Monthly gastroenterology and hepatology bulletin — October 8, 2026

Colleagues: this issue covers September 8 to October 8, 2026. The month was dominated by viral hepatology (hepatitis delta and the first approval of a "functional cure" for hepatitis B), an ACG guideline on preventive care in cirrhosis, a European trial that may lengthen the surveillance interval after high-risk adenomas, and a large negative trial of fecal transplantation in irritable bowel syndrome. In inflammatory bowel disease there were no new verifiable results in the period: the major data (obefazimod, among others) are being held for UEG Week and ACG this month. We include 8 items; we prefer fewer items to filler.

Inflammatory bowel disease and functional disorders

1. Fecal transplantation in IBS: the largest trial is negative (REFIT2)

[Clinical trial] [Norway]
Phase 3, randomized, double-blind trial at five Norwegian hospitals: 450 adults aged 18 to 65 with moderate-to-severe irritable bowel syndrome received a single enema of donor stool or their own stool (autologous placebo); 448 analyzed. The primary response (≥75-point drop in IBS-SSS at day 90) was 40% with donor stool versus 38% with placebo (difference 1.9 percentage points; 95% CI −8.1 to 12.0; p = 0.76). Published in The Lancet (coverage dated September 26, 2026).
Why it matters: this is the best-powered trial to date and contradicts earlier positive studies that used different doses and routes; it reinforces that fecal transplantation should not be offered for IBS outside trials, including in the Dominican Republic, where private "microbiota" services are opening. Limitation: a single enema dose; it does not rule out benefit with repeated dosing or upper-GI delivery.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)01424-8/abstract

Section note: we could not verify any new phase 3 publications in Crohn's disease or ulcerative colitis during the period. On September 30, Abivax announced seven obefazimod abstracts for UEG Week (including 44-week ABTECT maintenance); we will cover them once presented.
https://finviz.com/news/397291/abivax-to-present-data-on-obefazimod-at-united-european-gastroenterology-ueg-week-2026

Liver

2. Brelovitug meets the phase 3 primary endpoint in hepatitis delta (AZURE-1)

[Industry] [Global, USA]
On September 28, Mirum Pharmaceuticals reported results from the phase 3 portion of AZURE-1 with brelovitug, a subcutaneous anti-HBsAg monoclonal antibody, in treatment-naive chronic hepatitis delta: 153 patients randomized 2:2:1 to 300 mg weekly, 900 mg every four weeks, or delayed treatment. At week 24, the combined response (≥2 log HDV RNA decline or undetectable plus ALT normalization) was 56% and 45% versus 0% in the delayed arm (p < 0.0001); virologic response 86% and 85%. There were no serious adverse events or discontinuations in the active arms; injection-site reactions in 10% and 19%. The company plans an FDA filing in the first half of 2027; a second pivotal trial (AZURE-4) reads out in Q4 2026.
Why it matters: the first robust alternative to bulevirtide, with possible monthly dosing; but these are press-release data from a study with a delayed-treatment comparator (no placebo) at only 24 weeks, with no durability data. Relevant for hepatitis delta patients from endemic areas (Amazon basin, Africa, Eastern Europe) seen in the region.
https://www.businesswire.com/news/home/20260928804552/en/Mirum-Pharmaceuticals-Announces-Primary-Endpoint-Met-in-Phase-3-AZURE-1-Study-of-Brelovitug-in-Chronic-Hepatitis-Delta-Virus

