CURRENT STATUS

Hepatology contains both the clearest cure story in modern medicine and several hard frontiers. Hepatitis C is genuinely cured: direct-acting antivirals achieve >95% sustained virologic response in 8–12 weeks, converting a leading transplant indication into a short course of pills. Hepatitis B remains suppressible but not cured — the cccDNA reservoir persists — with siRNA and antisense agents racing toward functional cure. MASH gained its first approved therapy (resmetirom) in 2024, opening a broad anti-fibrotic pipeline. And because the liver uniquely regenerates, fibrosis — long thought irreversible — is now known to regress when the underlying driver is removed.

KEY BREAKTHROUGHS

Hepatitis C cure (Harvoni/Sovaldi) — first chronic viral disease cured by medicine

Resmetirom (Rezdiffra) — first FDA-approved drug for MASH/NASH liver disease

siRNA therapies (JNJ-3989, VIR-2218) reducing HBV surface antigen >1 log in Phase II

CRISPR-based HBV cccDNA disruption showing viral clearance in preclinical models

AI-COMPRESSED PIPELINE

AI TOOLS ACCELERATING CURES

Liver Fibrosis Staging AINASH Biomarker DiscoveryHepatocyte Differentiation ModelsViral Escape Prediction

KEY ORGANIZATIONS

Gilead SciencesArbutus BiopharmaAssembly BiosciencesMadrigal PharmaceuticalsRoche/Genentech

KEY CLINICAL TRIALS

B-Sure — Finite Treatment of Chronic Hepatitis B (Phase III)

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Janssen / Johnson & Johnson

Evaluating JNJ-73763989 (siRNA) + JNJ-56136379 (capsid inhibitor) + nucleos(t)ide analogue to achieve HBV functional cure — defined as sustained HBsAg loss off all therapy. A pivotal trial testing whether finite antiviral combinations can replace lifelong nucleoside treatment.

👥 ~450 participants with chronic HBV, HBeAg-negative📍 Global — US, EU, Asia Pacific, 150+ sites

SEQUOIA — Resmetirom (Rezdiffra) Long-Term Outcomes in MASH (Phase III)

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Madrigal Pharmaceuticals

Long-term extension evaluating whether resmetirom (the first FDA-approved MASH drug) reduces liver-related clinical events — decompensation, transplant, death — beyond its proven effect on fibrosis and steatohepatitis resolution. A landmark trial for MASH outcome data.

👥 ~1,200 participants with biopsy-confirmed MASH + fibrosis📍 US, EU, Latin America — multicenter

Bepirovirsen (GSK3228836) for Chronic HBV (Phase IIb)

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GSK (GlaxoSmithKline)

An antisense oligonucleotide targeting all HBV mRNAs and pregenomic RNA. Testing whether 24 weeks of bepirovirsen ± pegylated interferon can achieve sustained HBsAg loss — a potential functional cure — in patients already on nucleos(t)ide analogues.

👥 ~450 participants across multiple cohorts📍 Global — US, EU, Asia, Australia

TIMELINE ESTIMATE

Hepatitis C: cured today (>95%). HBV functional cure: 3–5 years. MASH combinations: 3–5 years. Liver regeneration / bioengineering: 7–15 years.

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