ViiV Healthcare announces data demonstrating the feasibility of Dovato (dolutegravir/lamivudine) as a treatment option for rapid initiation after diagnosis in adults with HIV-1

London, 20 August 2020 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced findings from the STAT study, a phase IIIb, multi-centre, open label, single arm, 48-week study in the United States presented at the American Conference for the Treatment of HIV (ACTHIV) 2020. The study evaluated Dovato (dolutegravir/lamivudine) for rapid initiation of treatment after diagnosis in adults with HIV-1. Dovato was found to be effective and well tolerated in this setting, indicating the feasibility of its use in Test and Treat strategies.1

The STAT study followed a rapid Test and Treat model of care increasingly seen in clinical practice, with treatment initiated within 14 days of diagnosis before baseline HBV co-infection status, renal function and resistance test results were available. All study participants were tested for HBV co-infection prior to receiving Dovato, with results available after initiation of treatment. In the study, 92% (n=102/111) of participants with available data* at 24 weeks, achieved a viral load of <50c/mL.1 This includes participants who stayed on Dovato and those who switched to alternative ART. Eight participants switched from Dovato to an alternative antiretroviral (ART) regimen; five of the eight due to HBV co-infection and one due to baseline resistance to lamivudine.1 Data were available for five of these participants and showed that they all achieved a viral load of <50c/mL at 24 weeks, without developing HBV or HIV resistance-associated mutations,1 indicating that rapid initiation of Dovato did not compromise outcomes for this subset of participants.  87% (n=97/111) of participants with available data at Week 24 and still taking Dovato* achieved a viral load of <50c/mL.1

Charlotte-Paige Rolle MD, MPH, Director of Research Operations at Orlando Immunology Center and principal investigator for the STAT study, said: “As physicians, we know the potential benefits of starting treatment as quickly as possible to reduce viral load, both to support the individual’s health as well as reduce the likelihood of HIV transmission. Data from the STAT study showed that the use of Dovato in treatment-naïve patients at the time of or soon after diagnosis, including those who were later found to have HBV co-infection or baseline resistance and underwent rapid therapy adjustment, did not adversely impact efficacy or safety outcomes.” 

At the start of the study, 8% (n=10) of participants had HIV-1 RNA >1,000,000 c/mL. At week 24, 80% (n=8) of these participants had HIV-1 RNA <50 c/mL.1

Kimberly Smith, MD, MPH, Head of Research & Development at ViiV Healthcare, said: “The results from the STAT study reinforce the proven efficacy of Dovato and provide further evidence supporting its use in settings where rapid treatment initiation is the standard. The STAT study also shows us that this treatment can be initiated when the baseline HBV co-infection or resistance status is unknown, as appropriate therapy adjustments can be made once results become available without compromising patient safety. These findings represent an important step forward in our understanding of current treatment options that can be rapidly initiated after an HIV diagnosis and confirm the validity of this approach with Dovato.”

At 24 weeks, 11% (n=15) of participants discontinued the study, including 9% (n=12) who were lost to follow-up or withdrew consent and 2% (n=3) due to physician decision. Data were not available at week 24 for 4% (n=5) of participants.1 The study found that Dovato was well tolerated, with low rates of grade 2-5 drug-related AEs (2%, n=2) and serious AEs (2%, n=2).1

About Dovato (dolutegravir/lamivudine)
Dovato is a once-daily, single-pill, 2-drug regimen (2DR) that combines the integrase strand transfer inhibitor (INI) dolutegravir (Tivicay, 50 mg) with the NRTI lamivudine (Epivir, 300 mg).2

Dovato (dolutegravir 50 mg/ lamivudine 300 mg tablets) is authorized in the EU for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the INI class, or lamivudine.2 In the US, the Food and Drug Administration (FDA) approved Dovato, a complete, once-daily, single-tablet regimen of dolutegravir 50 mg and lamivudine 300 mg for the treatment of HIV-1 infection in adults with no ARV treatment history and with no known resistance to either dolutegravir or lamivudine.3

Like a dolutegravir-based three-drug regimen, Dovato uses two drugs to inhibit the viral cycle at two different sites. INIs, like dolutegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Lamivudine is an NRTI that works by interfering with the conversion of viral ribonucleic acid (RNA) into deoxyribonucleic acid (DNA) which in turn stops the virus from multiplying.2

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About the STAT study (NCT03945981)1
The STAT study is a phase IIIb, multi-centre, open label, single arm, 48-week pilot study in the United States, evaluating the feasibility, efficacy and safety of using Dovato as a first line regimen in a rapid Test and Treat model of care in 131 newly diagnosed HIV-1 infected adults with treatment initiated within 14 days of diagnosis.

The primary analysis was the proportion of all participants who have plasma HIV-1 RNA <50 c/mL regardless of ART regimen. Missing viral load data at week 24, for any reason, is considered failure, with failure representing ≥50 c/mL (ITT-E missing=failure). A secondary analysis was the proportion of all participants with available data at Week 24 who achieved plasma HIV-1 RNA <50 c/mL, regardless of ART regimen (observed analysis), including those who switched to an alternative ART for any reason, such as baseline HBV co-infection or resistance.

Important Safety Information for Dovato
The following ISI is based on the Highlights section of the Prescribing Information for Dovato. Please consult the full Prescribing Information for all the labeled safety information for Dovato.