Efficacy and Tolerability of Ombitasvir/Paritaprevir/Ritonavir in HCV Genotype 1-infected Elderly Japanese Patients

2018 ◽  
Vol 17 (5) ◽  
pp. 0-10
Author(s):  
Haruki Uojima ◽  
Shuzo Kobayashi ◽  
Hisashi Hidaka ◽  
Takeshi Kinbara ◽  
Tomoaki Fujikawa ◽  
...  

We assessed the characteristics of virological response to a combination treatment of ombitasvir, paritaprevir, and ritonavir in hepatitis C virus genotype 1-infected elderly Japanese patients. This multicenter prospective study was conducted at six locations in Japan. Seventy patients with chronic hepatitis C virus genotype 1b infection were orally administered ombitasvir/paritaprevir/ritonavir once daily for 12 weeks. The primary endpoint was the proportion of elderly patients with sustained virological response (SVR) 12 weeks after the completion of treatment. Adverse events were also recorded to evaluate drug safety and tolerability during the trial period. SVR in elderly patients (age >65; 94% [47/50]) was lower than that in younger patients (100% [20/20]). No significant differences in SVR 12 weeks after the completion of treatment were observed between the age groups (P = 0.153). Adverse events were observed in 16 patients (23.3%). Multivariate analysis confirmed that the change or discontinuation of concomitant drugs owing to drug interactions was independent of risk factors for adverse events associated with this drug combination (P = 0.015; odds ratio, 15.9; 95% confidence interval, 1.79–148). Ombitasvir/paritaprevir/ritonavir combination treatment was highly effective in elderly patients. Tolerability should be monitored in older patients for whom concomitant medications are discontinued or changed because of drug interactions.

2016 ◽  
Vol 31 (10) ◽  
pp. 1674-1683 ◽  
Author(s):  
Hiromitsu Kumada ◽  
Satoshi Mochida ◽  
Fumitaka Suzuki ◽  
Kazuaki Chayama ◽  
Yoshiyasu Karino ◽  
...  

2013 ◽  
Vol 58 (2) ◽  
pp. 1136-1145 ◽  
Author(s):  
Edward J. Gane ◽  
Régine Rouzier ◽  
Alicja Wiercinska-Drapalo ◽  
Dominique G. Larrey ◽  
Peter N. Morcos ◽  
...  

ABSTRACTDanoprevir (DNV) is a hepatitis C virus (HCV) protease inhibitor that achieves high sustained virologic response (SVR) rates in combination with peginterferon alfa-2a–ribavirin in treatment-naive HCV genotype 1 (G1)-infected patients. This study explored the efficacy and safety of ritonavir-boosted DNV (DNVr) plus peginterferon alfa-2a–ribavirin in G1-infected prior peginterferon-ribavirin null responders. Null responders (<2-log10reduction in HCV RNA level at week 12) were given an open-label combination of 100 mg of ritonavir and 100 mg of DNV (100/100 mg DNVr) every 12 h (q12h) plus peginterferon alfa-2a–ribavirin for 12 weeks. All patients achieving an early virologic response (EVR; ≥2-log10decrease in HCV RNA by week 12) continued treatment with peginterferon alfa-2a–ribavirin; those without an EVR discontinued all study drugs. Twenty-four prior null responders were enrolled; 16 patients (67%) were infected with HCV G1b, and 8 (33%) were infected with G1a. Ninety-six percent of patients had anIL28Bnon-CC genotype. A sustained virologic response at 24 weeks posttreatment (SVR24) was achieved in 67% of patients, with a higher rate in G1b-infected (88%) than G1a-infected (25%) patients. Resistance-related breakthrough occurred in 4/8 G1a and 1/16 G1b patients through the DNV resistance-associated variant (RAV) NS3 R155K. NS3 R155K was also detected in 2/2 G1a patients who relapsed. Treatment was well tolerated. Two patients withdrew prematurely from study medications due to adverse events. Two serious adverse events were reported; both occurred after completion of DNVr therapy and were considered unrelated to treatment. No grade 3 or 4 alanine aminotransferase (ALT) elevations were observed. DNVr plus peginterferon alfa-2a–ribavirin demonstrated high SVR24 rates in HCV G1b-infected prior null responders and was well tolerated. (This study has been registered atClinicalTrials.govunder registration no. NCT01185860.)


SpringerPlus ◽  
2016 ◽  
Vol 5 (1) ◽  
Author(s):  
Takao Watanabe ◽  
Kouji Joko ◽  
Hirotaka Seike ◽  
Kojiro Michitaka ◽  
Norio Horiike ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document