Table 2.
Open in new tab

Reservoir Parameters at Baseline and at Week 48

ParameterDTG + 3TCDTG + FTC/TAFP Value Between Groupsa
Total HIV-1 DNA (copies/106 CD4+ T cells)
 Data available BL/week 48b, No.20/2020/20
 Baseline1194 (718–1986)1554 (832–2901).565
 Week 48255 (140–467)280 (155–504).925
 P value within groupc<.0001<.0001
 GMR week 48/BL (95% CI)0.21 (.17–.26)0.18 (.15–.21).325d
Intact HIV-1 DNA (copies/106 CD4+ T cells)
 Data available BL/week 48b, No.18/1818/18
 Baseline496 (248–989)581 (259–1304).389
 Week 4895.2 (52.5–172.5)104 (59–184).743
 P value within groupc<.0001<.0001
 GMR week 48/BL (95% CI)0.19 (.15–.25)0.18 (.13–.25).838d
HIV-1 ca-RNA (copies/103 copies TBP)
 Data available BL/week 48b, No.10/1016/15
 Baseline11.8 (3.9–36.0)8.8 (2.8–27.7).698
 Week 480.7 (0.2–2.9)0.6 (0.2–2.1).849
 P value within groupc.0020<.0001
 GMR week 48/BL (95% CI)0.06 (.03–.15)0.07 (.03–.16).8764d
VIP-SPOT (HAP cells/106 CD4+ T cells)
 Data available BL/week 48b, No.17/1615/14
 Baseline11.4 (5.9–22.3)21.2 (9.8–45.7).295
 Week 480.3 (0.2–0.6)0.5 (0.3–1.0).345
 P value within groupc<.0001.0001
 GMR week 48/BL (95% CI)0.03 (.01–.05)0.03 (.01–.06).3907d
ParameterDTG + 3TCDTG + FTC/TAFP Value Between Groupsa
Total HIV-1 DNA (copies/106 CD4+ T cells)
 Data available BL/week 48b, No.20/2020/20
 Baseline1194 (718–1986)1554 (832–2901).565
 Week 48255 (140–467)280 (155–504).925
 P value within groupc<.0001<.0001
 GMR week 48/BL (95% CI)0.21 (.17–.26)0.18 (.15–.21).325d
Intact HIV-1 DNA (copies/106 CD4+ T cells)
 Data available BL/week 48b, No.18/1818/18
 Baseline496 (248–989)581 (259–1304).389
 Week 4895.2 (52.5–172.5)104 (59–184).743
 P value within groupc<.0001<.0001
 GMR week 48/BL (95% CI)0.19 (.15–.25)0.18 (.13–.25).838d
HIV-1 ca-RNA (copies/103 copies TBP)
 Data available BL/week 48b, No.10/1016/15
 Baseline11.8 (3.9–36.0)8.8 (2.8–27.7).698
 Week 480.7 (0.2–2.9)0.6 (0.2–2.1).849
 P value within groupc.0020<.0001
 GMR week 48/BL (95% CI)0.06 (.03–.15)0.07 (.03–.16).8764d
VIP-SPOT (HAP cells/106 CD4+ T cells)
 Data available BL/week 48b, No.17/1615/14
 Baseline11.4 (5.9–22.3)21.2 (9.8–45.7).295
 Week 480.3 (0.2–0.6)0.5 (0.3–1.0).345
 P value within groupc<.0001.0001
 GMR week 48/BL (95% CI)0.03 (.01–.05)0.03 (.01–.06).3907d

Data are expressed as geometric mean (95% confidence interval) except otherwise indicated.

Abbreviations: BL, baseline; ca-RNA, cell-associated RNA; CI, confidence interval; DTG + 3TC, dolutegravir plus lamivudine; DTG + FTC/TAF, dolutegravir plus emtricitabine/tenofovir alafenamide; GMR, geometric mean ratio; HAP, human immunodeficiency virus antigen–producing; HIV-1, human immunodeficiency virus type 1; TBP, TATA-binding protein; VIP-SPOT, viral protein spot assay.

aMann-Whitney test.

bAnalyzed samples based on availability of cryopreserved peripheral blood mononuclear cells.

cWilcoxon matched-pairs signed rank test.

dMixed model for repeated measures including week and arm as fixed effects and subject as random effect.

