Darunavir indications and usage: Difference between revisions
Gerald Chi (talk | contribs) mNo edit summary |
Gerald Chi (talk | contribs) mNo edit summary |
||
Line 22: | Line 22: | ||
The use of other active agents with PREZISTA/ritonavir is associated with a greater likelihood of treatment response.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=814301f9-c990-46a5-b481-2879a521a16f#nlm34090-1 | publisher = | date = | accessdate = }}</ref> | The use of other active agents with PREZISTA/ritonavir is associated with a greater likelihood of treatment response.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = PREZISTA (DARUNAVIR) TABLET, FILM COATED PREZISTA (DARUNAVIR) SUSPENSION [JANSSEN PRODUCTS LP] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=814301f9-c990-46a5-b481-2879a521a16f#nlm34090-1 | publisher = | date = | accessdate = }}</ref> | ||
==References== | ==References== |
Revision as of 23:49, 31 December 2013
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
Indications and Usage
Adult Patients
PREZISTA®, co-administered with ritonavir (PREZISTA/ritonavir), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection.
This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from 2 controlled Phase 3 trials of 48 weeks duration in antiretroviral treatment-naïve and treatment-experienced patients and 2 controlled Phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients.
Pediatric Patients
PREZISTA, co-administered with ritonavir (PREZISTA/ritonavir), and with other antiretroviral agents, is indicated for the treatment of HIV-1 infection in pediatric patients 3 years of age and older.
The indication for treatment-experienced pediatric patients 3 to less than 18 years of age is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from two open-label Phase 2 trials in antiretroviral treatment-experienced pediatric subjects(24-week analysis for one trial in patients 6 to less than 18 years of age; 48-week analysis for one trial in patients 3 to less than 6 years of age) . The indication for treatment-naïve pediatric patients or antiretroviral treatment-experienced patients with no darunavir resistance associated substitutions is based on one open-label Phase 2 trial of 48 weeks duration in antiretroviral treatment-naïve subjects 12 to less than 18 years of age and pharmacokinetic modeling and simulation for patients 3 to less than 12 years of age.
In treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with PREZISTA/ritonavir:
Treatment history and, when available, genotypic or phenotypic testing should guide the use of PREZISTA/ritonavir.
The use of other active agents with PREZISTA/ritonavir is associated with a greater likelihood of treatment response.[1]
References
Adapted from the FDA Package Insert.