scholarly journals On-Treatment Elevation in Hepatic Transaminases during HCV Treatment with Ombitasvir, Paritaprevir, Dasabuvir, Ritonavir, and Ribavirin: A Case Series

2016 ◽  
Vol 2016 ◽  
pp. 1-4
Author(s):  
Madelyne Bean ◽  
Lydia Tang ◽  
Shyam Kottilil ◽  
Kimberly L. Beavers ◽  
Eric G. Meissner
Keyword(s):  
Liver Enzyme ◽  
African American Men ◽  
Case Series ◽  
Virologic Response ◽  
Small Subset ◽  
Genotype 1A ◽  
Hepatic Transaminases ◽  
Medication Modification ◽  
Patients Experience ◽  
Antiviral Medications

Eradication of chronic hepatitis C virus (HCV) infection is now possible with all oral antiviral medications, including the combination of ombitasvir, paritaprevir, dasabuvir, and ritonavir (PrOD) with or without ribavirin. While high rates of sustained virologic response (SVR) can be achieved, a small subset of patients experience on-treatment liver enzyme elevations, in particular women using concurrent estradiol-containing oral contraceptive medications (OCPs). Herein, we describe four cases of liver enzyme elevations within 2-3 weeks of PrOD initiation in African-American men infected with HCV genotype 1a or 1b. Three patients with varying degrees of hepatic fibrosis received a full treatment course without medication modification, achieved SVR, and experienced resolution of liver enzyme abnormalities. One patient with cirrhosis was switched mid-treatment to an alternate HCV regimen, experienced subsequent resolution of liver enzyme abnormalities, and achieved SVR. In summary, these cases suggest that all HCV patients treated with PrOD, independent of gender or concurrent medications, should have laboratory monitoring for liver enzyme elevations, with a particular emphasis on early monitoring in cirrhotic patients.

A case series of 72 neonates with renal vein thrombosis

2004 ◽  
Vol 92 (10) ◽  
pp. 929-933 ◽  
Author(s):  
Stefan Kuhle ◽  
Patti Massicotte ◽  
Anthony Chan ◽  
Lesley Mitchell
Keyword(s):  
Renal Vein ◽  
Case Reports ◽  
Activated Protein C ◽  
Case Series ◽  
Renal Vein Thrombosis ◽  
Diagnostic Techniques ◽  
Small Subset ◽  
Vein Thrombosis ◽  
Neonatal Renal Vein Thrombosis ◽  
Associated Conditions

SummaryNeonatal renal vein thrombosis (RVT) is a well-recognized clinical entity which is associated with serious morbidity. However, current information regarding RVT has been restricted to case reports and small case series. In this study, it was our objective to describe patient demographics, clinical presentation, location and risk factors of RVT. For our study design, we looked at a case series of 72 neonates with RVT referred to the 1-800-NO-CLOTS consultation service between 9/1996 and 8/2001. Data on age, gender, associated conditions, prothrombotic disorders, family history, location of the thrombosis, diagnostic techniques, and treatment were prospectively recorded using a standardized form. Our results show that RVT affected males (65%, CI 52-76%) significantly more often than females (35%, CI 24-48%). Median age at presentation was 2 days (0-21 days). RVT was unilateral in 72% (left side: 67%, CI 49-81%; right side: 33%, CI 19-51%), and bilateral in 28%. The majority (83%) had at least one associated condition: Prematurity (54%), central venous lines (17%), a diabetic mother (13%), asphyxia (6%), infections (6%). Prothrombotic testing was performed in 21 neonates. Activated protein C resistance was found in 8 children (38%), other defects in three. This is the largest case series of neonatal RVT to date. Data from the study show that i) male infants are affected twice as often as females and ii) there appears to be a left-sided predominance of neonatal RVT. Neonatal RVT is only infrequently associated with the presence of a catheter as compared to thrombosis at other sites. The majority of infants have associated conditions with prematurity being most frequent. A small subset of neonates were screened for prothrombotic abnormalities and 50% of the children screened were positive.

