ViiV HEALTHCARE EXPANDS ON REAL-WORLD DATA SUPPORTING USE OF LONG-ACTING THERAPIES IN DIVERSE PATIENT POPULATIONS AT HIV GLASGOW
- New analyses highlight use of long-acting injectable Vocabria + Rekambys (cabotegravir + rilpivirine LA) in clinical trial and real-world populations, and the economic and public health impact of Apretude (cabotegravir LA for PrEP)
- Findings from the DOLCE study explore the efficacy of 2-drug regimen Dovato (dolutegravir/lamivudine) to three-drug regimen in people with advanced HIV with CD4 count ≤ 200 cells/mm³
- Additional key abstracts include findings from pipeline bNAb asset, VH3810109, as a potential approach to treating HIV
London, 7 NOVEMBER 2024 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, will share new data from its industry-leading HIV treatment and prevention portfolio and pipeline at HIV Glasgow 2024, being held in Glasgow, Scotland from 10 – 13 November 2024. Spanning 42 abstracts, the data showcases how long-acting and two-drug regimens as care options for diverse populations in the face of a continuing HIV epidemic.
Harmony P. Garges, MD, Senior Vice President and Chief Medical Officer at ViiV Healthcare, said: “ViiV Healthcare is the first company to develop and launch long-acting options and two-drug regimens, and these therapies are transforming how physicians and providers treat and prevent HIV today. We continue evaluating how diverse populations living with or impacted by HIV respond to our therapies in the real world. Data from these studies include more than 10,000 people using Vocabria + Rekambys, more than 50,000 people using Dovato and more than 1,300 people using Apretude1. At HIV Glasgow, ViiV Healthcare is showcasing new, compelling data from our portfolio that reinforces how our medicines impact health outcomes and contribute to ending the HIV epidemic.”
Key data to be presented at HIV Glasgow 2024 by ViiV Healthcare and its study partners will include:
Analysis of cabotegravir + rilpivirine long-acting (CAB+RPV LA) in the real-world and across phase 3/3b studies: Findings from a large-scale post hoc analysis of the complete long-acting HIV treatment regimen CAB+RPV LA will be presented. The analysis, which pooled data from over 2,500 participants across four major phase 3/3b clinical trials (FLAIR, ATLAS, ATLAS-2M, and SOLAR), will compare virologic outcomes and isolated viraemic events between daily oral HIV treatment and CAB+RPV LA.2 Furthermore, the real-world utilisation of CAB+RPV LA will be explored in an analysis of adherence and persistence in a Canadian patient support program. These analyses will add to the growing body of clinical and real-world evidence for CAB+RPV LA and offer additional insights to healthcare providers on outcomes for CAB+RPV LA in diverse populations.
Data exploring the use of dolutegravir/lamivudine (DTG/3TC) in antiretroviral-naïve people living with HIV: Findings will be presented from the Fundación Huésped-sponsored DOLCE study. This is the first study to fully focus on evaluating the efficacy and safety of the 2-drug regimen DTG/3TC in people living with HIV with CD4 ≤ 200 cells/mm³.3 Additionally, data will be shared from the phase IV D2ARLING study, which compared the efficacy and safety of DTG/3TC against a 3-drug regimen in an antiretroviral-naïve population that did not have baseline drug-resistance testing results available4. Many guidelines recommend baseline drug resistance testing prior to ART initiation, that may not always be readily accessible, reinforcing the need and impact of these data in an antiretroviral-naïve population.
Cost-effectiveness and usage patterns for long-acting HIV prevention: Findings from a cost-effectiveness study examining the economic and public-health impact of cabotegravir long-acting (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in Canada will be presented. Researchers will compare the impact of the introduction of CAB LA for PrEP against daily oral PrEP (TDF/FTC) and no PrEP usage on cost savings and quality-adjusted life years.5 New findings from the PROTECT survey will be shared, exploring differences in interest and intention to use long-acting PrEP among men who have sex with men, and heterosexual men and women, in 20 European countries.6,7
Advancing novel mechanisms of action in HIV research: New findings from the BANNER study of VH3810109 (N6LS), an investigational, broadly neutralising antibody (bNAb), will be presented. Previously presented phase IIa proof-of-concept findings from the BANNER study suggested VH109 was well-tolerated and efficacious in people living with HIV.8 Researchers will share new findings exploring the correlation between baseline phenotypic sensitivity to N6LS and virologic response after treatment with N6LS.9 Additional research evaluating N6LS will focus on administration and dose responsiveness, adding to the growing body of evidence supporting the bNAb as a potential new approach to treating HIV.10
ViiV Healthcare-sponsored or supported studies to be presented at HIV Glasgow 2024:
| Title | First Author | Presentation |
| Cabotegravir + rilpivirine long-acting |
||
| Similar virologic outcomes and frequency of isolated viraemic events (blips, low-level viraemia and suspected virologic failure) between oral and long-acting antiretroviral therapy: a pooled analysis of phase 3/3b cabotegravir + rilpivirine long-acting studies | J. Thornhill | Poster Presentation |
| Real-world utilization of cabotegravir/rilpivirine: an observational analysis of adherence and persistence using a patient support program in Canada, preliminary results |
C. LaForty |
Poster Presentation |
| Feasibility and satisfaction of interventions measures (FIM and HIVTISQ) of implementation long-acting (LA) CAB+RPV administration out of HIV units: the IMADART study | A. Cabello |
Poster Presentation |
| Cabotegravir and rilpivirine concentrations and HIV-1 RNA suppression in male and female genital fluids and rectal tissue in people with HIV on antiretroviral therapy with long-acting intramuscular cabotegravir plus rilpivirine | A. Fernández | Oral Presentation |
