Nancy Reau, MD, is Professor of Internal Medicine, Richard B. Capps Chair of Hepatology, Associate Director of Solid Organ Transplantation, and Section Chief of Hepatology at Rush University Medical Center.

Monthly subcutaneous elebsiran plus tobevibart achieved undetectable hepatitis D virus (HDV) RNA with alanine aminotransferase (ALT) normalization in 44% of adults with chronic hepatitis delta at Week 48, compared with 0% in a delayed-treatment arm, according to results from the phase 3 ECLIPSE 1 trial presented at 

² ECLIPSE 1 is the first pivotal trial from the ECLIPSE registrational program to report.¹

Nancy Reau, MD, of Rush University Medical Center, presented the findings and discussed them in an interview with 

. She emphasized HDV remains underdiagnosed, as identifying it depends first on diagnosing hepatitis B virus infection, which often goes unrecognized in the US.

Monthly Treatment for Hepatitis D? Elebsiran + Tobevibart Data at AASLD 2026

“In order to find Delta, you first have to find B,” Reau said.

How Did Elebsiran and Tobevibart Perform in ECLIPSE 1?

The combination pairs elebsiran, a small interfering RNA targeting hepatitis B surface antigen (HBsAg) production, with tobevibart, a monoclonal antibody designed to bind viral particles and block entry. ECLIPSE 1 randomized 124 adults on nucleos(t)ide analog therapy, approximately 55% with compensated cirrhosis, 2:1 to elebsiran 200 mg plus tobevibart 300 mg every 4 weeks (n = 83) or treatment delayed until Week 12 (n = 41).¹

² Mean baseline HDV RNA was 5.5 log10 IU/mL.¹

The primary endpoint of HDV RNA target not detected plus ALT normalization was met by 44% of participants at Week 48 vs 0% in the delayed arm (P < .0001).² HDV RNA target not detected occurred in 79% vs 0% (P < .0001), and ALT normalization occurred in 53% vs 5%. HBsAg fell below 10 IU/mL in 95% of treated participants.²

Reau noted all participants achieved virologic response by Week 24, and HDV RNA target not detected rates were still climbing at Week 48. Among patients with compensated cirrhosis, 85% achieved target not detected, compared with 73% without cirrhosis.²

“You cannot blow a horn about efficacy without talking about safety,” Reau said.

All participants completed 48 weeks of treatment, with no treatment interruptions or discontinuations.² One grade 3 treatment-related adverse event, a decrease in neutrophil count, resolved within 15 days, and the most common treatment-related adverse event was flu-like symptoms, mainly after the first dose.² Reau noted 1 episode of neutropenia also occurred during the delayed-treatment period.

Reau said the once-monthly regimen of 2 subcutaneous injections offers convenience, whether administered at home or in clinic. She also highlighted new AASLD guidance announced at the meeting, a companion to the hepatitis B guidance, advocating screening for HDV in every person with hepatitis B, ideally through reflex testing.

Bulevirtide (Hepcludex) received accelerated approval from the US Food and Drug Administration in May 2026 as the first therapy for chronic HDV.³ ECLIPSE 2 is evaluating a switch to elebsiran plus tobevibart in patients without viral suppression on bulevirtide, and ECLIPSE 3 is a head-to-head comparison with bulevirtide, with data expected in the first quarter of 2027. Vir Biotechnology plans a US regulatory submission in mid-2027; the regimen holds FDA Breakthrough Therapy and Fast Track designations.²

Reau N, Chow S, Jucov A, et al. Primary endpoint results of ECLIPSE 1: a randomized open-label phase 3 study evaluating efficacy and safety of elebsiran and tobevibart for chronic hepatitis delta. Presented at: The Liver Meeting 2026; November 5-9, 2026; Denver, CO.

Vir Biotechnology. Vir Biotechnology announces primary endpoint met in pivotal phase 3 ECLIPSE 1 trial for elebsiran and tobevibart in chronic hepatitis delta. Published November 8, 2026. Accessed November 13, 2026. 

https://investors.vir.bio/news/news-details/2026/Vir-Biotechnology-Announces-Primary-Endpoint-Met-in-Pivotal-Phase-3-ECLIPSE-1-Trial-for-Elebsiran-and-Tobevibart-in-Chronic-Hepatitis-Delta/default.aspx

Bulevirtide receives historic first FDA approval for chronic hepatitis delta. HCPLive. Published May 22, 2026. Accessed November 13, 2026. 

https://www.hcplive.com/view/bulevirtide-historic-first-fda-approval-chronic-hepatitis-delta

Videos

Nancy Reau, MD, discusses ECLIPSE 1 data showing monthly elebsiran plus tobevibart achieved undetectable HDV RNA in 79% of patients with hepatitis delta.

