PMID- 36045503
OWN - NLM
STAT- MEDLINE
DCOM- 20230110
LR  - 20230413
IS  - 1096-9071 (Electronic)
IS  - 0146-6615 (Print)
IS  - 0146-6615 (Linking)
VI  - 95
IP  - 1
DP  - 2023 Jan
TI  - A Phase 2 open label study of ledipasvir/sofosbuvir for 12 weeks in subjects with 
      hepatitis B virus infection.
PG  - e28105
LID - 10.1002/jmv.28105 [doi]
LID - e28105
AB  - Retrospective data showed that when we administered ledipasvir/sofosbuvir 
      (LDV/SOF) to patients with hepatitis B and C coinfection, there was a modest 
      reduction in hepatitis B surface antigen (HBsAg). Therefore, we hypothesize that 
      similar HBsAg reduction can be seen in hepatitis B virus (HBV) monoinfected 
      subjects. Primary and secondary efficacy endpoints are the decline in HBsAg and 
      HBV DNA at Week 12 from baseline, respectively. We conducted an open-label Phase 
      2 pilot study to evaluate the safety, tolerability, and antiviral activity of 
      LDV and/or SOF for HBV. Eligible subjects were either suppressed on antivirals 
      (Group B) or inactive chronic HBV (Group A, C, D). Group A and B received 
      LDV/SOF. Group C and D received SOF 400 mg and LDV 90 mg, respectively. All 
      subjects completed the study, and all related adverse events (AEs) were mild. No 
      discontinuations due to AEs or hepatitis flare occurred. At Week 12, HBsAg 
      decline (log(10) IU/ml) was similar between Group A (0.399) and B (0.400), less 
      in Group C (0.207), and none in Group D, and there was HBV DNA decline in the 
      inactive chronic HBV groups. LDV and SOF are safe and well tolerated when given 
      to chronic hepatitis B subjects and have modest antiviral activity, particularly 
      when given in combination.
CI  - (c) 2022 The Authors. Journal of Medical Virology published by Wiley Periodicals 
      LLC.
FAU - Price, Angie S
AU  - Price AS
AD  - Institute of Human Virology, University of Maryland School of Medicine, 
      Baltimore, Maryland, USA.
FAU - Nelson, Amy K
AU  - Nelson AK
AD  - Institute of Human Virology, University of Maryland School of Medicine, 
      Baltimore, Maryland, USA.
FAU - Ghosh, Alip
AU  - Ghosh A
AD  - Institute of Human Virology, University of Maryland School of Medicine, 
      Baltimore, Maryland, USA.
FAU - Kottilil, Shyamasundaran
AU  - Kottilil S
AD  - Institute of Human Virology, University of Maryland School of Medicine, 
      Baltimore, Maryland, USA.
FAU - Chua, Joel V
AU  - Chua JV
AUID- ORCID: 0000-0002-7579-4672
AD  - Institute of Human Virology, University of Maryland School of Medicine, 
      Baltimore, Maryland, USA.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220912
PL  - United States
TA  - J Med Virol
JT  - Journal of medical virology
JID - 7705876
RN  - 0 (ledipasvir, sofosbuvir drug combination)
RN  - WJ6CA3ZU8B (Sofosbuvir)
RN  - 013TE6E4WV (ledipasvir)
RN  - 0 (Hepatitis B Surface Antigens)
RN  - 0 (DNA, Viral)
RN  - 0 (Antiviral Agents)
RN  - 0 (Fluorenes)
SB  - IM
MH  - Humans
MH  - Sofosbuvir/adverse effects
MH  - Hepatitis B virus/genetics
MH  - *Hepatitis B, Chronic/drug therapy
MH  - Hepatitis B Surface Antigens
MH  - Retrospective Studies
MH  - DNA, Viral
MH  - Pilot Projects
MH  - Hepacivirus/genetics
MH  - Symptom Flare Up
MH  - Antiviral Agents/adverse effects
MH  - Fluorenes/adverse effects
MH  - *Hepatitis B/drug therapy
PMC - PMC10087219
OTO - NOTNLM
OT  - HBV DNA
OT  - HBV infection
OT  - antiviral effect
OT  - chronic hepatitis B
OT  - hepatitis B surface antigen
OT  - ledipasvir
OT  - nucleos(t)ide analogues
OT  - quantitative HBV surface antigen
OT  - sofosbuvir
OT  - viral hepatitis B
COIS- The authors declare no conflict of interest.
EDAT- 2022/09/02 06:00
MHDA- 2023/01/11 06:00
PMCR- 2023/04/11
CRDT- 2022/09/01 00:13
PHST- 2022/08/15 00:00 [revised]
PHST- 2022/06/10 00:00 [received]
PHST- 2022/08/27 00:00 [accepted]
PHST- 2022/09/02 06:00 [pubmed]
PHST- 2023/01/11 06:00 [medline]
PHST- 2022/09/01 00:13 [entrez]
PHST- 2023/04/11 00:00 [pmc-release]
AID - JMV28105 [pii]
AID - 10.1002/jmv.28105 [doi]
PST - ppublish
SO  - J Med Virol. 2023 Jan;95(1):e28105. doi: 10.1002/jmv.28105. Epub 2022 Sep 12.