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HCV Reinfection Charges Examined Following Profitable Therapy

Cassandra Pardini, PharmD November 20, 2018 “Interventions to reduce reinfection risks are necessary to prevent ongoing transmission,” the stu...

 

November 20, 2018

“Interventions to reduce reinfection risks are necessary to prevent ongoing transmission,” the study authors concluded

“Interventions to reduce reinfection risks are necessary to prevent ongoing transmission,” the study authors concluded

Reinfection rates of hepatitis C virus (HCV) following treatment with direct-acting antivirals (DAA) were assessed in a large, population-based cohort study presented at The Liver Meeting 2018.

In order to determine HCV reinfection rates following sustained virologic response (SVR) in the overall population as well as in PWID, the study authors analyzed data obtained from a population-based study that included >1.7 million people that were tested for HCV. “We assessed HCV-infected individuals treated with DAAs between 1/1/2014 and 7/1/2017 who achieved SVR and had ≥1 subsequent HCV RNA test for reinfection,” the study authors explained. Reinfection was defined as one positive HCV RNA test following SVR and persistent reinfections were considered in patients who did not spontaneously clear. 

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An algorithm derived from physician diagnosis and hospitalization codes was utilized to assess current (<3 years prior to SVR) and former (≥3 years prior to SVR) PWID. The study authors stated, “Crude reinfection rates per 100 person-years (PYs) were calculated and Poisson regression was used to model age and sex-adjusted incidence rate ratios (IRRs).”

A total of 4,114 patients were included in the study, of which, 21% were current PWID and 44% were former PWID; 5% of PWID reported using opiate agonist therapy (OAT).

The study authors reported that the reinfection rate was calculated to be 1.45/100 person-years (PYs) and 1.19/100 PYs for persistent reinfection. Additionally, higher crude reinfection rates were observed in current PWID (3.1/100 PYs; IRR: 8.0; 95% CI: 2.4, 27) compared to former PWID (1.4/100 PYs; IRR: 4.2; 95% CI: 1.2, 14) and non-PWID (0.3/100 PYs).

Data analysis also found reinfection rates in current PWID to be higher for patients <45 years old compared to those ≥45 years old (10.4/100 PYs vs 2.0/100 PYs, respectively) as well as in male patients compared to female patients (3.8/100 PYs vs 1.7/100 PYs, respectively). The study authors added, “Among PWID, OAT use ≥28 days since completing therapy was associated with a non-significant reduction in reinfection risk (1.5 vs. 2.1/100 PYs, IRR: 0.7, 95% CI: 0.1, 3.3).”

According to the results of this study, HCV reinfection rates appear to be elevated following DAA therapy in PWID. “Interventions to reduce reinfection risks are necessary to prevent ongoing transmission,” the study authors concluded.

Reference

Rossi C, et al, Hepatitis C Virus Reinfection after Successful Treatment with Direct-Acting Antiviral Therapy in a Large Population-Based Cohort. Presented at AASLD The Liver Meeting 2018. Study number 1593.

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FDA: Threat of Extreme Enhance in Incapacity Following MS Remedy Discontinuation

 

November 21, 2018

In some instances, patients who were able to walk without assistance prior to discontinuing fingolimod came to require wheelchairs or became bedbound upon discontinuing

In some instances, patients who were able to walk without assistance prior to discontinuing fingolimod came to require wheelchairs or became bedbound upon discontinuing

The Food and Drug Administration (FDA) has issued a safety communication regarding the potential for disease worsening following the discontinuation of the multiple sclerosis treatment fingolimod (Gilenya; Novartis), which in rare cases may result in permanent disability. Fingolimod, a sphingosine 1-phosphate receptor modulator, was initially approved in 2010 to treat relapsing forms of MS. 

From September 2010 to February 2018, the FDA has identified 35 cases of severe increased disability accompanied by the presence of new lesions on MRI that occurred 2 to 24 weeks after stopping treatment with fingolimod; most of the disease worsening was observed in the first 12 weeks. The increase in disability was reportedly more severe than typical MS relapses and appeared unrelated to the patients’ prior disease state.

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In some instances, patients who were able to walk without assistance prior to discontinuing fingolimod came to require wheelchairs or became bedbound upon discontinuing. Corticosteroids were given as the initial treatment for all 35 patients. Some had partial recovery (N=17), some had permanent disability or no recovery (N=8), and others (N=6) returned to the level of disability before or during fingolimod treatment. 

Prior to starting fingolimod, healthcare professionals should inform patients about the potential risk of severe disability after discontinuing treatment. If stopped, patients should be monitored for signs of disease exacerbation via MRI and be treated appropriately. Patients should seek immediate medical attention if new or worsening MS symptoms develop upon discontinuing fingolimod. Symptoms may include weakness, increased difficulty using arms or legs, or changes in thinking, eyesight or balance. 

The FDA has added a new warning regarding this risk to the drug labeling and patient Medication Guide for Gilenya.

For more information visit FDA.gov.

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Hypoglycemia Following Antifungal Tx in Affected person With Kind 1 Diabetes

 
Micafungin is a member of the echinocandin class of antifungal agents

Micafungin is a member of the echinocandin class of antifungal agents

A recent report published in The Journal of Clinical Endocrinology and Metabolism, describes the case of a patient with type 1 diabetes mellitus (T1DM) who developed hypoglycemia following antifungal therapy for a severe infection.

The 29-year-old female patient had a long history of uncontrolled T1DM and was diagnosed with cervical necrotizing fasciitis with mediastinal spread after presenting for evaluation of worsening dysphagia and dyspnea. Several debridement surgeries as well as broad spectrum antibiotics and antifungal therapy were required to treat her. At admission, she had an HbA1c of 13.4%; due to worsening infection, continuous tube feeds, and multiple surgeries, her insulin needs subsequently increased.

