Ombitasvir, paritaprevir, and ritonavir with peginterferon-α2a plus ribavirin in treatment-experienced patients with chronic hepatitis C virus genotype 1 infection

Figures & data

Table 1 Medications contraindicated for use with the study drug regimen

Alfuzosin	Midazolam (oral)
Astemizole	Phenobarbital
Carbamazepine	Phenytoin
Cisapride	Pimozide
Efavirenz	Rifampin
Ergot derivatives (ergotamine,	Salmeterol
dihydroergotamine, ergonovine,	Sildenafila
methylergometrine)	Simvastatin
Estrogen-containing medications for	St John’s wort
systemic use	Terfenadine
Fusidic acid	Triazolam
Lovastatin

Notes:

a When used for the treatment of pulmonary arterial hypertension. Not all medications contraindicated with ritonavir, RBV, and pegIFN are listed. Investigators referred to the most current product labeling for each drug for a complete list.

Figure 1 Patient flow chart.

Notes: ^aPatients who were screen failures may have had more than one reason for screen failure.
Abbreviations: AE, adverse event; OBV, ombitasvir; pegIFN-α2a, pegylated interferon-α2a; PTV, paritaprevir; RBV, ribavirin.

Table 2 Baseline demographics and clinical characteristics

Characteristic	N=32
Male, n (%)	25 (78)
Age, median (range), years	54.5 (28.0–64.0)
Race, n (%)
White	30 (94)
Black	2 (6)
Hispanic or Latino ethnicity, n (%)	2 (6)
Body mass index, median (range), kg/m^2	27.9 (18.5–43.9)
IL28B non-CC genotype, n (%)	26 (81)
HCV genotype, n (%)
1a/1b	21 (66)/11 (34)
HCV RNA, mean ±SD, Log10 IU/mL	6.47 ± 0.54
HCV RNA ≥800,000 IU/mL, n (%)	29 (91)
Treatment in the initial DAA combination study, n (%)
OBV/PTV/r	1 (3)
OBV/PTV/r+DSV	9 (28)
OBV/PTV/r+DSV+RBV	6 (19)
OBV/PTV/r+RBV	3 (9)
PTV/r+DSV+RBV	3 (9)
TPV+pegIFN+RBV	10 (31)
Type of response to HCV treatment in initial DAA combination study, n (%)
On-treatment virologic failure	16 (50)
Post-treatment relapse	16 (50)
Fibrosis stage, n (%)
F0–F1	22 (73)
F2	2 (7)
F3 and F4	6 (20)

Abbreviations: DAA, direct-acting antiviral; DSV, dasabuvir; HCV, hepatitis C virus; IL28B, interleukin 28B; OBV, ombitasvir; pegIFN, pegylated interferon; PTV, paritaprevir; r, ritonavir; RBV, ribavirin; SD, standard deviation; TPV, telaprevir.

Table 3 AEs and post-baseline laboratory abnormalities after initiating treatment with OBV, PTV, and ritonavir plus pegIFN-α2a/RBV for 12 weeks (recorded until 30 days post treatment)

	N=32
AEs, n (%)
Any AE	29 (90.6)
Any severe AE	5 (15.6)
Any serious AE	1 (3.1)
Death	1 (3.1)
Any AE possibly or probably related to DAA	18 (56.3)
Any AE possibly or probably related to pegIFN	26 (81.3)
Any AE possibly or probably related to RBV	27 (84.4)
Any AE leading to study drug discontinuation	2 (6.3)
Any AE leading to pegIFN dose modification	13 (40.6)
Any AE leading to RBV dose modification	8 (25.0)
Common AEs (≥10%)
Headache	14 (43.8)
Fatigue	11 (34.4)
Nausea	9 (28.1)
Insomnia	8 (25.0)
Rash	8 (25.0)
Neutropenia	7 (21.9)
Diarrhea	6 (18.8)
Influenza-like illness	6 (18.8)
Pruritus	6 (18.8)
White blood cell count decreased	5 (15.6)
Cough	4 (12.5)
Dry skin	4 (12.5)
Dyspnea	4 (12.5)
Irritability	4 (12.5)
Pyrexia	4 (12.5)
Laboratory abnormalities, n/N (%)
Hemoglobin
Grade 2 (<10–8 g/dL)	1/30 (3.3)
Grade ≥3 (<8 g/dL)	0
Alanine aminotransferase
Grade 2 (>3–5 · ULN)	2/30 (6.7)c
Grade ≥3 (>5 · ULN)	0
Aspartate aminotransferase
Grade 2 (>3–5 · ULN)	0
Grade ≥3 (>5 · ULN)	0
Total bilirubin
Grade 2 (>1.5–3 · ULN)	5/30 (16.7)
Grade ≥3 (>3 · ULN)	0

Notes:

a As assessed by the investigator.

b One patient discontinued prematurely due to a fatal serious AE of myocardial infarction, which was assessed as not being related to any study drug.

c Grade 2 elevations present at baseline.

Abbreviations: AEs, adverse events; DAA, direct-acting antiviral; OBV, ombitasvir; PegIFN, pegylated interferon; PTV, paritaprevir; RBV, ribavirin; ULN, upper limit of normal.