Journal of Acquired Immune Deficiency Syndromes
Rapid and Durable Antiretroviral Effect of the HIV-1 Integrase Inhibitor Raltegravir as Part of Combination Therapy in Treatment-Naive Patients With HIV-1 Infection: Results of a 48-Week Controlled Study CME

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Release Date: January 17, 2008; Valid for credit through January 17, 2009
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Highly active antiretroviral therapy (HAART) reduces HIV-1-related morbidity and mortality. However, current treatment regimens are limited by emerging drug resistance as well as short- and long-term toxicities. Even treatment-naive patients can acquire drug-resistant HIV-1 through transmission; the rates of drug-resistant HIV-1 mutations in untreated individuals have been reported as 8% to 27%. These mutations can last for years and are associated with less favorable response to antiretroviral therapy. New drugs directed against novel targets are needed not only for treatment-experienced but also for treatment-naive patients. Raltegravir inhibits HIV-1 integrase, is well tolerated in treatment-experienced patients with multidrug-resistant HIV, and offers good viral suppression compared with placebo plus optimized background therapy in the treatment-experienced population. An earlier trial showed reduction of HIV-1 RNA levels in treatment-naive patients treated with raltegravir monotherapy twice daily. The current study evaluated the safety and efficacy of raltegravir after 48 weeks of combination therapy with tenofovir and lamivudine in treatment-naive patients compared with efavirenz plus tenofovir and lamivudine -- the current regimen recommended as initial therapy by the US Department of Health & Human Services (DHHS) guidelines.

  1. Rapid and Durable Antiretroviral Effect of the HIV-1 Integrase Inhibitor Raltegravir as Part of Combination Therapy in Treatment-Naive Patients With HIV-1 Infection: Results of a 48-Week Controlled Study
    Martin Markowitz, MD
    Bach-Yen Nguyen, MD
    Eduardo Gotuzzo, MD
    Fernando Mendo, MD
    Winai Ratanasuwan, MD
    Colin Kovacs, MD
    Guillermo Prada, MD
    Javier O. Morales-Ramirez, MD
    Clyde S. Crumpacker, MD
    Robin D. Isaacs, MD
    Lucinda R. Gilde, BS
    Hong Wan, MS
    Michael D. Miller, PhD
    Larissa A. Wenning, PhD
    Hedy Teppler, MD
    The Protocol 004 Part II Study Team

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Learning Objectives

Upon completion of this activity, participants will be able to:

  1. Discuss the efficacy of raltegravir combination therapy compared with efavirenz combination therapy
  2. Describe the safety profile of raltegravir combination therapy compared with efavirenz combination therapy
  3. Discuss the results that can be drawn from the study under discussion about use of raltegravir combination therapy for treatment-naive HIV patients
Authors and Disclosures

Martin Markowitz, MD
Disclosure: Martin Markowitz, MD, has disclosed no relevant financial relationships.


Bach-Yen Nguyen, MD
Disclosure: Bach-Yen Nguyen, MD, has disclosed no relevant financial relationships.


Eduardo Gotuzzo, MD
Disclosure: Eduardo Gotuzzo, MD, has disclosed no relevant financial relationships.


Fernando Mendo, MD
Disclosure: Fernando Mendo, MD, has disclosed no relevant financial relationships.


Winai Ratanasuwan, MD
Disclosure: Winai Ratanasuwan, MD, has disclosed no relevant financial relationships.


Colin Kovacs, MD
Disclosure: Colin Kovacs, MD, has disclosed no relevant financial relationships.


Guillermo Prada, MD
Disclosure: Guillermo Prada, MD, has disclosed no relevant financial relationships.


Javier O. Morales-Ramirez, MD
Disclosure: Javier O. Morales-Ramirez, MD, has disclosed no relevant financial relationships.


Clyde S. Crumpacker, MD
Disclosure: Clyde S. Crumpacker, MD, has disclosed no relevant financial relationships.


Robin D. Isaacs, MD
Disclosure: Robin D. Isaacs, MD, has disclosed no relevant financial relationships.


Lucinda R. Gilde, BS
Disclosure: Lucinda R. Gilde, BS, has disclosed no relevant financial relationships.


Hong Wan, MS
Disclosure: Hong Wan, MS, has disclosed no relevant financial relationships.


Michael D. Miller, PhD
Disclosure: Michael D. Miller, PhD, has disclosed no relevant financial relationships.


Larissa A. Wenning, PhD
Disclosure: Larissa A. Wenning, PhD, has disclosed no relevant financial relationships.


Hedy Teppler, MD
Disclosure: Hedy Teppler, MD, has disclosed no relevant financial relationships.


The Protocol 004 Part II Study Team
Disclosure: The Protocol 004 Part II Study Team has disclosed no relevant financial relationships.


Jacqueline A. Hart, MD
Disclosure: Jacqueline A. Hart, MD, has disclosed no relevant financial relationships.


 
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