Nicola Cunningham

Holdsworth House, Sydney, New South Wales, Australia

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Publications (4)64.6 Total impact

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    ABSTRACT: There are limited data on adherence to HIV treatment guidelines. We assessed adherence to US Department of Health and Human Services guidelines with Australian Commentary for adults initiating antiretroviral therapy (ART). Data were recorded regarding "when to start", "what to start" and pre-ART comorbid disease assessment for consecutive adults initiating ART at primary care and hospital clinics in Sydney and Melbourne from 2004 through 2008. Independent predictors of adherence to guidelines were calculated by stepwise logistic regression. For the 500 subjects (95.9% male, mean 40.2 years, median CD4 count 270 cells/μL) "when to start" adherence was 87.6%, and was less likely with initiation in a clinical trial [0.25 (95% CI: 0.13 to 0.49); P < 0.0001] and previous, short-term nontherapeutic antiretroviral exposure [0.08 (0.03 to 0.25); P < 0.0001]. "What to start" adherence was 69.0% for guideline-"preferred" regimens (85.8% for guideline-"preferred" or "alternative" regimens) and more likely with ART initiated in 2008 versus pre-2008 [OR: 2.69 (1.64 to 4.61); P = 0.0001]. Median comorbid disease assessment adherence was 56.8%, ranging from 25.6% for urinalysis to 99.2% for white blood cell count, and was more likely in patients with AIDS, and initiating ART in hospital or in a clinical trial. Hospital clinics were more likely to perform antiretroviral resistance testing (71.2% vs. 46.4%, P < 0.0001), to use "preferred" ART regimens (76.8% vs. 62.2%, P = 0.0002) but less likely to promote healthy diet and lifestyle (63.4% vs. 36.4%, P < 0.0001). "When to start" and "what to start" guidelines have been largely adhered to in Australia, but pre-ART comorbid disease assessment requires greater attention.
    JAIDS Journal of Acquired Immune Deficiency Syndromes 02/2012; 59(5):478-88. · 4.39 Impact Factor
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    ABSTRACT: To determine the prevalence, characteristics and virological outcomes of triple-class antiretroviral drug failure (TCF) and triple-class virological failure (TCVF) in HIV-infected patients attending an Australian high caseload primary care clinic. Cross-sectional observational study using a retrospective review of electronic medical records from 1007 patients with HIV attending Holdsworth House Medical Practice in Darlinghurst, Australia, between 2007 and 2008. TCF was defined as failure (virological, immunological, clinical, intolerance or other) of at least one drug in each of the three major classes of highly active antiretroviral therapy. A total of 51 patients (5.1%) with TCF were identified. Of these patients, 31.4% had experienced virological failure of each of the three main drug classes. Eighty-eight percent of patients with TCF and 75% of patients with TCVF had achieved virological suppression (HIV RNA <400 copies mL(-1)). Total mean (s.d.) duration on antiretroviral therapy (ART) was 12.2 (3.3) years, with patients receiving an average of 18 antiretroviral drugs during this period. Reasons for treatment change included intolerance (88% of patients), virological failure (84%), immunological failure (24%) and poor adherence (20%). The prevalence of TCF and TCVF in patients with long-term HIV infection and extensive antiretroviral experience is low in primary care sites. Despite experiencing failure to the three main classes of ART, successful virological outcomes are still achievable in the majority of such patients.
    Sexual Health 03/2010; 7(1):17-24. · 1.58 Impact Factor
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    Journal of the International AIDS Society 01/2010; 13. · 4.21 Impact Factor
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    ABSTRACT: BACKGROUND: Used in combination with antiretroviral therapy, subcutaneous recombinant interleukin-2 raises CD4+ cell counts more than does antiretroviral therapy alone. The clinical implication of these increases is not known. METHODS: We conducted two trials: the Subcutaneous Recombinant, Human Interleukin-2 in HIV-Infected Patients with Low CD4+ Counts under Active Antiretroviral Therapy (SILCAAT) study and the Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT). In each, patients infected with the human immunodeficiency virus (HIV) who had CD4+ cell counts of either 50 to 299 per cubic millimeter (SILCAAT) or 300 or more per cubic millimeter (ESPRIT) were randomly assigned to receive interleukin-2 plus antiretroviral therapy or antiretroviral therapy alone. The interleukin-2 regimen consisted of cycles of 5 consecutive days each, administered at 8-week intervals. The SILCAAT study involved six cycles and a dose of 4.5 million IU of interleukin-2 twice daily; ESPRIT involved three cycles and a dose of 7.5 million IU twice daily. Additional cycles were recommended to maintain the CD4+ cell count above predefined target levels. The primary end point of both studies was opportunistic disease or death from any cause. RESULTS: In the SILCAAT study, 1695 patients (849 receiving interleukin-2 plus antiretroviral therapy and 846 receiving antiretroviral therapy alone) who had a median CD4+ cell count of 202 cells per cubic millimeter were enrolled; in ESPRIT, 4111 patients (2071 receiving interleukin-2 plus antiretroviral therapy and 2040 receiving antiretroviral therapy alone) who had a median CD4+ cell count of 457 cells per cubic millimeter were enrolled. Over a median follow-up period of 7 to 8 years, the CD4+ cell count was higher in the interleukin-2 group than in the group receiving antiretroviral therapy alone--by 53 and 159 cells per cubic millimeter, on average, in the SILCAAT study and ESPRIT, respectively. Hazard ratios for opportunistic disease or death from any cause with interleukin-2 plus antiretroviral therapy (vs. antiretroviral therapy alone) were 0.91 (95% confidence interval [CI], 0.70 to 1.18; P=0.47) in the SILCAAT study and 0.94 (95% CI, 0.75 to 1.16; P=0.55) in ESPRIT. The hazard ratios for death from any cause and for grade 4 clinical events were 1.06 (P=0.73) and 1.10 (P=0.35), respectively, in the SILCAAT study and 0.90 (P=0.42) and 1.23 (P=0.003), respectively, in ESPRIT. CONCLUSIONS: Despite a substantial and sustained increase in the CD4+ cell count, as compared with antiretroviral therapy alone, interleukin-2 plus antiretroviral therapy yielded no clinical benefit in either study. ( numbers, NCT00004978 [ESPRIT] and NCT00013611 [SILCAAT study].)
    New England Journal of Medicine 10/2009; 361:1548-59. · 54.42 Impact Factor