Amnesia, Adverse Effects, and the Angel of History.

Ann Intern Med. 2019 09 17;171(6):434-435

Authors: Greene JA

PMID: 31525755 [PubMed - indexed for MEDLINE]

Reporting Adverse Drug Events.

Am J Gastroenterol. 2019 09;114(9):1411-1413

Authors: Feagins LA, Abdelsayed GG, Schairer J, FDA-Related Matters Committee of the American College of Gastroenterology

PMID: 31464745 [PubMed - indexed for MEDLINE]

Compliance in schizophrenia spectrum disorders: the role of clinical pharmacist.

Int Clin Psychopharmacol. 2019 11;34(6):298-304

Authors: Yalçin N, Ak S, Gürel ŞC, Çeliker A

Abstract
The inability of patients with psychiatric illness to achieve full compliance with treatment during the postdischarge period is a major problem. In this study, our aim was to evaluate whether drug education provided by a clinical pharmacist during discharging period has an effect on compliance. Forty adult patients diagnosed with psychotic disorders were included. A number of scales were used to evaluate the severity of illness, medication adverse effects and compliance. At time of discharge, it was emphasized to patients by a clinical pharmacist that medication compliance was important to prevent exacerbation or hospitalization. Six to eight weeks after discharge, patients were invited to be reevaluated using the same scales as those applied during hospitalization. There was a statistically significant increase in compliance after drug education (P < 0.001). A decrease in the baseline compliance score was associated with an increase in the total number of hospitalizations and the number of psychotropic drugs used. When the risk factors that may affect compliance were evaluated, akathisia was found to have the highest impact on compliance (P = 0.012). It is necessary to take advantage of counseling on medication use and to develop strategies in order to improve compliance in psychiatry.

PMID: 31343497 [PubMed - indexed for MEDLINE]

Adverse reactions.

Clin Med (Lond). 2019 07;19(4):357

Authors: Riste M, Trafford G

PMID: 31308126 [PubMed - indexed for MEDLINE]

Reintroduction of quazepam: an update on comparative hypnotic and adverse effects.

Int Clin Psychopharmacol. 2019 11;34(6):275-285

Authors: Moniri NH

Abstract
Insomnia is a prevalent disorder that affects over one-third of the U.S. population to varying degrees and is highly disruptive towards quality of life. Pharmacological treatments for insomnia include benzodiazepines (BZs) and the non-BZ 'Z-drugs' (zolpidem, zaleplon, eszopiclone, zopiclone), which are amongst the most widely prescribed medications. Yet, these agents can produce adverse effects such as tolerance to the hypnotic effect, rebound insomnia, next-day residual drowsiness, as well as amnesia and complex behaviours such as sleep-walking, sleep-eating and sleep-driving. Quazepam, one of the five BZ approved for treatment of insomnia, was recently relaunched to the U.S. market in 2016 and is distinguished amongst hypnotic BZ by unique pharmacological characteristics including selectivity for sleep-promoting α1-subunit containing γ-aminobutyric acid (GABA-A) receptors and a significantly lower relative receptor binding affinity. These features likely drive the decreased rate of adverse events seen clinically with quazepam, such as tolerance, rebound insomnia and amnesic behaviours, compared with other BZ. Given the recent reintroduction of quazepam as a pharmacotherapeutic option, and the lack of head-to-head comparative trials against newer agents, the purpose of this review is to provide an update on distinguishing features of quazepam with regard to its pharmacology, pharmacokinetics, sleep efficacy and potential adverse effects compared to other agents used for insomnia.

PMID: 31274695 [PubMed - indexed for MEDLINE]

Detection and prevention of adverse drug reactions in multi-morbid older patients.

