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A Breadth of Data Across Clinical Trials and a Range of People Living With HIV From Real-World Studies3-6*

A man and a woman representing virologically suppressed patients A man and a woman representing virologically suppressed patients

DOVATO in

Virologically Suppressed Patients

Virologic suppression and high barrier to resistance4†

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*Real-world data include observational studies, retrospective analyses, cohort studies, retrospective chart reviews, and real-life settings. Potential overlap between patient cohorts in real-world studies cannot be ruled out.

†TANGO is a Phase 3, noninferiority trial in virologically suppressed (HIV-1 RNA <50 copies/mL) adults with HIV-1 in which all participants were on a TCR and stable for >6 months. The proportion of participants with HIV-1 RNA ≥50 copies/mL at Week 48 (primary endpoint) was <1% vs <1% for the DOVATO (N=369) and TCR (N=372) arms, respectively (treatment difference: -0.3% [95% CI; -1.2%, 0.7%]). Patients in the TAF-containing regimen were switched to DOVATO at Week 148 if HIV-1 RNA <50 copies/mL (Late Switch). In TANGO, no treatment-emergent resistance was detected through Week 196. Only participants meeting CVW criteria (1 for DOVATO, 3 for TCR) were evaluated for treatment-emergent resistance. CVW was defined as HIV-1 RNA ≥50 copies/mL followed by a second consecutive HIV-1 RNA ≥200 copies/mL. At Week 144, the most common (≥0.5%) drug-related adverse events (Grades 2-5) in the DOVATO arm (n=369) and TCR arm (n=371), respectively, were insomnia (1%, 0), depression (<1%, <1%), constipation (<1%, <1%), weight increase (<1%, <1%), flatulence (<1%, 0), and nausea (0, <1%). 6% and 2% of participants, respectively, experienced adverse events that led to withdrawal. At Week 196 among patients who switched to DOVATO at Week 1 (Early Switch), 6% experienced at least one Grade 2-5 drug-related AE. For these Early-Switch patients, the most common drug-related AEs (≥2%) measured at Week 196 were weight increase (2%) and insomnia (2%). 7% experienced an AE leading to withdrawal at Week 196.3,4,8

One adult men representing treatment-naïve patients One adult men representing treatment-naïve patients

DOVATO in

Treatment-Naïve Patients

Proven virologic suppression and high barrier to resistance3,7‡

SEE THE DATA

‡In a pooled analysis from GEMINI 1 & 2, identical, Phase 3, randomized, double-blind to Week 96 (open-label Week 96 to Week 144), noninferiority trials in treatment-naïve adults with HIV-1 (≥18 years old), the proportion of participants with HIV-1 RNA <50 copies/mL at Week 48 (primary endpoint) was 91% vs 93% for the DOVATO (N=716) and DTG + TDF/FTC (N=717) arms, respectively (treatment difference: -1.7% [95% CI; -4.4%, 1.1%]). In GEMINI 1 & 2, CVW occurred in 21 participants (12 for DOVATO, 9 for DTG + TDF/FTC) at 144 weeks. Among all trial participants, 1 in the DOVATO arm developed treatment-emergent resistance. The most common (≥2%) drug-related adverse events (all Grades) in the DOVATO arm (N=716) and DTG + TDF/FTC arm (N=717), respectively, were headache (3%, 4%), nausea (2%, 6%), diarrhea (2%, 3%), insomnia (2%, 3%), fatigue (including fatigue, asthenia, and malaise [2%, 2%]), anxiety (2%, <1%), and dizziness (1%, 2%). 4% and 5% of participants, respectively, experienced adverse events that led to withdrawal.3,7,9

*Real-world data include observational studies, retrospective analyses, cohort studies, retrospective chart reviews, and real-life settings. Potential overlap between patient cohorts in real-world studies cannot be ruled out.

†TANGO is a Phase 3, noninferiority trial in virologically suppressed (HIV-1 RNA <50 copies/mL) adults with HIV-1 in which all participants were on a TCR and stable for >6 months. The proportion of participants with HIV-1 RNA ≥50 copies/mL at Week 48 (primary endpoint) was <1% vs <1% for the DOVATO (N=369) and TCR (N=372) arms, respectively (treatment difference: -0.3% [95% CI; -1.2%, 0.7%]). Patients in the TAF-containing regimen were switched to DOVATO at Week 148 if HIV-1 RNA <50 copies/mL (Late Switch). In TANGO, no treatment-emergent resistance was detected through Week 196. Only participants meeting CVW criteria (1 for DOVATO, 3 for TCR) were evaluated for treatment-emergent resistance. CVW was defined as HIV-1 RNA ≥50 copies/mL followed by a second consecutive HIV-1 RNA ≥200 copies/mL. At Week 144, the most common (≥0.5%) drug-related adverse events (Grades 2-5) in the DOVATO arm (n=369) and TCR arm (n=371), respectively, were insomnia (1%, 0), depression (<1%, <1%), constipation (<1%, <1%), weight increase (<1%, <1%), flatulence (<1%, 0), and nausea (0, <1%). 6% and 2% of participants, respectively, experienced adverse events that led to withdrawal. At Week 196 among patients who switched to DOVATO at Week 1 (Early Switch), 6% experienced at least one Grade 2-5 drug-related AE. For these Early-Switch patients, the most common drug-related AEs (≥2%) measured at Week 196 were weight increase (2%) and insomnia (2%). 7% experienced an AE leading to withdrawal at Week 196.3,4,8

