ViiV Healthcare to announce data from largest head-to-head randomised clinical trial for 2-drug regimen Dovato against 3-drug regimen Biktarvy at AIDS 2024

• Findings from the SEIMC-GeSIDA Foundation (FSG) PASO-DOBLE study will include treatment efficacy, safety, and weight gain experienced by participants taking Dovato (dolutegravir/lamivudine) or Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide)
• Additional key abstracts from ViiV Healthcare's industry-leading, long-acting pipeline and portfolio include data introducing a third-generation integrase strand transfer inhibitor (INSTI) with potential for ultra long-acting applications; pregnancy data for Apretude (cabotegravir long-acting injectable) for PrEP; and real-world evidence for long-acting treatment regimen Cabenuva (cabotegravir + rilpivirine long-acting)

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced it will be presenting the largest head-to-head, randomised clinical trial (RCT) of the 2-drug regimen Dovato (dolutegravir/lamivudine [DTG/3TC]) compared against the 3-drug regimen, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide [BIC/FTC/TAF]) at the 25th International AIDS Conference in Munich, Germany (22 – 26 July). The presentation is one of 25 abstracts evaluating the company's portfolio of marketed HIV treatment and prevention options alongside its next-generation pipeline assets.

Harmony P. Garges, M.D., Chief Medical Officer at ViiV Healthcare, said: "The exciting findings we'll be presenting at AIDS 2024 continue to underscore our position as industry leaders in the development of long-acting and 2-drug regimens and our pioneering approaches to both HIV treatment and prevention. People living with HIV continue to tell us they want more treatment options to allow for more personal choice to address needs beyond viral suppression. The breadth of the data we're announcing, including the head-to-head study between Dovato and Biktarvy, helps individuals better understand those options. We're proud to be at the forefront of innovative science, driving advancements that have and will continue to transform the future of HIV care and contribute to ending the epidemic."

Key abstracts to be presented at AIDS 2024 by ViiV Healthcare and its study partners will include:

Head-to-head study comparing ViiV Healthcare's oral 2-drug regimen against a commonly prescribed oral 3-drug regimen: The FSG-sponsored PASO-DOBLE head-to-head RCT of the 2-drug regimen Dovato (DTG/3TC) compared with the 3-drug regimen Biktarvy (BIC/FTC/TAF) will be presented as a late breaker abstract. The non-inferiority study assessed virologically suppressed adults on an established treatment regimen and who could benefit from treatment optimisation, who were randomised to switch to treatment with DTG/3TC or BIC/FTC/TAF. Researchers will share 48-week findings on treatment efficacy and safety, as well as changes in weight experienced by participants while taking either regimen.¹

Additional findings for DTG/3TC will include the DYAD study, presenting 48-week findings among virologically suppressed participants with no prior virologic failure who either switched to DTG/3TC or remained on BIC/FTC/TAF;² and 96-week findings from the SOUND study, which followed virologically suppressed participants with unknown resistance history who switched from BIC/FTC/TAF to DTG/3TC.³

Pregnancy data from the HPTN 084 open label extension study for Apretude: New findings will be presented from the HPTN 084 trial that assess the impact of cabotegravir long-acting (LA) for PrEP exposure during pregnancy.^4,5 The study focuses on maternal, pregnancy, and infant safety outcomes among participants who became pregnant during the open label extension of HPTN 084 and continued with injections of cabotegravir LA for PrEP.

New pipeline data from ViiV Healthcare's third generation INSTI: Researchers will share phase I findings from the first-time-in-human study of VH184, a third-generation integrase inhibitor (INSTI), along with analysis showing potent activity in vitro against multiple INSTI resistant mutations.⁶ This is the first data presentation of the company's next INSTI as a part of its ultra long-acting development strategy.

Real-world evidence from long-acting treatment regimen: Findings from several real-world studies of the complete long-acting HIV treatment regimen cabotegravir + rilpivirine long-acting (CAB+RPV LA) will be presented, including the perspectives of people living with HIV 12 months after switching their treatment regimen to CAB+RPV LA from the BEYOND study;^7,8 effectiveness, participant adherence to injections, and patient reported outcomes from the German cohort of the CARLOS study;⁹ and utilisation and effectiveness of CAB+RPV LA among virologically suppressed, treatment-experienced individuals from the COMBINE-2 study.¹⁰

Here is a list of ViiV Healthcare-sponsored or supported studies to be presented at AIDS 2024:

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.

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

About Vocabria

Vocabria (cabotegravir) injection is indicated - in combination with rilpivirine injection - for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitors (NNRTI) and integrase inhibitor (INI) class.

