INTRODUCTION

Evaluation of Outcomes in Patients Starting Antiretroviral Therapy During Evaluation of Outcomes in Patients Starting Antiretroviral Therapy During HospitalizationHospitalization

Leigh E. Efird, PharmD1, Manish Patel, PharmD1, and Minh Nguyen, MD2

Grady Health System, Department of Pharmacy and Drug Information, Atlanta, GA1 and Emory University School of Medicine, Atlanta, GA2

Primary Objective

To evaluate duration of uninterrupted CART after initiation of therapy in the hospital

Secondary Objective

To determine change in HIV viral load and CD4 count

To determine rehospitalization, mortality, and provider follow-up rates

CART recommended for all patients with an AIDS-defining illness

Since the introduction of CART, a significant reduction in mortality has resulted

CART provides a significant benefit to patients with opportunistic infections with limited or no treatment options

Primary Outcome Measure

Duration of uninterrupted CART up to six months after hospital initiation

Secondary Outcome Measures

Change in virologic response (HIV viral load)

Change in immunologic response (CD4 cell count)

Percentage of re-hospitalizations

Mortality

Percentage of outpatient provider follow-up

Study Design

Retrospective observational study

Inclusion Criteria

Patients ≥ 18 years of age, started on CART while in the hospital between August 1, 2006 and May 1, 2007

Exclusion Criteria

Patients on CART prior to hospitalization (i.e. continuation of therapy or discontinuation less than one month)

Outpatient HIV follow-up care not at a GHS affiliated clinic

OBJECTIVES

OUTCOME MEASURES

RESULTS

METHODS

Antiretroviral Therapy Indication

Secondary Outcomes

CONCLUSIONS

930

ParameterPatients

n=36, (%)SexMales 27 (75)Age, yearsMedian 43Range 18-62Race, n=36African American 35 (97)Caucasian 1 (3Antiretroviral Agents, number (%)

Protease InhibitorsNucleoside Reverse Transcriptase Inhibitors

Lopinavir/rtv 20 (55) Tenofovir 21 (58)

Atazanavir/rtv 3 (19) Emtricitabine 21 (58)

Nelfinavir 2 (6) Zidovudine 14 (39)

Daurunavir/rtv 1 (3) Lamivudine 13 (36)

Fosamprenavir/rtv 1 (3) Abacavir 3 (8)Didanosine 2 (6)

Non-Nucleoside Reverse Tanscriptase Inhibitors Efavirenz 8 (22)Nevirapine 1 (3)

Baseline Characteristics

Presented at the 45th Annual IDSA Meeting, October 4-7 2007, San Diego, California

RESULTS (CONTINUED)

Percent of patients with defined diagnosis, n=36

Background: Combined antiretroviral therapy (CART) is recommended in all patients with an AIDS defining illness. In the past few years patients have been started on CART for urgent indications during their hospitalization. However, little is known on the outcome of those patients.

Methods: This is a retrospective chart review of HIV/AIDS hospitalized patients from 8/1/06 to 3/31/07 who initiated CART during their hospital stay. Excluded were those who continued or restarted CART, and those who did not have follow up at an affiliated clinic. Demographic data, rationale for initiating CART, date of initiation, baseline and subsequent HIV viral load and CD4 count, 6 month mortality, pharmacy pick up as well as frequency of medical follow up were collected. Outcome measures included: proportion on CART at 1, 3, 6 months, percentage with undetectable viral load (UVL [<400 copies/ml]), mean CD4 count and mortality at 3 and 6 months. Analysis of the data for continuous and categorical variables were performed using SAS 9.1.

Results: Forty four patients were identified, of which 36 met inclusion criteria. Median age was 43 years, 27 (75 %) male, 35 (97%) Aftrican Americans. Principal reasons for starting inpatient CART were: HIV-associated dementia complex (25%), HIVAN (14%), KS (11%), cryptosporidiosis (11%), PML (6%), PCNSL (3%). One month after initiation, 79% of 28 patients had continued CART uninterrupted, 64% of 25 at 3 months, and 65% of 17 at 6 months. At three months, 86% of 22 patients had UVL. At six months, 64% of 14 patients had UVL. The median CD4 count at baseline was 16, at 3 months 64, and at 6 months 64 cells/mm3 for 36, 24 and 14 evaluable patients respectively. Re-hospitalization rates were 11% at 1 month, 34% at 3 months and 53% at 6 months. Mortality rates were 8% at 1 month, 17% at 3 months and 22% at 6 months.

Conclusions: This study showed that few patients who initiated CART in the hospital remained on it, with the greatest drop off at month after discharge. There is a need to intensify our follow up of those patients at discharge

Majority of patients discontinued CART prior to study completion

Undectable HIV viral loads achieved and CD4 counts increased over time

25%14%

11%

11%

6%3%

33%

HAD

HIVAN

KS

Cryptosporidium

PML

PCNSL

Other

Parameter Patients (%)

Undetectable HIV viral load [<400 copies/ml]

Month 3 (n=22)

Month 6 (n=14)

19 (86)

9 (64)

CD4 count (cells/mm3)

Median (Range)

Baseline (n=36)

Month 3 (n=24)

Month 6 (n=14)

16 (2 – 277)

64 (6 – 971)

64 (5 – 500)

Time Re-hospitalization Provider follow-up

Month 1

Month 3

Month 6

11% (n=35)

34% (n=29)

53% (n=19)

66% (n=32)

66% (n=29)

84% (n=19)

Correspondence:

Leigh E. Efird, PharmDJohns Hopkins HospitalDepartment of Pharmacy600 N Wolfe StBaltimore, MD 21287lefird1@jhmi.eduPager: (410) 434-1108

Disclosure The authors of this presentation have the following disclosures concerning possible financial or personal relationships with commercial entities: Leigh Efird: Nothing to disclose;,Manish Patel: Nothing to disclose; Minh Nguyen: Nothing to disclose

65%(n=17)

70%(n=20)

63%(n=24)

64%(n=25)

67%(n=27)

79%(n=28)

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Duration of Uninterrupted CART