News

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Clinical

clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

Hepatology

Hepatitis B

Hepatitis B page, resources on the topics of medical news and expert insight into HCV can be found. Content includes articles, interviews, videos, podcasts, and breaking news on hepatitis B virus research, treatment, and drug development.

Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

What ECLIPSE 1 Means for Hepatitis Delta Treatment, With Nancy Reau, MD

Michael S. Blaiss, MD, clinical professor at the Medical College of Georgia at Augusta University.

Double-dose FMXIN002 (NS002), an investigational intranasal epinephrine powder, raised systolic blood pressure without cardiovascular or serious adverse events in adults with 

, according to data presented at the 2026 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting in Pheonix.¹

In an interview with HCPLive, investigator Michael S. Blaiss, clinical professor of pediatrics at the Medical College of Georgia at Augusta University, detailed the blood pressure, heart rate, and adverse event findings from the phase 2 double-dose study and explained how he counsels patients on a second dose. 

, in which FMXIN002 reached plasma epinephrine of 100 pg/mL faster than a 0.3-mg autoinjector.²

“Our biggest problem with patients right now is carrying an auto injector with them and having it when, in fact, they may have an anaphylactic reaction,” Blaiss said. He added a small, needle-free device could address this gap for patients who need to carry epinephrine at all times.

Intranasal Epinephrine Powder Safety After Double Dose, With Michael Blaiss, MD

FMXIN002 Blood Pressure and Heart Rate After Double Dosing

The study enrolled 50 adults with allergic rhinitis. Participants received 2 doses of FMXIN002 4 mg 10 minutes apart, under normal conditions or after a nasal allergen challenge (NAC), with a double-dose 0.3-mg autoinjector as the comparator.¹ Pharmacodynamic measures included systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate.¹

Across both normal and NAC conditions, mean SBP rose by approximately 22 mm Hg at 15 to 20 minutes with FMXIN002, compared with approximately 6 mm Hg with the autoinjector, according to Blaiss. DBP stayed near baseline under both conditions. Heart rate was broadly equivalent between groups, with some increase relative to the autoinjector.

Blaiss said no participant had a cardiovascular adverse event. Pharmacodynamic responses followed expected epinephrine effects and remained within normal physiological limits.¹

FMXIN002 Adverse Events and Second-Dose Counseling

What adverse events occurred with double-dose FMXIN002?


No serious AEs were reported. Most AEs were local, self-resolving, and mild; the most common were runny nose, administration site discomfort, nasal itching, and nasal congestion.

How did double-dose FMXIN002 affect blood pressure?


Mean SBP rose about 22 mm Hg at 15 to 20 minutes with FMXIN002, compared with about 6 mm Hg with the autoinjector, according to Blaiss. No cardiovascular AEs occurred.

When should patients take a second dose of epinephrine?


Blaiss advises a second dose if a patient does not feel significant improvement within 5 to 10 minutes of the first dose or if symptoms worsen.

No serious adverse events (AEs) were reported with either treatment.¹ According to Blaiss, most AEs with FMXIN002 were local and self-resolving, and 95% were mild, although AEs were more frequent after double dosing. The main difference from the autoinjector was the type of AE: events with FMXIN002 were mostly local, and events with the autoinjector were mostly systemic.

The most common local AEs with FMXIN002 were runny nose, administration site discomfort, nasal itching, and nasal congestion. Systemic AEs, including headache, nausea, shakiness, stomach discomfort, lightheadedness, and vomiting, occurred only after double dosing under NAC conditions, Blaiss said.

Blaiss advises patients to take a second dose if they do not feel significant improvement within 5 to 10 minutes of the first or if their symptoms worsen.

“I’m very liberal as far as patients getting a second dose,” Blaiss said. “If there’s any question they’re not having a significant improvement as far as decrease of symptoms of anaphylaxis with the first dose, they should definitely administer the second dose in that 10-minute time frame.”

Blaiss M, Lapidot T, Megiddo D, Abrutzky C, Temtsin Krayz G. Enhanced absorption of intranasal powder epinephrine (FMXIN002) after double dose in adults with allergic rhinitis. Presented at: American College of Allergy, Asthma & Immunology 2026 Annual Scientific Meeting; November 12-16, 2026; Phoenix, AZ.

FMXIN002 double dose delivers faster epinephrine exposure than autoinjector. 

https://www.hcplive.com/view/fmxin002-double-dose-faster-epinephrine-exposure-autoinjector

. HCPLive. Published November 12, 2026. Accessed November 13, 2026.

