Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dolutegravir twice daily · 1 trial · 1 indication
Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1) and Day 8. Change from Baseline was calculated as the value at Day 8 minus the value at Baseline (Day 1). The analysis was performed using statistical modeling correcting for Baseline plasma HIV-1 RNA, Baseline Dolutegravir (DTG) fold change (FC), the overall susceptibility score (OSS) of the failing regimen, and the interaction between DTG FC and treatment. Means and differences were calculated using the average Baseline DTG FC of the entire Intent-to-Treat Exposed (ITT-E) Population. The last observation carried forward with discontinuation equals Baseline (LOCFDB) dataset was used for the analysis. For the LOCFDB dataset, missing values were carried forward from the previous, non-missing, available on-treatment assessment, except formissing values due to premature withdrawal or Day 8 missing values, which had the Baseline value imputed.
| Arm | Type | Description |
|---|---|---|
| DTG 50 mg BID | EXPERIMENTAL | Subjects will receive dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all subjects will continue to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase. |
| Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase | EXPERIMENTAL | Subjects will receive matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all subjects will continue to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase. |
| Name | Type | Description |
|---|---|---|
| Dolutegravir 50 mg twice daily | DRUG | Active dolutegravir plus failing background regimen (Day 1 to Day 7). Open label dolutegravir plus optimized background regimen (from Day 8) |
| Dolutegravir placebo twice daily | DRUG | Dolutegravir placebo plus failing background regimen (Day 1 to Day 7) |
Inclusion Criteria: * Screening plasma HIV-1 RNA ≥1000 copies/mL * ART-experienced, INI-experienced, DTG naïve * Current virological failure on raltegravir (RAL) or elvitegravir (ELV) regimen * The subject's HIV-1 shows genotypic resistance to RAL or ELV at Screening * Subject has been on stable AR...
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Dolutegravir twice daily is used to treat HIV-1 infection in adults whose virus has developed resistance to the integrase inhibitors raltegravir and/or elvitegravir. It is a higher-frequency dosing regimen of dolutegravir, given as 50 mg twice daily, intended for patients with limited remaining treatment options due to viral resistance.
Dolutegravir twice daily is developed by GSK plc, which trades under the ticker GSK. GSK is the company behind the dolutegravir program, including this twice-daily dosing strategy for HIV-1 patients with resistance to other integrase inhibitors.
Dolutegravir twice daily has been studied in Phase 3 clinical development. The Phase 3 trial evaluating this regimen in HIV-1 infected subjects with virus resistant to raltegravir and/or elvitegravir has been completed. It is an investigational dosing strategy and is not described as approved for this specific resistant population.
Dolutegravir twice daily has been evaluated in one completed Phase 3 trial, NCT01568892, titled "Study Assessing Dolutegravir in HIV-1 Infected Subjects With Virus Resistant to Raltegravir and/or Elivitegravir." The trial enrolled 30 participants in the United States, was randomized, double-blind, and controlled, and included adults 18 years and older of all sexes.