DOVATO is indicated as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of DOVATO.

Information for ASO professionals

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Learn about DOVATO and how to talk to your clients about a complete HIV-1 regimen with just 2 medicines in 1 pill.

To connect with a ViiV Healthcare representative near you, call: 1-877-844-8872

ASO=AIDS service organization; CBO=community-based organization.

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Picture of DOVATO Patient: Alphonso
Picture of DOVATO Patient: Alphonso

Alphonso

Living with HIV

Compensated by ViiV Healthcare

To connect with a ViiV Healthcare representative near you, call: 1-877-844-8872

ASO=AIDS service organization; CBO=community-based organization.

Sign up to receive more valuable information
about DOVATO.

CLINICAL

STUDIES

DOVATO* was studied in 3 randomized, phase 3, multicenter clinical trials. GEMINI-1 and GEMINI-2 included treatment-naïve patients, and TANGO included treatment-experienced patients.

GEMINI

STUDIES

Studied through 96 weeks1 in treatment-naïve adults

The GEMINI studies compared DOVATO to a 3-drug regimen, measuring the percentage of patients with an undetectable§ viral load at 48 weeks (primary endpoint) and 96 weeks to assess the long-term effectiveness and safety of DOVATO.

Study participants1,2

DOVATO was studied in a diverse range of adults. Pooled data from GEMINI-1 & GEMINI-2 studies:

  • The median age was 33 years, and 10% were 50 years of age or older
  • 31% Hispanic/Latino ethnicity
  • 11% Black or African American
  • 15% female
  • 9% were classified as HIV Stage 3 (AIDS)
  • 6% also had hepatitis C virus

Patients who entered this study were treatment-naïve adults (18 years or older) with HIV-1 infection and a screening viral load of 1,000 to ≤500,000 copies/mL. They could not participate if they had hepatitis B infection or preexisting major resistance substitutions/mutations.

STUDY

RESULTS

DOVATO is proven to work at both 48 and 96 weeks.

As effective as a 3-drug regimen

In the GEMINI studies, DOVATO was clinically proven to be as effective at helping people reach and stay undetectable as a regimen containing 3 medicines. Results may vary. 

Reach undetectable1

About 9 out of 10 patients (91%) taking DOVATO reached undetectable at 48 weeks and 86% remained undetectable at 96 weeks.

About 9 out of 10 patients (93%) taking a 3-drug regimen reached undetectable at 48 weeks and 90% remained undetectable at 96 weeks.

How fast does DOVATO work?3

About 7 out of 10 patients taking DOVATO reached undetectable within 4 weeks.

About 7 out of 10 patients taking a 3-drug regimen reached undetectable within 4 weeks. 

Side effects

Across the combined GEMINI studies, 20% of patients taking DOVATO versus 25% taking a 3-drug regimen experienced side effects through 96 weeks.1

The most common side effects, reported by ≥2% of patients in either treatment group through 96 weeks, were3:

 

DOVATO

A 3-Drug Regimen

Headache 3% 4%
Nausea 2% 5%
Diarrhea 2% 3%
Insomnia 2% 3%
Fatigue 2% 2%
Anxiety 2% 1%
Dizziness 1% 2%

The study medication was discontinued due to adverse events in 3% of patients in both treatment groups.3 The most common class of adverse events leading to patients stopping DOVATO was psychiatric disorders (1%).1

*In GEMINI-1 and -2, subjects were randomized to receive the individual tablets of dolutegravir and lamivudine, administered once daily.

The GEMINI trials were double-blind through week 96 and open-label from week 96 to week 148. The TANGO study was open-label.

Dolutegravir + tenofovir disoproxil fumarate/emtricitabine.

§Undetectable means reducing HIV in the blood to less than 50 copies per mL.

References
  1. Cahn P, Madero JS, Arribas JR, et al. Durable efficacy of dolutegravir plus lamivudine in antiretroviral treatment–naive adults with HIV-1 infection: 96-week results from the GEMINI-1 and GEMINI-2 randomized clinical trials. J Acquir Immune Defic Syndr. 2020;83(3):310-318.
  2. Cahn P, Madero JS, Arribas JR, et al. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive 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. 2018;393(10167):143-155.
  3. Data on file. ViiV Healthcare group of companies. Research Triangle Park, NC.

TANGO

STUDY

Studied through 48 weeks1 in adults already on treatment and undetectable*

The TANGO study compared DOVATO to a 3- or 4-drug regimen, measuring the proportion of patients who stayed undetectable at week 48.

Study participants1,2

DOVATO was studied in a range of adults:

  • The median age was 39 years, and 23% were 50 years of age or older
  • 18% Hispanic/Latino ethnicity
  • 15% Black or African American
  • 8% female
  • 5% were classified as HIV Stage 3 (AIDS)
  • 4% also had hepatitis C virus

Patients who entered this study were adults (≥18 years) already on treatment and undetectable with HIV-1 RNA viral levels <50 copies/mL for at least 6 months while on a stable 3- or 4-drug regimen. They could not participate if they had hepatitis B infection or preexisting major resistance substitutions/mutations. 

Stay undetectable1

In the TANGO study, DOVATO was proven to help patients already on treatment stay undetectable as effectively as a regimen containing 3 or 4 medicines.

  • Percentage of patients without an undetectable viral load ≥50 copies/mL: <1% for both patients taking DOVATO or a 3- or 4-drug regimen at 48 weeks.
    • 93% of people taking DOVATO remained undetectable at 48 weeks.
    • 93% of people on a 3- or 4-drug regimen remained undetectable at 48 weeks.

Side effects1,2

Across the TANGO study, 12% of patients taking DOVATO versus 1% taking a 3- or 4-drug regimen experienced side effects through 48 weeks. The majority of side effects were mild in severity.

The most common side effects reported by ≥1% of patients in either treatment group through 48 weeks were:

 

DOVATO

A 3- or
4-Drug Regimen

Insomnia 2% 0%
Nausea 1% <1%
Diarrhea 1% <1%
Anxiety 1% 0%

The study medication was discontinued due to adverse events in 4% of patients in the DOVATO group, and <1% in the 3- or 4-drug regimen group. The most common adverse events for stopping DOVATO were insomnia, anxiety, fatigue, and weight increase (all reported in <1% of patients).1

*Undetectable means reducing HIV in the blood to very low levels (less than 50 copies/mL).

Tenofovir alafenamide-based 3- or 4-drug regimen.

References
  1. van Wyk J, Ajana F, Bisshop F, et al. Efficacy and safety of switching to dolutegravir/lamivudine fixed-dose two-drug regimen versus continuing a tenofovir alafenamide-based three- or four-drug regimen for maintenance of virologic suppression in adults with HIV-1: phase 3, randomized, non-inferiority TANGO study [published online ahead of print January 6, 2020]. Clin Infect Dis. doi:10.1093/cid/ciz1243
  2. Data on file. ViiV Healthcare group of companies. Research Triangle Park, NC.

DOWNLOADABLE PDF

FOR ASO PROFESSIONALS

Here's a helpful overview to help you understand information about DOVATO, a possible option for your clients.

DOVATO Info Sheet

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