3. Bepirovirsen: Japan approves the first "functional cure" for hepatitis B, and Chinese-population data are presented

[Regulatory MHLW] [Japan, China] [Outside the period: August 24]
GSK announced on August 24 that Japan's Ministry of Health, Labour and Welfare approved Hibsago (bepirovirsen), an antisense oligonucleotide, for functional cure of chronic hepatitis B in adults with at least six months of nucleos(t)ide analogue therapy and HBsAg ≤3,000 IU/mL with suppressed HBV DNA (<90 IU/mL). It rests on the B-Well 1 and 2 trials (29 countries): functional cure in 19% (233/1,220) versus 0/614 with placebo, and 26% (200/768) versus 0/393 with HBsAg ≤1,000 IU/mL. On September 5, in Singapore, Professor Hou Jinlin (Nanfang Hospital) presented the Chinese B-Well subgroup data for the first time, with functional cure rates of "up to 61%", according to Sina Finance coverage, which does not specify the subgroup or the number of patients; GSK says further regulatory decisions are pending in other countries, including the US. (source in Chinese)
Why it matters: the approval is 45 days old, outside our usual window, but its weight justifies inclusion, and the Chinese data do fall in the period. Caution: the 61% figure comes from press coverage of a congress presentation, without peer-reviewed publication or a known denominator; the overall figure is 19–26%. In the Dominican Republic access will be delayed, and identifying the ideal candidate (low HBsAg, suppressed viral load) requires quantitative HBsAg, which is not routinely available in many centers.
https://www.gsk.com/en-gb/media/press-releases/hibsago-bepirovirsen-approved-in-japan-as-first-and-only-functional-cure-for-chronic-hepatitis-b/
https://finance.sina.com.cn/jjxw/2026-09-05/doc-iniquptn3533414.shtml

4. ACG guideline on preventive care in cirrhosis: 18 recommendations

[Guideline] [USA]
Published online October 5 in the American Journal of Gastroenterology (Tapper, Kardashian, Debes, et al.), using GRADE methodology. Strong recommendations: carvedilol or endoscopic band ligation as primary prophylaxis for high-risk varices; ultrasound and alpha-fetoprotein every six months for HCC surveillance in treatment candidates; vaccination (hepatitis A, influenza, SARS-CoV-2, RSV at ≥50 years) and smoking cessation. Conditional: carvedilol to prevent first ascites in compensated cirrhosis with clinically significant portal hypertension, lactulose for minimal hepatic encephalopathy, two to three days of prophylactic antibiotics in upper GI bleeding, guided nutrition, exercise, and bisphosphonates. Against: aspirin for HCC prevention and rifaximin as primary prevention of overt encephalopathy in patients with minimal encephalopathy.
Why it matters: nearly all evidence is low certainty (only carvedilol/ligation is moderate certainty), but it is an inexpensive checklist applicable in Dominican practice: carvedilol, vaccines and semiannual surveillance require no costly technology.
https://hcplive.com/view/acg-guideline-sets-18-preventive-care-recommendations-for-cirrhosis
https://doi.org/10.14309/ajg.0000000000004186

Endoscopy and pancreatobiliary

5. EPoS II: first surveillance colonoscopy at 5 years is noninferior to 3 years after high-risk adenomas

[Clinical trial] [Europe, eight countries]
NEJM, September 17 (Jover et al.). Pragmatic randomized noninferiority trial in 10,799 adults aged 40 to 74 after complete removal of high-risk adenomas (≥10 mm, high-grade dysplasia, villous component, or 3–10 adenomas): first surveillance at 5 years (n = 5,398) versus 3 and 5 years (n = 5,401). At the 5.5-year interim analysis, cumulative colorectal cancer incidence was 0.77% versus 0.82% (difference −0.05 percentage points; upper bound of the one-sided 99.12% CI: 0.68, below the prespecified 0.70 margin). The primary endpoint is 10-year incidence. Colorectal cancer deaths: 3 versus 2.
Why it matters: if confirmed at 10 years, it would free up substantial endoscopic capacity; but it is an interim analysis and depends on a high-quality index colonoscopy (complete resection, adequate prep), which is not always the case in our setting. Guidelines have not yet changed.
https://www.nejm.org/doi/full/10.1056/NEJMoa2603816

Section note: in pancreas, ERCP, EUS and endoscopic AI we found no verifiable high-impact publications within the period.

