Durable Sustained Virologic Response After Oral Directly Acting Antiviral Therapy Despite Immunosuppressive Treatment.

Treatment for hepatitis C has evolved from interferon-based therapy to all oral, directly acting antiviral (DAA) therapy. The influence of immunosuppression on maintaining sustained virologic response (SVR) in patients who have been treated with these directly acting agents is unknown. In this study, we report sustained hepatitis C virus (HCV) suppression in 3 patients undergoing various immunosuppressive treatments after achieving SVR with DAA therapy. Three patients, who were enrolled in 1 of 2 single-center National Institutes of Health clinical trials, achieved SVR12. Each patient had undergone between 6 and 24 weeks of DAA therapy with or without ribavirin. Immunosuppression was varied among the 3 patients. Therapy included adalimumab, carboplatin/irinotecan, or capecitabine. In all 3 cases, patients maintained HCV RNA levels below detection after immunosuppression. All patients had undetectable viral load and normalized liver-related enzymes during immunosuppressive therapy. This report suggests that SVR as a result of novel DAA therapy is durable and likely not affected by immunosuppressive therapy. Larger studies are required to confirm these results, but findings are promising for the treatment of large numbers of HCV-infected patients who may require subsequent immunosuppressive or immunomodulating therapies.

Enoxaparin-Induced Liver Injury: Case Report and Review of the Literature and FDA Adverse Event Reporting System (FAERS).

Anticoagulants are a well known cause of drug-induced liver injury (DILI). We recently encountered a 45-year-old male who developed DILI during treatment with enoxaparin, a low-molecular-weight heparin (LMWH), for dural venous thrombosis. The man received enoxaparin 80 mg subcutaneously, twice daily. After 4 days, the patient was asymptomatic but he developed liver aminotransferase elevations: AST 340 U/L and ALT 579 U/L. Investigation revealed an R ratio of 19.9 by day 5 and a Roussel Uclaf Causality Assessment Method score of 10, giving a high probable likelihood that enoxaparin was the cause of hepatic injury. Enoxaparin was discontinued on day 7, and 1 week later AST and ALT had decreased to 61 and 273 U/L, respectively. This case prompted a literature search and a review of the FDA Adverse Event Reporting System (FAERS) database for the range of hepatic adverse events (HAEs) associated with this class. A MEDLINE/PubMed search was conducted using DILI terms and cross-referenced with the anticoagulant classes. A Freedom of Information Act (FOIA) request was also made to identify adverse events (AEs) associated with enoxaparin in FAERS. Case type, severity of outcome, and demographic information were analyzed. Five publications have reported DILI with enoxaparin. Trial data found elevations in ALT >3 times the upper limit of normal (ULN) for unfractionated heparins (UFH) and LMWH in 8 and 4-13 % of subjects, respectively. However, liver injury in all cases was mild, self-limited, and asymptomatic. Our FOIA request yielded 8336 adverse events related to enoxaparin over a 14-year period (Jan 2000-Sept 2014). Specific HAEs were found in 4 % of reports, but all were described with other serious adverse events. The reported outcomes of hospitalization (75 %), death (17 %), and life-threatening medical events (5 %) were likely due to other related serious adverse events such as hemorrhage (28 %) and thrombocytopenia (11 %). We conclude that LMWH-related liver injury is uncommon and reversible. The mechanism of liver injury is not known, although an idiosyncratic effect is postulated. Although the FAERS database lists hepatic injury in 4 % of all enoxaparin-related AEs, it appears that serious outcomes are related to non-hepatic events.

Hospitalized patients' understanding of their plan of care.

OBJECTIVE: To evaluate hospitalized patients' understanding of their plan of care. PATIENTS AND METHODS: Interviews of a cross-sectional sample of hospitalized patients and their physicians were conducted from June 6 through June 26, 2008. Patients were asked whether they knew the name of the physician and nurse responsible for their care and specific questions about 6 aspects of the plan of care for the day (primary diagnosis, planned tests, planned procedures, medication changes, physician services consulted, and the expected length of stay). Physicians were interviewed and asked about the plan of care in the same fashion as for the patients. Two board-certified internists reviewed responses and rated patient-physician agreement on each aspect of the plan of care as none, partial, or complete agreement. RESULTS: Of 250 eligible patients, 241 (96%) agreed to be interviewed. A total of 233 (97%) of 241 physicians completed the interview, although sample sizes vary because of missing data elements. Of 239 patients, 77 (32%) correctly named at least 1 of their hospital physicians, and 143 patients (60%) correctly named their nurses. For each aspect of care, patients and physicians lacked agreement on the plan of care in a large number of instances. Specifically, there was no agreement between patients and physicians on planned tests or procedures for the day in 87 (38%) of 231 [corrected] instances and in 22 (10%) of 231 [corrected] instances. Complete agreement on the anticipated length of stay occurred in only 85 (39%) of 218 instances. CONCLUSION: A substantial portion of hospitalized patients do not understand their plan of care. Patients' limited understanding of their plan of care may adversely affect their ability to provide informed consent for hospital treatments and to assume their own care after discharge.

Impact of localizing physicians to hospital units on nurse-physician communication and agreement on the plan of care.

BACKGROUND: A significant barrier to communication among patient care providers in hospitals is the geographic dispersion of team members. OBJECTIVE: To determine whether localizing physicians to specific patient care units improves nurse-physician communication and agreement on patients' plans of care. METHODS: We conducted structured interviews of a cross-sectional sample of nurses and physicians before and after an intervention to localize physicians to specific patient care units. Interviews characterized patterns of nurse-physician communication and assessed understanding of patients' plans of care. Two internists reviewed responses and rated nurse-physician agreement on six aspects of the plan of care as none, partial, or complete agreement. RESULTS: Three hundred eleven of 342 (91%) and 291 of 294 (99%) patients' nurses and 301 of 342 (88%) and 285 of 294 (97%) physicians completed the interview during the pre- and post-localization periods. Two hundred nine of 285 (73%) patients were localized to physicians' designated patient care units in the post-localization period. After localization, a higher percentage of patients' nurses and physicians was able to correctly identify one another (93% vs. 71%; p < 0.001 and 58% vs. 36%; p < 0.001, respectively). Nurses and physicians reported more frequent communication after localization (68% vs. 50%; p < 0.001 and 74% vs. 61%; p < 0.001, respectively). Nurse-physician agreement was significantly improved for two aspects of the plan of care: planned tests and anticipated length of stay. CONCLUSIONS: Although nurses and physicians were able to identify one another and communicated more frequently after localizing physicians to specific patient care units, there was little impact on nurse-physician agreement on the plan of care.