Treatment of HIV-1–Infected Adultswith No Antiretroviral Treatment History in GEMINI-1 and GEMINI-2 Trials at Week 48(Snapshot Algorithm)
Virologic Outcomes
GEMINI-1 and GEMINI-2
Pooled Data
TIVICAY
plus EPIVIR
(n = 716)
TIVICAY plus
TRUVADA
(n = 717)
HIV-1 RNA <50 copies/mL 91% 93%
Treatment Differencea
-1.7%
(95% CI: -4.4%, 1.1%)
Virologic nonresponse 3% 2%
Reasons
Data in window not <50 copies/mL 1% <1%
Discontinued for lack of efficacy <1% <1%
Discontinued for other reasons and ≥50 copies/mL <1% <1%
Change in ART <1% <1%
No virologic data at Week 48 window 6% 5%
Reasons
Discontinued trial due to adverse event or death 1% 2%
Discontinued trial for other reasons 4% 3%
Missing data during window but on trial <1% 0%
Proportion (%) of Subjects with HIV-1 RNA <50 copies/mL by Baseline Category
% (n/N) % (n/N)
Plasma Viral Load (copies/mL)
≤100,000
>100,000
91% (526/576)
92% (129/140)
94% (531/564)
90% (138/153)
CD4+
(cells/mm3
)
≤200 79% (50/63) 93% (51/55)
>200 93% (605/653) 93% (618/662)
Gender
Male 92% (555/603) 94% (580/619)
Female 88% (100/113) 91% (89/98)
Race
White 93% (447/480) 95% (471/497)
African-American/African Heritage 84% (83/99) 84% (64/76)
Asian 94% (67/71) 94% (68/72)
Other 88% (58/66) 92% (66/72)
Ethnicity
Hispanic or Latino 90% (193/215) 93% (216/232)
Not Hispanic or Latino 92% (462/501) 93% (453/485)
Age (years)
<50 92% (597/651) 94% (597/637)
50 89% (58/65) 90% (72/80)
a Based on Cochran–Mantel–Haenszel-stratified analysis adjusting for the following baseline
stratification factors: plasma HIV-1 RNA (≤100,000 copies/mL versus >100,000 copies/mL)
and CD4+
cell count (≤200 cells/mm3
versus >200 cells/mm3
). Pooled analysis also stratified by
trial. Assessed using a non-inferiority margin of 10%.
Virologic outcomes by baseline CD4+
(cells/mm3
) in GEMINI-1 and GEMINI-2 are shown in
Table 12. In both trials, lower response rates (HIV-1 RNA <50 copies/mL) were observed in
subjects with baseline CD4+ ≤200 cells/mm3
. These findings were seen irrespective of baseline
plasma HIV-1 RNA.
Table 12. Virologic Outcomes by Baseline CD4+
in GEMINI-1 and GEMINI-2 Trials at
Week 48 (Snapshot Algorithm)
GEMINI-1 GEMINI-2
TIVICAY plus
EPIVIR
(n = 356)
TIVICAY plus
TRUVADA
(n = 358)
TIVICAY plus
EPIVIR
(n = 360)
TIVICAY plus
TRUVADA
(n = 359)
Proportion (%) of Subjects with HIV-1 RNA <50 copies/mL
Baseline CD4+
(cells/mm3
)
≤200
>200
81% (25/31)a
91% (295/325)
90% (26/29)
93% (306/329)
78% (25/32)a
95% (310/328)
96% (25/26)
94% (312/333)
a With the exception of one subject treated with TIVICAY plus EPIVIR in GEMINI-1 who waswithdrawn due to confirmed loss of virologic response, none of the subjects treated withTIVICAY plus EPIVIR who did not have HIV-1 RNA <50 copies/mL at Week 48 (based onSnapshot Algorithm) were discontinued for treatment-related reasons by Week 48.
A subject in
GEMINI-1 whose last HIV-1 RNA was 64,366 copies/mL was lost to follow-up.
The adjusted mean change from baseline in CD4+
cell count based on the pooled analysis at
Week 48 was 224 cells/mm3
for the group receiving TIVICAY plus EPIVIR |