Age Ageing. 2019 01 01;48(1):10-13

Authors: Jennings E, Gallagher P, O'Mahony D

Abstract
Adverse drug reactions (ADRs) are a recognised unintentional form of iatrogenic harm, which commonly occur in older adults who have high levels of multi-morbidity and associated polypharmacy. Previous studies estimate that at least one in 10 hospitalised older patients will experience an ADR. While recent research indicates that this could be as high as 39% in hospitalised multi-morbid, older adults, up to two-thirds of these ADRs can be considered preventable and therefore potentially avoidable. In addition to increasing patient morbidity and contributing to avoidable mortality, there is an associated cost implication with ADR occurrence. This commentary summarises current mainstream research in terms of ADR detection, prediction and prevention in multi-morbid older patients. At present, the biggest barrier to understanding and comparing ADRs in the literature is the large heterogeneity that exists in the population and study methods. Furthermore, there is the lack of standardised universally accepted methodology for ADR prediction, detection, causality assessment and subsequent prevention in older people. Standard available methods of ADR prediction applied to a heterogeneous multi-morbid population are generally unsatisfactory. Without an instrument that consistently and reliably predicts ADR risk in a reproducible manner, ADR prevention in multi-morbid older patients is challenging. Further attention should be focused on the culprit drugs that commonly lead to major ADRs in older multi-morbid hospitalised patients with polypharmacy. Risk associated with particular drug classes may possibly predict ADR occurrence better than patient characteristics alone. Current research is examining this drug class focus for ADR prevention in multi-morbid older people.

PMID: 30299453 [PubMed - indexed for MEDLINE]

'They must help if the doctor gives them to you': a qualitative study of the older person's lived experience of medication-related problems.

Age Ageing. 2019 01 01;48(1):147-151

Authors: Parekh N, Gahagan B, Ward L, Ali K

Abstract
Objective: medication-related problems (MRP) are common for older adults and can lead to harm. The older person's perspective on MRP has been seldom reported in published literature. This study explored the lived experience of MRP in older adults with varying functional levels, focussing on the hospital discharge period.
Design, setting, participants: this qualitative study was conducted in Brighton and Hove, UK. A purposive sample of 20 older people with experience of MRP, involving carers, took part in focus groups and semi-structured interviews. Data were thematically analysed using a 'framework' approach.
Results: four major themes associated with MRP were identified; (1) experience of the healthcare system, (2) practicalities of using medicines, (3) management of medication problems and (4) participant beliefs. Participants encountered problems in communication with healthcare professionals such as passive listening and paternalistic consultations. A conflict was acknowledged between participants' implicit trust in the healthcare system and their negative experience of MRP. Participants felt vulnerable around hospital discharge, describing reduced capacity to comprehend information, pressured discharge circumstances and lack of integrated care in the community. Drug formulations, packaging and information leaflets were felt to be poorly tailored to the needs of older people.
Conclusions: the lived experience of older people with MRP in this study was multifaceted and complex. Participants felt communication was poor around hospital discharge, and insufficient support with medicines was offered in the community when problems arose. Harm due to MRP might be reduced if the contributory factors described by patients inform clinical and policy-level intervention.

PMID: 30165466 [PubMed - indexed for MEDLINE]

Oxcarbazepine for trigeminal neuralgia may induce lower extremity weakness: A case report.

World J Clin Cases. 2020 Mar 06;8(5):922-927

Authors: Song HG, Nahm FS

Abstract
BACKGROUND: Although few studies have reported hyponatremia due to carbamazepine or oxcarbazepine in patients with epilepsy, no study has investigated cases of carbamazepine- or oxcarbazepine-induced hyponatremia or unsteady gait in patients with neuropathic pain. Herein, we report a case of oxcarbazepine-induced lower leg weakness in a patient with trigeminal neuralgia and summarize the diagnosis, treatment, and changes of clinical symptoms.
CASE SUMMARY: A 78-year-old male with a history of lumbar spinal stenosis was admitted to the hospital after he experienced lancinating pain around his right cheek, eyes, and lip, and was diagnosed with trigeminal neuralgia at the right maxillary and mandibular branch. He was prescribed oxcarbazepine (600 mg/d), milnacipran (25 mg/d), and oxycodone/naloxone (20 mg/10 mg/d) for four years. Four years later, the patient experienced symptoms associated with spinal stenosis, including pain in the lower extremities and unsteady gait. His serum sodium level was 127 mmol/L. Assuming oxcarbazepine to be the cause of the hyponatremia, oxcarbazepine administration was put on hold and the patient was switched to topiramate. At subsequent visit, the patient's serum sodium level had normalized to 143 mmol/L and his unsteady gait had improved.
CONCLUSION: Oxcarbazepine-induced hyponatremia may cause lower extremity weakness and unsteady gait, which should be differentiated from those caused by spinal stenosis.

PMID: 32190628 [PubMed]

Waddling Gait: A complication of valproate therapy and a thought beyond vitamin D deficiency.

