Efficacy, safety, and tolerability of etravirine with and without darunavir/ritonavir or raltegravir in treatment-experienced patients: analysis of the etravirine early access program in the United States
| Autor: | Michael Sension, Michael S. Gottlieb, Michael Wohlfeiler, Annemie Hoogstoel, Jonathan S Appelbaum, Steven Nijs, William J. Towner, Paul Bellman, Rodica Van Solingen-Ristea, Joseph Gathe, Robert Ryan, Jacob Lalezari, James Witek |
|---|---|
| Rok vydání: | 2010 |
| Předmět: |
Adult
Male medicine.medical_specialty Anti-HIV Agents Population Etravirine HIV Infections Pharmacology Raltegravir Potassium Internal medicine Nitriles medicine Humans Pharmacology (medical) education Darunavir education.field_of_study Sulfonamides Ritonavir business.industry Middle Aged Viral Load Raltegravir Pyrrolidinones United States CD4 Lymphocyte Count Pyridazines Regimen Infectious Diseases Pyrimidines Tolerability HIV-1 Female business medicine.drug |
| Zdroj: | Journal of acquired immune deficiency syndromes (1999). 53(5) |
| ISSN: | 1944-7884 |
| Popis: | Etravirine, a nonnucleoside reverse transcriptase inhibitor, was provided through an international early access program (EAP) prior to regulatory approval.The Phase III, nonrandomized, open-label EAP investigated etravirine 200 mg twice daily plus a background regimen (BR) in patients who had failed multiple antiretroviral regimens. Efficacy and safety are reported for HIV-infected adults from the United States through week 48, including subgroups receiving etravirine +/- darunavir/ritonavir and/or raltegravir.The intent-to-treat population included 2578 patients; 62.4% and 56.7% of patients received darunavir/ritonavir and raltegravir, respectively, in their BR. At week 48, 62.3% of patients achieved viral loads75 copies per milliliter; responses across subgroups were similar. Median CD4 count increase from baseline was100 cells per cubic millimeter. No unexpected safety concerns emerged; serious AEs and deaths due to AEs, considered possibly related to etravirine, occurred in 2.0% and 0.3% of patients, respectively. Discontinuations due to AEs were low overall (4.4%) and comparable across subgroups.Etravirine combined with a BR, often including other new antiretrovirals, such as darunavir/ritonavir and/or raltegravir, provided an effective treatment option in treatment-experienced patients with HIV-1. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|