Systolic blood pressure rose about 22 mm Hg with double-dose FMXIN002 vs 6 mm Hg with an autoinjector, without cardiovascular adverse events.

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Anaphylaxis

The HCPLive anaphylaxis page is a comprehensive resource for clinical news and insights on acute allergic reactions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for preventing anaphylaxis, and more.

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for 

. He is also the executive producer of two podcasts: 

. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.


Icotrokinra is a once-daily oral peptide that blocks the IL-23 receptor. It is approved for moderate to severe plaque psoriasis in patients aged 12 years and older weighing at least 40 kg.


At week 16, 55.2% of patients taking icotrokinra reached PASI 90 and 70.4% reached IGA 0/1, compared with 3.6% and 9.5% with placebo.


Icotrokinra was noninferior to ustekinumab at week 28, with numerically higher clearance rates, but statistical superiority was not demonstrated.

Once-daily oral icotrokinra (Icotyde) outperformed placebo and was noninferior to ustekinumab in adults and adolescents with 

 in the phase 3 ICONIC-ASCEND study, according to topline results Johnson & Johnson announced in November 2026.¹

Icotrokinra is a targeted oral peptide that blocks the interleukin-23 (IL-23) receptor. In the US, it is already approved for moderate to severe plaque psoriasis in patients aged 12 years and older weighing at least 40 kg who are eligible for systemic therapy or phototherapy. It is also approved in Europe, Japan, and China.¹ ICONIC-ASCEND is the first head-to-head comparison of an oral agent with an injectable biologic in plaque psoriasis.¹

What Did ICONIC-ASCEND Show for Icotrokinra Versus Placebo?

ICONIC-ASCEND (NCT06934226) is a randomized, double-blind, placebo-controlled phase 3 trial comparing icotrokinra with placebo and ustekinumab in patients aged 12 years and older.² Participants were enrolled into 2 prespecified cohorts. About 24% had never received systemic therapy, or had stopped a prior systemic agent for reasons other than efficacy, tolerability, or contraindication. The other 76% had an inadequate response, intolerance, or contraindication to at least 1 systemic therapy.¹

Both co-primary endpoints were met at week 16. A 90% or greater improvement in the Psoriasis Area and Severity Index (PASI 90) was reached by 55.2% of patients taking icotrokinra versus 3.6% of placebo recipients. An Investigator’s Global Assessment score of clear or almost clear (IGA 0/1) was achieved by 70.4% and 9.5%, respectively.¹

How Did Icotrokinra Compare with Ustekinumab?

At week 28, icotrokinra was noninferior to ustekinumab across all multiplicity-controlled key secondary endpoints. According to Johnson & Johnson, IGA 0, IGA 0/1, PASI 90, and PASI 100 response rates were numerically higher with icotrokinra in both systemic-naive and biologic-experienced patients, although statistical superiority was not shown.¹

In a prespecified analysis of systemic-naive patients, 48.1% of those taking icotrokinra achieved complete skin clearance (PASI 100) at week 28, compared with 31.2% of those receiving ustekinumab (nominal P = .028). The company also noted the ustekinumab arm performed above historical levels.¹

The safety profile of icotrokinra was consistent with earlier studies, and no new safety signals emerged. The announcement did not include full patient numbers or detailed adverse event data.¹

Icotrokinra is also being studied in psoriatic arthritis in the ICONIC-PsA 1 and ICONIC-PsA 2 trials, and in ulcerative colitis and Crohn’s disease.¹

Editor's Note: This summary has been edited for grammar and clarity using artificial intelligence tools.

Johnson & Johnson. New ICOTYDE (icotrokinra) data reinforces first-line systemic use in plaque psoriasis with powerful skin clearance and consistent safety profile. Published November 6, 2026. Accessed November 13, 2026. 

https://www.jnj.com/media-center/press-releases/new-icotyde-icotrokinra-data-reinforces-first-line-systemic-use-in-plaque-psoriasis-with-powerful-skin-clearance-and-consistent-safety-profile

ClinicalTrials.gov. A study to assess efficacy and safety of JNJ-77242113 compared to placebo and ustekinumab in participants with moderate-to-severe plaque psoriasis (ICONIC-ASCEND). NCT06934226. Accessed November 13, 2026. 

https://clinicaltrials.gov/study/NCT06934226

Articles

Once-daily oral icotrokinra, an IL-23 receptor–blocking peptide, met co-primary endpoints in phase 3 ICONIC-ASCEND, demonstrating robust week-16 efficacy versus placebo in adolescents and adults with moderate to severe plaque psoriasis. In the first head-to-head trial of an oral agent versus an injectable biologic in this setting, icotrokinra was noninferior to ustekinumab across multiplicity-controlled key secondary endpoints at week 28, with numerically higher skin-clearance rates. Safety was consistent with prior studies, without new signals reported.