Sultan Qaboos Univ Med J. 2020 Feb;20(1):e104-e108

Authors: Sharma A, Sinha S, Narang A, Chouhan DK, Gupta S

Abstract
Proximal muscle weakness is a common presentation in paediatric-orthopaedic clinics and is frequently paired with a vitamin D deficiency diagnosis. Recently, side effects of the extensive use of antiepileptic and antipsychotic drugs such as sodium valproate in childhood disorders are being documented. Sodium valproate causes a time-dependent, drug-induced proximal myopathy. We report a 13-year-old female patient who presented at the Orthopaedic Outpatient Department at Lady Hardinge Medical College, New Delhi, India, in 2019 with an abnormal gait. The patient was taking a combination therapy of sodium valproate, risperidone and trihexyphenidyl for absence seizures and a mood disorder. Following clinical investigations, the patient was diagnosed with proximal myopathy. As a result of elevated serum alkaline phosphatase and creatine kinase myocardial band levels, sodium valproate was replaced with ethosuximide and a carnitine supplementation was prescribed. The patient fully recovered and regained full mobility. Proximal myopathy had been incorrectly managed and assumed to be caused by a vitamin D deficiency.

PMID: 32190378 [PubMed - in process]

Successful implementation of an automated electronic support system for patient safety monitoring: The alemtuzumab in multiple sclerosis safety systems (AMS3) study.

Mult Scler. 2019 07;25(8):1124-1131

Authors: Reddel SW, Barnett MH, Riminton S, Dugal T, Buzzard K, Wang CT, Fitzgerald F, Beadnall HN, Erickson D, Gahan D, Wang D, Ackland T, Thompson R

Abstract
BACKGROUND: Alemtuzumab is a highly effective treatment for relapsing-remitting multiple sclerosis (MS) but requires ongoing pathology monitoring for autoimmune adverse effects. The Alemtuzumab in MS Safety Systems (AMS3) study evaluated the implementation of an automated pathology-monitoring system.
OBJECTIVES: To develop an efficient automated clinical decision support system (CDSS) to electronically prompt and track pathology collection and to provide prescribers and patients with customised alerts of abnormal results for identified risks.
METHODS: A total of 10 patients with relapsing-remitting MS treated with alemtuzumab were enrolled to test the system. Standard care laboratory monitoring was performed and compared to the performance of the CDSS.
RESULTS: The automated CDSS, an integrated patient smartphone application and an additional pre-screening tool were all successfully developed. Compliance with pathology monitoring was 96.7%. The automated analysis of pathology results was significantly faster than standard care neurologist review (p < 0.001). The system correctly identified and alerted abnormalities, including one case of immune thrombocytopenia (ITP) while the treating neurologist was on leave, enabling prompt treatment of serious adverse events. During the course of the study, the CDSS was deployed throughout Australia.
CONCLUSION: We successfully developed automated pathology monitoring with a CDSS, demonstrating real-world benefits of high compliance and timely alerting of important results.

PMID: 29911471 [PubMed - indexed for MEDLINE]

12 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2020/03/19

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

12 new pubmed citations were retrieved for your search. Click on the search hyperlink below to display the complete search results:

("drug-induced" OR "drug-related") AND ("adverse events" OR "side effects" OR "side-effects")

These pubmed results were generated on 2020/03/19

PubMed comprises more than millions of citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

The efficacy and safety of PD-1/PD-L1 inhibitors in patients with recurrent or metastatic nasopharyngeal carcinoma: A systematic review and meta-analysis.

Oral Oncol. 2020 Mar 14;104:104640

Authors: Wang BC, Cao RB, Fu C, Chen WB, Li PD, Lin GH, Qian XJ, Li YT, Liu Q

Abstract
OBJECTIVES: There is currently no effective salvage therapeutic modality that improves the survival outcomes of patients with recurrent or metastatic nasopharyngeal carcinoma. However, the programmed cell death protein 1 (PD-1) and its ligand (PD-L1) inhibitors may provide clinical benefit for these advanced patients.
MATERIALS AND METHODS: The databases, including PubMed, Web of Science, EMBASE and Cochrane Library, were systematically searched up to Nov 5, 2019. Data of objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) rate, overall survival (OS) rate, and drug-related adverse events were extracted and pooled meta-analyzed.
RESULTS: From 71 search records, eight studies were included in the systematic review, of which three were eligible for final meta-analysis. In recurrent or metastatic nasopharyngeal carcinoma patients treated with anti-PD-1 therapy, the pooled ORR was 27% (95% confidence interval [CI] 19-36%), DCR was 63% (95% CI 50-75%), 6 months PFS rate was 49% (95% CI 40-58%), 1-year PFS rate was 25% (95% CI 19-32%), 1-year OS rate was 61% (95% CI 49-72%). The pooled incidences of any grade and grade ≥ 3 drug-related adverse events were 94% and 20% respectively.
CONCLUSION: We present the aggregate response rates, survival rates and incidences of drug-related adverse events for recurrent or metastatic nasopharyngeal carcinoma patients receiving PD-1/PD-L1 blockage treatment, which could provide useful information for future design of clinical studies. There is a need for more randomized controlled studies with head-to-head comparison of PD-1/PD-L1 inhibitors and traditional chemotherapeutic strategies to enable better recommendations for optimal advanced nasopharyngeal carcinoma treatment.

