The Human Immunodeficiency Virus (HIV) is a retrovirus that can lead to Acquired Immune Deficiency Syndrome (AIDS). HIV attacks those cells of the immune system that protect the body.
For 2012 the UNAIDS reports 2.3 million new infections and 1.6 million deaths. 1)
The Boehringer Ingelheim Corporate HIV/AIDS website
(1) UNAIDS report on the global AIDS epidemic (Status: September 2013)
A non-nucleoside reverse transcriptase inhibitor (NNRTI), indicated for use in combination with other antiretroviral agents for the treatmentof HIV-1 infection. Resistant virus emerges rapidly and uniformly when Viramune® is administered as monotherapy. Therefore, Viramune® should always be administered in combination with at least two additional antiretroviral agents.
Viramune® may be used alone as a single oral dose to the mother during labour and a single oral dose to the infant within 24 hours after birth for the prevention of mother-to-child transmission of HIV-1 pregnant women who are not taking antiretroviral therapy at time of labour. Where other antiretroviral medicines are accessible, the single dose Viramune® regimen should be combined with additional effective antiretroviral medicines (as recommended in international recognized guidelines).
A non-peptidic protease inhibitor blocks the viral protease, an enzyme needed to complete HIV replication.
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.
This indication is based on the results of two phase III studies, performed in highly pre-treated adult patients (median number of 12 prior antiretroviral agents) with virus resistant to protease inhibitors and of one phase II study investigating pharmacokinetics, safety and efficacy of Aptivus® in mostly treatment-experienced adolescent patients aged 12 to 18 years.
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®, co-administered with low dose ritonavir.
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