Dolutegravir in antiretroviral-naive adults with HIV-1: 96-week results from a randomized dose-ranging study
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Dolutegravir in antiretroviral-naive adults with HIV-1: 96-week results from a randomized dose-ranging study. / Stellbrink, Hans-Jürgen; Reynes, Jacques; Lazzarin, Adriano; Voronin, Eugene; Pulido, Federico; Felizarta, Franco; Almond, Steve; St Clair, Marty; Flack, Nancy; Min, Sherene; SPRING-1 Team.
In: AIDS, Vol. 27, No. 11, 17.07.2013, p. 1771-8.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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T1 - Dolutegravir in antiretroviral-naive adults with HIV-1: 96-week results from a randomized dose-ranging study
AU - Stellbrink, Hans-Jürgen
AU - Reynes, Jacques
AU - Lazzarin, Adriano
AU - Voronin, Eugene
AU - Pulido, Federico
AU - Felizarta, Franco
AU - Almond, Steve
AU - St Clair, Marty
AU - Flack, Nancy
AU - Min, Sherene
AU - SPRING-1 Team
AU - van Lunzen, Jan
PY - 2013/7/17
Y1 - 2013/7/17
N2 - OBJECTIVE: To evaluate the efficacy and safety/tolerability of dolutegravir (DTG, S/GSK1349572), a potent inhibitor of HIV integrase, through the full 96 weeks of the SPRING-1 study.DESIGN: ING112276 (SPRING-1) was a 96-week, randomized, partially blinded, phase IIb dose-ranging study.METHODS: Treatment-naive adults with HIV received DTG 10, 25, or 50 mg once daily or efavirenz (EFV) 600 mg once daily (control arm) combined with investigator-selected dual nucleos(t)ide reverse transcriptase inhibitor backbone regimen (tenofovir/emtricitabine or abacavir/lamivudine). The primary endpoint of the study was the proportion of participants with plasma HIV-1 RNA less than 50 copies/ml, based on time to loss of virologic response at 16 weeks (conducted for the purpose of phase III dose selection), with a planned analysis at 96 weeks. Safety and tolerability were also assessed.RESULTS: Of 208 participants randomized to treatment, 205 received study drug. At week 96, the proportion of participants achieving plasma HIV-1 RNA less than 50 copies/ml was 79, 78, and 88% for DTG 10, 25, and 50 mg, respectively, compared with 72% for EFV. The median increase from baseline in CD4 cells was 338 cells/μl with DTG (all treatment groups combined) compared with 301 cells/μl with EFV (P = 0.155). No clinically significant dose-related trends in adverse events were observed, and fewer participants who received DTG withdrew because of adverse events (3%) compared with EFV (10%).CONCLUSION: Throughout the 96 weeks of the SPRING-1 study, DTG demonstrated sustained efficacy and favorable safety/tolerability in treatment-naive individuals with HIV-1.
AB - OBJECTIVE: To evaluate the efficacy and safety/tolerability of dolutegravir (DTG, S/GSK1349572), a potent inhibitor of HIV integrase, through the full 96 weeks of the SPRING-1 study.DESIGN: ING112276 (SPRING-1) was a 96-week, randomized, partially blinded, phase IIb dose-ranging study.METHODS: Treatment-naive adults with HIV received DTG 10, 25, or 50 mg once daily or efavirenz (EFV) 600 mg once daily (control arm) combined with investigator-selected dual nucleos(t)ide reverse transcriptase inhibitor backbone regimen (tenofovir/emtricitabine or abacavir/lamivudine). The primary endpoint of the study was the proportion of participants with plasma HIV-1 RNA less than 50 copies/ml, based on time to loss of virologic response at 16 weeks (conducted for the purpose of phase III dose selection), with a planned analysis at 96 weeks. Safety and tolerability were also assessed.RESULTS: Of 208 participants randomized to treatment, 205 received study drug. At week 96, the proportion of participants achieving plasma HIV-1 RNA less than 50 copies/ml was 79, 78, and 88% for DTG 10, 25, and 50 mg, respectively, compared with 72% for EFV. The median increase from baseline in CD4 cells was 338 cells/μl with DTG (all treatment groups combined) compared with 301 cells/μl with EFV (P = 0.155). No clinically significant dose-related trends in adverse events were observed, and fewer participants who received DTG withdrew because of adverse events (3%) compared with EFV (10%).CONCLUSION: Throughout the 96 weeks of the SPRING-1 study, DTG demonstrated sustained efficacy and favorable safety/tolerability in treatment-naive individuals with HIV-1.
KW - Adult
KW - Anti-HIV Agents
KW - Antiretroviral Therapy, Highly Active
KW - Female
KW - HIV Infections
KW - HIV-1
KW - Heterocyclic Compounds, 3-Ring
KW - Humans
KW - Male
KW - RNA, Viral
KW - Single-Blind Method
KW - Treatment Outcome
KW - Viral Load
U2 - 10.1097/QAD.0b013e3283612419
DO - 10.1097/QAD.0b013e3283612419
M3 - SCORING: Journal article
C2 - 23807273
VL - 27
SP - 1771
EP - 1778
JO - AIDS
JF - AIDS
SN - 0269-9370
IS - 11
ER -
