449. Efficacy of NGX-4010 (Qutenza), a Capsaicin 8% Patch, Applied for 30 Minutes in Patients with HIV-Associated Neuropathy: Results of Integrated Analyses
Session: Poster Abstract Session: HIV Challenges and Complications
Friday, October 21, 2011
Room: Poster Hall B1
Background: HIV-associated neuropathy (HIV-AN) is present in 57% of patients with HIV and 38% of these report neuropathic pain. There are no FDA-approved treatments for this condition and those used can have unwanted side effects and/or burdensome treatment regimens. NGX-4010 (Qutenza®) is a capsaicin 8% patch, approved in the US for the management of neuropathic pain associated with postherpetic neuralgia, and was tested in two randomized, double-blind, 12-week controlled studies in patients with painful HIV-AN.

Methods: Integrated analyses from these studies included 239 patients receiving a single 30-minute treatment with NGX-4010 and 100 patients receiving a 0.04% capsaicin control patch. Patients recorded their ‘average pain for the past 24 hours’ daily using the Neuropathic Pain Rating Scale (NPRS) and completed the Patient Global Impression of Change (PGIC) at study conclusion. The percentage change in NPRS score from baseline to Weeks 2–12, the proportion of responders (patients with ≥30% reduction in NPRS score from baseline to Weeks 2–12) and the PGIC were analyzed.  Subgroup analyses by gender, baseline pain score, HIV-AN duration and use of concomitant neuropathic pain medications were also performed. Adverse events (AEs) were recorded.

Results: During Weeks 2–12, NGX-4010 reduced the NPRS score 27.0% versus 15.7% for control (p=0.0020) and 39% of NGX-4010 patients responded (23% in control, p=0.0051). At study conclusion, 36% of NGX-4010 patients reported being much or very much improved on the PGIC (22% in control, p=0.0162). Efficacy was observed regardless of gender, baseline pain score, duration of HIV-AN and use of concomitant neuropathic pain medication; treatment differences were greater in patients treated with NGX-4010 alone. Mild-to-moderate, transient application site pain and erythema were the most common adverse events.

Conclusion: These integrated analyses show that a single 30-minute NGX-4010 application can reduce neuropathic pain due to HIV-AN for 12 weeks and is well tolerated.


Subject Category: H. HIV/AIDS and other retroviruses

Stephen Brown, MD1, David Simpson, MD2, Graeme Moyle, MBBS, MD3, Bruce Brew4, Giovanni Schifitto5, Nicholas Larbalestier6, Chloe Orkin7, Martin Fisher8, Jeffrey Tobias, PhD9 and Trudy Vanhove, MD, PhD9, (1)AIDS Research Alliance, West Hollywood, CA, (2)Mount Sinai School of Medicine, New York, NY, (3)Chelsea and Westminster Hospital, London, United Kingdom, (4)St Vincent's Hospital, Darlinghurst, Australia, (5)University of Rochester, Rochester, NY, (6)St Thomas' Hospital, London, United Kingdom, (7)Barts and The London NHS Trust, London, United Kingdom, (8)HIV/GUM Research Department, Elton John Centre, Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom, (9)NeurogesX, Inc, San Mateo, CA

Disclosures:

S. Brown, NeurogesX: Investigator, Compensation for Clinical Study conduct

D. Simpson, NeurogesX: Consultant and Speaker's Bureau, Consulting fee and Speaker honorarium
Astellas: Speaker's Bureau, Speaker honorarium
Eli Lilly: Consultant and Speaker's Bureau, Consulting fee and Speaker honorarium
Pfizer: Grann support, Grant recipient

G. Moyle, None

B. Brew, NeurogesX: Investigator, Compensation for Clinical Study conduct

G. Schifitto, NeurogesX: Investigator, Compensation for Clinical Study conduct

N. Larbalestier, NeurogesX: Investigator, Compensation for Clinical Study conduct

C. Orkin, NeurogesX: Investigator, Compensation for Clinical Study conduct

M. Fisher, NeurogesX: Investigator, Compensation for Clinical Study conduct

J. Tobias, NeurogesX: Employee, Salary

T. Vanhove, NeurogesX: Employee, Salary

Findings in the abstracts are embargoed until 12:01 a.m. EST Thursday, Oct. 20 with the exception of research findings presented at IDSA press conferences.