‡In a pooled analysis from GEMINI 1 & 2, identical, Phase 3, randomized, double-blind to Week 96 (open-label Week 96 to Week 144), noninferiority trials in treatment-naïve adults with HIV-1 (≥18 years old), the proportion of participants with HIV-1 RNA <50 copies/mL at Week 48 (primary endpoint) was 91% vs 93% for the DOVATO (N=716) and DTG + TDF/FTC (N=717) arms, respectively (treatment difference: -1.7% [95% CI; -4.4%, 1.1%]). In GEMINI 1 & 2, CVW occurred in 21 participants (12 for DOVATO, 9 for DTG + TDF/FTC) at 144 weeks. Among all trial participants, 1 in the DOVATO arm developed treatment-emergent resistance. The most common (≥2%) drug-related adverse events (all Grades) in the DOVATO arm (N=716) and DTG + TDF/FTC arm (N=717), respectively, were headache (3%, 4%), nausea (2%, 6%), diarrhea (2%, 3%), insomnia (2%, 3%), fatigue (including fatigue, asthenia, and malaise [2%, 2%]), anxiety (2%, <1%), and dizziness (1%, 2%). 4% and 5% of participants, respectively, experienced adverse events that led to withdrawal.3,7,9

WHAT CAN THE #1 FASTEST-GROWING SINGLE-TABLET REGIMEN FOR PATIENTS SWITCHING THERAPIES IN 2021, 2022, AND 2023 OFFER YOUR PATIENTS? 3§

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§Based on data licensed from IQVIA: Patient Insights (New to Brand) reflecting estimates of real-world activity. All rights reserved. Calculated by % change=[week ending (w/e) 1/8/21–1/29/21] vs [w/e 12/10/21–12/31/21]; [w/e 1/7/22–1/28/22] vs [w/e 12/9/22–12/30/22]; and [w/e 1/6/23–1/27/23] vs [w/e 12/8/23–12/29/23].3

ViiVConnect Savings Card

A Patient Support Card: Patients may pay as little as $0 copay per fil A Patient Support Card: Patients may pay as little as $0 copay per fil

Eligible, commercially insured patients pay as little as $0# with a ViiVConnect Savings Card3

See How

Subject to eligibility and program terms and conditions; ViiVConnect programs do not constitute health insurance. 

#Subject to patient and prescription eligibility. Up to $6250 per year with no monthly limit for DOVATO. Total savings across eligible ViiV Healthcare medicines not to exceed $7500 per year. Restrictions apply.

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AE=adverse event; CI=confidence interval; CVW=confirmed virologic withdrawal; DTG=dolutegravir; FTC=emtricitabine; TAF=tenofovir alafenamide; TCR=TAF-containing regimen; TDF=tenofovir disoproxil fumarate.

References:

1. The INSIGHT START Study Group. Initiation of antiretroviral therapy in early asymptomatic HIV infection. N Engl J Med. 2015;373(9):795-807. doi:10.1056/NEJMoa1506816

2. Antiretroviral Therapy Cohort Collaboration. Survival of HIV-positive patients starting antiretroviral therapy between 1996 and 2013: a collaborative analysis of cohort studies. Lancet HIV. 2017;4(8):e349-e356. doi:10.1016/S2352-3018(17)30066-8

3. Data on file, ViiV Healthcare.

4. Osiyemi O, De Wit S, Ajana F, et al. Efficacy and safety of switching to dolutegravir/lamivudine (DTG/3TC) versus continuing a tenofovir alafenamide-based 3- or 4-drug regimen for maintenance of virologic suppression in adults living with HIV-1: results through week 144 from the phase 3, noninferiority TANGO randomized trial. Clin Infect Dis. 2022;75(6):975-986. doi:10.1093/cid/ciac036

5. Llibre JM, Brites C, Cheng C-Y, et al. Efficacy and safety of switching to the 2-drug regimen dolutegravir/lamivudine versus continuing 
a 3- or 4-drug regimen for maintaining virologic suppression in adults living with HIV-1: week 48 results from the phase 3, noninferiority SALSA randomized trial. Clin Infect Dis. 2023;76(4):720-729. doi:10.1093/cid/ciac130

6. Rolle C-P, Berhe M, Singh T, et al. Sustained virologic suppression with dolutegravir/lamivudine in a test-and-treat setting through 48 weeks. Open Forum Infect Dis. 2023;10(3):ofad101. doi:10.1093/ofid/ofad101

7. Cahn P, Madero JS, Arribas JR, et al; GEMINI Study Team. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naïve adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019;393(10167):143-155. doi:10.1016/S0140-6736(18)32462-0

8. De Wit S, Bonnet F, Osiyemi O, et al. Durable efficacy of switching from a 3-/4-drug tenofovir alafenamide (TAF)-based regimen to the 2-drug regimen dolutegravir/lamivudine (DTG/3TC) in the TANGO study through week 196. Presented at: HIV Drug Therapy Glasgow; October 23-26, 2022; Virtual and Glasgow, Scotland. Slides MO41.

9. Cahn P, Madero JS, 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

DLLWCNT240011 March 2024