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Atazanavir Once Daily Protease Inhibitor Adherence Evaluated
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Reported by Jules Levin
Atazanavir (Retataz or ATV) is the first once daily protease inhibitor and was approved by the FDA several months ago. It’s taken as 400 mg once daily or as a boosted PI regimen of 300/100 (ATV/r) in combination with additional drugs. This study presented at the European AIDS Conference (Oct 2003, Warsaw, Poland) is a report by Bristol Myers Squibb, the company developing Reyataz, on a comparison of adherence between Reyataz and nelfinavir in the phase II studies. Nelfinavir is a protease inhibitor taken twice daily. Adherence to HAART is a strong predictor of clinical outcomes. ATV is administered as two pills, once a day. Long-term efficacy and safety data of ATV were collected in studies 041and 044.
Study 007 subjects were followed in the open label trial 041. Combined with 2 NRTIs (majority DDI, D4T), subjects on previous ATV were switched to ATV 400 mg QD and subjects on NFV 750 TID continued on NFV. Study 008 subjects were followed in 044. Combined with 2 NRTIs (majority 3TC,D4T), subjects on NFV 1250 mg BID switched to ATV 400 mg QD, ATV subjects remained on prior dose, 400 or 600 mg. In English speaking subjects, self-reported adherence was assessed at baseline and mid-study using MACS questionnaire. Adherence was assessed using MACS algorithm. Those adherent to all drugs in a regimen were considered regimen adherent.
In 041, 138 subjects were analyzed (ATV:103; NFV:35). At entry, 83% of the ATV group and 78% of the NFV group were adherent (not significant). At mid-study, 86%, 59%, respectively, remained adherent (chisq p<0.005).
At 044 entry, (ATV 400mg:66, ATV 600mg:66, NFV switching to ATV:30), 71, 78, and 74% were adherent. After 12 weeks, adherence rate remained stable, 79, 85, and 76% respectively.
The authors concluded that adherence to ATV appears to be high and durable compared to NFV in 041. Switching from NFV to ATV maintained high adherence in 044.
Reference: 9TH EUROPEAN AIDS CONFERENCE (EACS), 1st EACS RESISTANCE & PHARMACOLOGY WORKSHOP. October 25 - 29, 2003 Warsaw • Poland
Absteact 1/15: ATAZANAVIR (ATV) IS ASSOCIATED WITH BETTER PATIENT ADHERENCE (AD): LONG-TERM FOLLOW-UP DATA FROM BMS 041 AND 044 STUDIES. Wu Y., Odeshoo L., Iloeje U., Mukherjee J., Cross A., Giordano M. Bristol-Myers Squibb Company, Wallingford, CT, United States
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