Switch from efavirenz to rilpivirine quells CNS toxicity, improves sleep
Mark Mascolini, NATAP.org
Switching from Atripla (efavirenz plus tenofovir/emtricitabine [TDF/FTC]) to Eviplera (rilpivirine plus TDF/FTC) significantly relieved central nervous system (CNS) toxicity and improved sleep in people with those problems while taking Atripla.
All but 1 of 40 study participants who switched in this London/Brighton study maintained virologic control through 24 weeks.
The once-daily single-tablet combination pill Atripla remains a recommended and popular first-line antiretroviral regimen. People who start efavirenz in Atripla or other regimens often suffer short-term neurologic side effects, but sometimes those problems persist. Eviplera (Complera in the US) is a once-daily single-tablet combination of TDF/FTC with another NNRTI, rilpivirine.
UK researchers conducted this single-arm study to track changes in CNS toxicity and sleep patterns after people who had those problems with Atripla switched to Eviplera.
To gauge changes in side effects, the investigators used the AIDS Clinical Trials Group CNS toxicity questionnaire, including 10 items such a dizziness, depression, anxiety, and somnolence. The sleep questionnaire included 19 items.
The analysis included 40 people with Atripla-related CNS toxicity, 36 of them men. Age averaged 47 (range 24 to 73), and people had taken efavirenz for a median of 42 months (range 24 to 100).
Median CD4 count at the switch measured 610 (interquartile range 436 to 884). One person had a detectable viral load at 60 copies 12 weeks after switching to Eviplera. After that, this person stopped keeping study visits. All other study participants maintained a viral load below 50 copies through 24 weeks.
CD4 counts did not change substantially through 24 weeks of follow-up. Median total CNS score fell from 40 at the switch to Eviplera to 12 after 4 weeks, 20 after 12 weeks, and 13 after 24 weeks (p < 0.001 for all comparisons). Proportions of people reporting grade 2 to 4 adverse events improved significantly from baseline to week 24 for abnormal dreams, anxiety, confusion, depression, dizziness, insomnia, impaired concentration, and somnolence.
Median total sleep questionnaire score improved from 30 at the switch to 14 at week 24 (p 0.001). Twenty-four weeks after the switch to Eviplera, study participants had significant improvements in total cholesterol (-0.9 mmol/L), low-density lipoprotein cholesterol (-0.57 mmol/L), and triglycerides (-0.35 mmol/L) (p< 0.001 for all changes from baseline).
A single serious adverse event, thrombocytopenia, emerged in 1 person. The researchers proposed that identifying people with efavirenz toxicity “is essential as use of alternate agents leads to improvement in tolerability and toxicity.”
Rowlands J et al. Multicenter open-label study of switching from Atripla to Eviplera for CNS toxicity. ICAAC 2014. September 5-9, 2014. Washington, DC. Abstract H-1005.