Medical Advocates for Social Justice
Conference Poster

 

5th International Congress on Drug Therapy in HIV Infection
Glasgow, Scotland, October 22-26, 2000

Durable Suppression of HIV+RNA After Two Years of Therapy with ABT-378/Ritonavir (ABT-378/r) Treatment in Single Protease Inhibitor Experienced Patients [Abstract P101]

J FEINBERG, S BRUN, Y XU, T MARSH, C. BENSON, S. DEEKS, H  KESSLER, R MURPHY, R GULICK, D WHEELER, C HICKS, J ERON, P SAX, R STRYKER, S RIDDLER1, M. THOMPSON, M. KING, K. REAL, A HSU, R. BERTZ.  D KEMPF, A JAPOUR1, & E. SUN1 FOR THE M97-765 STUDY GROUP.

 

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ABT-378/r is a novel HIV protease inhibitor (PI) with mean trough concentrations that exceed its protein binding corrected EC50 for wild type HIV by more than 75-fold when dosed at 400/100 mg BID. This increased inhibitory quotient (IQ) should provide antiviral activity in patients who have developed resistance to other PIs.

Single PI experienced/NNRTI naive pts. (n=70) with viral load (VL) 103-105 copies/mL on current therapy were randomized to a blinded ABT-378/r dose (400/100 vs. 400/200 mg BID) with nevirapine and two NRTIs (at least one new).

Previous PI included IDV (44%), NFV (36%), SQV (13%), RTV (6%), and APV (1%). For baseline viral isolates with full PI phenotype data available (N=57), 63% had ³ 4-fold loss in susceptibility to their previous PI and 32% to ³ 3 licensed PIs. Median baseline VL was 4.0 log10 copies/mL. At wk 96, 61% of patients for the Intent-to-Treat Missing = Failure analysis (On-treatment: 85%) in the 400/100 mg dose group and 59% of patients ITT M = F (On-treatment: 83%) in the 400/200 mg dose group had VL < 400 copies/mL. Analyses using an ultrasensitive viral load assay (< 50 copies/mL) are in progress. Mean increase from baseline in CD4 cells at wk 96 was 199 cells/m L overall. The most common drug-related adverse events of at least moderate severity were diarrhea and asthenia. Lipid elevations were the most common laboratory abnormality. Both doses have been well tolerated to date with 4 discontinuations for adverse events related to ABT-378/r through 96 weeks.

ABT-378/r is well tolerated and in combination with NVP AND 2 NRTIs exhibits durable antiretroviral effect through 96 weeks in the majority of patients who have previously failed a single PI-based regimen.

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Durable Suppression of HIV+RNA After Two Years of Therapy with ABT-378/Ritonavir
(ABT-378/r) Treatment in Single Protease Inhibitor Experienced Patients

© 2000 Medical Advocates for Social Justice