Tenofovir disoproxil fumarate in Asian or Pacific Islander chronic hepatitis B patients with high viral load (≥ 9 log10 copies/ml).

Abstract

BACKGROUND & AIMS:

We evaluated the antiviral response of Asian or Pacific Islander (API) patients with chronic hepatitis B (CHB) who had baseline high viral load (HVL), defined as pre-treatment hepatitis B virus (HBV) DNA ≥9 log10 copies/ml, following up to 288 weeks of tenofovir disoproxil fumarate (TDF) treatment.

METHODS:

A total of 205 HBeAg-negative and HBeAg-positive self-described API patients received 48 weeks of TDF 300 mg (HVL n = 18) or adefovir dipivoxil 10 mg (HVL n = 15) in a blinded fashion, followed by open-label TDF for an additional 240 weeks. The proportions of HVL vs. non-HVL patients with HBV DNA <400 copies/ml were compared. Mean declines in HBV DNA were evaluated in API vs. non-API patients.

RESULTS:

Throughout the first 72 weeks of treatment, a smaller proportion of HVL API patients reached HBV DNA <400 copies/ml than non-HVL API patients. However, after this timepoint similar proportions of HVL and non-HVL API patients achieved HBV DNA <400 copies/ml (100% vs. 97%, respectively), which was maintained through week 288, where 92% of HVL patients and 99% of non-HVL API patients on treatment had HBV DNA <400 copies/ml. During the 288 weeks of treatment, API patients had similar mean HBV DNA declines as non-API patients, regardless of whether patients were HVL or non-HVL. No API HVL patient had persistent viremia at week 288. No resistance was detected among HVL or non-HVL patients.

CONCLUSIONS:

API patients with HVL CHB achieve HBV DNA <400 copies/ml with long-term TDF treatment; however, achieving viral suppression may take longer for HVL patients relative to non-HVL API patients.

• Authors: Scott Fung, Stuart C Gordon, Zahary Krastev, Andrzej Horban, Jörg Petersen, Jan Sperl, Edward Gane, Ira M Jacobson, Leland J Yee, Phillip Dinh, Eduardo B Martins, John F Flaherty, Kathryn M Kitrinos, Geoffrey Dusheiko, Huy Trinh, Robert Flisiak, Vinod K Rustgi, Maria Buti, Patrick Marcellin
• Journal: Liver international : official journal of the International Association for the Study of the Liver (Liver Int) Vol. 35 Issue 2 Pg. 422-8 (Feb 2015) ISSN: 1478-3231 [Electronic] United States
• PMID: 25277773 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Chemical References

• Organophosphonates
• Tenofovir
• Adenine

Topics

• Adenine (analogs & derivatives, pharmacology, therapeutic use)
• Adult
• Asian People
• Drug Resistance, Viral (physiology)
• Hepatitis B, Chronic (drug therapy)
• Humans
• Native Hawaiian or Other Pacific Islander
• Organophosphonates (pharmacology, therapeutic use)
• Statistics, Nonparametric
• Tenofovir
• Viral Load (drug effects)