PMID: 32182550 [PubMed - as supplied by publisher]

Effectiveness and Safety of Direct-Acting Antivirals in Hepatitis C Infected Patients with Mental Disorders: Results in Real Clinical Practice.

J Med Virol. 2020 Mar 17;:

Authors: Margusino-Framiñán L, Pérez EB, Cid-Silva P, Rodríguez-Sotelo A, Yáñez-Rubal JC, Mena-de-Cea Á, Suárez-López F, Prieto-Pérez A, Giménez-Arufe V, Delgado-Blanco M, Sanclaudio-Luhia AI, Martín-Herranz I, Castro-Iglesias Á

Abstract
INTRODUCTION AND OBJECTIVES: The aim of this study is to analyse the effectiveness and safety of direct-acting antivirals (DAAs) in psychiatric patients with chronic hepatitis C (CHC). Secondary objectives included adherence and drug-drug interaction (DDIs) evaluations.
MATERIAL AND METHODS: Prospective, observational, comparative study carried out during 3 years. Psychiatric patients were included and mental illness classified by a psychiatric team based on clinical records. Main effectiveness and safety variables were sustained virologic response at post-treatment week 12 (SVR12) and rate of on-treatment serious drug-related adverse events (AEs), respectively.
RESULTS: 242 psychiatric and 900 non-psychiatric were included. SVR12 by intention-to-treat (ITT) analysis of psychiatric vs non-psychiatric patients was 92.6% (89.1-96.1, 95%CI) vs 96.2% (94.9-97.5, 95%CI), (p=0.02). SVR12 by modified-ITT analysis was 97.8% (95.0-99.3, 95%CI) vs 98.4% (97.5-99.3, 95%CI), (p=0.74). 92.2% of psychiatric patients with mental disorders secondary to multiple drug use (MDSDU) and 93.0% of psychiatric patients without MDSDU vs 96.2% of non-psychiatric patients reached SVR12 (p=0.05 and 0.20, respectively). The percentage of adherent patients to DAAs did not show differences between cohorts (p=0.08). 30.2% of psychiatric patients and 27.6% of non-psychiatric patients presented clinically relevant DDIs (p=0.47). 1.7% vs 0.8% of psychiatric vs non-psychiatric patients developed serious AEs (p=0.39); no serious psychiatric AEs were present.
CONCLUSIONS: DAAs have shown a slightly lower effectiveness in psychiatric patients with CHC, as a result of loss of follow-up, which justifies the need for integrated and multidisciplinary health care teams. DAAs safety, adherence and DDIs, however, are similar to that of non-psychiatric patients. This article is protected by copyright. All rights reserved.

PMID: 32181917 [PubMed - as supplied by publisher]

Successful desensitization of Pegvaliase (Palynziq®) in a patient with phenylketonuria.

Mol Genet Metab Rep. 2020 Jun;23:100575

Authors: Patrawala M, Kuruvilla M, Li H

Abstract
Pegvaliase (Palynziq®) was FDA approved in 2018 as an enzyme substitution therapy in patients with Phenylketonuria. However, various drug induced hypersensitivity adverse events (HAEs) have been reported. We present a case of Pegvaliase (Palynziq®) induced anaphylaxis and successful desensitization. A 13-step desensitization protocol was performed using three solution concentrations of Palynziq with premedication of diphenhydramine and prednisone in an outpatient setting. The patient tolerated the desensitization and was able to continue Palynziq.

PMID: 32181140 [PubMed]

Intravenous pentoxifylline is well tolerated in critically ill preterm infants with sepsis or necrotizing enterocolitis.