To provide broader antimicrobial coverage, micafungin, a member of the echinocandin class of antifungal agents, was initiated. After administration of micafungin, the patient’s insulin requirement dropped to 0 for more than 48 hours. Upon discontinuing micafungin and switching to a different antifungal, her insulin needs increased again.

“This is the first report of decreased insulin requirements in a patient with T1DM correlating with micafungin administration,” noted the authors. While the exact mechanism by which micafungin induces hypoglycemia has yet to be established, they hypothesized that the agent reduces blood glucose levels through inhibition of sodium-glucose transporter-1 (SGLT1) function.

Extreme Acute Respiratory Misery Syndrome Following HCTZ Administration

 

October 31, 2018

Although most cases resolve with supportive care, severe cases may require intubation and vv-ECMO

Although most cases resolve with supportive care, severe cases may require intubation and vv-ECMO

A recent report published in The Journal of Emergency Medicine describes the case of a male patient who experienced hydrochlorothiazide (HCTZ)-induced pulmonary edema that was complicated by acute respiratory distress syndrome (ARDS) and discusses the approach that was taken for his treatment.

The patient, who was in his 50s, had a past medical history significant for hypertension, which was managed with HCTZ. The study authors reported that the patient began to feel unwell and experienced difficulty breathing 30 minutes after administration of HCTZ. After developing ARDS and progressive hypoxemia in the emergency department of a referring hospital, he was transferred to the study authors’ institution for evaluation of refractory hypoxemia. During his transfer of care, the patient’s pulses could not be palpated, therefore chest compressions and intravenous epinephrine were initiated. Chest compressions were discontinued once his pulses were palpated again.

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After performing a physical examination and various laboratory tests, vasopressors were initiated. “Although the patient was persistently hypotensive and requiring high-dose vasopressors, we thought that this was most likely due to profound hypoxemia and acidemia causing global myocardial depression and vasoplegia rather than a primary cardiogenic shock,” the study authors explained.

The patient was therefore cannulated for venovenous extracorporeal membrane oxygenation (vv-ECMO) in the emergency department. “Packed red blood cells were infused empirically when the patient was placed on the ECMO circuit and within 15 min of ECMO cannulation, persistent pulse oximetry readings above 88% were achieved,” the study authors reported.

The patient’s ARDS resolved after several days of ECMO, at which point, he was decannulated and extubated. The allergy and medical teams later obtained an extensive patient history, which revealed that the patient had likely experienced 2 previous episodes of HCTZ-induced pulmonary edema.

“One of the most commonly prescribed antihypertensives, HCTZ is associated with rare cases of pulmonary edema, which typically develop within minutes to hours of the initial dose of the medication,” the study authors stated. They added, “Although most cases resolve with supportive care, severe cases may require intubation and even vv-ECMO.”

Reference

Jansson PS, Leisten DC, Sarkisian TM, Wilcox SR, Lee J. Recurrent Hydrochlorothiazide-Induced Acute Respiratory Distress Syndrome Treated With Extracorporeal Membrane Oxygenation. The Journal of Emergency Medicine. 2018 DOI: doi.org/10.1016/j.jemermed.2018.09.019.

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Case: Hypertensive Disaster Following Use of Armodafinil + MAOI

 

August 15, 2018

In the ED, the patient was found to be hypertensive with a blood pressure of 186/120 mmHg

Within the ED, the affected person was discovered to be hypertensive with a blood strain of 186/120 mmHg

A report printed within the Journal of the Neurological Sciences particulars a case of acute hypertensive disaster and extreme headache following concurrent remedy with armodafinil and tranylcypromine.

Whereas the labeling for armodafinil and modafinil advises warning when prescribing these wakefulness promoters with monoamine oxidase inhibitors (MAOIs) comparable to tranylcypromine, little knowledge exist to substantiate the potential dangers related to concurrent use. This case concerned a 36-year-old feminine with bipolar dysfunction who offered to the emergency division (ED) with blurry imaginative and prescient, neck stiffness and the “worst headache of (her) life” after taking armodafinil with tranylcypromine.

Her remedy historical past indicated that she had been taking tranylcypromine (20mg twice every day) with armodafinil (250mg every day) for two months, along with brexpiprazole zero.5mg every day. The morning of her admittance to the ED, the tranylcypromine dose was adjusted from 20mg twice every day to 40mg within the morning.

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Within the ED, the affected person was discovered to be hypertensive with a blood strain (BP) of 186/120 mmHg. She was handled with intravenous morphine, which diminished the severity of the headache, and her BP decreased over the course of the day. She was admitted for statement throughout which her drugs had been discontinued; three days later, her signs had subsided.

To analyze the outcomes of comparable circumstances, the authors carried out a literature evaluation and recognized 6 different circumstances the place sufferers had been handled with modafinil and an MAOI; 5 of those sufferers had no adversarial occasions, whereas 1 (Vytopil et al. 2007) developed acute chorea and hyperthermia three days after modafinil was added to tranylcypromine. Relating to brexpiprazole, the authors famous latest research which confirmed that the usage of atypical antipsychotics with MAOIs or armodafinil gave the impression to be secure, nonetheless, they added “it’s doable that brexpiprazole exacerbated or contributed to the underlying signs.”

Primarily based on the findings of this case and others within the literature, the authors concluded, “We […] advocate that physicians train warning if utilizing these lessons of medication collectively.”

For extra data go to JNS-journal.com.

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