H4. Treatment
Oral Abstract Submission
Gregory D. Huhn, MD
Associate Professor, Infectious Diseases
The Ruth M. Rothstein CORE Center
Chicago, IL
Disclosure: Gilead: Consultant, Grant/Research Support
Janssen: Consultant, Grant/Research Support
Proteus: Grant/Research Support
US National Institutes of Health: Research Grant or Support
ViiV: Consultant, Grant/Research Support
Moti Ramgopal, MD
Consultant Physician/Director Associates in Infectious Diseases
Midway Immunology and Research Center
Fort Pierce, FL
Disclosure: AbbVie: Speaker's Bureau
Allergan: Speaker's Bureau
Gilead: Advisor or Review Panel member, Speaker's Bureau
Insamed: Speaker's Bureau
Janssen: Advisor or Review Panel member, Speaker's Bureau
Merck: Advisor or Review Panel member
ViiV: Advisor or Review Panel member, Speaker's Bureau
Gordon Crofoot, MD
Owner
Crofoot Research Center
Houston, TX
Disclosure: Gilead: Grant/Research Support
Janssen: Grant/Research Support
Merck: Grant/Research Support
ViiV: Grant/Research Support
Joseph Gathe, Jr., MD
Medical Director
Therapeutic Concepts
Houston, TX
Disclosure: Abbott: Scientific Research Study Investigator
AbbVie: Grant/Research Support, Other Financial or Material Support, Consultant or speaker in company-supported conferences
Avexa: Scientific Research Study Investigator
Boehringer Ingelheim: Grant/Research Support, Scientific Research Study Investigator
Bristol-Myers Squibb: Grant/Research Support, Other Financial or Material Support, Consultant or speaker in company-supported conferences
Gilead: Grant/Research Support, Scientific Research Study Investigator, Consultant or speaker in company-supported conferences
GlaxoSmithKline: Grant/Research Support, Scientific Research Study Investigator, Other Financial or Material Support, Consultant or speaker in company-supported conferences
Hiesped: Scientific Research Study Investigator
Janssen: Grant/Research Support, Scientific Research Study Investigator, Consultant or speaker in company-supported conferences
Merck: Grant/Research Support, Scientific Research Study Investigator, Consultant or speaker in company-supported conferences
Parexel: Scientific Research Study Investigator
Pfizer: Grant/Research Support, Scientific Research Study Investigator
Roche: Scientific Research Study Investigator
ViiV: Grant/Research Support, Other Financial or Material Support, Consultant or speaker in company-supported conferences
Sareh Seyedkazemi, PharmD
Disease Area Strategic Coordinator
Janssen Scientific Affairs, LLC
Titusville, NJ
Disclosure: Janssen: Employee, Shareholder
Patricia Cosler, PharmD
Senior Medical Science Liaison
Janssen Scientific Affairs, LLC
Titusville, NJ
Disclosure: Janssen: Employee, Shareholder
Richard Bruce Simonson, BS
Director, Clinical Project Scientist Medical Affairs, Infectious Diseases
Janssen Scientific Affairs, LLC
Titusville, NJ
Disclosure: Janssen: Employee, Shareholder
Donghan Luo, PhD
Associate Director, Medical Affairs Biostatistics
Janssen Research & Development, LLC
Titusville, NJ
Disclosure: Janssen: Employee, Shareholder
Keith Dunn, PharmD
Medical Director, Infectious Diseases
Janssen Scientific Affairs, LLC
Titusville, NJ
Disclosure: Janssen: Employee, Shareholder
Background : Rapid initiation of ART requires that clinicians start therapy prior to having baseline laboratory results. High rates of virologic suppression and retention were reported in the DIAMOND trial. Efficacy and safety are presented, according to baseline disease characteristics.
Methods : DIAMOND (ClinicalTrials.gov: NCT03227861), a phase 3, single-arm, open-label, prospective, multicenter study, assessed efficacy/safety of D/C/F/TAF in rapid initiation. Adults enrolled within 14 days of diagnosis and started D/C/F/TAF without baseline laboratory results; investigators reviewed results as they became available. Primary endpoint was virologic suppression (HIV-1 RNA < 50 copies[c]/mL; intent-to-treat (ITT); Food and Drug Administration [FDA] snapshot) at Week 48. Virologic suppression < 50 c/mL and < 200 c/mL were also assessed via an observed analysis, excluding patients with missing data.
Results : Overall, 109 patients were enrolled; 25% had HIV-1 RNA ≥100,000 c/mL and 21% had CD4+ < 200 cells/μL (Table 1). 21% of patients started therapy within 24 hours of diagnosis. At Week 48, 84% and 88% of patients had HIV-1 RNA < 50 c/mL and < 200 c/mL (FDA snapshot), respectively. In the observed analysis, 96% and 100% of patients had HIV-1 RNA < 50 c/mL and < 200 c/mL, respectively, at Week 48. Earlier ART initiation, HIV-1 RNA < 100,000 c/mL, and CD4+ > 200 cells/μLwere associated with numerically higher virologic suppression rates (ITT-FDA snapshot; Table 2). No patient discontinued due to lack of efficacy or met protocol-defined virologic failure (PDVF) criteria. In the observed analysis, virologic suppression rates were consistent across all subgroups; all patients were suppressed < 200 c/mL at Week 48. One patient discontinued due to an adverse event (AE); incidences of grade 3/4 (10%) and serious (9%) AEs were low, with no serious AEs related to study drug and no deaths.
Conclusion : In the first phase 3 study of an STR in a rapid initiation model, no patients rapidly starting D/C/F/TAF discontinued therapy due to lack of efficacy or had PDVF through 48 weeks. High rates of virologic suppression were achieved and maintained with a variety of baseline characteristics, and treatment was safe and well tolerated, indicating D/C/F/TAF as a preferred ART option for patients rapidly starting treatment.