Evaluation of hypersensitivity reactions to oxaliplatin in gastrointestinal malignancies.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 709-709 ◽  
Author(s):  
Kelly Markey ◽  
Tyra Gatewood ◽  
Tiffany Valone ◽  
Jonathan R. Strosberg
Keyword(s):  
Adverse Event Reporting System ◽  
Treatment Strategies ◽  
Case Series ◽  
Adverse Event Reporting ◽  
Hypersensitivity Reactions ◽  
Success Rates ◽  
Gastrointestinal Malignancies ◽  
Grade 3 ◽  
Patients Experience ◽  
To Receive

709 Background: Oxaliplatin is an important component of therapy for multiple gastrointestinal cancers. The incidence of hypersensitivity reaction (HSR) to oxaliplatin is approximately 10%, and about 3% are serious in nature (Grade 3 or 4). Data on management of hypersensitivity reactions is limited to small case series, with scarce information on the success rates of rechallenging patients who have previously reacted. Methods: We conducted a retrospective review of patients who had a documented hypersensitivity (HSR) to oxaliplatin utilizing our internal adverse event reporting system from January 1, 2007 until December 31, 2012. Results: 44 patients met inclusion criteria for this study. The majority had a grade 1 or 2 reaction (n = 36 or 81.82%). Seven patients had a grade 3 reaction and one patient experienced a grade 4 reaction. 29 patients were rechallenged with oxaliplatin during subsequent courses. Infusion durations were extended in 79% of cases, and additional premedications were administered in 90%. Two patients were treated with a desensitization protocol, which consisted of serial dilutions of oxaliplatin (given over approximately 8 hours) with a two-stage premedication regimen. With these measures, seventeen of the twenty-nine patients (66%) were able to receive 3 or more additional infusions, thirteen (45%) received 5 or more additional infusions, and 4 (14%) we able to receive 10 or more additional infusions. Conclusions: Our review of hypersensitivity reactions to oxaliplatin demonstrates that the majority of patients experience mild (Grade 1 or 2) reactions and are able to be successfully rechallenged in subsequent courses with modifications in the infusion rate and premedications. The use of these treatment strategies may prevent premature discontinuation of an important backbone drug for the treatment of gastrointestinal malignancies.

scholarly journals PERIPHERALLY INSERTED CENTRAL CATHETERS IN ORTHOPEDIC PATIENTS: EXPERIENCE FROM 1023 PROCEDURES

2018 ◽  
Vol 26 (3) ◽  
pp. 206-210 ◽  
Author(s):  
THAIS QUEIROZ SANTOLIM ◽  
ANDRÉ MATHIAS BAPTISTA ◽  
ARLETE MAZZINI MIRANDA GIOVANI ◽  
JUAN PABLO ZUMÁRRAGA ◽  
OLAVO PIRES DE CAMARGO
Keyword(s):  
Case Series ◽  
Complete Information ◽  
Intravenous Therapy ◽  
Level Of Evidence ◽  
Catheter Tip ◽  
Long Course ◽  
Orthopedic Patients ◽  
Patients Experience ◽  
Central Catheters ◽  
De Medicina

ABSTRACT Objectives The advantages of using a peripherally inserted central catheter (PICC) in hospitalized patients make this device very important for intravenous therapy. This study describes the use of PICCs at the Institute of Orthopedics and Traumatology at the Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo over the last 10 years. Methods This retrospective study analyzed 1,057 medical records and included 1,023 medical files with complete information on the punctured vein, diagnosis, duration of catheterization, complications, and catheter tip positioning. Results Seven hundred and twenty PICCs (70.4%) were considered successfully positioned, and mean duration of catheterization was 34.3 days. The basilic vein was used in 528 (51.6%) patients, while 157 (15.4%) catheters were removed due to complications. No cases of catheter-related thrombosis or infection were found. Eight hundred and sixty-six (84.6%) patients completed their treatment with PICC in place. Conclusion PICC is a safe intravenous device that can be successfully utilized for medium- and long-course intravenous therapy in hospitalized and discharged orthopedic patients. Level of Evidence IV; Case series.