Oral icotrokinra beat placebo and was noninferior to ustekinumab in moderate to severe plaque psoriasis in the phase 3 ICONIC-ASCEND trial.

Plaque Psoriasis

The HCPLive plaque psoriasis page is a resource for medical news and expert insights on psoriasis. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for psoriatic disease, and more.

ICONIC-ASCEND: Icotrokinra Tops Placebo, Matches Ustekinumab in Psoriasis

"Stewardship and Empiric Therapy in AMR Gram-Negative Infections " closes the series by reframing stewardship as a tool for getting the right drug to the right patient sooner. Antimicrobial stewardship for novel gram-negative agents is most effective when it expands appropriate empiric use as deliberately as it restricts inappropriate use. Dr. Tamma asks how institutions should steward these drugs, and Dr. Shields explains that his health system restricts them around the clock while using mechanism-based algorithms to guide selection, because most clinicians encounter these organisms too rarely to master the enzymology.

Stewardship and Empiric Therapy in AMR Gram-Negative Infections

Dr. Shields notes that restriction tends to work smoothly because actionable laboratory data usually emerge during the day. He emphasizes the counterintuitive point that stewardship teams should also be liberal in starting these agents empirically for the right patients, such as those with a recent history of NDM, rather than defaulting to a conventional beta-lactam.

Dr. Pogue builds on this idea, arguing that intensive care unit (ICU) clinicians know their patients best at the moment empiric decisions are made. He describes empowering ICU pharmacists to start novel agents for patients with known histories or high-risk exposures, such as those arriving from a long-term acute care facility, with the option to de-escalate within a day or two. He reminds viewers that the primary goal of stewardship is optimizing outcomes for patients with infections.

In closing reflections, Dr. Shields encourages clinicians who rarely see carbapenem-resistant organisms to engage with the guidance anyway, because it also reexamines long-standing practices for ESBL and AmpC producers and dosing assumptions rooted in weak evidence. Dr. Tamma invites feedback on the guidance and urges clinicians with relevant patient data to publish it. The series ends with a reminder that evidence in this field evolves rapidly and practice should evolve with it.

Thank you for watching this Contagion Live Peer Exchange series on antimicrobial-resistant gram-negative infections. Please subscribe to our eNewsletter for information on upcoming video series.

Effective stewardship of novel gram-negative agents pairs restriction with deliberate promotion of timely empiric use in high-risk patients, keeping optimized outcomes, rather than limitation, as the central goal.

New antimicrobials help patients only when laboratories can test them and clinicians understand what the results mean, so implementation depends on partnerships with microbiology and on thoughtful education. Dr. Tamma recalls how delays in susceptibility testing slowed uptake of earlier agents and asks Dr. Shields how hospitals should prepare their laboratories for drugs such as cefepime-zidebactam.

Microbiology Lab Readiness and Education in AMR Care

Dr. Shields frames the conversation as a balance of clinical priority, laboratory capacity, and testing accuracy. Because automated panels have limited space, many new agents require add-on gradient strips or disks. He notes encouraging trends, including testing devices that now become available before or alongside drug launch and standardized isolate banks from public health agencies that simplify verification.

He advocates reflex testing algorithms, such as automatically setting up sulbactam-durlobactam testing when CRAB grows in a blood culture, rather than waiting for a clinician request. Dr. Shields also expresses sympathy for overstretched laboratories and suggests that leading with a clear clinical need is the most effective way to secure their collaboration.

Dr. Tamma then asks Dr. Haidar how infectious diseases specialists should communicate resistance mechanisms to colleagues. Dr. Haidar argues that trainees should learn to ask how an organism became resistant before choosing a drug, contrasting a pan-resistant E. coli, likely a KPC producer in his region, with a pan-resistant Pseudomonas, whose resistance has no single explanation. He also cautions against conflating ceftolozane-tazobactam and ceftazidime-avibactam. Dr. Tamma adds that local algorithms and stewardship approval can guide non-specialists who cannot track every detail.

The episode underscores that laboratory readiness and mechanism-based reasoning together determine whether new agents reach the right patients.

The series concludes with "Stewardship and Empiric Therapy in AMR Gram-Negative Infections," as Dr. Shields and Dr. Pogue reframe what stewardship should accomplish.

Early collaboration with microbiology laboratories, reflex testing algorithms, and mechanism-based teaching help ensure that new antimicrobials reach the right patients and that resistance results are interpreted correctly.

Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

HIBISCUS showed a 48.7% vs 7.2% hemoglobin response at week 24, with an FDA decision expected in 2027.

Hematology

FDA News

Sickle Cell

Sickle Cell condition center page, resources on the topics of medical news and expert insight into sickle cell disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on sickle cell research, treatment, and drug development.

Etavopivat Submitted to FDA After 27% VOC Reduction in Phase 3 SCD Trial

Cytokines produced in mucosal tissue drive pathogenic IgA, which makes BAFF and APRIL logical targets. VISIONARY data on selective APRIL inhibition showed a positive eGFR slope, a first in a phase 3 IgAN trial.

Targeting BAFF and APRIL in IgAN: Mechanisms and VISIONARY eGFR Data

Empiric use of novel agents should follow patient-level risk and unit-level epidemiology, while a shared vocabulary for carbapenem-resistant Enterobacterales and their carbapenemases underpins every subsequent treatment decision.

Empiric Risk Assessment and Carbapenemase Classification in AMR Infections

Overall gram-negative resistance rates have plateaued, but the carbapenemases driving carbapenem resistance have shifted, with NDM expanding alongside KPC and reshaping treatment considerations across the Enterobacterales.

Shifting AMR Gram-Negative Resistance Trends in the US

The 2025 KDIGO guidelines endorse treating both the IgA pathway and supportive care from the start. Dr. Geara and Dr. Cheung discuss treatment inertia, early diagnosis, and matching each agent to patient risk and preferences.

2025 KDIGO Guidelines in IgAN: Treatment Selection and Overcoming Inertia

Christopher G. Bunick, MD, PhD, is an associate professor of dermatology at Yale University School of Medicine.

Experts outline when to stop cycling topical steroids in chronic hand eczema and where topical delgocitinib now fits.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

ABCs in Dermatology

Welcome to ABC’s in Dermatology, HCPLive’s newest dermatology podcast, hosted by a pair of the field’s leading minds in Lindsay Ackerman, MD, and Chris Bunick, MD, PhD.

Created by the same team behind The Medical Sisterhood and Skin of Color Savvy, ABCs in Dermatology is a monthly podcast designed to deliver candid conversations, clinical insight, and forward-looking perspectives from the voices shaping dermatology today.

Atopic Dermatitis

Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

Podcasts

podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, and Heart Trials.

ABCs in Dermatology: Rethinking Corticosteroid Stewardship in Chronic Hand Eczema

60% to 82% of adults reached plasma epinephrine of 100 pg/mL or more within 2.5 minutes with a double-dose intranasal epinephrine powder, according to Michael Blaiss, MD.

FMXIN002 Double Dose Delivers Faster Epinephrine Exposure Than Autoinjector

Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

TRANSCEND-T2D-2 topline data show retatrutide lowered A1C more and produced over twice the weight loss of semaglutide 2 mg in type 2 diabetes.

Type 2 Diabetes

Endocrinology

The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

This page also hosts content previously published by EndocrinologyNetwork. 


Diabetes Dialogue

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives is a podcast hosted by Diana Isaacs, PharmD, and Natalie Bellini, DNP, aimed at providing a regular roundup of the latest clinically applicable insights across diabetes and metabolic diseases, with a focus on leveraging technology to improve care.

Strategic Alliance Partnership

Diabetes Dialogue: Retatrutide Tops Semaglutide on A1C, Weight in T2D

Gerard Criner, MD, is chair and professor of thoracic medicine and surgery at Lewis Katz School of Medicine at Temple University and director of the Temple Lung Center.

Gerard Criner, MD, discusses mucus plugging, multimorbidity, and moderate exacerbation risk in COPD from the GOLD 2026 conference in Philadelphia.

COPD

COPD condition center page, resources on the topics of medical news and expert insight into chronic obstructive pulmonary disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on COPD research, treatment, and drug development.

Looking Beyond the Lungs in COPD Care, With Gerard Criner, MD

Tom Martens, MD, joins Diana Isaacs, PharmD, and Natalie Bellini, DNP, to discuss CONNECT trial data on CGM in non-insulin-treated type 2 diabetes.

Latest News

What ECLIPSE 1 Means for Hepatitis Delta Treatment, With Nancy Reau, MD

Intranasal Epinephrine Powder Safety After Double Dose, With Michael Blaiss, MD

ICONIC-ASCEND: Icotrokinra Tops Placebo, Matches Ustekinumab in Psoriasis

Stewardship and Empiric Therapy in AMR Gram-Negative Infections

Microbiology Lab Readiness and Education in AMR Care