anilides/adverse effects ; Anilides/therapeutic use ; Antiviral Agents/adverse effects ; Antiviral Agents/therapeutic use ; Carbamates/adverse effects ; Carbamates/therapeutic use ; Drug Resistance, Viral ; Drug Therapy, Combination ; Female ; Genotype ; Hemoglobins/analysis ; Hepacivirus/genetics ; Hepacivirus/isolation & purification ; Hepatitis C, Chronic/drug therapy ; Hepatitis C, Chronic/virology ; Humans ; Macrocyclic Compounds/adverse effects ; Macrocyclic Compounds/therapeutic use ; Male ; Middle Aged ; RNA, Viral/blood ; Recurrence ; Ribavirin/adverse effects ; Ribavirin/therapeutic use
Chemical Substances	Anilides ; Antiviral Agents ; Carbamates ; Hemoglobins ; Macrocyclic Compounds ; RNA, Viral ; ombitasvir (2302768XJ8) ; Ribavirin (49717AWG6K) ; paritaprevir (OU2YM37K86)
Language	English
Publishing date	2014-05-04
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMoa1402338
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Article ; Online: Low Resource Complexity R-peak Detection Based on Triangle Template Matching and Moving Average Filter.

Nguyen, Tam / Qin, Xiaoli / Dinh, Anh / Bui, Francis

Sensors (Basel, Switzerland)

2019 Volume 19, Issue 18

Abstract: A novel R-peak detection algorithm suitable for wearable electrocardiogram (ECG) devices is ... matching to accentuate the slope information of the R-peaks and (2) a single moving average filter ... all of which show great potential for detection R-peaks in ECG signals collected from wearable devices. ...

Abstract	A novel R-peak detection algorithm suitable for wearable electrocardiogram (ECG) devices is proposed with four objectives: robustness to noise, low latency processing, low resource complexity, and automatic tuning of parameters. The approach is a two-pronged algorithm comprising (1) triangle template matching to accentuate the slope information of the R-peaks and (2) a single moving average filter to define a dynamic threshold for peak detection. The proposed algorithm was validated on eight ECG public databases. The obtained results not only presented good accuracy, but also low resource complexity, all of which show great potential for detection R-peaks in ECG signals collected from wearable devices.
Language	English
Publishing date	2019-09-16
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2052857-7
ISSN	1424-8220 ; 1424-8220
ISSN (online)	1424-8220
ISSN	1424-8220
DOI	10.3390/s19183997
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Article ; Online: Spatial Transcriptomic Analysis Using R-Based Computational Machine Learning Reveals the Genetic Profile of Yang or Yin Deficiency Syndrome in Chinese Medicine Theory

Cheng Zhang / Chi wing Tam / Guoyi Tang / Yuanyuan Chen / Ning Wang / Yibin Feng

Evidence-Based Complementary and Alternative Medicine, Vol

2022 Volume 2022

Abstract: ... a transcriptomic data set retrieved from the GEO database using R-based machine learning analyses, which lays ... conventional methods for target mining, we took the advantage of spatial transcriptomic analysis using R-based ... on functions in R including GEOquery, DESeq2, WGCNA (target identification with a scale-free topological ...

