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Quality of Life and Tolerability After Administration of Enfuvirtide with a Thin-Walled Needle: QUALITÉ Study

Abstract Purpose: Use of enfuvirtide-containing regimens leads to virologic and immunologic benefits and quality of life (QoL) improvements. This study (QUALITÉ) was designed to primarily identify baseline predictors of QoL improvements and characterize injection site reaction (ISR) signs/symptoms using a thinner/shorter needle. Method: Enfuvirtide-naïve, antiretroviral (ARV)-experienced patients with CD4 counts >50 cells/mm3 enrolled in this prospective, 12-week, multisite, open-label study. Patients self-administered enfuvirtide, 90 mg bid, using thin-walled, 31-gauge/8-mm needles in combination with other ARVs. QoL was evaluated with MOS-HIV. Results: Of the 361 patients enrolled, 346 contributed to QoL assessments. Baseline median HIV RNA and CD4 counts were 4.21 log10 copies/mL and 203 cells/mm3, respectively. Although no baseline factors were predictive of week 12 QoL improvement, 9 of 11 MOS-HIV domain scores improved significantly, including physical function (p = .0002) and mental health (p = .0006). Through week 12, 87% of patients reported ISRs; 59% and 28% reported worst pain/discomfort grade ≤1 and grade ≥2, respectively, and none were considered serious. Patients reported that self-injection minimally impacted daily functioning or activities. Conclusion: Although no predictors of QoL were identified, significant improvements in QoL were observed with minimal clinically significant ISRs (grade ≥2) using the 31-gauge/8-mm needle.