TY - JOUR
T1 - Gemini
T2 - A noninferiority study of saquinavir/ritonavir versus lopinavir/ritonavir as initial HIV-I therapy in adults
AU - Walmsley, Sharon
AU - Avihingsanon, Anchalee
AU - Slim, Jihad
AU - Ward, Douglas J.
AU - Ruxrungtham, Kiat
AU - Brunetta, Jason
AU - Bredeek, U. Fritz
AU - Jayaweera, Dushyantha
AU - Guittari, Carol Jean
AU - Larson, Peter
AU - Schutz, Malte
AU - Raffi, François
PY - 2009/4
Y1 - 2009/4
N2 - Introduction: Direct comparison of the efficacy and safety of different agents is needed to guide selection of optimal treatment regimens for therapy-naive HIV-1-infected patients. Methods: Gemini was a 48-week, multicenter, open-label, noninferiority trial in treatment-naive HIV-1-infected adults randomized to either saquinavir/ritonavir (SQV/r) 1000 mg/100 mg twice a day or lopinavir/ritonavir (LPV/r) 400 mg/100 mg twice a day, each with emtricitabine/tenofovir 200 mg/300 mg every day. Results: A similar proportion of participants in the SQV/r (n = 167) and LPV/r (n = 170) arms had HIV-I RNA levels <50 copies per milliliter at week 48: 64.7% vs 63.5% and estimated difference in proportion for noninferiority: 1.14%, 96% confidence interval: -9.6 toi 1.9 (P < 0.012), confirming that SQV/r was noninferior to LPV/r treatment. There were no significant differences in week 48 CD4 counts between arms. The rate and severity of adverse events were similar in both groups. There were no significant differences in the median change from baseline between arms in plasma lipids except for triglyceride levels, which were significantly higher in the LPV/r at week 48. Conclusions: In treatment-naive, HIV-I-infected patients, SQV/r treatment was noninferior in virologie suppression at 48 weeks to LPV/r treatment and offered a better triglyceride profile.
AB - Introduction: Direct comparison of the efficacy and safety of different agents is needed to guide selection of optimal treatment regimens for therapy-naive HIV-1-infected patients. Methods: Gemini was a 48-week, multicenter, open-label, noninferiority trial in treatment-naive HIV-1-infected adults randomized to either saquinavir/ritonavir (SQV/r) 1000 mg/100 mg twice a day or lopinavir/ritonavir (LPV/r) 400 mg/100 mg twice a day, each with emtricitabine/tenofovir 200 mg/300 mg every day. Results: A similar proportion of participants in the SQV/r (n = 167) and LPV/r (n = 170) arms had HIV-I RNA levels <50 copies per milliliter at week 48: 64.7% vs 63.5% and estimated difference in proportion for noninferiority: 1.14%, 96% confidence interval: -9.6 toi 1.9 (P < 0.012), confirming that SQV/r was noninferior to LPV/r treatment. There were no significant differences in week 48 CD4 counts between arms. The rate and severity of adverse events were similar in both groups. There were no significant differences in the median change from baseline between arms in plasma lipids except for triglyceride levels, which were significantly higher in the LPV/r at week 48. Conclusions: In treatment-naive, HIV-I-infected patients, SQV/r treatment was noninferior in virologie suppression at 48 weeks to LPV/r treatment and offered a better triglyceride profile.
KW - Antiretroviral therapy
KW - Drug-resistant HIV mutations
KW - Fasting plasma lipids
KW - HIV protease inhibitor
KW - Lopinavir
KW - Saquinavir
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U2 - 10.1097/QAI.0b013e318198a815
DO - 10.1097/QAI.0b013e318198a815
M3 - Article
C2 - 19214123
AN - SCOPUS:64249163753
VL - 50
SP - 367
EP - 374
JO - Journal of acquired immune deficiency syndromes (1999)
JF - Journal of acquired immune deficiency syndromes (1999)
SN - 1525-4135
IS - 4
ER -