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Limitations Of Use
- Efficacy of OLYSIO in combination with peginterferon alfa (Peg-IFN-alfa) and ribavirin (RBV) is substantially reduced in patients infected with HCV genotype 1a with an NS3 Q80K polymorphism at baseline compared to patients infected with hepatitis C virus (HCV) genotype 1a without the Q80K polymorphism [see DOSAGE AND ADMINISTRATION and Microbiology].
- OLYSIO is not recommended in patients who have previously failed therapy with a treatment regimen that included OLYSIO or other HCV protease inhibitors [see Microbiology].
DOSAGE AND ADMINISTRATION
Testing Prior To Initiation Of Therapy
Q80K Testing In HCV Genotype 1a-Infected Patients
Prior to initiation of treatment with OLYSIO in combination with sofosbuvir, screening patients infected with HCV genotype 1a for the presence of virus with the NS3 Q80K polymorphism may be considered [see Microbiology].
Prior to initiation of treatment with OLYSIO in combination with Peg-IFN-alfa and RBV, screening patients with HCV genotype 1a infection for the presence of virus with the NS3 Q80K polymorphism is strongly recommended and alternative therapy should be considered for patients infected with HCV genotype 1a containing the Q80K polymorphism [see INDICATIONS AND USAGE and Microbiology].
Hepatic Laboratory Testing
Monitor liver chemistry tests before and during OLYSIO combination therapy [see WARNINGS AND PRECAUTIONS].
OLYSIO Combination Treatment
Administer OLYSIO in combination with other antiviral drugs for the treatment of chronic HCV infection. OLYSIO monotherapy is not recommended. The recommended dosage of OLYSIO is one 150 mg capsule taken orally once daily with food [see CLINICAL PHARMACOLOGY]. The capsule should be swallowed as a whole. For specific dosing recommendations for the antiviral drugs used in combination with OLYSIO, refer to their respective prescribing information.
OLYSIO can be taken in combination with sofosbuvir or in combination with Peg-IFN-alfa and RBV.
OLYSIO + Sofosbuvir
Table 1 displays the recommended treatment regimen and duration of OLYSIO in combination with sofosbuvir in mono-infected patients with HCV genotype 1 infection.
Table 1: Recommended Treatment Regimen and Duration
for OLYSIO and Sofosbuvir Combination Therapy in Patients with Chronic HCV
Genotype 1 Infection
|Patient Population (Genotype 1)||Treatment Regimen and Duration|
|Treatment-naive and treatment-experienced patients:*|
|without cirrhosis||12 weeks of OLYSIO + sofosbuvir|
|with cirrhosis||24 weeks of OLYSIO + sofosbuvir|
|* Treatment-experienced patients include prior relapsers, prior partial responders and prior null responders who failed prior IFN-based therapy.|
OLYSIO + Peg-IFN-alfa + RBV:
Table 2 displays the recommended treatment regimen and duration of OLYSIO in combination with Peg-IFN-alfa and RBV in mono-infected and HCV/HIV-1 co-infected patients with HCV genotype 1 or 4 infection. Refer to Table 3 for treatment stopping rules for OLYSIO combination therapy with Peg-IFN-alfa and RBV.
Table 2: Recommended Treatment Regimen and Duration
for OLYSIO, Peg-IFN-alfa, and RBV Combination Therapy in Patients with Chronic
HCV Genotype 1 or 4 Infection
|Patient Population (Genotype 1 or 4)||Treatment Regimen and Duration|
|Treatment-naive patients and prior relapsers:*|
|with or without cirrhosis, who are not co-infected with HIV||12 weeks of OLYSIO + Peg-IFN-alfa + RBV followed by an additional 12 weeks of Peg-IFN-alfa + RBV (total treatment duration of 24 weeks)†|
|without cirrhosis, who are co-infected with HIV|
|with cirrhosis, who are co-infected with HIV||12 weeks of OLYSIO + Peg-IFN-alfa + RBV followed by an additional 36 weeks of Peg-IFN-alfa + RBV (total treatment duration of 48 weeks)†|
|Prior non-responders (including partial‡ and null responders#):|
|with or without cirrhosis, with or without HIV co-infection||12 weeks of OLYSIO + Peg-IFN-alfa + RBV followed by an additional 36 weeks of Peg-IFN-alfa + RBV (total treatment duration of 48 weeks)†|
|HIV = human immunodeficiency virus.
* Prior relapser: HCV RNA not detected at the end of prior IFN-based therapy and HCV RNA detected during follow-up [see Clinical Studies].
† Recommended duration of treatment if patient does not meet stopping rules (see Table 3).
‡ Prior partial responder: prior on-treatment ≥ 2 log10 IU/mL reduction in HCV RNA from baseline at Week 12 and HCV RNA detected at end of prior IFN-based therapy [see Clinical Studies].
# Prior null responder: prior on-treatment < 2 log10 IU/mL reduction in HCV RNA from baseline at Week 12 during prior IFN-based therapy [see Clinical Studies].
Discontinuation Of Dosing
Use With Sofosbuvir
No treatment stopping rules apply to the combination of OLYSIO with sofosbuvir [see Clinical Studies].
Use with Peg-IFN-Alfa and RBV
During treatment, HCV RNA levels should be monitored as clinically indicated using a sensitive assay with a lower limit of quantification of at least 25 IU/mL.
Because patients with an inadequate on-treatment virologic response (i.e., HCV RNA greater or equal to 25 IU/mL) are not likely to achieve a sustained virologic response (SVR), discontinuation of treatment is recommended in these patients. Table 3 presents treatment stopping rules for patients who experience an inadequate on-treatment virologic response at Weeks 4, 12, and 24.
Table 3: Treatment Stopping Rules in Patients
Receiving OLYSIO in Combination with Peg-IFN-alfa and RBV with Inadequate
On-Treatment Virologic Response
|Week 4||≥ 25 IU/mL||Discontinue OLYSIO, Peg-IFN-alfa, and RBV|
|Week 12||Discontinue Peg-IFN-alfa, and RBV (treatment with OLYSIO is complete at Week 12)|
|Week 24||Discontinue Peg-IFN-alfa, and RBV (treatment with OLYSIO is complete at Week 12)|
Dosage Adjustment Or Interruption
To prevent treatment failure, avoid reducing the dosage of OLYSIO or interrupting treatment. If treatment with OLYSIO is discontinued because of adverse reactions or inadequate on-treatment virologic response, OLYSIO treatment must not be reinitiated [see WARNINGS AND PRECAUTIONS].
If adverse reactions potentially related to the antiviral drug(s) used in combination with OLYSIO occur, refer to the instructions outlined in their respective prescribing information for recommendations on dosage adjustment or interruption.
If any of the other antiviral drugs used in combination with OLYSIO for the treatment of chronic HCV infection are permanently discontinued for any reason, OLYSIO should also be discontinued.
Not Recommended In Patients With Moderate Or Severe Hepatic Impairment
OLYSIO is not recommended for patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, Use In Specific Populations, and CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
OLYSIO is available as a white gelatin capsule marked with “TMC435 150” in black ink. Each capsule contains 150 mg simeprevir.
Storage And Handling
OLYSIO 150 mg capsules are white, marked with “TMC435 150” in black ink. The capsules are packaged into a bottle containing 28 capsules (NDC 59676-225-28) or a bottle of 7 capsules (emergency supply; NDC 59676-225-07).
Store OLYSIO capsules in the original bottle in order to protect from light at room temperature below 30°C (86°F).
Manufactured by: Janssen-Cilag SpA, Latina, Italy. Manufactured for: Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ 08560. Revised: February 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/31/2016
Additional Olysio Information
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