Annals of Internal Medicine
Summaries for Patients Nonnucleoside Reverse Transcriptase Inhibitor–Sparing Antiretroviral Regimens for Treatment-Naive Volunteers Infected With HIV-1
The full report is titled “Efficacy and Tolerability of 3 Nonnucleoside Reverse Transcriptase Inhibitor–Sparing Antiretroviral Regimens for Treatment-Naive Volunteers Infected With HIV-1. A Randomized, Controlled Equivalence Trial.” It is in the 7 October 2014 issue of Annals of Internal Medicine (volume 161, pages 461-471). The authors are J.L. Lennox, R.J. Landovitz, H.J. Ribaudo, I. Ofotokun, L.H. Na, C. Godfrey, D.R. Kuritzkes, M. Sagar, T.T. Brown, S.E. Cohn, G.A. McComsey, F. Aweeka, C.J. Fichtenbaum, R.M. Presti, S.L. Koletar, D.W. Haas, K.B. Patterson, C.A. Benson, B.P. Baugh, R.Y. Leavitt, J.F. Rooney, D. Seekins, and J.S. Currier, for the ACTG A5257 Team.
What is the problem and what is known about it so far? Some of the most effective combination antiretroviral regimens for the treatment of HIV infection include efavirenz. However, some people, including women considering becoming pregnant and patients with severe psychiatric disease, are not good candidates to receive efavirenz because it can cause birth defects and may be linked to suicidal ideation and suicide. Why did the researchers do this particular study? To better understand the efficacy and safety of 3 HIV regimens that do not include efavirenz in people with HIV infection. Who was studied? More than 1800 adults with HIV infection at 57 sites in the United States and Puerto Rico who had never received antiretroviral drugs and had sufficient virus levels in their blood to monitor viral response and whose virus was not resistant to the drugs being tested. How was the study done? Every patient received emtricitabine, 200 mg/d, plus tenofovir disoproxil fumarate, 300 mg/d. In addition, each patient was randomly assigned to receive either atazanavir, 300 mg/d, with ritonavir, 100 mg/d; raltegravir, 400 mg twice daily; or darunavir, 800 mg/d, with ritonavir, 100 mg/d. What did the researchers find? All 3 regimens performed similarly in suppressing the amount of HIV in the blood and restoring immune function. They differed somewhat in how well they were tolerated. What were the limitations of the study? The doctors and patients knew what drugs patients were receiving, which may have influenced their decision to switch from atazanavir when patients had symptoms and signs of liver function abnormality. What are the implications of the study? Patients and doctors seem to have several good options for the initial treatment of HIV infection with regimens that do not contain efavirenz.
Summaries for Patients are a service provided by Annals to help patients better understand the complicated and often mystifying language of modern medicine. Summaries for Patients are presented for informational purposes only. These summaries are not a substitute for advice from your own medical provider. If you have questions about this material, or need medical advice about your own health or situation, please contact your physician. The summaries may be reproduced for not-for-profit educational purposes only. Any other uses must be approved by the American College of Physicians. I-22 © 2014 American College of Physicians
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Summaries for Patients Nonnucleoside Reverse Transcriptase Inhibitor–Sparing Antiretroviral Regimens for Treatment-Naive Volunteers Infected With HIV-1
The full report is titled “Efficacy and Tolerability of 3 Nonnucleoside Reverse Transcriptase Inhibitor–Sparing Antiretroviral Regimens for Treatment-Naive Volunteers Infected With HIV-1. A Randomized, Controlled Equivalence Trial.” It is in the 7 October 2014 issue of Annals of Internal Medicine (volume 161, pages 461-471). The authors are J.L. Lennox, R.J. Landovitz, H.J. Ribaudo, I. Ofotokun, L.H. Na, C. Godfrey, D.R. Kuritzkes, M. Sagar, T.T. Brown, S.E. Cohn, G.A. McComsey, F. Aweeka, C.J. Fichtenbaum, R.M. Presti, S.L. Koletar, D.W. Haas, K.B. Patterson, C.A. Benson, B.P. Baugh, R.Y. Leavitt, J.F. Rooney, D. Seekins, and J.S. Currier, for the ACTG A5257 Team.
What is the problem and what is known about it so far? Some of the most effective combination antiretroviral regimens for the treatment of HIV infection include efavirenz. However, some people, including women considering becoming pregnant and patients with severe psychiatric disease, are not good candidates to receive efavirenz because it can cause birth defects and may be linked to suicidal ideation and suicide. Why did the researchers do this particular study? To better understand the efficacy and safety of 3 HIV regimens that do not include efavirenz in people with HIV infection. Who was studied? More than 1800 adults with HIV infection at 57 sites in the United States and Puerto Rico who had never received antiretroviral drugs and had sufficient virus levels in their blood to monitor viral response and whose virus was not resistant to the drugs being tested. How was the study done? Every patient received emtricitabine, 200 mg/d, plus tenofovir disoproxil fumarate, 300 mg/d. In addition, each patient was randomly assigned to receive either atazanavir, 300 mg/d, with ritonavir, 100 mg/d; raltegravir, 400 mg twice daily; or darunavir, 800 mg/d, with ritonavir, 100 mg/d. What did the researchers find? All 3 regimens performed similarly in suppressing the amount of HIV in the blood and restoring immune function. They differed somewhat in how well they were tolerated. What were the limitations of the study? The doctors and patients knew what drugs patients were receiving, which may have influenced their decision to switch from atazanavir when patients had symptoms and signs of liver function abnormality. What are the implications of the study? Patients and doctors seem to have several good options for the initial treatment of HIV infection with regimens that do not contain efavirenz.
Summaries for Patients are a service provided by Annals to help patients better understand the complicated and often mystifying language of modern medicine. Summaries for Patients are presented for informational purposes only. These summaries are not a substitute for advice from your own medical provider. If you have questions about this material, or need medical advice about your own health or situation, please contact your physician. The summaries may be reproduced for not-for-profit educational purposes only. Any other uses must be approved by the American College of Physicians. I-22 © 2014 American College of Physicians
Downloaded From: http://annals.org/ on 11/01/2016
