Source: http://www.medscape.com/viewarticle/723712?sssdmh=dm1.622418&src=nldne&uac=148789HX

by Emma Hitt, PhD

Nurse-managed care of patients receiving antiretroviral therapy (ART) for HIV may result in comparable outcomes to physician-managed care and enable expanded access to care in resource-poor settings.

Ian Sanne, MD, from the University of the Witwatersrand, in Johannesburg, South Africa, and colleagues with the Comprehensive International Program for Research in AIDS in South Africa conducted a randomized noninferiority trial at 2 South African primary-care clinics. They published their findings online June 16 in The Lancet.

According to Dr. Sanne and colleagues, a shortage of 4.3 million health workers (ie, physicians, midwives, nurses, and support workers) exists worldwide, and only 17.4 medical practitioners, most located in urban areas, are available to treat 100,000 people in South Africa.

To compare outcomes of nurse vs physician management of physician-initiated ART care for HIV-infected patients, researchers randomly assigned HIV-positive individuals with a CD4 cell count of fewer than 350 cells per microliter or World Health Organization (WHO) stage 3 or 4 disease to ART care monitored by either nurses (n = 404) or physicians (n = 408).

Treatment failure was defined as a composite of the following endpoints: traditional virological failure, occurrence of dose-limiting toxic effects, death, and all clinic losses that translated to failure of the treatment strategy to maintain patients on ART.

Of the patients, 46% demonstrated treatment failure — 48% in the nurse group and 44% in the physician group (hazard ratio, 1.09; 95% confidence interval, 0.89 – 1.33), which was within the limits for noninferiority.

Other outcomes at a median follow-up of 120 weeks were also comparable between the nurse- and physician-monitored patients, including deaths (10 vs 11), virological failures (44 vs 39), toxicity failures (68 vs 66), and program losses (70 vs 63).

According to the researchers, approximately 16% to 17% of patients were considered treatment failures because of the dose-limiting toxic effects of stavudine, which included a high frequency of lipomorphological changes and lactate increases.

“WHO and South African guidelines have moved away from reliance on stavudine; however, this drug remains widely used in resource-poor HIV therapy programmes,” they write. “The dose reduction of stavudine to 30 mg after the first year of the study, which was in line with WHO recommendations, might have reduced drug-limiting toxic effects,” they add.

“The results of this study lend support to the expanded access to treatment with use of models of task shifting in primary health care,” the authors conclude.

Independent commentators Mark Boyd, MD, from National Centre in HIV Epidemiology and Clinical Research and St Vincent’s Hospital, , Sydney, Australia, and Chidi Nwizu, MBBS, from the University of Maryland School of Medicine, in Baltimore, point out that “it is marvellous to see the results of a practical and innovative study which helps propel the field forward and improves our collective confidence that despite all the obstacles we can succeed.”

However, they add that many HIV-infected patients reside and access care in rural areas. “The study sites in [the Comprehensive International Program for Research in AIDS in South Africa] were not rural and had reasonable access to laboratories and ancillary services,” they write. “These are potential challenges in decentralisation models that include task-shifting.”

The study was supported by the National Institutes of Health, the US Agency for International Development, and the National Institute of Allergy and Infectious Diseases. The authors and Dr. Nwizu have disclosed no relevant financial relationships. Dr. Boyd serves on an HIV advisory board for MSD Australia and for Bristol-Myers Squibb Australia; has received funding and/or has partnered with Merck, Abbott, and the American Foundation for AIDS Research; and has spoken at events for Abbott and Merck, received honoraria from MSD Australia and Janssen-Cilaq Australia, and serves as vice president of the Australasian Society for HIV Medicine.