PMID- 36047126
OWN - NLM
STAT- MEDLINE
DCOM- 20230516
LR  - 20230614
IS  - 1349-7235 (Electronic)
IS  - 0918-2918 (Print)
IS  - 0918-2918 (Linking)
VI  - 62
IP  - 10
DP  - 2023 May 15
TI  - Real-world Safety and Effectiveness of 24-week Sofosbuvir and Ribavirin Treatment 
      in Patients Infected with Rare Chronic Hepatitis C Virus Genotypes 3, 4, 5, or 6 
      in Japan.
PG  - 1405-1414
LID - 10.2169/internalmedicine.0067-22 [doi]
AB  - Objectives Real-world evidence on the safety and effectiveness of direct-acting 
      antivirals in patients infected with chronic hepatitis C virus (HCV) genotypes 
      (GTs) 3, 4, 5, or 6 in Japan is limited. This prospective observational study 
      assesses the real-world safety profile and treatment effectiveness among patients 
      prescribed sofosbuvir with ribavirin (SOF+RBV) for HCV GT3-6 infection in Japan. 
      Methods Adults receiving 24-week SOF+RBV treatment for HCV GT3-6 infection were 
      prospectively enrolled and observed through 24 weeks post-treatment for 
      treatment-emergent adverse events (AEs) considered related to SOF and/or RBV by 
      treating physicians and for a sustained virologic response at 12 and 24 weeks 
      post-treatment (SVR12, SVR24). Incidence rates of related AEs and serious AEs 
      (SAEs) were calculated. Proportions of patients experiencing related AEs/SAEs and 
      those achieving SVR12 and SVR24 were assessed overall and by baseline 
      characteristics, including treatment experience and cirrhosis status. Results 
      Among the 50 patients included in the safety analysis, 92% had GT3 infection. The 
      incidence rates of related AEs and SAEs were low overall (1.52 and 0.25 per 100 
      person-weeks, respectively), with 6.0% and 14.0% patients experiencing AEs 
      related to SOF or RBV, respectively. There were no marked differences in the 
      occurrence of related AEs/SAEs by patient baseline characteristics. SVR12 and 
      SVR24 were achieved in 83.7% (41/49) and 82.2% (37/45) of patients, respectively. 
      Lower effectiveness was observed among treatment-experienced patients and 
      patients with cirrhosis at baseline. Conclusion This study demonstrated that 
      SOF+RBV treatment for HCV GT3-6 infection was safe, effective, and an important 
      treatment option for this difficult-to-treat patient population in Japan.
FAU - Mita, Eiji
AU  - Mita E
AD  - National Hospital Organization Osaka National Hospital, Japan.
FAU - Liu, Lauren J
AU  - Liu LJ
AD  - Gilead Sciences, USA.
FAU - Shing, Danielle
AU  - Shing D
AD  - Gilead Sciences International, United Kingdom.
FAU - Force, Lindsey
AU  - Force L
AD  - Gilead Sciences, USA.
FAU - Aoki, Kouji
AU  - Aoki K
AD  - Gilead Sciences, Japan.
FAU - Nakamoto, Daisuke
AU  - Nakamoto D
AD  - Gilead Sciences, Japan.
FAU - Ishizaki, Akinobu
AU  - Ishizaki A
AD  - Gilead Sciences, Japan.
FAU - Konishi, Hiroki
AU  - Konishi H
AD  - Gilead Sciences, Japan.
FAU - Mizutani, Hajime
AU  - Mizutani H
AD  - Gilead Sciences, Japan.
FAU - Ng, Leslie J
AU  - Ng LJ
AD  - Gilead Sciences, USA.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20220830
PL  - Japan
TA  - Intern Med
JT  - Internal medicine (Tokyo, Japan)
JID - 9204241
RN  - WJ6CA3ZU8B (Sofosbuvir)
RN  - 49717AWG6K (Ribavirin)
RN  - 0 (Antiviral Agents)
SB  - IM
MH  - Adult
MH  - Humans
MH  - Sofosbuvir/adverse effects
MH  - Ribavirin/adverse effects
MH  - Antiviral Agents/adverse effects
MH  - *Hepatitis C, Chronic
MH  - Japan/epidemiology
MH  - *Hepatitis C/drug therapy
MH  - Hepacivirus/genetics
MH  - Treatment Outcome
MH  - Drug Therapy, Combination
MH  - Liver Cirrhosis/drug therapy
MH  - Genotype
PMC - PMC10258100
OTO - NOTNLM
OT  - genotype
OT  - hepatitis C
OT  - ribavirin
OT  - safety
OT  - sofosbuvir
OT  - sustained virologic response
COIS- Author's disclosure of potential Conflicts of Interest (COI). Eiji Mita: 
      Honoraria, Gilead Sciences. Lauren J. Liu: Employment, Gilead Sciences; Stock 
      ownership, Gilead Sciences. Danielle Shing: Employment, Gilead Sciences; Stock 
      ownership, Gilead Sciences. Lindsey Force: Employment, Gilead Sciences; Stock 
      ownership, Gilead Sciences. Kouji Aoki: Employment, Gilead Sciences; Stock 
      ownership, Gilead Sciences. Daisuke Nakamoto: Employment, Gilead Sciences; Stock 
      ownership, Gilead Sciences. Akinobu Ishizaki: Employment, Gilead Sciences; Stock 
      ownership, Gilead Sciences. Hiroki Konishi: Employment, Gilead Sciences; Stock 
      ownership, Gilead Sciences. Hajime Mizutani: Employment, Gilead Sciences; Stock 
      ownership, Gilead Sciences. Leslie J. Ng: Employment, Gilead Sciences; Stock 
      ownership, Gilead Sciences.
EDAT- 2022/09/02 06:00
MHDA- 2023/05/16 06:42
PMCR- 2023/05/15
CRDT- 2022/09/01 03:43
PHST- 2023/05/16 06:42 [medline]
PHST- 2022/09/02 06:00 [pubmed]
PHST- 2022/09/01 03:43 [entrez]
PHST- 2023/05/15 00:00 [pmc-release]
AID - 10.2169/internalmedicine.0067-22 [doi]
PST - ppublish
SO  - Intern Med. 2023 May 15;62(10):1405-1414. doi: 10.2169/internalmedicine.0067-22. 
      Epub 2022 Aug 30.