Journal
HIV CLINICAL TRIALS
Volume 13, Issue 5, Pages 233-244Publisher
TAYLOR & FRANCIS LTD
DOI: 10.1310/hct1305-233
Keywords
abacavir; antiretroviral therapy; atazanavir; lamivudine; ritonavir
Categories
Funding
- ViiV Healthcare
- Abbott
- Boehringer-Ingelheim
- Bristol-Myers Squibb
- Gilead Sciences
- GlaxoSmithKline (GSK)
- Koronis
- Merck
- Pfizer
- Schering-Plough
- Tibotec
- Tobira
- Merck Co.
- Monogram Biosciences
- Janssen
- Vertex
- ViralEd
- Janssen Pharmaceuticals
- Kowa Research Institute
- Tobira Pharmaceuticals
- Gilead
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Background: The open-label study ARIES (ClinicalTrials.gov NCT00440947) utilized a ritonavir (/r)-boosted protease inhibitor treatment simplification strategy. Antiretroviral-naive subjects received abacavir/lamivudine (ABC/3TC)+atazanavir/ritonavir (ATV/r) from baseline through randomization at week 36, then maintained or discontinued ritonavir for an additional 108 weeks. Non-inferiority of the unboosted regimen was demonstrated at week 84. In this optional extension phase, virologic suppression and adverse events were assessed through week 144. Methods: Patients were randomized at week 36 if they had confirmed HIV RNA <50 copies/mL by week 30 and no previous virologic failure (VF; defined as failure to achieve HIV RNA <400 copies/mL or confirmed rebound after achieving HIV RNA >= 400 copies/mL). Three hundred sixty-nine subjects who completed 84 weeks in ARIES participated in the extension phase and maintained their randomized regimen for an additional 60 weeks post randomization. Results: At week 144, 146/189 (77%) versus 132/180 (73%) subjects in the unboosted ATV and ATV/r groups, respectively, maintained HIV RNA <50 copies/mL. Post randomization (weeks 36-144), treatment-related grade 2-4 adverse events were more common in the ATV/r-treated (23%) compared to the ATV-treated (13%) group; the most frequently reported was increased serum bilirubin (6% of ATV-treated subjects vs 14 % of ATV/r-treated subjects). During the extension phase, 3% (11/369) of subjects met protocol-defined VF (5 ATV-treated and 6 ATV/r-treated subjects); one ATV/r-treated subject had treatment-emergent major viral resistance-associated mutations. The median change in fasting triglycerides from baseline to week 144 was significantly different (P=.001) in the AN-treated (-8.5 mg/dL) compared to the ATV/r-treated (28.5 mg/dL) groups. Conclusions:These long-term study results demonstrate that AN in combination with ABC/3TC is a potent, well-tolerated regimen in patients who have achieved initial suppression on a ritonavir-boosted regimen.
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