Eur J Pediatr. 2020 Mar 16;:

Authors: Schüller SS, Kempf K, Unterasinger L, Strunk T, Berger A

Abstract
Pentoxifylline (PTX) is a candidate adjuvant medication for the treatment of sepsis and necrotizing enterocolitis in preterm infants. There is only limited data on safety and compatibility with other commonly used intravenous medications. This retrospective single-center study of 198 preterm infants (September 2012-September 2018) was performed at a level IV neonatal intensive care unit. Electronic data of all preterm infants who received pentoxifylline for sepsis or necrotizing were extracted from routine databases. We analyzed a total of 1081 PTX treatment days from 217 treatment episodes in 198 preterm infants (mean gestational age 27 weeks; mean birth weight 1060 g). At a mean daily dose of 28 mg/kg, no clinically relevant side effects were observed. PTX therapy was not associated with clinically significant changes of blood biochemistry and hematology parameters. Concomitant infusion of PTX with other common NICU medications was well tolerated, and there was no evidence of incompatibility.Conclusion: Intravenous PTX is compatible with standard NICU drugs and well tolerated in critically ill preterm infants.What is Know:•Currently, there are no evidence-based adjuvant medications available that target the harmful inflammatory host response in neonatal sepsis or necrotizing enterocolitis.•Pentoxifylline (PTX) is a candidate adjuvant medication for the treatment of sepsis and necrotizing enterocolitis in preterm infants; however, safety data are rare and PTX is currently used off-label.What is New:•Here we report on our experience in the pragmatic routine use of PTX as adjuvant therapy in 198 preterm infants with sepsis or NEC.•Concomitant infusion of PTX with other common NICU medications was well tolerated, and there was no evidence of incompatibility. No clinically relevant side effects were observed.

PMID: 32179980 [PubMed - as supplied by publisher]

Efficacy and safety of sofosbuvir-based therapy in hepatitis C virus recurrence post living donor liver transplant: A real life egyptian experience.

J Med Virol. 2019 04;91(4):668-676

Authors: Yosry A, Gamal Eldeen H, Medhat E, Mehrez M, Zayed N, Elakel W, Abdelmoniem R, Kaddah M, Abdelaziz A, Esmat G, El-Serafy M, Doss W

Abstract
BACKGROUND AND AIM: Direct acting antiviral has offered treatment of hepatitis C virus (HCV) recurrence post liver transplantation (LT) with an all-oral regimen for short duration, excellent safety profile, and high sustained virological response (SVR). The aim of this study was to evaluate the efficacy and safety of sofosbuvir (SOF)-based regimens in the real world among a cohort of Egyptian patients with recurrent HCV post living donor LT (LDLT).
METHODS: Patients with HCV-G4 recurrence post-LDLT were recruited from National Committee of Control of Viral Hepatitis, Egypt, from November 2014 to May 2017. They received different SOF-based regimens according to the treatment protocols available during this period. Patients' outcome and Adverse effects (AE) were evaluated.
RESULTS: One hundred ninety patients (170 males, mean age 56.8 ± 7.9 years) were included. Calcineurin inhibitors were the main immunosuppression used (173 patients). Out of 190, 119 (62.6%) received SOF/ribavirin (RBV), 38 (20%) SOF/simeprevir (SMV), 22 (11.6%) SOF/daclatasvir (DSV)/ ± RBV, and 11 (5.8%) received SOF/LDV/ ± RBV. Overall SVR12 was 89.5%, 84.9% in SOF/RBV group, 94.7% in SOF/SMV, 100% in SOF/DCV, and 100% in SOF/LDV with no statistically significant difference ( P = 0.104). The AE reported were as follows: anemia (n = 65, 34.4%) mainly in SOF/RBV group, transient hyperbilirubinemia during SOF/SMV in 13 patients (34%), mild Acute cellular rejection in eight patients (4.2%), and hepatocellular carcinoma in two patients (1%) mainly driven by underlying liver condition. Two deaths were unlikely related to HCV therapy.
CONCLUSION: Different SOF-based regimens were effective with high SVR12 rates in a difficult-to-treat population, recurrent HCV post LDLT.

PMID: 30549048 [PubMed - indexed for MEDLINE]

Beware of on-treatment safety analyses.

