Abstract
BackgroundHIV-associated distal sensory polyneuropathy (HIV-DSP) is the most frequently reported neurologic complication associated with HIV infection. NGX-4010 is a capsaicin 8% dermal patch with demonstrated efficacy in the treatment of HIV-DSP. Data from two phase III, double-blind studies were integrated to further analyze the efficacy and safety of NGX-4010 and explore the effect of demographic and baseline factors on NGX-4010 treatment in HIV-DSP.MethodsData from two similarly designed studies in which patients with HIV-DSP received NGX-4010 or a low-concentration control patch (capsaicin 0.04% w/w) for 30 or 60 minutes were integrated. Efficacy assessments included the mean percent change from baseline in Numeric Pain Rating Scale (NPRS) scores to Weeks 2–12. Safety and tolerability assessments included adverse events (AEs) and pain during and after treatment.ResultsPatients (n = 239) treated with NGX-4010 for 30 minutes demonstrated significantly (p = 0.0026) greater pain relief compared with controls (n = 100); the mean percent change in NPRS scores from baseline to Weeks 2–12 was −27.0% versus −15.7%, respectively. Patients who received a 60-minute application of NGX-4010 (n = 243) showed comparable pain reductions (−27.5%) to patients treated for 30 minutes, but this was not statistically superior to controls (n = 115). NGX-4010 was effective regardless of gender, baseline pain score, duration of HIV-DSP, or use of concomitant neuropathic pain medication, although NGX-4010 efficacy was greater in patients not receiving concomitant neuropathic pain medications. NGX-4010 was well tolerated; the most common AEs were application-site pain and erythema, and most AEs were mild to moderate. The transient increase in pain associated with NGX-4010 treatment decreased the day after treatment and returned to baseline by Day 2.ConclusionsA single 30-minute application of NGX-4010 provides significant pain relief for at least 12 weeks in patients with HIV-DSP and is well tolerated.Trial registrationC107 = NCT00064623; C119 = NCT00321672
Highlights
HIV-associated distal sensory polyneuropathy (HIV-DSP) is the most frequently reported neurologic complication associated with HIV infection
Age, race, baseline Numeric Pain Rating Scale (NPRS) score, CD4 cell count, viral load, and the percentage of patients receiving some form of concomitant neuropathic pain treatment at baseline were similar between the two phase III studies and between treatment groups within the two studies (NeurogesX unpublished data) [22,23]
Death: Other: Death: Other: Figure 1 Disposition of all patients from both phase III HIV-DSP studies used in the integrated analysis. *One patient randomly assigned to receive the 30-minute control treatment received the 60-minute control treatment. These analyses demonstrated that the 30- and 60-minute NGX-4010 doses provided comparable pain reduction (−26.9% and −27.9%, respectively)
Summary
HIV-associated distal sensory polyneuropathy (HIV-DSP) is the most frequently reported neurologic complication associated with HIV infection It can be caused by the virus itself [1] or by the use of antiretroviral drugs; for example, some nucleoside reverse transcriptase inhibitors have been shown to have a dose-dependent toxic effect in 15–30% of patients [1]. Symptomatic HIV-DSP reflects the involvement of both small and large sensory nerve fibers and includes distal painful dysesthesias, allodynia, severe burning pain, pins and needles, and numbness [1,2]. These symptoms usually begin in the feet and may progress bilaterally up the legs and to the arms in severe HIV-DSP
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