Patients wit
h c
hronic
hepatitis C
virus (HCV) infection and cirr
hosis
ha
ve a
hig
her risk for li
ver-related complications and
ha
ve
historically
been more difficult to cure t
han patients wit
hout cirr
hosis. We e
valuated t
he safety and efficacy of om
bitas
vir/paritapre
vir/ritona
vir and dasa
bu
vir, wit
hout ri
ba
virin, for 12 weeks in patients wit
h HCV genotype 1
b infection and compensated cirr
hosis.<
h4 id="a
bsSec_2">Met
hods
h4>
Treatment-naïve and peginterferon/ribavirin treatment-experienced patients received 12 weeks of ombitasvir/paritaprevir/ritonavir (25/150/100 mg once daily) and dasabuvir (250 mg twice daily). Key inclusion criteria were hemoglobin ⩾10 g/dl, albumin ⩾2.8 g/dl, platelet count ⩾25 × 109/L, creatinine clearance ⩾30 ml/min, and Child-Pugh score ⩽6. Efficacy was assessed by the percentage of patients achieving SVR (HCV RNA <25 IU/ml) 12 weeks post-treatment (SVR12). Efficacy and safety were assessed in all patients receiving study drug.
<
h4 id="a
bsSec_3">Results
h4>
Sixty patients with HCV genotype 1b infection and cirrhosis received treatment. The study population comprised 62% male, 55% treatment-experienced, 83% with IL28B non-CC genotype, 22% with platelet count <90 × 109/L, and 17% with albumin <3.5 g/dl. All 60 patients completed treatment, and SVR12 was achieved in 100% (95% CI, 94.0–100%) of patients. The most common adverse events were fatigue (22%), diarrhea (20%), and headache (18%). Only one patient (1.7%) experienced a serious adverse event. Laboratory abnormalities were infrequently observed and not clinically significant.
<
h4 id="a
bsSec_4">Conclusions
h4>
The HCV regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir without ribavirin for 12 weeks achieved 100% SVR12 and was well tolerated in HCV genotype 1b-infected patients with cirrhosis, suggesting that this 12-week ribavirin-free regimen is sufficient in this population.