R. Wood*1, C. Trepo2, J. M. Livrozet3, K. Arasteh4, J. Eron5, P. Kaur6, O. Naderer7, and M. B. Wire7.
1Somerset Hosp., Capetown, South Africa;2Hosp. Hotel Dieu, Lyon, France;3Hosp. Edouard Herriot, Lyon, France;4Auguste Victoria Krankenhaus, Berlin, Germany;5Univ. of North Carolina, Chapel Hill;6Glaxo Wellcome, Greenford, UK; and7Glaxo Wellcome Inc., Res. Triangle Park, NC.
Background:APV Cminis significantly increased with co-administration of RTV. Data in HIV-1 infected subjects has shown APV (600 mg)/RTV (100 mg) BID and APV (1200 mg)/RTV (200 mg) QD to be optimal dosing combinations [Wood, et al, Glasgow, 2000].
Methods:Subjects who completed the randomized phase of APV20001 and continued into an open label phase with APV/ABC/3TC were allowed to switch to an APV/RTV regimen. Thirty-nine subjects opted to switch to either a BID or QD APV/RTV regimen in combination with ABC/3TC. Preliminary safety and efficacy results are for all subjects who have completed 12 weeks of therapy. No subjects who entered either APV/RTV group have discontinued therapy prematurely.
Adverse events were minimal and primarily gastrointestinal related.
Conclusion:Switching APV (1200 mg) BID to APV (600 mg)/RTV (100 mg) or APV (1200 mg)/RTV (200 mg) QD allows reduction of the total daily dose of APV (from 16 to 8 capsules daily) with maintenance of virologic suppression and minimal safety issues.© 8th Conference on Retroviruses and Opportunistic Infections