Table 2.
Open in new tab

Reservoir Parameters at Baseline and at Week 48

ParameterDTG + 3TCDTG + FTC/TAFP Value Between Groupsa
Total HIV-1 DNA (copies/106 CD4+ T cells)
 Data available BL/week 48b, No.20/2020/20
 Baseline1194 (718–1986)1554 (832–2901).565
 Week 48255 (140–467)280 (155–504).925
 P value within groupc<.0001<.0001
 GMR week 48/BL (95% CI)0.21 (.17–.26)0.18 (.15–.21).325d
Intact HIV-1 DNA (copies/106 CD4+ T cells)
 Data available BL/week 48b, No.18/1818/18
 Baseline496 (248–989)581 (259–1304).389
 Week 4895.2 (52.5–172.5)104 (59–184).743
 P value within groupc<.0001<.0001
 GMR week 48/BL (95% CI)0.19 (.15–.25)0.18 (.13–.25).838d
HIV-1 ca-RNA (copies/103 copies TBP)
 Data available BL/week 48b, No.10/1016/15
 Baseline11.8 (3.9–36.0)8.8 (2.8–27.7).698
 Week 480.7 (0.2–2.9)0.6 (0.2–2.1).849
 P value within groupc.0020<.0001
 GMR week 48/BL (95% CI)0.06 (.03–.15)0.07 (.03–.16).8764d
VIP-SPOT (HAP cells/106 CD4+ T cells)
 Data available BL/week 48b, No.17/1615/14
 Baseline11.4 (5.9–22.3)21.2 (9.8–45.7).295
 Week 480.3 (0.2–0.6)0.5 (0.3–1.0).345
 P value within groupc<.0001.0001
 GMR week 48/BL (95% CI)0.03 (.01–.05)0.03 (.01–.06).3907d
ParameterDTG + 3TCDTG + FTC/TAFP Value Between Groupsa
Total HIV-1 DNA (copies/106 CD4+ T cells)
 Data available BL/week 48b, No.20/2020/20
 Baseline1194 (718–1986)1554 (832–2901).565
 Week 48255 (140–467)280 (155–504).925
 P value within groupc<.0001<.0001
 GMR week 48/BL (95% CI)0.21 (.17–.26)0.18 (.15–.21).325d
Intact HIV-1 DNA (copies/106 CD4+ T cells)
 Data available BL/week 48b, No.18/1818/18
 Baseline496 (248–989)581 (259–1304).389
 Week 4895.2 (52.5–172.5)104 (59–184).743
 P value within groupc<.0001<.0001
 GMR week 48/BL (95% CI)0.19 (.15–.25)0.18 (.13–.25).838d
HIV-1 ca-RNA (copies/103 copies TBP)
 Data available BL/week 48b, No.10/1016/15
 Baseline11.8 (3.9–36.0)8.8 (2.8–27.7).698
 Week 480.7 (0.2–2.9)0.6 (0.2–2.1).849
 P value within groupc.0020<.0001
 GMR week 48/BL (95% CI)0.06 (.03–.15)0.07 (.03–.16).8764d
VIP-SPOT (HAP cells/106 CD4+ T cells)
 Data available BL/week 48b, No.17/1615/14
 Baseline11.4 (5.9–22.3)21.2 (9.8–45.7).295
 Week 480.3 (0.2–0.6)0.5 (0.3–1.0).345
 P value within groupc<.0001.0001
 GMR week 48/BL (95% CI)0.03 (.01–.05)0.03 (.01–.06).3907d

Data are expressed as geometric mean (95% confidence interval) except otherwise indicated.

Abbreviations: BL, baseline; ca-RNA, cell-associated RNA; CI, confidence interval; DTG + 3TC, dolutegravir plus lamivudine; DTG + FTC/TAF, dolutegravir plus emtricitabine/tenofovir alafenamide; GMR, geometric mean ratio; HAP, human immunodeficiency virus antigen–producing; HIV-1, human immunodeficiency virus type 1; TBP, TATA-binding protein; VIP-SPOT, viral protein spot assay.

aMann-Whitney test.

bAnalyzed samples based on availability of cryopreserved peripheral blood mononuclear cells.

cWilcoxon matched-pairs signed rank test.

dMixed model for repeated measures including week and arm as fixed effects and subject as random effect.

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