DI-042 Trametinib safety and acceptability in paediatric oncology patients: experience based on a case series

2017 ◽  
Author(s):  
A Comes Escoda ◽  
JL Vinent Genestar ◽  
H Hernández Salvador ◽  
F Bossacoma Busquets ◽  
J Arrojo Suárez ◽  
...  
Keyword(s):  
Case Series ◽  
Paediatric Oncology ◽  
Oncology Patients ◽  
Patients Experience

scholarly journals Case Report: Ursodeoxycholic acid treatment in Niemann-Pick disease type C; clinical experience in four cases

2017 ◽  
Vol 2 ◽  
pp. 75 ◽  
Author(s):  
William R.H. Evans ◽  
Elena-Raluca Nicoli ◽  
Raymond Y. Wang ◽  
Nina Movsesyan ◽  
Frances M. Platt
Keyword(s):  
Bile Acid ◽  
Ursodeoxycholic Acid ◽  
Liver Enzyme ◽  
Liver Dysfunction ◽  
Case Series ◽  
Later Life ◽  
Lysosomal Storage ◽  
Elevated Liver Enzymes ◽  
Type C ◽  
Niemann Pick

In this case series, we demonstrate that Ursodeoxycholic acid (UDCA) improves liver dysfunction in Niemann-Pick type C (NPC) and may restore a suppressed cytochrome p450 system. NPC disease is a progressive neurodegenerative lysosomal storage disease caused by mutations in either the NPC1 or NPC2 genes. Liver disease is a common feature presenting either acutely as cholestatic jaundice in the neonatal period, or in later life as elevated liver enzymes indicative of liver dysfunction. Recently, an imbalance in bile acid synthesis in a mouse model of NPC disease was linked to suppression of the P450 detoxification system and was corrected by UDCA treatment. UDCA (3α, 7β-dihydroxy-5β-cholanic acid), a hydrophilic bile acid, is used to treat various cholestatic disorders. In this report we summarise the findings from four independent cases of NPC, three with abnormal liver enzyme levels at baseline, that were subsequently treated with UDCA. The patients differed in age and clinical features, they all tolerated the drug well, and in those with abnormal liver function, there were significant improvements in their liver enzyme parameters.

scholarly journals Safety and Efficacy Concerns of Lopinavir/Ritonavir in COVID-19 Affected Patients: A Retrospective Series

2020 ◽  
Author(s):  
Marc-Antoine Lepage ◽  
Nicholas Rozza ◽  
Richard Kremer ◽  
Ami Grunbaum
Keyword(s):  
Human Immunodeficiency Virus ◽  
Side Effects ◽  
Liver Enzyme ◽  
Gastrointestinal Symptoms ◽  
Case Series ◽  
Hiv Patients ◽  
Therapeutic Concentration ◽  
Safety And Efficacy ◽  
Immunodeficiency Virus ◽  
Trough Concentrations

Context: Originally developed for the treatment of human immunodeficiency virus (HIV), the antiviral combination lopinavir/ritonavir (LPV/r) is being investigated for use against coronavirus disease (COVID-19). We present a case series raising safety and efficacy concerns in COVID-19 affected patients. Methods: We measured LPV trough concentrations in 12 patients treated at our center and reviewed their clinical charts for side effects known to occur in HIV patients. Results: Compared to established LPV trough concentrations in HIV treated patients, concentrations in COVID-19 affected patients were 3-fold greater (20.64 +/- 10.14 mcg/mL versus 6.25 mcg/mL). In addition, cholestasis and dyslipidemia toxicity thresholds were exceeded in 12/12 and 11/12 patients respectively. No patients achieved the presumed therapeutic concentration. The side effects noted were mainly gastrointestinal symptoms (5/12, 42%), electrolytes imbalances (4/12, 33%), liver enzyme disturbances (5/12, 42%), and triglyceride elevations (2/12, 17%). Conclusion: None of our patients reached presumed therapeutic LPV concentrations despite experiencing side effects and exceeding cholestasis and dyslipidemia toxicity thresholds. This raises concerns for the safety and efficacy of LPV/r. Clinicians should consider closely monitoring for side effects and not necessarily attribute them to COVID-19 itself.

scholarly journals Convalescent Plasma in treatment of COVID-19: A review of evidence for a living systematic benefit-risk assessment

2020 ◽  
Author(s):  
Miranda Davies ◽  
Samantha Lane ◽  
Alison Evans ◽  
Jacqueline Denyer ◽  
Sandeep Dhanda ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Controlled Trial ◽  
Intervention Group ◽  
Case Series ◽  
Data Availability ◽  
Control Group ◽  
Small Subset ◽  
Summary Table ◽  
Current Time ◽  
Benefit Risk Assessment

