Patients With HIV Show CNS Symptom Improvement Following a Switch From Efavirenz to Etravirine: Presented at AIDS 2010
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Patients With HIV Show CNS Symptom Improvement Following a Switch From Efavirenz to Etravirine: Presented at AIDS 2010

By Jenny Powers

VIENNA -- July 22, 2010 -- Patients with HIV who experienced persistent central nervous system (CNS) adverse events following treatment with efavirenz demonstrated reduced symptoms after being switched to etravirine, according to a study presented here on July 19 at the 18th International AIDS Conference.

Laura Waters, MD, St. Stephen's AIDS Research, Chelsea & Westminster Hospital, London, United Kingdom, remarked that some patients receiving efavirenz as part of their first-line therapy experience persistent CNS toxicity resulting in symptoms such as insomnia, abnormal dreaming, and nervousness.

The study included 38 male patients who continued to experience CNS adverse events (AE) after 12 weeks of efavirenz-based highly active antiretroviral therapy (HAART).

Patients were randomised in a double-blinded fashion to continue receiving 2 nucleoside reverse transcriptase inhibitors (NRTI) plus efavirenz and placebo (delayed switch; n = 18) or to 2 NRTIs plus etravirine and placebo (immediate switch; n = 20).

After 12 weeks of treatment, all patients received treatment with 2 NRTIs plus etravirine (open-label phase).

The study's endpoint was the percentage of CNS grade 2 adverse events, scored as 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening) following 12 weeks of altered treatment.

Follow-up was completed by 19 patients in the immediate-switch group and by 13 patients in the delayed-switch group.

In the immediate-switch arm, 90% of patients reported CNS adverse events at baseline -- this fell to 60% at week 12. In the delayed-switch group, 88.9% of patients experienced CNS adverse events at baseline and 81.3% at week 12.

CNS score at week 12 declined from 14 to 6 (P = .001) in the immediate-switch group and patients in the delayed-switch arm had a score reduction from 10 to 7.5 (P = .192).

The combined percent decrease in grade 2 to 4 CNS adverse events after 12 weeks of etravirine was significant for overall adverse events, insomnia, abnormal dreams, and nervousness (P = .009, .016, .001, .046, respectively).

Viral load was maintained in all patients throughout the study.

[Presentation title: A Phase IV, Double Blind, Multi Centre, Randomised, Placebo Controlled, Pilot Study to Assess the Feasibility of Switching Individuals Receiving Efavirenz (EFV) With Continuing Central Nervous System (CNS) Adverse Events (AE) to Etravirine (ETR). Abstract MOPDB103]


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