Clin Trials. 2019 02;16(1):63-70

Authors: Yang F, Wittes J, Pitt B

Abstract
INTRODUCTION: Assessing safety is important to evaluating new medications. In many randomized clinical trials, assessment of safety relies on so-called on-treatment analysis, where data on adverse events are collected only while the participant is taking study medication and perhaps for a few (7, 14, or 30) days after stopping. This article discusses the consequence of such failure to use intent-to-treat analyses in assessing safety.
METHODS: This article discusses two approaches to analysis of safety data: intention-to-treat and on-treatment analysis with reference to principles of the design of randomized clinical trial.
RESULTS: On-treatment analysis violates randomization and is often not well defined. Moreover, because the typical on-treatment analysis ignores the reason participants in clinical trials stop treatment, on-treatment analyses can lead to biased estimates of risk. Examples show biases that can result from failure to count all adverse events. An example from a study of rofecoxib shows an on-treatment analysis that led to likely underestimation of harm; an example from a study of saxagliptin shows an on-treatment analysis that led to a likely overestimate of harms.
CONCLUSION: For major safety outcomes in long-term clinical trials, intention-to-treat analysis should be performed in the framework of benefit-risk evaluation. More generally, analyses of safety should be tailored to the specific question being asked with the specific study design under consideration. On-treatment analyses are subject to bias; however, the direction of that bias is not necessarily clear.

PMID: 30445833 [PubMed - indexed for MEDLINE]

High Cure Rates With Grazoprevir-Elbasvir With or Without Ribavirin Guided by Genotypic Resistance Testing Among Human Immunodeficiency Virus/Hepatitis C Virus-coinfected Men Who Have Sex With Men.

Clin Infect Dis. 2019 02 01;68(4):569-576

Authors: Braun DL, Hampel B, Kouyos R, Nguyen H, Shah C, Flepp M, Stöckle M, Conen A, Béguelin C, Künzler-Heule P, Nicca D, Schmid P, Delaloye J, Rougemont M, Bernasconi E, Rauch A, Günthard HF, Böni J, Fehr JS, Swiss HIV Cohort Study

Abstract
Background: This study was performed to investigate the efficacy and safety of grazoprevir-elbasvir guided by baseline resistance-associated substitutions (RASs) in the Swiss HCVree Trial.
Methods: We performed hepatitis C virus (HCV) RNA screening among all men who have sex with men (MSM) enrolled in the Swiss HIV Cohort Study. Individuals with replicating HCV genotype 1 or 4 infection were eligible for grazoprevir-elbasvir treatment. Genotype 1a-infected individuals with baseline RASs and genotype 4-infected individuals with prior failure of HCV treatment received 16 weeks of grazoprevir-elbasvir combined with ribavirin. All other individuals received 12 weeks of grazoprevir-elbasvir alone. Patients reporting unprotected sex with occasional partners were offered a HCV risk reduction-oriented behavioral intervention.
Results: We screened 3722 MSM and identified 177 (4.8%) with replicating infection. A total of 122 individuals (3.3%) were eligible for study treatment. Six of 76 patients infected with genotype 1a (7.3%) harbored baseline RASs. Sustained virological response after 12 weeks of follow-up was achieved in 121 patients (99%), including all with genotype 1a infection. Overall, 8 serious adverse events occurred, none of which was related to the study drug. Seventy-five percent of eligible MSM participated in the risk counseling program.
Conclusions: Grazoprevir-elbasvir for 12 or 16 weeks, with or without ribavirin, achieved high cure rates and had an excellent safety profile. Unique to other studies, the treatment duration was guided by the presence of baseline RASs among genotype 1a-infected individuals, and the treatment phase was accompanied by an HCV risk reduction-oriented behavioral intervention. This successful population-wide treatment approach lays the groundwork to achieve HCV elimination in coinfected MSM.
Clinical Trials Registration: NCT02785666.

PMID: 30107485 [PubMed - indexed for MEDLINE]

Bezlotoxumab.

Clin Infect Dis. 2019 02 01;68(4):699-704

Authors: Johnson S, Gerding DN

Abstract
Clostridium difficile infection (CDI) is mediated by actions of toxin A and toxin B. Fully human monoclonal antibodies directed against the binding domains of these toxins were developed. Despite preclinical studies suggesting efficacy for the anti-toxin A monoclonal, actoxumab, the anti-toxin B monoclonal, bezlotoxumab, alone was shown to be effective in clinical trials. Intravenous infusion of bezlotoxumab at a 10 mg/kg dosage as adjunctive treatment reduced the risk of recurrent CDI over placebo for adult patients at increased risk for CDI recurrence in 2 large randomized, double-blind trials. Significant benefit was noted for patients with 1 or more of the following predefined risks: age >65 years, history of CDI, immunocompromise, severe CDI. Overall, bezlotoxumab appeared to be safe; however, an unexplained increased risk of heart failure was noted for patients with underlying congestive heart failure. Further refinement of who would benefit most and when best to administer bezlotoxumab is warranted.

PMID: 30020417 [PubMed - indexed for MEDLINE]