Abstract	Objectives. Yang and Yin are two main concepts responsible for harmonious balance reflecting health conditions based on Chinese medicine theory. Of note, deficiency of either Yang or Yin is associated with disease susceptibility. In this study, we aim to clarify the molecular feature of Yang and Yin deficiency by reanalyzing a transcriptomic data set retrieved from the GEO database using R-based machine learning analyses, which lays a foundation for medical diagnosis, prevention, and treatment of unbalanced Yang or Yin. Methods. Besides conventional methods for target mining, we took the advantage of spatial transcriptomic analysis using R-based machine learning approaches to elucidate molecular profiles of Yin and Yang deficiency by reanalyzing an RNA-Seq data set (GSE87474) in the GEO focusing on peripheral blood mononuclear cells (PBMCs). The add-on functions in R including GEOquery, DESeq2, WGCNA (target identification with a scale-free topological assumption), Scatterplot3d, Tidyverse, and UpsetR were used. For information in the selected GEO data set, PBMCs representing 20,740 expressed genes were collected from subjects with Yang or Yin deficiency (n = 12 each), based on Chinese medicine-related diagnostic criteria. Results. The symptomatic gene targets for Yang deficiency (KAT2B, NFKB2, CREBBP, GTF2H3) or Yin deficiency (JUNB, JUND, NGLY1, TNF, RAF1, PPP1R15A) were potentially discovered. CREBBP was identified as a shared key contributive gene regulating either the Yang or Yin deficiency group. The intrinsic molecular characteristics of these specific genes could link with clinical observations of Yang/Yin deficiency, in which Yang deficiency is associated with immune dysfunction tendency and energy deregulation, while Yin deficiency mainly contains oxidative stress, dysfunction of the immune system, and abnormal lipid/protein metabolism. Conclusion. Our study provides representative gene targets and modules for supporting clinical traits of Yang or Yin deficiency in Chinese medicine theory, which is ...
Keywords	Other systems of medicine ; RZ201-999
Subject code	006
Language	English
Publishing date	2022-01-01T00:00:00Z
Publisher	Hindawi Limited
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A Cost Analysis and Cost-Utility Analysis of a Community Pharmacist-Led Intervention on Reducing Cardiovascular Risk: The Alberta Vascular Risk Reduction Community Pharmacy Project (R

Tam-Tham, Helen / Clement, Fiona / Hemmelgarn, Brenda R / Manns, Braden J / Klarenbach, Scott W / Tonelli, Marcello / Tsuyuki, Ross T / Al Hamarneh, Yazid N / Penko, Joanne / Weaver, Colin G W / Au, Flora / Weaver, Robert G / Jones, Charlotte A / McBrien, Kerry A

Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

2019 Volume 22, Issue 10, Page(s) 1128–1136

Abstract: Background: A randomized trial (the Alberta Vascular Risk Reduction Community Pharmacy Project) showed that a community pharmacist-led intervention was efficacious for reducing cardiovascular (CV) risk. However, the cost of this strategy is unknown.: ... ...

Abstract	Background: A randomized trial (the Alberta Vascular Risk Reduction Community Pharmacy Project) showed that a community pharmacist-led intervention was efficacious for reducing cardiovascular (CV) risk. However, the cost of this strategy is unknown. Objectives: We examined the short- and long-term cost of a pharmacist-led intervention to reduce CV risk compared to usual care. Methods: We conducted a trial-based cost analysis from the perspective of a publicly funded healthcare system. Over 3 and 12 months of follow-up, we examined specific intervention costs (pharmacy claims), related intervention costs (laboratory tests and medications), and ongoing healthcare costs (physician claims, emergency department visits, and hospital admissions). We also used the validated CV Disease Policy Model-Canada to estimate the long-term effects. Results: A total of 684 participants (mean age 62, 57% male) were included. Overall, there were no significant differences in healthcare costs at 3 or 12 months between the usual care and intervention groups (P = .127). The CV disease-related healthcare cost of managing a patient over a lifetime was estimated to be Can$45 530 (95% uncertainty interval [UI], 45 460-45 580) and Can$40 750 (95% UI, 37 780-43 620) in usual care and intervention groups, respectively, an incremental cost savings of Can$4770 per patient (95% UI, 1900-7760). The intervention dominated usual care (better outcomes and lower costs) across 3-year, 5-year, 10-year, and lifetime horizons. Conclusion: This economic analysis suggests that a clinical pathway-driven pharmacist-led intervention (previously shown to reduce CV risk) was associated with similar measured healthcare costs over 1 year, and lower extrapolated healthcare costs over a patient lifetime. This strategy could be broadly implemented to realize its benefits.
MeSH term(s)	Aged ; Alberta ; Cardiovascular Diseases/prevention & control ; Cost-Benefit Analysis ; Female ; Health Promotion/economics ; Humans ; Male ; Middle Aged ; Pharmaceutical Services ; Professional Role ; Professional-Patient Relations ; Risk Reduction Behavior
Language	English
Publishing date	2019-08-17
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1471745-1
ISSN	1524-4733 ; 1098-3015
ISSN (online)	1524-4733
ISSN	1098-3015
DOI	10.1016/j.jval.2019.05.012
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Article ; Online: Venetoclax plus R- or G-CHOP in non-Hodgkin lymphoma: results from the CAVALLI phase 1b trial.

