Rilpivirine contraindications: Difference between revisions
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==Indications And Usage== | |||
EDURANT®, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve adult patients with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy. | |||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=03880372-2c68-45c6-a53a-f420c49541d6 | publisher = | date = | accessdate = }}</ref> | This indication is based on safety and efficacy analyses through 96 weeks from 2 randomized, double-blind, active controlled, Phase 3 trials in treatment-naïve subjects [see Clinical Studies]. | ||
The following points should be considered when initiating therapy with EDURANT: | |||
*More EDURANT treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥ 50 copies/mL) compared to EDURANT treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL [see Clinical Studies]. | |||
*Regardless of HIV-1 RNA at the start of therapy, more EDURANT treated subjects with CD4+ cell count less than 200 cells/mm3 experienced virologic failure compared to EDURANT treated subjects with CD4+ cell count greater than or equal to 200 cells/mm3 [see Clinical Studies]. | |||
*The observed virologic failure rate in EDURANT treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz [see Microbiology (12.4)]. | |||
*More subjects treated with EDURANT developed [[tenofovir]] and [[lamivudine]]/[[emtricitabine]] associated resistance compared to [[efavirenz]] [see Microbiology]. | |||
EDURANT is not recommended for patients less than 18 years of age [see Use In Specific Populations].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = EDURANT (RILPIVIRINE HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PRODUCTS, LP] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=03880372-2c68-45c6-a53a-f420c49541d6 | publisher = | date = | accessdate = }}</ref> | |||
Latest revision as of 00:42, 10 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
Indications And Usage
EDURANT®, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve adult patients with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy.
This indication is based on safety and efficacy analyses through 96 weeks from 2 randomized, double-blind, active controlled, Phase 3 trials in treatment-naïve subjects [see Clinical Studies].
The following points should be considered when initiating therapy with EDURANT:
- More EDURANT treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥ 50 copies/mL) compared to EDURANT treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL [see Clinical Studies].
- Regardless of HIV-1 RNA at the start of therapy, more EDURANT treated subjects with CD4+ cell count less than 200 cells/mm3 experienced virologic failure compared to EDURANT treated subjects with CD4+ cell count greater than or equal to 200 cells/mm3 [see Clinical Studies].
- The observed virologic failure rate in EDURANT treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz [see Microbiology (12.4)].
- More subjects treated with EDURANT developed tenofovir and lamivudine/emtricitabine associated resistance compared to efavirenz [see Microbiology].
EDURANT is not recommended for patients less than 18 years of age [see Use In Specific Populations].[1]
References
Adapted from the FDA Package Insert.