Objectives: We aimed to review the evidence for a living systematic benefit risk assessment for convalescent plasma use amongst patients with severe COVID-19 disease, based on currently available data. Methods: The assessment used the Benefit-Risk Action Team (BRAT) framework. Convalescent plasma treatment in severe COVID-19 was compared to standard of care, placebo or other treatments. A literature search was conducted to identify published papers from January 1st, 2019 until July 8th, 2020. A value tree was constructed which included ranked key benefits and risks. Results: We screened 396 papers from PubMed and 127 papers from Embase. Four studies were eligible for inclusion as they contained comparative data. Results from a randomised controlled trial revealed a non-statistically significant shortening of time to clinical improvement of 2.15 days (95% CI, −5.28 to 0.99 days) in the intervention group compared with the control group, with a possible signal of increased efficacy amongst a small subset of patients with severe disease (but not life threatening disease), however this study may have been underpowered. Interpretation of findings amongst the three controlled non-randomised studies were limited by small patient numbers, lack of randomisation, and confounding by co-administration of other treatments. Limited data availability at the current time precluded construction of a data summary table and further quantitative analysis. Conclusions: There was insufficient evidence from controlled studies to complete a data summary table for a systematic benefit-risk assessment of the use of CP for severe COVID-19 disease at the current time, and as such a benefit-risk conclusion could not be made. Whilst uncontrolled case series have suggested positive findings with CP, results from these studies are very difficult to interpret. We provide a framework which can be updated when further data that have an impact on the benefit-risk become available.

BRCA mutations in metastatic colorectal cancer (mCRC) and response to chemotherapy.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 235-235
Author(s):  
Sophie Feng ◽  
Laith Al-Showbaki ◽  
Monika K. Krzyzanowska ◽  
Rebecca M. Prince ◽  
Tracy Stockley ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Case Series ◽  
Molecular Characteristics ◽  
Small Subset ◽  
Chemotherapy Response ◽  
First Line ◽  
Brca Mutations ◽  
Response To Chemotherapy ◽  
Brca 1 ◽  
The Impact

235 Background: Mutations in BRCA 1/2 are typically associated with breast, ovarian, pancreatic and prostate cancers. BRCA mutations have been reported in colorectal cancer in sporadic case series. Unlike other cancers, the significance of BRCA mutations in mCRC is not known. We report the prevalence and molecular characteristics associated with BRCA 1/2 mutations in mCRC, and investigate the impact of these mutations on chemotherapy response since both oxaliplatin (OX) and irinotecan (IRI) interfere with DNA repair pathways. Methods: The Ontario-wide Cancer Targeted Nucleic Acid Evaluation (OCTANE) database was queried to identify mCRC patients (pts) harbouring BRCA 1/2 mutations. BRCA 1/2 mutations were detected using panel-based next generation sequencing (NGS) on archival tumour tissue. Clinical and molecular variables were collected, together with treatment outcomes. Results: Of 279 mCRC pts within the OCTANE database as of March 2019, 9 pts with BRCA 1/2 mutations were identified (3.2%): 4 BRCA 1 and 5 BRCA 2 mutations. Each patient had a unique variant with 8/9 missense mutations and 1/9 splicing error. Allele frequency ranged from 0.11 to 0.57. RAS or BRAF mutations were present in 67%. Common co-mutations included TP53 (56%), APC (56%), TSC1 (44%), ROS1 (33%) and ATM(33%). 2 pts were mismatch repair deficient. Median age was 48.5 years (range: 31-69 years), 56% males. 5 pts presented with de novo metastatic disease. First line OX-containing chemotherapy was administered to 4 pts, and IRI to 3 pts. 2 pts did not receive chemotherapy (1 had surgery only post-adjuvant OX, and 1 immunotherapy). Overall response rate (ORR) was 71%, with all pts achieving a partial response or stable disease. The median progression-free survival was 7.5 months (range: 1.8- 31.7 months) and median overall survival 68.5 months (range: 10.5- 68.5 months) respectively. Conclusions: BRCA 1/2 mutations are present in a small subset of mCRC pts. Pts with these mutations tend to be younger at diagnosis. BRCA 1/2 mutations are associated with favourable response to first line chemotherapy. Targeting BRCA 1/2 mutations may broaden treatment options for these patients.

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