Esophagus, stomach and microbiota

6. EMA confirms refusal of a standardized fecal microbiota product (Xervyteg)

[Regulatory EMA] [European Union]
At the September 14–17 CHMP meeting, after re-examination, the European agency upheld its negative opinion on Xervyteg (pooled allogeneic fecal microbiota) for acute graft-versus-host disease.
Why it matters: the outcome sets a high regulatory bar for standardized fecal microbiota products in Europe; together with REFIT2, the month sends a message of caution about microbiota therapy beyond Clostridioides difficile.
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-september-2026

Section note: there were no new verifiable trials in the period in reflux, Barrett's esophagus, Helicobacter pylori or GI bleeding.

Cross-cutting

7. Glepaglutide receives a positive EMA opinion for short bowel syndrome

[Regulatory EMA] [European Union, Denmark]
On September 17 the CHMP adopted a positive opinion for Zeydovio (glepaglutide, Zealand Pharma), a long-acting GLP-2 analogue in a prefilled pen, for adults with short bowel syndrome. According to the EMA summary of opinion, the main benefit was a greater reduction in weekly parenteral support volume than placebo after 24 weeks of twice-weekly dosing. The European Commission decision is pending.
Why it matters: a second option after teduglutide with less frequent dosing; the EMA summary gives no effect sizes, so the label is worth waiting for. Access in the Caribbean will be limited and costly.
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-september-2026
https://www.ema.europa.eu/es/node/286927

8. WCOG 2026 held in India for the first time

[Congress] [India]
The World Congress of Gastroenterology (WCOG) was held September 30 to October 3 in New Delhi, with about 3,000 delegates from 61 countries; the opening day focused on prevention and earlier diagnosis of digestive disease.
Why it matters: we could not verify trial results with figures; we cite it as a milestone for the Global South agenda, which shares problems with our region such as gastric cancer and metabolic liver disease.
https://biospectrumindia.com/news/16/28582/health-minister-unveils-10-commandments-for-gastrointestinal-health.html
https://medicaldialogues.in/news/health/jp-nadda-highlights-governments-holistic-approach-to-healthcare-at-world-congress-of-gastroenterology-2026-180401

Regional coverage: this month we found no verifiable, in-period items from Brazil, Russia, Turkey, Korea or the Middle East.

Upcoming meetings and dates

• ACG 2026 Annual Scientific Meeting: October 9–14, Nashville (USA). https://acgmeetings.gi.org/annual-meeting
• UEG Week 2026: October 17–20, Barcelona and online. https://www.ueg.eu/week/
• AASLD The Liver Meeting 2026: November 5–9, Denver (USA). https://www.aasld.org/tlm-26

Monthly gastroenterology and hepatology bulletin — October 8, 2026

8 verified items from the past month, from NEJM, The Lancet, the American Journal of Gastroenterology, EMA and industry announcements.

Three worth your time:
• EPoS II (NEJM): in 10,799 patients after high-risk adenomas, first surveillance at 5 years was noninferior to 3 years (colorectal cancer 0.77% vs 0.82%). Interim analysis; requires a high-quality index colonoscopy.
• Brelovitug in hepatitis delta (AZURE-1): week-24 combined response 56% and 45% vs 0%. Delayed-treatment comparator, no placebo, press-release data.
• REFIT2 (The Lancet): fecal transplant in 450 IBS patients, 40% vs 38% with placebo. Negative, and the largest to date.

Full bulletin, with a critical appraisal of each study and links to their sources:
https://boletinesmedicos.com/en/gastroenterologia/2026-10-08.html

#Gastroenterology #Hepatology #HepatitisD #Colonoscopy #Microbiome

EPoS II: 5-year surveillance after high-risk adenomas noninferior to 3 years (CRC 0.77% vs 0.82%). Brelovitug in hepatitis delta: combined response 56% and 45% vs 0% at week 24 (press release). https://boletinesmedicos.com/en/gastroenterologia/2026-10-08.html