THE GEMINI STUDIES: REASSURANCE FOR YOUR PATIENTS OUT TO 144 WEEKS
Few Confirmed Virological Withdrawals* at 144 weeks[1]
- While taking DTG + 3TC separates, 1 participant developed resistance-associated mutations
DTG 50 mg + 3TC 300 mg used in the GEMINI studies.
*Patients met confirmed virological withdrawal criteria if a second and consecutive HIV-1 RNA value met any of the following definitions: decrease from baseline in HIV-1 RNA of <1 log10 copies/mL unless HIV-1 RNA of <200 copies/mL by Week 12; confirmed plasma HIV-1 RNA of ≥200 copies/mL after confirmed consecutive HIV-1 RNA <200 copies/mL.
VIRAL REBOUND DID NOT LEAD TO RESISTANCE AMONG CVWs
STEEP INCREASE IN VIRAL LOAD, FOLLOWED BY A DECREASE, IS CONSISTENT WITH NON-ADHERENCE/TREATMENT INTERRUPTION
Individual HIV-1 RNA Viral Load Progression by Visit for Participants Meeting CVW Criteria[2]
Adapted from Underwood et al, 2020.[2]
- Arrows represent the week in which CVW occurred out to 96 weeks. The colour of the arrow corresponds to the colour assigned to each participant
THE SINGLE CASE OF RESISTANCE IN THE DOVATO ARM WAS NOT A CVW
DTG 50 mg + 3TC 300 mg used in the GEMINI studies.
CVW=confirmed virological withdrawal; SVW=suspected virological withdrawal.
HIGHER ADHERENCE RATES ARE ASSOCIATED WITH HIGHER EFFICACY
THE GEMINI STUDIES: DOVATO OFFERS COMPARABLE SUPPRESSION vs DTG + TDF/FTC ACROSS ADHERENCE SUBGROUPS
Proportion of Patients With HIV-1 RNA <50 copies/mL at 144 weeks by Adherence Category (Snapshot and Last On-treatment Viral Load)[3]
Adapted from Fernvik et al, 2021.[3]
- Increased risk of not being suppressed if DOVATO or DTG + TDF/FTC are taken less than once daily
THE STAT STUDY: 0 CASES OF ACQUIRED RESISTANCE IN A TEST-AND-TREAT SETTING WITH DOVATO
ZERO TREATMENT-EMERGENT HIV-1 RESISTANCE[5]
Two participants met criteria for confirmed virological failure; both remained on DOVATO*
ALL PARTICIPANTS WITH AVAILABLE DATA WHO HAD AN ART ADJUSTMENT AND REMAINED ON A STUDY AT WEEK 48 HAD HIV-1 RNA <50 copies/mL[5]
Ten patients were switched before Week 48
- Five participants switched due to baseline HBV
- Two participants switched due to decision by participant or proxy
- One participant switched due to baseline resistance
- Participant achieved HIV-1 RNA <40 copies/mL at Week 7, before ART regimen adjustment
- One participant switched due to an adverse event (rash)
- One participant switched due to pregnancy
Two participants were switched after Week 48 HIV-1 RNA assessment (1 due to lack of efficacy and 1 due to non-adherence)
*One participant suppressed to HIV-1 RNA <50 copies/mL and 1 had HIV-1 RNA 70 copies/mL at Week 48.
REAL-WORLD EVIDENCE CONFIRMS HIGH BARRIER TO RESISTANCE SEEN IN CLINICAL TRIALS
ZERO RESISTANCE-ASSOCIATED MUTATIONS EMERGED
among 135 treatment-naïve PLHIV throughout 48 weeks[6]
References:
- Cahn P, Madero SJ, Arribas JR, et al. Three-year durable efficacy of dolutegravir plus lamivudine in antiretroviral therapy-naïve adults with HIV-1 infection. AIDS. 2022;36(1):39-48. doi:10.1097/QAD.0000000000003070
- Underwood M, Wang R, Benson P, et al. DTG + 3TC vs DTG + TDF/FTC (GEMINI-1 & -2): confirmed virologic withdrawals through Week 96. Presented at: Conference on Retroviruses and Opportunistic Infections; March 8-11, 2020; Boston, MA. Poster 483.
- Fernvik E, Madero JS, Espinosa N, et al. Impact of treatment adherence on efficacy of DTG + 3TC and DTG + TDF/FTC: pooled week 144 analysis of the GEMINI-1 and GEMINI-2 clinical studies. Presented at: 18th European AIDS Conference; October 27-30, 2021; Virtual and London, United Kingdom. Poster PE2/63.
- Orkin C, DeJesus E, Sax PE, et al; GS-US-380-1489 and GS-US-380-1490 Study Investigators. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials. Lancet HIV. 2020;7(6):e389-e400. doi:10.1016/S2352-3018(20)30099-0
- Rolle C-P, Berhe M, Singh T, et al. High rates of virologic suppression with DTG/3TC in newly diagnosis adults with HIV-1 infection and baseline viral load ≥500,000 c/mL: 48-week subgroup analysis of the STAT study. Presented at: IDWeek 2021; September 29-October 3, 2021; Virtual.
- Cabello A, López Bernaldo de Quiros JC, Pulido F, et al. 48 weeks efficacy and tolerability of dolutegravir (DTG) + lamivudine (3TC) in adult HIV naïve patients. A multicenter real life cohort. Presented at: The 11th International AIDS Society Conference on HIV Science; July 18-21, 2021; Virtual.
October 2022 PM-GB-DLL-WCNT-220005
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221441.
If you are from outside the UK, you can report adverse events to GSK/ViiV by selecting your region and market, here.
