RESUMEN
Clostridium difficile infections (CDI) are a leading cause of antibiotic-associated diarrhea, and recurrent infections are common despite effective antibiotic treatments. Recurrent CDI causes a significant burden to the patient and healthcare system, which has led to efforts to find an effective treatment to prevent recurrent CDI. Recent studies have shown the efficacy and safety of orally and rectally administered microbiota treatment to prevent recurrent Clostridium difficile. This study systematically reviewed the data on the efficacy and safety of RBX2660 (REBYOTA®), the first rectally administered microbiota product to prevent recurrent Clostridium difficile infections approved by the United States Food and Drug Administration (FDA). Our analysis showed that RBX2660 (REBYOTA) effectively prevented recurrent CDI. Patients who received RBX2660 (REBYOTA) were significantly less likely to have recurrent Clostridium difficile than controls eight weeks after treatment. This effect is seen in both those who got one or two doses of RBX2660 (REBYOTA), although the FDA currently approves one dose.
RESUMEN
BACKGROUND & AIMS: There is controversy over the effects of direct-acting antiviral (DAA) therapies for hepatitis C virus (HCV) infection on hepatocellular carcinoma (HCC) recurrence and tumor aggressiveness. We compared HCC recurrence patterns between DAA-treated and untreated HCV-infected patients who had achieved a complete response to HCC treatment in a North American cohort. METHODS: We conducted a retrospective cohort study of patients with HCV-related HCC with a complete response to resection, local ablation, transarterial chemo- or radioembolization, or radiation therapy from January 2013 through December 2017 at 31 health systems throughout the United States and Canada. Cox regression was used to examine the association between DAA therapy and time to recurrence after a complete response, with DAA therapy analyzed as a time-varying exposure. We also estimated the association between DAA therapy and risk of early HCC recurrence (defined as 365 days after complete response). RESULTS: Of 793 patients with HCV-associated HCC, 304 (38.3%) received DAA therapy and 489 (61.7%) were untreated. HCC recurred in 128 DAA-treated patients (42.1%; early recurrence in 52 patients) and 288 untreated patients (58.9%; early recurrence in 227 patients). DAA therapy was not associated with HCC recurrence (hazard ratio 0.90, 95% confidence interval 0.70-1.16) or early HCC recurrence (hazard ratio 0.96, 95% confidence interval 0.70-1.34) after we adjusted for study site, age, sex, Child-Pugh score, α-fetoprotein level, tumor burden, and HCC treatment modality. In DAA-treated and untreated patients, most recurrences were within the Milan criteria (74.2% vs 78.8%; P = .23). A larger proportion of DAA-treated than untreated patients received potentially curative HCC therapy for recurrent HCC (32.0% vs 24.6%) and achieved a complete or partial response (45.3% vs 41.0%) but this did not achieve statistical significance. CONCLUSION: In a large cohort of North American patients with complete response to HCC treatment, DAA therapy was not associated with increased overall or early HCC recurrence. HCC recurrence patterns, including treatment response, were similar in DAA-treated and untreated patients.
