Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 30 November 2017
Indication(s)
- Aptivus 250 mg soft capsules
Aptivus, co-administered with low dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adults and adolescents 12 years of age or older with virus resistant to multiple protease inhibitors. Aptivus should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options.
In deciding to initiate treatment with Aptivus, co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of Aptivus. Initiation of treatment should take into account the combinations of mutations which may negatively impact the virological response to Aptivus, coadministered with low dose ritonavir.
- Aptivus 100 mg/ml oral solution
Aptivus, co-administered with low dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated children from 2 to 12 years of age with virus resistant to multiple protease inhibitors. Aptivus should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options.
In deciding to initiate treatment with Aptivus, co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of Aptivus. Initiation of treatment should take into account the combinations of mutations which may negatively impact the virological response to Aptivus, coadministered with low dose ritonavir.
Learning Zones
An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.
Chronic Obstructive Pulmonary Disease (COPD)
View highlights from recent congresses presented in new expert videos with leading physicians.
+ 7 more
Chronic Obstructive Pulmonary Disease (COPD)
View highlights from recent congresses presented in new expert videos with leading physicians.
+ 7 more
Chronic Spontaneous Urticaria (CSU)
Use our patient case studies to discover how experts diagnose and treat chronic spontaneous urticaria.
+ 7 more
Chronic Spontaneous Urticaria (CSU)
Use our patient case studies to discover how experts diagnose and treat chronic spontaneous urticaria.
+ 7 more
Inflammatory Bowel Disease Knowledge Centre
The Inflammatory Bowel Disease (IBD) Knowledge Centre contains key information relating to the epidemiology and pathophysiology of Crohn’s disease and ulcerative colitis, highlighting prevalence, impact and unmet needs and the underlying inflammatory processes that drive IBD, considering some of the key inflammatory pathways.
Inflammatory Bowel Disease Knowledge Centre
The Inflammatory Bowel Disease (IBD) Knowledge Centre contains key information relating to the epidemiology and pathophysiology of Crohn’s disease and ulcerative colitis, highlighting prevalence, impact and unmet needs and the underlying inflammatory processes that drive IBD, considering some of the key inflammatory pathways.
Allergic Rhinitis
Allergic rhinitis causes great strain on the workforce. Help to reduce sick days and improve productivity with appropriate treatment options.
+ 4 more
Allergic Rhinitis
Allergic rhinitis causes great strain on the workforce. Help to reduce sick days and improve productivity with appropriate treatment options.
+ 4 more
Related Content
Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018)
To establish a new treatment option for treatment-naïve participants with HIV-1, the efficacy and safety of doravirine will be determined relative to a protease inhibitor (PI).
Added 5 months ago
A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care
The purpose of this study is to assess the efficacy of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) fixed-dose combination (FDC) in a Test and Treat model of care in newly diagnosed human immunodeficiency virus...
Added 5 months ago
Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants
The purpose of this study is to demonstrate non-inferiority in efficacy while switching to a once-daily single-tablet regimen containing darunavir (DRV)/ cobicistat (COBI)/ emtricitabine (FTC)/ tenofovir alafenamide (TAF)...
Added 5 months ago
An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir (DTG) Plus Lamivudine (3TC) With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Subjects (Gemini 2)
This study will compare safety, efficacy, and tolerability of a two drug regimen of dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two nucleoside reverse transcriptase inhibitors...
Added 7 months ago
An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir Plus Lamivudine With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Subjects (Gemini 1)
This study will compare safety, efficacy, and tolerability of a two drug regimen of dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two nucleoside reverse transcriptase inhibitors...
Added 7 months ago
Darunavir for the treatment of HIV infection.
The authors present and discuss the efficacy and safety data of DRV when used in antiretroviral-naïve, multiexperienced subjects and in the setting of treatment deintensification in subjects with viral suppression.
Added 7 months ago
Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial.
Bictegravir, co-formulated with emtricitabine and tenofovir alafenamide, has shown good efficacy and tolerability, and similar bone, renal, and lipid profiles to dolutegravir, abacavir, and lamivudine, in treatment-naive adults with HIV-1...
Added 7 months ago
Efficacy and safety of switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from boosted protease inhibitor-based regimens in virologically suppressed adults with HIV-1: 48 week results of a randomised, open-label, multicentre, phase 3, non-inferiority trial.
Switching from therapy based on a boosted protease inhibitor to bictegravir, emtricitabine, and tenofovir alafenamide could avoid drug interactions and unwanted side-effects in virologically suppressed adults with HIV-1 infection...
Added 7 months ago
EACS GUIDELINES Version 9.0 October 2017
EACS produces the European Guidelines for treatment of HIV-positive adults in Europe.
Added 7 months ago
British HIV Association guidelines for the treatment of HIV-1-positive adults with antiretroviral therapy 2015 (2016 interim update)
The overall purpose of these guidelines is to provide guidance on best clinical practice in the treatment and management of adults with HIV infection on antiretroviral therapy (ART).
Added 3 years ago
British HIV Association guidelines for HIV-associated malignancies 2014
The overall purpose of these guidelines is to provide guidance on best clinical practice in the treatment and management of adults with HIV infection and malignancy.
Added 5 years ago
More information
| Category | Value |
|---|---|
| Agency product number | EMEA/H/C/000631 |
| Orphan designation | No |
| Date First Approved | 25-10-2005 |
| Type | Medicinal product subject to restricted medical prescription |
| Marketing authorisation holder | Boehringer Ingelheim International GmbH |