Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children

Simple item page
dc.contributor.authorTurkova, A.
dc.contributor.authorWhite, E.
dc.contributor.authorMujuru, H.A.
dc.contributor.authorKekitiinwa, A.R.
dc.contributor.authorKityo, C.M.
dc.contributor.authorViolari, A.
dc.contributor.authorLugemwa, A.
dc.contributor.authorCressey, T.R.
dc.contributor.authorMusoke, P.
dc.contributor.authorVariava, E.
dc.contributor.authorCotton, M.F.
dc.contributor.authorArchary, M.
dc.contributor.authorPuthanakit, T.
dc.contributor.authorBehuhuma, O.
dc.contributor.authorKobbe, R.
dc.contributor.authorWelch, S.B.
dc.contributor.authorDangarembizi, M. Bwakura
dc.contributor.authorAmuge, P.
dc.contributor.authorKaudha, E.
dc.contributor.authorMosha, L. Barlow
dc.contributor.authorMakumbi, S.
dc.contributor.authorRamsagar, N.
dc.contributor.authorNgampiyaskul, C.
dc.contributor.authorMusoro, G.
dc.contributor.authorAtwine, L.
dc.contributor.authorLiberty, A.
dc.contributor.authorMusiime, V.
dc.contributor.authorBbuye, D.
dc.contributor.authorAhimbisibwe, G.M.
dc.contributor.authorChalermpantmetagul, S.
dc.contributor.authorAli, S.
dc.contributor.authorSarfati, T.
dc.contributor.authorWynne, B.
dc.contributor.authorShakeshaft, C.
dc.contributor.authorColbers, A.
dc.contributor.authorKlein, N.
dc.contributor.authorBernays, S.
dc.contributor.authorSaïdi, Y.
dc.contributor.authorCoelho, A.
dc.contributor.authorGrossele, T.
dc.contributor.authorCompagnucci, A.
dc.contributor.authorGiaquinto, C.
dc.contributor.authorRojo, P.
dc.contributor.authorFord, D.
dc.contributor.authorGibb, D.M.
dc.contributor.authorfor the ODYSSEY Trial Team
dc.date.accessioned2022-01-31T11:38:51Z
dc.date.available2022-01-31T11:38:51Z
dc.date.issued2021
dc.description.abstractChildren with human immunodeficiency virus type 1 (HIV-1) infection have limited options for effective antiretroviral treatment (ART).We conducted an open-label, randomized, noninferiority trial comparing three-drug ART based on the HIV integrase inhibitor dolutegravir with standard care (non–dolutegravir-based ART) in children and adolescents starting first- or second-line ART. The primary end point was the proportion of participants with virologic or clinical treatment failure by 96 weeks, as estimated by the Kaplan–Meier method. Safety was assessed.From September 2016 through June 2018, a total of 707 children and adolescents who weighed at least 14 kg were randomly assigned to receive dolutegravir-based ART (350 participants) or standard care (357). The median age was 12.2 years (range, 2.9 to 18.0), the median weight was 30.7 kg (range, 14.0 to 85.0), and 49% of the participants were girls. By design, 311 participants (44%) started first-line ART (with 92% of those in the standard-care group receiving efavirenz-based ART), and 396 (56%) started second-line ART (with 98% of those in the standard-care group receiving boosted protease inhibitor–based ART). The median follow-up was 142 weeks. By 96 weeks, 47 participants in the dolutegravir group and 75 in the standard-care group had treatment failure (estimated probability, 0.14 vs. 0.22; difference, –0.08; 95% confidence interval, −0.14 to −0.03; P=0.004). Treatment effects were similar with first- and second-line therapies (P=0.16 for heterogeneity). A total of 35 participants in the dolutegravir group and 40 in the standard-care group had at least one serious adverse event (P=0.53), and 73 and 86, respectively, had at least one adverse event of grade 3 or higher (P=0.24). At least one ART-modifying adverse event occurred in 5 participants in the dolutegravir group and in 17 in the standard-care group (P=0.01).In this trial involving children and adolescents with HIV-1 infection who were starting first- or second-line treatment, dolutegravir-based ART was superior to standard care. (Funded by ViiV Healthcare; ODYSSEY ClinicalTrials.gov number, NCT02259127. opens in new tab; EUDRACT number, 2014-002632-14. opens in new tab; and ISRCTN number, ISRCTN91737921. opens in new tab.)en_US
dc.identifier.citationTurkova, A., White, E., Mujuru, H. A., Kekitiinwa, A. R., Kityo, C. M., Violari, A., ... & Gibb, D. M. (2021). Dolutegravir as First-or Second-Line Treatment for HIV-1 Infection in Children. New England Journal of Medicine, 385(27), 2531-2543.DOI: 10.1056/NEJMoa2108793en_US
dc.identifier.urihttps://nru.uncst.go.ug/xmlui/handle/123456789/1665
dc.language.isoenen_US
dc.publisherNew England Journal of Medicineen_US
dc.titleDolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Childrenen_US
dc.typeArticleen_US
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children.pdf
Size:
499.5 KB
Format:
Adobe Portable Document Format
Description:
Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children
Download
License bundle
Now showing 1 - 1 of 1
No Thumbnail Available
Name:
license.txt
Size:
1.71 KB
Format:
Item-specific license agreed upon to submission
Description:
Download
Collections
Medical and Health Sciences