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Abstract Details
One-quarter of chronic hepatitis D patients reach HDV-RNA decline or undetectability during the natural course of the disease
Aliment Pharmacol Ther. 2021 Jun 28. doi: 10.1111/apt.16485. Online ahead of print.
Adriana Palom12, Sara Sopena3, Mar Riveiro-Barciela124, Angela Carvalho-Gomes45, Antonio Madejón46, Sergio Rodriguez-Tajes47, Luisa Roade124, María García-Eliz5, Javier García-Samaniego46, Sabela Lens47, Marina Berenguer-Hayme45, Francisco Rodríguez-Frías234, Helena Hernandez-Évole5, Ana Isabel Gil-García46, Ana Barreira124, Rafael Esteban124, Maria Buti124
Author information
1Liver Unit, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
2Department of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain.
3Biochemistry and Microbiology Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
4Instituto de Salud Carlos III, Madrid, Spain.
5Liver Transplantation and Hepatology Unit, Hospital U. y P. La Fe, Universitat de València, Valencia, Spain.
6Liver Unit, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain.
7Liver Unit, Hospital Clinic Barcelona, IDIBAPS, Universitat de Barcelona, Barcelona, Spain.
Abstract
Background: Spontaneous HDV-RNA fluctuations, assessed by nonstandardised in-house assays, have been reported during the course of chronic hepatitis delta (CHD).
Aims: To evaluate changes in serum HDV-RNA concentrations in untreated CHD patients and correlate these changes with other HBV markers.
Methods: A total of 323 consecutive serum samples from 56 CHD patients (detectable HDV-RNA) followed for >3 years were retested for HDV-RNA levels by a sensitive technique using the first WHO international HDV-RNA standard. Quantitative HBsAg, HBV-DNA, and HBV-RNA were also determined.
Results: Most participants were male, middle-aged, white European, and HBeAg-negative (82%). Almost half had liver cirrhosis and 64% were receiving nucleos(t)ide analogues. At inclusion, median-HDV-RNA was 5.3 (4.2-6.5) log10 IU/mL, HBsAg 4.0 (3.5-4.3) log10 IU/mL, and HBV-DNA 1.6 (1.0-2.6) log10 IU/mL; ALT values were normal in 13 (23%). During a mean follow-up of 5.6 (3-16) years, 14 (25%) showed ≥2log10 HDV-RNA decline, including 11 (20%) who spontaneously achieved undetectable HDV-RNA. Four patients (7%) lost HBsAg, with undetectable HDV-RNA. The remaining 42 (75%) had persistently detectable HDV-RNA. During follow-up, patients with a ≥2log10 HDV-RNA decline showed a greater HBsAg drop (-0.7 ± 1.1 vs -0.09 ± 0.9 log IU/mL; P = 0.039) than those with a <2 log10 HDV-RNA decline. Overall, ALT and HBV-DNA levels decreased over time. There were no differences in clinical outcomes between groups.
Conclusions: One-quarter of untreated CHD patients showed a ≥2log10 decline in HDV-RNA and 20% reached HDV-RNA undetectability during a mean follow-up of 5.6 years. The decline was associated with ALT decrease. These findings have implications for designing new therapies for CHD.