Vocabria tablets are indicated - in combination with rilpivirine tablets - for the short-term treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class for:

• oral lead in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting Vocabria injection plus long acting rilpivirine injection.
• oral therapy for adults who will miss planned dosing with Vocabria injection plus rilpivirine injection.

Vocabria tablets are only indicated for treatment of HIV-1 in combination with rilpivirine tablets, therefore, the prescribing information for Edurant tablets should also be consulted for recommended dosing.

Please consult the full Summary of Product Characteristics for all the safety information: Vocabria 400mg/600 mg prolonged-release suspension for injection and Vocabria 30 mg film-coated tablets.

About Rekambys

Rekambys is indicated - in combination with cabotegravir injection - for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class.

Rekambys should always be co-administered with a cabotegravir injection. The prescribing information for cabotegravir injection should be consulted for recommended dosing. Rekambys may be initiated with oral lead-in or without (direct to injection).

Please consult the full Summary of Product Characteristics for all the safety information: Rekambys 600mg/900 mg prolonged-release suspension for injection.

About Apretude

Apretude is a medicine used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis or PrEP) in adults and adolescents weighing at least 35 kg who are at high risk of being infected. It should be used in combination with safer sex practices, such as using condoms. Apretude contains the active substance cabotegravir.

Please consult the full Summary of Product Characteristics for all the safety information: Apretude 600 mg prolonged-release suspension for injection.

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 SEIMC-GeSIDA Foundation (FSG)

The SEIMC-GeSIDA Foundation (FSG) was founded by the Spanish Society of Clinical Microbiology and Infectious Diseases as a tool to promote high-quality investigation in the field of HIV infection and other infectious diseases. The Foundation is composed of qualified professionals with experience in the field of clinical trials and multicentre studies. Its streamlined infrastructure facilitates performance of clinical studies and responds to the needs of investigators in terms of methodology/statistical analysis and of logistics and management of trials and other multicentre studies. For more information on the SEIMC-GeSIDA Foundation (FSG), please visit https://fundacionseimcgesida.org/en/quienes-somos/.

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 Q1 Results for 2024.

References

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¹ P. Ryan, et al. Non-inferior efficacy and less weight gain when switching to DTG/3TC than when switching to BIC/FTC/TAF in virologically suppressed people with HIV (PWH): the PASODOBLE (GeSIDA 11720) randomized clinical trial. Presented at the 25 International AIDS Conference. July 2024.

² C.P. Rolle, et al. Efficacy, safety and tolerability of switching to dolutegravir/lamivudine in virologically suppressed adults living with HIV on bictegravir/emtricitabine/tenofovir alafenamide - 48-week results from the DYAD study. Presented at the 25 International AIDS Conference. July 2024.

³ J. Slim, et al. Switch to dolutegravir/lamivudine (DTG/3TC) in people living with HIV-1 suppressed on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF): 96-week final analysis from the SOUND study. Presented at the 25 International AIDS Conference. July 2024.

⁴ S. Delany-Moretlwe, et al. Initial evaluation of CAB-LA Safety during pregnancy in the HPTN 084 open-label extension. Presented at the 25th International AIDS Conference. July 2024.

⁵ M. Marzinke, et al. Evaluation of Long-Acting Cabotegravir (CAB-LA) Pharmacokinetics During Pregnancy: A Sub-Study Analysis of the HPTN 084 Open Label Extension. Presented at the 25th International AIDS Conference. July 2024.

⁶ L. Rogg, et al. Phase 1 study of VH4524184 (VH-184), a new third-generation integrase strand transfer inhibitor (INSTI) with a unique resistance profile. Presented at the 25th International AIDS Conference. July 2024.

⁷ S. Schneider, et al. Clinical outcomes at Month 12 after initiation of cabotegravir and rilpivirine long acting (CAB+RPV LA) in an observational real-world study (BEYOND). Presented at the 25th International AIDS Conference. July 2024.

⁸ W. Valenti, et al. Perspectives of people with HIV (PWH) 12 months following a switch to cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world US study (BEYOND). Presented at the 25th International AIDS Conference. July 2024.

⁹ CJ. Oldenbüttel, et al. 12-Month outcomes of cabotegravir plus rilpivirine long-acting every 2 months in a real-world setting: effectiveness, adherence to injections, and patient-reported outcomes from people with HIV-1 in the German CARLOS cohort. Presented at the 25th International AIDS Conference. July 2024.

¹⁰ A. Pozniak, et al. Real-world utilization and effectiveness of long-acting cabotegravir + rilpivirine in virologically suppressed treatment experienced individuals in Europe: data from COMBINE-2 cohort study. Presented at the 25th International AIDS Conference. July 2024.

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