Blood

2019 Volume 133, Issue 18, Page(s) 1964–1976

Abstract: ... with rituximab or obinutuzumab and cyclophosphamide, doxorubicin, vincristine, and prednisone (R-/G-CHOP ... in the G-CHOP arm; however, safety was manageable. Overall response rates were 87.5% (R-CHOP and G-CHOP ...

Abstract	Novel strategies, such as chemosensitization with targeted agents, that build on the success of standard immunochemotherapy show promise for the treatment of non-Hodgkin lymphoma (NHL). Here, we report a phase 1b study investigating dose escalation of the BCL2 inhibitor, venetoclax, in combination with rituximab or obinutuzumab and cyclophosphamide, doxorubicin, vincristine, and prednisone (R-/G-CHOP) chemotherapy in B-cell NHL. Objectives included safety assessment and determination of a recommended phase 2 dose (RP2D). Fifty-six patients were enrolled, most with follicular lymphoma (43%) or diffuse large B-cell lymphoma (DLBCL; 32%). Dose-limiting toxicities were reported in 3/14 patients at the first venetoclax dose (200 mg/d), after which dosing was changed from daily to 10 days per cycle and escalated to 800 mg. A further reduction to 5 days per cycle occurred at the 800-mg dose level in the G-CHOP arm. Cytopenias were predominant among grade 3/4 events and reported at a higher rate than expected, particularly in the G-CHOP arm; however, safety was manageable. Overall response rates were 87.5% (R-CHOP and G-CHOP combinations); complete response (CR) rates were 79.2% and 78.1%, respectively. Most double-expressor (BCL2
MeSH term(s)	Aged ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Bridged Bicyclo Compounds, Heterocyclic/therapeutic use ; Cyclophosphamide/therapeutic use ; Disease-Free Survival ; Doxorubicin/therapeutic use ; Female ; Humans ; Lymphoma, Non-Hodgkin/drug therapy ; Lymphoma, Non-Hodgkin/mortality ; Male ; Maximum Tolerated Dose ; Middle Aged ; Prednisone/therapeutic use ; Rituximab/therapeutic use ; Sulfonamides/therapeutic use ; Vincristine/therapeutic use
Chemical Substances	Antibodies, Monoclonal, Humanized ; Bridged Bicyclo Compounds, Heterocyclic ; R-CHOP protocol ; Sulfonamides ; Rituximab (4F4X42SYQ6) ; Vincristine (5J49Q6B70F) ; Doxorubicin (80168379AG) ; Cyclophosphamide (8N3DW7272P) ; venetoclax (N54AIC43PW) ; obinutuzumab (O43472U9X8) ; Prednisone (VB0R961HZT)
Language	English
Publishing date	2019-03-08
Publishing country	United States
Document type	Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	80069-7
ISSN	1528-0020 ; 0006-4971
ISSN (online)	1528-0020
ISSN	0006-4971
DOI	10.1182/blood-2018-11-880526
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Article ; Online: Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks.

Feld, Jordan J / Moreno, Christophe / Trinh, Roger / Tam, Edward / Bourgeois, Stefan / Horsmans, Yves / Elkhashab, Magdy / Bernstein, David E / Younes, Ziad / Reindollar, Robert W / Larsen, Lois / Fu, Bo / Howieson, Kevin / Polepally, Akshanth R / Pangerl, Andreas / Shulman, Nancy S / Poordad, Fred

Journal of hepatology

2015 Volume 64, Issue 2, Page(s) 301–307

Abstract: Background & aims: Patients with chronic hepatitis C virus (HCV) infection and cirrhosis have a higher risk for liver-related complications and have historically been more difficult to cure than patients without cirrhosis. We evaluated the safety and ... ...

