673. Randomized-Controlled trial of every 4 month versus every 6 months monitoring in HIV-infected patients controlled on Highly Active Antiretroviral Therapy
Session: Oral Abstract Session: HIV Clinical Trials and Outcomes
Friday, October 4, 2013: 11:15 AM
Room: The Moscone Center: 250-262
Background: In the U.S. life expectancy for newly diagnosed HIV positive patients has increased from 10.5 years to 22.5 years.  Effective HIV care requires life-long therapy and monitoring.  Recent HIV treatment guidelines recommend starting HIV therapy early and monitoring HIV viral load (VL) and CD4 count every 3-4 months.  As people are living longer with HIV, the cost-effectiveness and practicality of this approach has been questioned.  The best interval for routine HIV monitoring has been identified as area in which gaps in knowledge exist. The goal of this study is to compare every 4 months HIV monitoring to every six months monitoring in virologically suppressed HIV infected patients on antiretroviral therapy.

Methods: Randomized controlled trial of HIV positive patients who are on cART with a CD4 count ≥250 cells with an undetectable viral load for at least one year. Patients were randomized to every 4 months monitoring (Group I) or 6 month monitoring (Group II). At each scheduled visit patients completed an adherence survey and quality of life questionnaire (QOL) which has Mental Health (MHS) and Physical Health scores (PHS).  Study participants were also monitored for VL failure, anbd number of medical visits.

Results: 165 subjects were enrolled (Group I: 86, Group 2: 79).  Mean age at enrollment was 46.8 years.  72% of participants were male, 57% AA, 38% White, 44% reported MSM risk factor, 46% heterosexual exposure.  33% were on a PI based regimen, 48% on a non-nucleoside regimen. 45% had no co-mordid conditions and 25% had ≥ 2 conditions.  Mean baseline and nadir CD4 count was 574 and 244 cells, respectively. Baseline characteristics did not differ between the groups.  Subjects have been followed for 1.5.  There was only one VL failure in Group I.  There was no difference in time to VL failure between the groups, p 0.43.   During the follow up period mean PHS scores were 49.0 and 51.3 for Groups I and II,  respectively, p = .097  Mean follow up MHS scores were 50.0 for Group I and 49.6 for Group II, p = .067.  Adherence scores for Group I and II were 13.8 and 13.1, respectively, p = .10.  There was no difference in the number of HIV or non-HIV related visits/year.

Conclusion: For this stable, HIV VL suppressed population less frequent HIV monitoring was safe during this short follow up.  There was no difference in VL failure, QOL or adherence.  Longer term follow up is needed.

Kamla Sanasi, MD1, Veena Seshadri2, David Parker, PhD3, Shana Dykema4, James Hussey, PhD5 and Sharon Weissman, MD1, (1)Medicine, University of South Carolina, Columbia, SC, (2)University of South Carolina, Columbia, SC, (3)West Virginia University, Morgantown, WV, (4)South Carolina Hospital Association, Columbia, SC, (5)unviersity of South Carolina, Columbia, SC


K. Sanasi, None

V. Seshadri, None

D. Parker, None

S. Dykema, University of South Carolina: Employee, Salary

J. Hussey, None

S. Weissman, University of South Carolina: Grant Investigator, Research grant

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