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In the pursuit to cure* chronic hepatitis C virus (HCV) genotype 1 infection…Consider once-daily OLYSIO® in combination with sofosbuvir (SOF) for your individual patient needs

OLYSIO® has a demonstrated safety profile, with 12- and 24-week treatment duration

OLYSIO® side effects

§The 12 week group represents subjects pooled from COSMOS, OPTIMIST-1, and OPTIMIST-2 trials.

‖The 24 week group represents subjects from COSMOS trial.

The overall safety profile appeared similar among cirrhotic and non-cirrhotic subjects. The majority of the adverse events reported were Grade 1 or 2 in severity. Grade 3 or 4 adverse events were reported in 4% and 13% of subjects receiving 12 or 24 weeks of OLYSIO® with sofosbuvir, respectively. Serious adverse events were reported in 2% and 3% of subjects receiving 12 or 24 weeks of OLYSIO® with sofosbuvir, respectively. One percent and 6% of subjects receiving 12 or 24 weeks of OLYSIO® with sofosbuvir, respectively, discontinued treatment due to adverse events.

Rash and Photosensitivity

In trials of OLYSIO in combination with sofosbuvir, rash (including photosensitivity reactions) was observed in 12% of OLYSIO-treated subjects receiving 12 weeks of treatment compared to 16% of OLYSIO-treated subjects receiving 24 weeks of treatment.

Most of the rash events in OLYSIO-treated subjects were of mild or moderate severity (Grade 1 or 2). Among 317 subjects, Grade 3 rash was reported in one subject (<1%), leading to treatment discontinuation; none of the subjects experienced Grade 4 rash.

Most photosensitivity reactions were of mild severity (Grade 1); Grade 2 photosensitivity reactions were reported in 2 of 317 subjects (<1%). No Grade 3 or 4 photosensitivity reactions were reported and none of the subjects discontinued treatment due to photosensitivity reactions.

Laboratory Abnormalities

Among subjects who received OLYSIO in combination with sofosbuvir, the most common Grade 3 and 4 laboratory abnormalities were amylase and lipase elevations. Most elevations in amylase and lipase were transient and of mild or moderate severity. Amylase and lipase elevations were not associated with pancreatitis.

Laboratory Abnormalities

§The 12 week group represents subjects pooled from COSMOS, OPTIMIST-1, and OPTIMIST-2 trials.

‖The 24 week group represents subjects from COSMOS trial.

*No Grade 4 changes in amylase were observed.

†ULN = Upper Limit of Normal