Week-12 Response to Therapy as a Predictor of Week 24, 48, and 96 Outcome in Patients Receiving the HIV Fusion Inhibitor Enfuvirtide in the T-20 versus Optimized Regimen Only (TORO) Trials

Raffi, François; Katlama, Christine; Saag, Michael; Wilkinson, Martin; Chung, Jain; Smiley, Lynn; Salgo, Miklos
March 2006
Clinical Infectious Diseases;3/15/2006, Vol. 42 Issue 6, p870
Academic Journal
Background. Early virological response to antiretroviral therapy is predictive of long-term treatment outcome in therapy-naive patients. In treatment-experienced patients, such correlations are less well defined, because initial responses may be less pronounced and transient because of accumulated cross-resistance to prior therapies. Our objectives were to explore how the virological and immunological status of treatment-experienced patients at an early time point (week 12) during enfuvirtide-based therapy predicted their responses at weeks 24, 48, and 96 in the T-20 versus Optimized Regimen Only (TORO) trials. Methods. Post hoc, modified, on-treatment and intent-to-treat analyses were performed to determine whether the relationship between virological and immunological outcomes at weeks 24, 48, and 96 were predicted by the patients' week-12 responses to therapy. Results. Using a modified on-treatment analysis for patients who, by week 12, achieved a decrease in their HIV-1 RNA load of ⩾1 log10 copies/mL, 39.2% (95% CI, 33.6%-44.8%) and 59.5% (95% CI, 53.8%-65.1%) achieved a viral load of <50 copies/mL or <400 copies/mL at week 96, respectively, compared with 1.3% (95% CI, 0%-3.8%) and 2.6% (95% CI, 0%-6.1%) of patients, respectively, who did not achieve an early virological response. Using the same modified on-treatment analysis method for patients who, at week 12, achieved a CD4 cell count increase of ⩾50 cells/mm³, 87.2% (95% CI, 82.6-91.8) maintained or improved this response through week 96, compared with 56.6% (95% CI, 47.5-65.8) of patients who did not achieve this early categorical im- munological response. Conclusion. Enfuvirtide-based treatment regimens are associated with a rapid and durable response. Week-12 virological and immunological responses to treatment with enfrivirtide are predictive of subsequent outcomes in triple-class treatment-experienced patients.


Related Articles

  • Effect of Maintaining Highly Active Antiretroviral Therapy on AIDS Events among Patients with Late-Stage HIV Infection and Inadequate Response to Therapy. Gandhi, Tejal; Wei Wei; Amin, Kamal; Kazanjian, Powel // Clinical Infectious Diseases;3/15/2006, Vol. 42 Issue 6, p878 

    Background. We evaluated the effect of maintaining highly active antiretroviral therapy (HAART) on the development of new acquired immunodeficiency syndrome (AIDS)-related events in patients with late-stage human immunodeficiency virus (HIV) infection who had suboptimal CD4+ cell count and viral...

  • Impact of Indinavir on the Quality of Life in Patients with Advanced HIV Infection Treated with Zidovudine and Lamivudine. Coplan, Paul M.; Cook, John R.; Carides, George W.; Heyse, Joseph F.; Wu, Albert W.; Hammer, Scott M.; Nguyen, Bach-Yen; Meibohm, Anne R.; DiNubile, Mark J. // Clinical Infectious Diseases;8/1/2004, Vol. 39 Issue 3, p426 

    Objective. in AIDS Clinical Trial Group (ACTG) study 320, triple-combination antiretroviral therapy including indinavir significantly slowed progression to acquired immunodeficiency syndrome or death, compared with treatment with dual nucleoside reverse-transcriptase inhibitors (NRTIs) alone, in...

  • Hope and hype.  // Network Magazine of the Canadian Women's Health Network;Winter1998/1999, Vol. 2 Issue 1, p3 

    Relates how the author decided to go on combination therapy to combat HIV-related symptoms. Author's initial refusal to take any AIDS drugs; Details of how the author reached the decision to try a combination of AIDS drugs; Author's daily medication routine; Effects of the combination therapy.

  • Living in rural New England amplifies the risk of depression in patients with HIV. Sheth, Siddharth H.; Jensen, Paul T.; Lahey, Timothy // BMC Infectious Diseases;2009, Vol. 9 Issue 1, Special section p1 

    Background: The importance of depression as a complication of HIV infection is increasingly understood, and people living in rural areas are at increased risk for depression. However, it is not known whether living in rural areas amplifies the risk of depression in patients with HIV. Methods: We...

  • Patient Adherence To HAART Regimens: Challenges For Physician Assistants And Health Care Providers. Day, Marvin // Internet Journal of Academic Physician Assistants;2003, Vol. 3 Issue 1, p42 

    Patients often adhere incompletely and inadequately to highly active antiretroviral therapy (HAART) regimens used in the treatment of HIV infection. This permits the emergence of HIV variants that are resistant to current treatment. The physician assistant often assumes the responsibility for...

  • Comparative Cost-Efficacy Analysis of Darunavir/ritonavir and Other Ritonavir-Boosted Protease Inhibitors for First-Line Treatment of HIV-1 Infection in the United States. Brogan, Anita J.; Mrus, Joseph; Hill, Andrew; Sawyer, Anthony W.; Smets, Erik // HIV Clinical Trials;May/Jun2010, Vol. 11 Issue 3, p133 

    Purpose: A comprehensive study comparing the costs and efficacies of darunavir/ritonavir 800/100 mg qd and the other ritonavir-boosted (/r) protease inhibitors (PIs) recommended for treatment-naïve individuals with HIV-1 infection would help health care decision makers identify the value of...

  • HIV-Related Wasting in HIV-Infected Drug Users in the Era of Highly Active Antiretroviral Therapy. Campa, Adriana; Zhifang Yang; Shenghan Lai; Lihua Xue; Phillips, J. Craig; Sales, Sabrina; Page, J. Bryan; Baum, Marianna K. // Clinical Infectious Diseases;10/15/2005, Vol. 41 Issue 8, p1179 

    Background. A decrease in the rate of human immunodeficiency virus (HIV) infection-related wasting has been reported in the era of highly active antiretroviral therapy (HAART). We investigated this concern in a hard- to-reach population of HIV-infected drug users in Miami, Florida. Methods....

  • Risk factors and correlates for anemia in HIV treatment-naive infected patients: a cross-sectional analytical study. Mata-Marín, José A.; Gaytán-Martínez, Jesús E.; Martínez-Martínez, Rosa E.; Arroyo-Anduiza, Carla I.; Fuentes-Allen, José L.; Casarrubias-Ramirez, Moisés // BMC Research Notes;2010, Vol. 3, p230 

    Background: Hematologic manifestations of the human immunodeficiency virus (HIV) infection are a well-recognized complication of the disease and may be clinically important. Our objective was to determine the risk factors for anemia and its correlation with HIV treatment-naïve infected...

  • Prevalence and Clinical Implications of Interactive Toxicity Beliefs Regarding Mixing Alcohol and Antiretroviral Therapies among People Living with HIV/AIDS. Kalichman, Seth C.; Amaral, Christina M.; White, Denise; Swetsze, Connie; Pope, Howard; Kalichman, Moira O.; Cherry, Chauncey; Eaton, Lisa // AIDS Patient Care & STDs;Jun2009, Vol. 23 Issue 6, p449 

    Alcohol use is a barrier to medication adherence. Beyond the cognitive effects of intoxication, people living with HIV/AIDS who believe that alcohol should not be mixed with their medications may temporarily stop taking medications when drinking. To examine the effects of alcohol-treatment...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics