How effective is Dovato for HIV?

Dovato (a 2-drug regimen) has been shown to be as effective as 3- or 4-drug HIV treatments in helping you to reach or stay at undetectable levels (less than 50 copies HIV per mL). Dovato is a single tablet that contains two HIV medicines. It is taken once daily (with or without food).

• Dovato has been shown to be as effective as using a 3-drug regimen if you have never received HIV treatment before. Overall, at 48 weeks 91% of people taking Dovato were undetectable levels (less than 50 copies per mL) compared to 93% of those taking the 3-drug regimen.
• It is also as effective as a 3- or 4-drug regimen containing tenofovir alafenamide (TAF) if you are switching from a different HIV treatment. Overall, 93% in each group were undetectable at 48 weeks.

Dovato is a complete, 2-drug regimen for the treatment of HIV-1 infection and use with other HIV treatments is not recommended. Dovato contains dolutegravir (an integrase strand transfer inhibitor and lamivudine (a nucleoside analogue reverse transcriptase inhibitor).

It is approved for adults and and adolescents 12 years of age and older and weighing at least 25 kg who are untreated OR to replace the current regimen in those who are:

• virologically suppressed (HIV-1 RNA less than 50 copies per mL), and
• on a stable antiretroviral regimen with no history of treatment failure, and
• without known substitutions associated with resistance to the individual components of Dovato.

Overall, the most common side effects seen in at least 2% of patients receiving Dovato were:

• headache
• nausea
• diarrhea
• insomnia
• fatigue
• anxiety
• weight gain

Learn more: Dovato Side Effects and Warnings (in more detail)

Studies for Dovato Effectiveness and Side Effects

Patients New to HIV Treatment

The Phase 3 GEMINI studies evaluated 1433 adult participants who were new to HIV treatment. The primary objective was to compare the safety and effectiveness of the 2-drug regimen equivalent to Dovato (dolutegravir 50 mg plus lamivudine 300 mg) administered once daily compared to the 3-drug regimen of dolutegravir (Tivicay 50 mg) + tenofovir disoproxil fumarate / emtricitabine (Truvada) given once daily.

The endpoint was the proportion of people who were able to reach and maintain undetectable levels (less than 50 copies per mL) at Week 48. Secondary endpoints were assessed at 96 weeks and 144 weeks.

• Overall, 91% of people taking Dovato met the primary objective at 48 weeks and were able to reach and maintain undetectable levels (less than 50 copies per mL) compared to 93% of those taking the 3-drug regimen DTG + TDF/ FTC (met non-inferiority in the pooled data; treatment difference of -1.7% [95% CI: -4.4%, 1.1%]). Most people in the GEMINI studies were undetectable at 1 year, which lasted through 144 weeks.
• At 96 weeks, 86% of patients receiving Dovato were undetectable compared to 93% taking dolutegravir (Tivicay) + tenofovir disoproxil fumarate / emtricitabine (Truvada).
• At 144 weeks, 82% of patients receiving Dovato were undetectable compared to 84% taking dolutegravir (Tivicay) + tenofovir disoproxil fumarate / emtricitabine (Truvada).

Dovato Side Effects: Phase 3 Gemini 1 & 2 Studies

In the GEMINI studies, 20% of patients taking Dovato experienced side effects over a 3-year period compared to 27% taking dolutegravir + tenofovir disoproxil fumarate / emtricitabine. The most common side effects were:

Table 1. GEMINI study: Side effect incidence over 3-year period

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Patients Already on HIV Treatment

In the Phase 3, open-label TANGO study with 740 adults, researchers compared 2-drug Dovato to a tenofovir alafenamide–based (TAF) 3- or 4-drug regimen in patients who had already been treated with HIV medication and were switching treatment. Patients had been on treatment for a median of 2.8 to 2.9 years.

Those on a stable tenofovir alafenamide-based regimen (TBR) received either Dovato once daily or continued with their TBR for up to 148 weeks. The primary efficacy endpoint was the proportion of subjects with plasma HIV-1 RNA ≥50 copies/mL (virologic non-response) at Week 48. At 148 weeks, those on the TBR regimen were switched to Dovato once daily up to Week 200.

• Dovato was shown to help people already on HIV treatment stay undetectable as effectively as a regimen containing 3 or 4 medicines. Overall, 93% in each group were undetectable at 48 weeks and most patients stayed undetectable over a 3-year period. At week 144, 86% of those in the Dovato group and 82% in the TBR regimen group remained undetectable.
• One percent (1%) or less of both treatment groups had a detectable viral load (50 or more copies per mL) at 1 year. Similar results were seen at 3 years.
• No adults who switched to Dovato developed resistance through 3 years in this study.
• In TANGO, the results between treatment arms were similar across a wide range of diverse characteristics, including treatment class (PI, INSTI, or NNRTI), age, sex, race or CD4+ cell count.

Dovato Side Effects: TANGO Study

In the TANGO study, 15% of patients taking Dovato experienced side effects over a 3-year period compared to 5% taking a 3- or 4-drug TAF-based regimen. Most side effects were mild.

Table 2. TANGO study: Side effect incidence over 3-year period

Studies in adolescent 12 years and older (weighing at least 25 kg)

The DANCE trial in adolescent 12 years and older and weighing at least 25 kg and evidence from adult studies (GEMINI-1, GEMINI-2, TANGO) has shown that the safety and effectiveness of Dovato was comparable to the results observed adult studies. There was no clinically significant difference in exposure for the components of Dovato.

This is not all the information you need to know about Dovato for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.