Quality of life and tolerability after administration of enfuvirtide with a thin-walled needle: QUALITE Study.
OBJECTIVE
Use of enfuvirtide-containing regimens leads to virologic and immunologic benefits and quality of life (QoL) improvements. This study (QUALITE) was designed to primarily identify baseline predictors of QoL improvements and characterize injection site reaction (ISR) signs/symptoms using a thinner/shorter needle.


METHODS
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 < or = 1 and grade > or = 2, respectively, and none were considered serious. Patients reported that self-injection minimally impacted daily functioning or activities.


CONCLUSIONS
Although no predictors of QoL were identified, significant improvements in QoL were observed with minimal clinically significant ISRs (grade > or = 2) using the 31-gauge/8-mm needle.
Shalit
Peter
P
Swedish Medical Center, Seattle, WA 98104, USA. psmd@mac.com
True
Andrea
A
Thommes
James A
JA
D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D000077560:Enfuvirtide; D005260:Female; D006678:HIV; D015700:HIV Envelope Protein gp41 / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D023581:HIV Fusion Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D009339:Needles / Q000592:standards; D010446:Peptide Fragments / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D012648:Self Care; D016896:Treatment Outcome; D014481:United States
D044966:Anti-Retroviral Agents; D015700:HIV Envelope Protein gp41; D023581:HIV Fusion Inhibitors; D010446:Peptide Fragments; D000077560:Enfuvirtide