This study seeks to assess the durability of response and persistence of resistance to ombitasvir/ paritaprevir/ritonavir in Japanese participants who enrolled in a Phase 2 or 3 clinical study with these agents for the treatment of chronic hepatitis C.
Study Type
OBSERVATIONAL
Enrollment
344
Hepatitis C virus ribonucleic acid (HCV RNA) levels
HCV RNA levels in plasma
Time frame: 60 months after completion of the 2D treatment in M12-536 or M13-004 study
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Paritaprevir in Non-structural Viral Protein 3 (NS3)
Time frame: For approximately 5 years
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Ombitasvir in Non-structural Viral Protein 5A (NS5A)
Time frame: For approximately 5 years
Percentage of participants with hepatocellular carcinoma
Time frame: Up to 60 month after completion of the 2D treatment in M12-536 or M13-004
Number of participants with serious adverse events (SAEs)
All serious adverse events will be monitored during the observation period.
Time frame: Up to 60 month after completion of the 2D treatment in M132-536 or M13-004 study
Hepatitis C virus ribonucleic acid (HCV RNA) levels
HCV RNA levels in plasma
Time frame: 18, 24, 30, 36, 42, 48, 52 months after completion of the 2D treatment in M12-536 or M13-004 study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Nagoya City University Hospital /ID# 157439
Nagoya, Aichi-ken, Japan
Matsuyama Red Cross Hospital /ID# 152125
Matsuyama, Ehime, Japan
National Hospital Organization Kyushu Medical Center /ID# 161759
Fukuoka, Fukuoka, Japan
Fukuoka University Hospital /ID# 155965
Fukuoka, Fukuoka, Japan
Kurume University Hospital /ID# 152123
Kurume-shi, Fukuoka, Japan
Ogaki Municipal Hospital /ID# 158105
Ogaki-shi, Gifu, Japan
Gunma University Hospital /ID# 158118
Maebashi, Gunma, Japan
National Hospital Organization Takasaki General Medical Center /ID# 152128
Takasaki-shi, Gunma, Japan
Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital /ID# 152178
Hiroshima, Hiroshima, Japan
Hiroshima University Hospital /ID# 152232
Hiroshima, Hiroshima, Japan
...and 43 more locations