Fifth International Congress

Drug Therapy in HIV Infection


22-26 October, 2000
Glasgow, UK

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TENOFOVIR DISOPROXIL FUMARATE (TDF) FOR THE TREATMENT OF ANTIRETROVIRAL EXPERIENCED PATIENTS: A 48 WEEK ANALYSIS OF A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY

R. Schooley1, P. Ruane2, R. Myers3, G. Beall4, H. Lampiris5, D. Berger6, M. Miller7, A. Cheng7, R. Mills7 and I. McGowan7 for the Study 902 Team
1University of Colorado, Denver, Colorado; 2Tower ID, Los Angeles, California; 3Body Positive, Phoenix, Arizona; 4Harbor-UCLA, Los Angeles, California; 5VA Medical Center, San Francisco, California; 6Northstar Medical Center, Chicago, Illinois; 7Gilead Sciences, Foster City, California, USA

Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL6.3
AIDS 2000, Oct 22-26;14(Suppl. 4);S6

Tenofovir DF is a once daily nucleotide analogue reverse transcriptase (RT) inhibitor with potent activity against wild type and nucleoside resistant HIV. Patients with HIV RNA between 400 and 100 000 copies/ml were randomized 2 : 2 : 2 : 1 in a blinded fashion to receive 75 150 or 300 mg of TDF or placebo in addition to their stable antiretroviral therapy (ART) at 22 sites. Placebo patients received 300 mg of TDF from week 24. Patients were highly treatment experienced with a mean of 4.6 years on ART and a mean baseline (BL) CD4 count of 374. BL genotyping demonstrated that 97% of patients had nucleoside associated RT mutations, 57% had protease inhibitor associated resistance mutations and 32% had non nucleoside associated RT resistance mutations. 189 patients were enrolled from September 1998 to March 1999. Through 48 weeks, 24% of patients on 300 mg tenofovir DF discontinued treatment whereas 25% of placebo patients discontinued treatment (data through 24 weeks). As of July 2000, median and maximum duration on study were 71 and 96 weeks, respectively. 48 week efficacy data are summarized below (Table PL6.3).

Table PL6.3
Tenofovir DF group (mg) PIb/TDF* 75 150 300
N 28 53 51 54
Mean BL HIV RNA (Log10) 3.8 3.6 3.6 3.7
Mean change in HIV RNA
  Week 24 (n = 164) –0.1 –0.4 –0.4 –0.7
  Week 48 (n = 139) –0.6* –0.4 –0.6 –0.6
Mean BL CD4 Count 298 374 410 381
Mean change in CD4 count
  Week 24 (n = 168) 20 18 0 –14
  Week 48 (n = 139) –2* 10 20 11
*Placebo patients received tenofovir DF 300 mg daily from week 24.

Once daily tenofovir DF provides durable antiviral suppression. Through 48 weeks of treatment there was no evidence of dose-related toxicity in treatment experienced HIV-infected patients receiving concomitant antiretroviral therapy.

Presenting author: R. Schooley

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2000-10-22
PL6-3

Originally published in AIDS Volume 14, Supplement 4 and hosted with permission of the publisher Lippincott Williams & Wilkins, 250 Waterloo Road, London, SE1 8RD, UK. Tel: +44 (0)20 7981 0700 Fax: +44 (0) 7981 0701

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