US REAL-WORLD EVIDENCE FOR DOVATO
These real-world data complement the Phase 3 clinical trials of DOVATO. See the real-world study data in addition to the TANGO, GEMINI, and STAT studies.
OPERA Study1
OPERA includes routine clinical data from electronic health records from 84 clinics across 18 states or territories within the United States. The inclusion criteria required patients to be ≥13 years old (the study population did not include any patients <18 years of age), virologically suppressed (<50 copies/mL), and have had no known history of virologic failure or resistance. DOVATO is indicated for adults ≥18 years old.
This cohort included 787 PLHIV in the United States1,2
switched to DOVATO from BIC/TAF/FTC*—the largest cohort of Biktarvy-to-DOVATO patients
had ≥1 actively managed comorbidity in the last 12 months
were Ryan White/ADAP program beneficiary
Loss of suppression rates†
HIV-1 RNA ≥50 copies/mL:
14.02 IR per 100 py (95% CI; 11.7%–16.79%)
HIV-1 RNA ≥200 copies/mL:
3.29 IR per 100 py (95% CI; 2.3%–4.71%)
Incidence of confirmed virologic failure‡:
0.43 IR per 100 py (95% CI; 0.16%–1.00%) Months of follow-up, Median (IQR), 13.6 (8.2–22.3)
Rate of treatment-related discontinuations:
*PLHIV switched to DOVATO from DTG/ABC/3TC (n=421), BIC/TAF/FTC (n=240), or DTG + TDF/FTC (n=126).
†Loss of suppression was defined as the first HIV-1 RNA ≥50 copies/mL or the first HIV-1 RNA ≥200 copies/mL.
‡CVF was defined as 2 HIV-1 RNA ≥200 copies/mL or discontinuation after 1 HIV-1 RNA ≥200 copies/mL.
§Discontinuations due to detectable VL, adverse diagnosis/side effect, or lab abnormality. Non-treatment-related discontinuations were due to other reasons (n=66) or none identified (n=101). There was no further safety information provided by the authors.
TANDEM: Evidence in a Diverse, Real-World, US Population3
In TANDEM, a retrospective review of medical charts from 24 sites in the United States, PLHIV (N=318) were ≥18 years old and initiated on DOVATO with ≥6 months of follow-up. PLHIV were treatment-naïve or virologically suppressed (HIV-1 RNA <50 copies/mL for ≥3 months).
Across both cohorts, the following were included (mean %):
non-white PLHIV
cisgender-female or transgender-female PLHIV
on Medicare/ Medicaid
on ADAP
Suppressed switch (n=192)
remained suppressed while receiving DOVATO
Rate of treatment-related discontinuations: 1.6% (n=3)‖
Treatment-naïve (n=126)
received DOVATO as part of a rapid start paradigm
achieved suppression
remained suppressed¶
Rate of treatment-related discontinuations: 0.8% (n=1)#
TANDEM REINFORCES THE EFFICACY AND SAFETY OF DTG/3TC, BOTH IN ART-NAÏVE AND TREATMENT-EXPERIENCED PLHIV
||Discontinuations due to toxicity/intolerance (n=1), concerns about weight gain (n=1), and PLHIV preference (n=1). There was no further safety information provided by the authors.
¶4.8% of PLHIV rebounded. 5.6% were lost to follow-up.
#Discontinuation due to viremia.
VIEW DOVATO SAFETY INFORMATION
3TC=lamivudine; ABC=abacavir; ADAP=AIDS Drug Assistance Program; ART=antiretroviral therapy; BIC=bictegravir; CI=confidence interval; CVF=confirmed virologic failure; DTG=dolutegravir; FTC=emtricitabine; IQR=interquartile range; IR=incidence rate; PLHIV=people living with HIV; py=person-years; STAT=Study of Test and Treat; TAF=tenofovir alafenamide; TDF=tenofovir disoproxil fumarate; VL=viral load.
References:
1. Pierone G, Brunet L, Fusco JS, et al. Switching to dolutegravir/lamivudine two-drug regimen: durability and virologic outcomes in routine U.S. clinical care. Presented at: 24th International AIDS Conference; July 29–August 2, 2022; Virtual and Montreal, Canada. Poster.
2. Data on file, ViiV Healthcare.
3. Schneider S, Burke C, Ward D, et al. Real-world treatment experience of single tablet dolutegravir/lamivudine in the US: results from the TANDEM study. Presented at: 24th International AIDS Conference; July 29–August 2, 2022; Virtual and Montreal, Canada. Poster EPB147.
DLLWCNT230007 July 2023
