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"Tolerability of central nervous system symptoms among
HIV-1 infected efavirenz users: analysis of patient electronic
medical record data"
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About 1% in US Stop Efavirenz in First Year Because of CNS Toxicity
IDWeek 2015, October 7-11, San Diego
Mark Mascolini
Only 1% of US residents in a large electronic medical records database stopped efavirenz because of central nervous system (CNS) side effects within a year of starting the nonnucleoside as part their first antiretroviral regimen [1]. CNS side effects arose at a similar frequency in people who did and did not quit efavirenz.
CNS symptoms are well-known and much studied in people taking the efavirenz. In clinical trials 2.1% of participants stopped efavirenz because of CNS side effects, according to prescribing information. In a Swiss HIV Cohort Study analysis, people switched from efavirenz to another antiretroviral because of CNS problems at a rate below 4 per 100 person-years [2]. To get an up-to-date read on how often people stop efavirenz because of CNS problems, researchers at Bristol-Myers Squibb, maker of efavirenz, conducted this study.
The analysis focused on a large electronic medical records database of people at least 12 years old taking efavirenz in a first-line regimen from July 2008 through June 2014. The database came from a nationally representative sample of clinicians caring for 28 million people in the United States. The primary outcome was stopping efavirenz because of CNS-related symptoms, defined as the percentage of efavirenz starters who switched to a replacement antiretroviral within 30 days of a new CNS symptom in the first year of therapy and who did not have virologic failure. Thus the analysis did not include people who may have endured CNS symptoms longer than a month before stopping efavirenz.
The database included 1742 people who started efavirenz. The group averaged 48 years in age, 77% were male, 43% white, and 31% black or Hispanic. Almost 1 in 5 (18.7%) had a history of psychiatric symptoms, and 8.1% had a history of CNS symptoms before efavirenz use. During the first year of therapy, 174 people (10%) reported one or more CNS symptoms.
Overall 282 people (16.2%) stopped efavirenz in the first year of therapy, but only 19 (1.1%) stopped efavirenz because of CNS symptoms. (Sixteen people, 0.9%, stopped efavirenz because of virologic failure.) An average 129.9 days (about 4 months) passed between starting efavirenz and stopping because of CNS symptoms. People stopped the nonnucleoside an average 9.6 days after reporting CNS symptoms.
The most frequent new-onset symptoms reported after people started efavirenz were insomnia (5.3%), headache (3.3%), dizziness (1.0%), impaired concentration (0.7%), and somnolence (0.2%). Overall CNS symptoms frequency was 10.3% in people who stopped efavirenz for any reason in the first year of therapy and 9.9% in people who did not stop. Eighty-six people (4.9%) stopped efavirenz in the first year because of other possible side effects.
The researchers noted that their analysis is limited by probable underreporting of symptoms, but the frequency of CNS symptoms was consistent before and after starting efavirenz. They concluded that these "real-world electronic medical record data" indicate only rare efavirenz discontinuations for CNS symptoms.
Reference
1. Rosenblatt L, Broder MS, Bentley TGK, et al. Tolerability of central nervous system symptoms among HIV-1 infected efavirenz users: analysis of patient electronic medical record data. IDWeek 2015, October 7-11, San Diego. Abstract 1077.
2. Elzi L, Marzolini C, Furrer H, et al. Treatment modification in human immunodeficiency virus-infected individuals starting combination antiretroviral therapy between 2005 and 2008. Arch Intern Med. 2010;170:57-65.
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Reported by Jules Levin
Tolerability of central nervous system symptoms among HIV-1 infected efavirenz users:
analysis of patient electronic medical record data
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