Side Effects

Adverse effects associated with the use of Olysio may include, but are not limited to, the following:

Rash (including photosensitivity)

Pruritus

Nausea

Dosing/Administration

Olysio is supplied as a capsule for oral administration. The recommended dose is one 150 mg capsule taken once daily with food. Olysio should be administered with both peginterferon alfa and ribavirin. The recommended treatment duration of Olysio with peginterferon alfa and ribavirin is 12 weeks, followed by either 12 or cc36 additional weeks of peginterferon alfa and ribavirin depending on prior response status.

Clinical Trial Results

FDA Approval
The FDA approval of Olysio was based on the following trials:

Treatment-Naïve Adult Subjects with HCV Genotype 1 Infection
Two randomized, double-blind, placebo-controlled, two-arm, multicenter trials (QUEST 1 and QUEST 2) were conducted. The design of both trials was similar. All subjects received 12 weeks of once-daily treatment with 150 mg Olysio or placebo, plus Peg-IFN-alfa-2a (QUEST 1 and QUEST 2) or Peg-IFN-alfa-2b (QUEST 2) and RBV, followed by 12 or 36 weeks of therapy with Peg-IFN-alfa and RBV in accordance with the on-treatment protocol-defined RGT criteria. Subjects in the control groups received 48 weeks of Peg-IFN-alfa-2a or -2b and RBV alone. In the pooled analysis of QUEST 1 and QUEST 2, 88 percent (459/521) of Olysio-treated subjects were eligible for a total treatment duration of 24 weeks. In these subjects, the SVR12 rate was 88 percent (405/459). Seventy-eight percent (78 percent; 404/521) of Olysio-treated subjects had undetectable HCV RNA at Week 4 (RVR); in these subjects the SVR12 rate was 90 percent (362/404), while 8 percent (32/392) with undetectable HCV RNA at end of treatment had viral relapse. SVR12 rates were higher for subjects receiving Olysio with Peg-IFN-alfa-2a or Peg-IFN-alfa-2b and RBV (88 percent and 78 percent, respectively) compared to subjects receiving placebo with Peg-IFN-alfa-2a or Peg-IFN-alfa-2b and RBV (62 percent and 42 percent, respectively) (QUEST 2).

Adult Subjects with HCV Genotype 1 Infection who Failed Prior Therapy
A randomized, double-blind, placebo-controlled, two-arm, multicenter, phase 2 trial, PROMISE, was conducted in subjects with HCV genotype 1 infection who relapsed after prior IFN-based therapy. All subjects received 12 weeks of once-daily treatment with 150-mg Olysio or placebo, plus Peg-IFN-alfa-2a and RBV, followed by 12 or 36 weeks of therapy with Peg-IFN-alfa-2a and RBV in accordance with the protocol-defined RGT criteria. Subjects in the control group received 48 weeks of Peg-IFN-alfa-2a and RBV alone. In PROMISE, 93 percent (241/260) of Olysio-treated subjects were eligible for a total treatment duration of 24 weeks. In these subjects, the SVR12 rate was 83 percent (200/241). Seventy-seven percent (77 percent; 200/260) of Olysio-treated subjects had undetectable HCV RNA at Week 4 (RVR); in these subjects the SVR12 rate was 87 percent (173/200), while 13 percent (25/196) with undetectable HCV RNA at end of treatment had viral relapse. A second randomized, double-blind, placebo-controlled, seven-arm, phase 2b trial, ASPIRE, was also conducted. ASPIRE enrolled subjects with HCV genotype 1 infection who failed prior therapy with Peg-IFN-alfa and RBV (including prior relapsers, partial responders or null responders). Subjects received 12, 24 or 48 weeks of 100-mg or 150-mg Olysio in combination with 48 weeks of Peg-IFN-alfa-2a and RBV, or 48 weeks of placebo in combination with 48 weeks of Peg-IFN-alfa-2a and RBV. In prior partial responders, SVR24 rates in subjects receiving Olysio with Peg-IFN-alfa and RBV were 47 percent and 77 percent in subjects with HCV genotype 1a and 1b, respectively, compared to 13 percent and 7 percent, respectively, in subjects receiving placebo with Peg-IFN-alfa and RBV. In prior null responders, SVR24 rates in subjects receiving OLYSIO with Peg-IFN-alfa and RBV were 41 percent and 47 percent in subjects with HCV genotype 1a and 1b, respectively, compared to 0 percent and 33 percent, respectively, in subjects receiving placebo with Peg-IFN-alfa and RBV.