Abstract	Background & aims: Patients with chronic hepatitis C virus (HCV) infection and cirrhosis have a higher risk for liver-related complications and have historically been more difficult to cure than patients without cirrhosis. We evaluated the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir, without ribavirin, for 12weeks in patients with HCV genotype 1b infection and compensated cirrhosis. Methods: Treatment-naïve and peginterferon/ribavirin treatment-experienced patients received 12weeks of ombitasvir/paritaprevir/ritonavir (25/150/100mg once daily) and dasabuvir (250mgtwicedaily). Key inclusion criteria were hemoglobin ⩾10g/dl, albumin ⩾2.8g/dl, platelet count ⩾25×10(9)/L, creatinine clearance ⩾30ml/min, and Child-Pugh score ⩽6. Efficacy was assessed by the percentage of patients achieving SVR (HCV RNA <25IU/ml) 12weeks post-treatment (SVR12). Efficacy and safety were assessed in all patients receiving study drug. Results: Sixty patients with HCV genotype 1b infection and cirrhosis received treatment. The study population comprised 62% male, 55% treatment-experienced, 83% with IL28B non-CC genotype, 22% with platelet count <90×10(9)/L, and 17% with albumin <3.5g/dl. All 60 patients completed treatment, and SVR12 was achieved in 100% (95% CI, 94.0-100%) of patients. The most common adverse events were fatigue (22%), diarrhea (20%), and headache (18%). Only one patient (1.7%) experienced a serious adverse event. Laboratory abnormalities were infrequently observed and not clinically significant. Conclusions: The HCV regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir without ribavirin for 12weeks achieved 100% SVR12 and was well tolerated in HCV genotype 1b-infected patients with cirrhosis, suggesting that this 12-week ribavirin-free regimen is sufficient in this population.
MeSH term(s)	Adult ; Aged ; Anilides/administration & dosage ; Anilides/adverse effects ; Antiviral Agents/administration & dosage ; Antiviral Agents/adverse effects ; Carbamates/administration & dosage ; Carbamates/adverse effects ; Drug Administration Schedule ; Drug Combinations ; Drug Resistance, Viral ; Drug Therapy, Combination/methods ; Female ; Genotype ; Hepacivirus/genetics ; Hepatitis C, Chronic/complications ; Hepatitis C, Chronic/drug therapy ; Hepatitis C, Chronic/virology ; Humans ; Liver Cirrhosis/complications ; Liver Cirrhosis/drug therapy ; Liver Cirrhosis/virology ; Macrocyclic Compounds/administration & dosage ; Macrocyclic Compounds/adverse effects ; Male ; Middle Aged ; Ribavirin/administration & dosage ; Ribavirin/adverse effects ; Ritonavir/administration & dosage ; Ritonavir/adverse effects ; Sulfonamides/administration & dosage ; Sulfonamides/adverse effects ; Sustained Virologic Response ; Treatment Outcome ; Uracil/administration & dosage ; Uracil/adverse effects ; Uracil/analogs & derivatives
Chemical Substances	Anilides ; Antiviral Agents ; Carbamates ; Drug Combinations ; Macrocyclic Compounds ; Sulfonamides ; ombitasvir (2302768XJ8) ; Ribavirin (49717AWG6K) ; Uracil (56HH86ZVCT) ; dasabuvir (DE54EQW8T1) ; Ritonavir (O3J8G9O825) ; paritaprevir (OU2YM37K86)
Language	English
Publishing date	2015-10-22
Publishing country	Netherlands
Document type	Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	605953-3
ISSN	1600-0641 ; 0168-8278
ISSN (online)	1600-0641
ISSN	0168-8278
DOI	10.1016/j.jhep.2015.10.005
Database	MEDical Literature Analysis and Retrieval System OnLINE

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