Summary of the safety profile

The safety summary is based on pooled data from phase 2 and 3 clinical trials in more than 2,600 subjects who received Viekirax and dasabuvir with or without ribavirin.

Viekirax and dasabuvir with ribavirin in subjects with genotype 1 hepatitis C infection (including subjects with compensated cirrhosis)

In subjects receiving Viekirax and dasabuvir with ribavirin, the most commonly reported adverse reactions (greater than 20% of subjects) were fatigue and nausea. The proportion of subjects who permanently discontinued treatment due to adverse reactions was 0.2% (5/2,044). 0.2% (5/2,044) of subjects interrupted treatment due to adverse reactions. 4.8% (99/2,044) of subjects had ribavirin dose reductions due to adverse reactions.

With the exception of increased rates of transient hyperbilirubinemia, the safety profile of Viekirax and dasabuvir with ribavirin in subjects with compensated cirrhosis was similar to that of subjects without cirrhosis.

Viekirax and dasabuvir without ribavirin in subjects with genotype 1 hepatitis C infection

No subjects permanently discontinued treatment or had treatment interruptions due to adverse reactions.

Tabulated list of adverse reactions

Table 3 lists adverse reactions for which a causal relationship between paritaprevir/ombitasvir/ritonavir, in combination with dasabuvir and/or ribavirin, and the adverse event is at least a reasonable possibility. The majority of adverse reactions presented in Table 3 were of grade 1 severity in Viekirax and dasabuvir-containing regimens.

The adverse reactions are listed below by system organ class and frequency. Frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000).

Table 3. Adverse drug reactions identified with Viekirax in combination with dasabuvir with and without ribavirin

*Data set includes all genotype 1-infected subjects in Phase 2 and 3 trials including subjects with cirrhosis.

Note: For laboratory abnormalities, refer to Table 4

Description of selected adverse reactions

Laboratory abnormalities

Changes in selected laboratory parameters are described in Table 4. A side-by-side tabulation is shown to simplify presentation; direct comparison across trials should not be made due to differing trial designs.

Table 4. Selected treatment emergent laboratory abnormalities

Serum ALT elevations

In a pooled analysis of clinical trials with Viekirax and dasabuvir with and without ribavirin, 1% of subjects experienced serum ALT levels greater than 5 times the upper limit of normal (ULN) after starting treatment. As the incidence of such elevations was 26% among women taking a concomitant ethinylestradiol-containing medicinal product, such medicinal products are contraindicated wit