SPRING-2 — The First Phase III Trial of Dolutegravir in ART-Naive Patients

In a randomized, double-blind, multisite trial, 88% of patients taking dolutegravir combined with a nucleoside reverse transcriptase inhibitor backbone had HIV RNA levels <50 copies/mL at week 48.

Dolutegravir is a promising investigational HIV integrase inhibitor with excellent antiviral activity and tolerability in phase I and II clinical trials. In SPRING-2 — a manufacturer-sponsored, 96-week, phase III, randomized, double-blind, noninferiority study conducted at 100 sites — researchers compared once-daily dolutegravir with twice-daily raltegravir in treatment-naive, HIV-infected adults. All participants also received coformulated tenofovir/FTC or abacavir/3TC. The primary endpoint was the proportion of patients with HIV RNA levels <50 copies/mL at week 48.

At baseline, the 822 participants (86% men; 85% white) had a median CD4 count of around 360 cells/mm³ and a viral load of around 35,500 copies/mL; only 28% had viral loads >100,…

Reviewing Author

Charles B. Hicks, MD

Disclosures

Consultant / Advisory boardGilead Sciences; ViiV; Merck

RoyaltiesUpToDate, Inc.

Grant / Research supportNIH; Department of Health and Human Services

Charles B. Hicks, MD

Disclosures

Consultant / Advisory boardGilead Sciences; ViiV; Merck

RoyaltiesUpToDate, Inc.

Grant / Research supportNIH; Department of Health and Human Services

SPRING-2 — The First Phase III Trial of Dolutegravir in ART-Naive Patients

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Reviewing Author