Trial Files: Inpatient Initiation of Hep C Treatment, Small-Volume Phlebotomy to Reduce Transfusions, and A Potential PPI Alternative for GERD

Dec 28, 2023

Opportunistic Treatment of Hepatitis C Infection Among Hospitalized People Who Inject Drugs (OPPORTUNI-C)

Midgard H et al. Clinical Infectious Diseases (November 2023)

Bottom line: This was a pragmatic, stepped wedge cluster randomized trial to evaluate the efficacy of opportunistic treatment of hepatitis C virus (HCV) infection among hospitalized people who inject drugs (PWID). The study included 200 HCV RNA positive individuals admitted for inpatient care in departments of internal medicine, addiction medicine, and psychiatry at three hospitals in Oslo, Norway over two years. The intervention group received immediate treatment initiation while the comparator group received standard of care referral to outpatient care. The primary outcome was treatment completion, with 68.4% (95% CI 58.2-77.4) of the intervention group completing treatment compared to 35.3% (95% CI 26.1-45.4) of the control group (risk difference 33.1% [95% CI 20.0-46.2]; risk ratio 1.9 [95% CI 1.4-2.6]). Sustained virologic response was documented in 61.2% (95% CI 50.8-70.9) of the intervention group and 64.7% (95% CI 54.6-73.9) of the control group. These results indicate that an opportunistic test-and-treat approach to HCV infection is superior to standard of care among hospitalized PWID.

LINK TO ARTICLE (Midgard et al.)


Small-Volume Blood Collection Tubes to Reduce Transfusions in Intensive Care (STRATUS)

Siegal D et al. JAMA (October 2023)

Bottom Line: This stepped-wedge cluster randomized trial assessed whether a transition from standard-volume (4.0-6.0 mLs) to small-volume (1.8-3.5 mLs) blood collection tubes for laboratory testing in ICUs reduces red blood cell (RBC) transfusion. 27,411 patients from 25 adult medical-surgical ICUs in Canada were included in the study. The intervention group transitioned from standard-volume to small-volume tubes for laboratory testing. The primary outcome was RBC transfusion (units per patient per ICU stay). Secondary outcomes included patients receiving at least 1 RBC transfusion, hemoglobin decrease during ICU stay (adjusted for RBC transfusion), specimens with insufficient volume for testing, length of stay in the ICU and hospital, and mortality in the ICU and hospital. Results showed that transitioning from standard-volume to small-volume tubes for blood collection in ICUs reduced RBC transfusion (RR, 0.88 [95% CI, 0.77 to 1.00]; P = .04; absolute reduction of 9.84 RBC units/100 patients per ICU stay [95% CI, 0.24 to 20.76]), without compromising laboratory testing procedures. Median decrease in transfusion-adjusted hemoglobin was not statistically different in the primary population (mean difference, 0.10 g/dL [95% CI, −0.04 to 0.23]) and lower in the secondary population (mean difference, 0.17 g/dL [95% CI, 0.05 to 0.29]). These findings indicate that use of small-volume blood collection tubes in the ICU may decrease RBC transfusions without affecting laboratory analysis.

LINK TO ARTICLE (Siegal et al.)


Poliprotect vs Omeprazole in the Relief of Heartburn, Epigastric Pain, and Burning in Patients Without Erosive Esophagitis and Gastroduodenal Lesions: A Randomized, Controlled Trial

Corazziari E et al. American Journal of Gastroenterology (November 2023)

Bottom Line: This randomized, controlled, double-blind, double-dummy, multicenter trial assessed the efficacy and safety of mucosal protective agent Poliprotect (neoBianacid, Sansepolcro, Italy) vs omeprazole in 275 endoscopy-negative outpatients with heartburn and/or epigastric pain syndrome (EPS) over an 8-week period. Subjects received either 4 weeks of treatment with omeprazole (20 mg q.d.) or 4 weeks of Poliprotect (5 times daily for the initial 2 weeks and on demand thereafter), followed by an open-label 4-week treatment period with Poliprotect on-demand. The primary efficacy endpoint was the comparison between groups of the visual analog scale (VAS) score for severity of heartburn and/or epigastric pain or burning at day 1, day 3, and day 7. Results showed that Poliprotect was noninferior to omeprazole in symptom relief (between-group difference in the change in VAS symptom score: [mean, 95% confidence interval] -5.4, -9.9 to -0.1; -6.2, -10.8 to -1.6; intention-to-treat and per-protocol populations, respectively). The number of rescue medication satchets used was significantly lower in the Poliprotect group. Additionally, Poliprotect had no effect on gut microbiota and no relevant adverse events were reported in either treatment arm. Thus, Poliprotect may be appropriate as first-line treatment for heartburn and EPS, and as a substitute for PPI in conditions for which they are contraindicated.

LINK TO ARTICLE (Corazziari et al.)


Trial Files Issue #2023-15

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