ViiV Healthcare Announces Data Demonstrating Dovato (DTG/3TC) Is Highly Effective in Treatment-Naïve People With Advanced HIV

• Data presented at HIV Glasgow from the DOLCE study demonstrates our commitment to offering effective 2-drug HIV regimens, for people living with advanced HIV
• A post-hoc analysis shows the 2-drug regimen's efficacy was comparable to 3-drug therapy in individuals with low baseline CD4 count, regardless of baseline viral load

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced 48-week findings from the DOLCE study, sponsored by Fundación Huésped and the Bahiana Foundation of Infectiology, showing the 2-drug regimen Dovato (dolutegravir/lamivudine [DTG/3TC]) achieved similar results to 3-drug therapy in viral suppression in a population of adults with advanced HIV. A post-hoc analysis of the study showed DTG/3TC was non-inferior to 3-drug therapy regardless of the participant's baseline viral load. These data were presented at HIV Glasgow 2024, being held in Glasgow, Scotland from 10 – 13 November.

Harmony P. Garges, M.D., Chief Medical Officer, at ViiV Healthcare, said: "We know taking fewer medicines is an important consideration for many in the HIV community, and these new data continue to reinforce the efficacy and safety of Dovato, a 2-drug regimen. The findings from the DOLCE study build on the robust body of evidence supporting its use in treatment-naïve adults living with HIV and shows comparable efficacy to a 3-drug regimen, even in people with low CD4 counts and high viral loads."

DOLCE is a randomised, open-label, multicentre study assessing the efficacy and safety of DTG/3TC in 230 antiretroviral treatment (ART)-naïve people with advanced HIV (low CD4 counts [≤200 cells/mL]).¹ In the clinical trial, participants were randomised in a 2:1 ratio to receive DTG/3TC (n=152) or DTG+TDF/XTC (n=77). The baseline characteristics of the participants were similar between the two treatment groups and represented a population of people with severe immunosuppression – 43% of participants having baseline CD4 counts less than 100 cells/mL, 69% having baseline viral load (VL) greater than 100,000 copies (c)/mL, and 23% having a very high baseline VL, greater than 500,000 copies (c)/mL.

The primary endpoint of the study was the proportion of subjects with VL <50 copies/ml at week 48. At week 48 comparable efficacy was observed, with 82% of individuals in the DTG/3TC group and 80% in the 3-drug regimen group achieving a VL<50. Furthermore, a post-hoc analysis showed that Dovato was non-inferior to the 3-drug regimen in achieving a VL<50.

Prof. Pedro Cahn, Scientific Director of Fundación Huésped study investigator of the DOLCE study, said: "It's encouraging to see additional new data that continue to support the efficacy and safety of 2-drug regimens compared to traditional 3-drug regimens. The results from DOLCE provide healthcare providers with further confidence in prescribing DTG/3TC and are important findings for people living with HIV taking medicines to suppress their virus."

A post-hoc analysis reported that DTG/3TC was non-inferior to 3-drug therapy (adjusted risk difference of 2.0%, 95% CI -8.6; 12.8%).¹ The study also showed that secondary efficacy measures of viral load decline, time to viral suppression, and CD4 recovery were similar between arms. Efficacy by baseline viral load categories was similar across both arms, including those with baseline viral load greater than 500,000 copies with 74% in the DTG/3TC arm, and 67% in the DTG+TDF/XTC arm achieving virologic success. The change in median CD4 count from baseline to Week 48 showed an increase of 200 cells/mL in the DTG/3TC arm and an increase of 177 cells/mL in the triple therapy arm.

Safety through Week 48 was comparable across both arms and consistent with known safety profiles and showed similar rates of serious adverse events (SAEs) and immune reconstitution inflammatory syndrome across arms. The rate of discontinuation in both arms was also similar (DTG/3TC = 12.8%; DTG+TDF/XTC = 6.8%).

About DOLCE

The DOLCE (NCT04880395) randomised clinical trial is a phase IV, open-label, multicentre clinical trial assessing the efficacy of DTG/3TC for the treatment of HIV-1 in treatment-naïve adults 18 years or older with CD4+ T-cell count ≤200 c/mm3 and HIV-1 RNA >1,000 copies/mL with no known ART-resistance or HBV co-infection, conducted in 11 sites across Argentina and Brazil. The primary endpoint was the proportion of participants with plasma HIV-1 RNA <50 c/mL at Week 48 (FDA snapshot for ITT-E population) and secondary outcomes included, among others, efficacy, resistance, safety, and tolerability.

About Dovato

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.

Dovato is approved in the US, Europe, Japan, Australia, and other countries worldwide.

Please consult the full Summary of Product Characteristics for all the safety information: Dovato 50 mg/300 mg film-coated tablets.

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

About Fundación Huésped

Fundación Huésped is an Argentine organisation with a regional reach that has been working in public health since 1989, aiming to ensure the right to health and the control of diseases are guaranteed. Our comprehensive approach includes the development of research, practical solutions, and communications related to public health policies in our country and the region. Our mission is to conduct scientific research and implement preventive actions and rights-promotion initiatives to ensure access to healthcare and reduce the impact of diseases, with a focus on HIV/AIDS, viral hepatitis, vaccine-preventable diseases, and other transmissible diseases, as well as sexual and reproductive health.

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE:PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012. The company's aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk factors" in GSK's Annual Report on Form 20-F for 2023, and GSK's Q3 Results for 2024.

References

¹M. I. Figueroa, et al. Comparable efficacy and safety of dolutegravir / lamivudine to a three drug regimen amongst ARV naive people living with HIV with CD4 <200/mm3: the DOLCE study. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland.

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