Introduction: ABT-378/r

• ABT-378 is a novel protease inhibitor with excellent in vitro activity.
• ABT-378 is co-formulated with low dose ritonavir which acts as a pharmacokinetic enhancer.
• Trough concentrations of ABT-378 are 30-fold above the EC 50 of wild type HIV at steady state.

Study Design

• Antiretroviral-naïve
• HIV RNA > 5,000 copies/mL
• Any CD4 count

Results

Reasons for Discontinuation:

• Drug addiction (1)
• Lymphoma (1)
• Non-compliance (2)
• Moved ex-U.S. (1)

Study Design

• Viral load between 10³-10⁵ copies/mL
• Currently on treatment with 1 PI and 2 NRTIs for > 3 months
• Naïve to at least one NRTI
• No prior NNRTI or dual PI therapy

Results

• PI susceptibility data (phenotype) available for 55/70 baseline viral isolates
• 64% have > 4-fold loss in susceptibility to previous PI
• 33% have > 4 fold loss in susceptibility to > 3 PIs

Reasons for discontinuation:

• Adverse event related to ABT-378/r (1)
• Adverse event related to ABT-378/r + NVP (1)
• Adverse event unrelated to drug (1)
• Personal Reasons (2)
• Death (2)
• Lost to follow-up (1)

Conclusions at 36 Weeks

• ABT-378/r is safe and well tolerated.
• Only 2 of 170 patients discontinued for ABT-378/r related adverse events.
• In antiretroviral naive patients on treatment:
  • HIV RNA was <400 copies/mL in 96% of patients.
  • HIV RNA was <50 copies/mL in 89% of patients.
• In PI experienced patients on treatment:
  • HIV RNA was <400 copies/mL for 78% of patients.

Acknowledgements

University of Colorado Health Sciences Center – Sally Canmann, RN, Bev Putnam, RN, ANP, M. Graham Ray, MSN, ANP

San Francisco General Hospital – Dorie Heeren

University of North Carolina-Chapel Hill – Barbara Longmire, RN, Cheryl Marcus, RN, Linh Ngo, FNP

University of Cincinnati – Jarlath Black, RN, Pam Daniel, RN, Jill Leonard, RN

Cornell Clinical Trials Unit – Todd Stroberg, RN,Tricia Sarraco, RN

Duke University Medical Center – Julieta Giner, RN,ACRN, Les Harmon, RN, MSN,ANP

Rush Presbyterian St.Luke’s Medical Center – Elke Narkiewicz, RN, BSN

Northwestern University – Jim Bruce, RN,ACRN, Pam Donath, RN, Siddharth Padia

University of Pittsburgh – Rosella Rosener, RN

Brigham and Women’s Hospital – Martha VanDerVleit

Pacific Oaks Research – Kai Gu, RN, Donna Morales, RN

AIDS Research Consortium of Atlanta – Tim Enstrom, PA-C

Infectious Disease Physicians – Stephen Poretz, Ja’Ree Thompson, CRC

Thomas Street Clinic – Barbara Sepcie, RN

PPD Development, Inc. – Sandy McCarley, RN, Shannon Jackson, RN, Alice Donnelly