H-892. Elvucitabine Phase II 48 Week Interim Results Show Safety and Efficacy Profiles Similar to Lamivudine in Treatment Naive HIV-1 Infected Patients with a Unique Pharmacokinetic Profile
Session: Slide Session: Antiretroviral Therapy
Sunday, October 26, 2008: 12:00 AM
Room: Independence A (Grand Hyatt)
Background: Elvucitabine (ACH123,446)(ELV) is a cytosine NRTI analog with potent in-vitro activity against wild type HIV-1 virus Methods: A Phase II, prospective, randomized, blinded, comparison of ELV 10 mg versus lamivudine (LAM) 300 mg both administered daily in combination with efavirenz 600 mg and tenofovir DF 300 mg in HIV-1-infected, treatment-naïve subjects. Results: 77 subjects were randomized with 76 subjects receiving at least one dose of study medication. Seventy-four subjects (37 per treatment group) had both baseline and post-baseline HIV-1 RNA measurements.Fifty-five subjects completed 48 weeks of treatment. The reasons for not completing 48 weeks were: physician decision (n=5), voluntary withdrawal (n=5), adverse event (n=4), lost to follow-up (n=4), sponsor decision (n=3), and death (n=1). Baseline characteristics were similar between treatment groups. The proportion of subjects at week 48 with HIV-1 levels of less than 50 copies/mL in the ITT patient population was : 65% in the ELV and 78% in the LAM treatment group (95% CI for the difference = -0.34, 0.07)( as-treated patient population was 96% for ELV and 97% for LAM). At week 48, the ELV treatment group experienced a mean (SD) change in percent CD4 of +9.9 (6.3) versus +9.1 (7.2) with LAM. The incidence, frequency, type, and severity of adverse events were similar between treatment groups. Conclusions: ELV administered in combination with tenofovir and efavirenz demonstrates substantial anti-viral activity.
Barbara Wade1, D. Saple2, Edwin DeJesus, MD, FACP3, Elizabeth Olek4, Heather Robison4, Javier Morales-Ramirez5, N. Kumarasamy6, Nicholaos Bellos, MD7, Ron Gugliotti4, Thomas Jefferson8 and  E. DeJesus,
Achillion Pharmaceuticals, Inc. Role(s): Investigator., (1)Center for the Prevention and Treatment of Infections, (2)Dr. Saple's Clinic, (3)Orlando Immunology Center, Orlando, FL, (4)Achillion Pharmaceuticals, Inc., (5)Clinical Research Puerto Rico, (6)YRGCare VHS, (7)SW Infectious Disease Assoc., Dallas, TX, (8)Health for Life Clinic

Dr. DeJesus is a graduate from the University of Puerto Rico, School of Medicine. He completed his Internal Medicine training and Infectious Disease fellowship at the Medical College of Pennsylvania in Philadelphia and is board certified in Infectious Diseases. He has been a Fellow of the American College of Physicians since 1996. Dr. DeJesus is the Medical Director for the Orlando Immunology Center in downtown-Orlando and maintains a secondary office with Infectious Disease Consultants (IDC) in Altamonte Springs, Florida. Since 1993, Dr. DeJesus has devoted most of his time caring for HIV and hepatitis infected patients. He is the Principal Investigator for the OIC Research Facility, where he oversees the conduction of several phase I-IV clinical trials. In this capacity, he has presented several study results in major international conferences such as AIDS World Conference, International AIDS Society Conference, Interscience Conference on Antimicrobial Agents and Chemotherapy and The Conference on Retroviruses and Opportunistic Infections. Dr. DeJesus has remained highly active in the Florida HIV Hispanic Community where he has implemented and supported educational, preventative, and research programs. He has participated as a guest speaker for community programs, medical forums and as part of the HIV and ID training of physicians in medical centers around the country. Dr. DeJesus serves as a consultant to many pharmaceutical companies including: Glaxo-SmithKline, Bristol-Myers Squibb, Merck, Vertex, Gilead Science and Tibotec.

Dushyantha T. Jayaweera MD, MRCOG (UK) FACP
I am an Associate Professor in Medicine, at the Division of Infectious Diseases, in the Department of Medicine at University of Miami School of Medicine. I am investigator for several ongoing clinical studies evaluating the safety and efficacy of various antiviral treatment regimens for HIV and Hepatitis/HIV coinfection.
After graduating from University of Sri Lanka in Colombo, I completed training in OBGYN in Sri Lanka and in England. Following this training I changed my specialty to medicine and completed a residency program in internal medicine in Chicago (Loyola/Hines VA program) and returned to England for further training in HIV and Sexually Transmitted Diseases. In 1992 I joined the University of Miami as an Assistant Professor in Medicine and have been working at the University since then. I was promoted to Associate Professor in 1997. I have been the director for the HIV fellowship program for the last 7 years.
I am a fellow in the American College of Physicians and a Member of the Royal College of OBGYN. I am a member of the ethics committee at the university of Miami and have also worked as ad hoc member in NIH review panels. I have been a visiting professor to many countries which include, Si Lanka, Nigeria, Jamaica and China. I have published many articles in peer reviewed journals and most of this work has been in HIV and hepatitis B.
Faculty List Information:
Dushyantha T. Jayaweera MD, MRCOG (UK) FACP
Associate Professor in Medicine
Department of Medicine
Division of Infectious Diseases
1500 NW 12th Ave, 8th Floor West
Miami, FL 33136
Phone: 305 243 5621
Fax: 305 243 3005
Email: djayawee@med.miami.edu



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