| Use of long-acting cabotegravir and rilpivirine in a real-life setting: 12-month results of virological outcome, adherence, safety, durability, in the ANRS CO3 AquiVIH-NA cohort-France | M. Hessamfar | Poster Presentation |
| Results at month 7 of CABO-CHANCE study: real-world-evidence (RWE) on the use of intramuscular cabotegravir plus rilpivirine long-acting (CAB+RPV LA) dosed every 2 months in viral suppressed people with HIV (PWH) | C. H. Tenorio | Poster Presentation |
| Re-suppression regimens and outcomes after virological failure in randomised controlled trials and real-world evidence studies evaluating cabotegravir and rilpivirine (CAB+RPV) | A. Elias | Poster Presentation |
| Virological failure rate and emergent resistance in real-world studies evaluating long-acting cabotegravir and rilpivirine in people with baseline viral suppression | M. Smuk | Poster Presentation |
| Cabotegravir long-acting for PrEP | ||
| PrEP-associated stigma in Europe: findings from a real-world survey | M. Schroeder | Poster Presentation |
| Cost-effectiveness and public-health impact of cabotegravir long-acting injectable for HIV pre-exposure prophylaxis in Canada | A. Adelakun | Poster Presentation |
| Prevalence of HIV drug resistance in people newly diagnosed with HIV who have used pre-exposure prophylaxis in Europe; the PrEPaRe study | V. Cambiano | Poster Presentation |
| Differences in oral PrEP use patterns and intention to use long-acting regimens among MSM between formal and informal PrEP provision pathways in 20 European countries: a latent class analysis | H. Wang | Oral Presentation |
| Preparing for long-acting PrEP delivery: provider preferences for the provision of long-acting PrEP differ between MSM and heterosexual individuals in Europe | H. M. L. Zimmerman | Poster Presentation |
| Intention to use long-acting PrEP among heterosexual women and men in 20 European countries – results from the PROTECT survey | K. Jonas | Poster Presentation |
| Dolutegravir |
||
| Two-year long-term data on the efficacy and tolerability of dolutegravir-based regimens from the prospective multi-centre TESLA cohort study in ART-naive and pre-treated people living with HIV in Russia | A. Basova |
Poster Presentation |
| The analysis of metabolic parameters in people living with HIV using dolutegravir-based regimens in routine clinical practice in Russia | A. Basova |
Poster Presentation |
| Outcomes following prenatal exposure to DTG-containing antiretroviral therapy regimens: data from the DOLOMITE-EPPICC study | R. Sconza | Poster Presentation |
| Incident hypertension with antiretroviral therapy: real-world evidence from the OPERA cohort | P. Lackey |
Poster Presentation |
| A multicentre observational study to determine the safety and effectiveness of dolutegravir (DTG) use during pregnancy: data from DOLOMITE-NEAT ID Network study | J. D. Kowalska | Poster Presentation |
| Mortality using raltegravir versus other integrase inhibitors in people with HIV in Europe and Australia | E. Tusch |
Poster Presentation |
| Mental health in PWH: Patient-reported outcomes in the DUALIS study | E. Wolf | Poster Presentation |
| Evaluating the cardiovascular risk and the achievement of target levels in low-density lipoprotein cholesterol in PLWH: Insights from the DUALIS study | F. Voit | Poster Presentation |
| Dolutegravir-based antiretroviral therapy does not reduce plasma levonorgestrel or medroxyprogesterone acetate concentrations among contraceptive users living with HIV compared with HIV-negative controls | R. Ryan | Poster Presentation |
| Efficacy and safety of dolutegravir (DTG)-based antiretroviral treatment (ART) in patients with HIV and solid organ transplantation (SOT): A single-arm clinical trial (DTG-SOT) | J. Miro | Poster Presentation |
| Dolutegravir/lamivudine | ||
| PAIRED - PAtIent Reported Experiences and perceiveD benefit of treatment with dolutegravir/lamivudine (DTG/3TC): a sub-analysis of people with HIV (PWH) switching from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in the United States (US) | J. Slim |
Poster Presentation |
| Treatment-emergent integrase strand transfer inhibitor (INSTI) resistance-associated mutations among people living with HIV-1 treated with dolutegravir (DTG) + lamivudine (3TC) with pre-existing M184V/I from real-world and interventional studies | D. Fox |
Poster Presentation |
| An EYEWITNESS to successful diversity in antiretroviral switch studies | C. V. Dam | Poster Presentation |
| CARAVEL: evaluation of real-world effectiveness and sustainability of the 2-drug regimen dolutegravir/lamivudine fixed-dose combination in treatment-naive adults and pre-treated adults who are virologically suppressed, in routine clinical care, in France. Two-year interim analysis results | P. Philibert | Poster Presentation |
| Real world experience of DTG+3TC regimen: results from the French Dat'AIDS cohort (2015-2022) | C. Allavena | Poster Presentation |
| Changes in patient-reported neuropsychological outcomes in virologically suppressed persons with HIV switching to DTG/3TC or BIC/FTC/TAF: a substudy of the PASO-DOBLE randomized clinical trial | L. Garcia-Fraile |
Poster Presentation |
| 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 | M. I. Figueroa |
Oral Presentation |
| RUMBA’s week 144 results confirm reassuring metabolic outcomes in both DTG/3TC and B/FTC/TAF | S. Degroote |
Poster Presentation |
| Efficacy of dolutegravir plus lamivudine in treatment-naïve people living with HIV without baseline drug-resistance testing available: 48-week results from the randomised D2ARLING study |
E. Cordova |
Poster Presentation |
| Long-term efficacy and safety of Dolutegravir/Lamivudine in virologically suppressed persons with resistance to Lamivudine: Week 96 results of VOLVER clinical trial - GESIDA 11820 | M. De Lagarde | Poster Presentation |
| Fostemsavir | ||
| CD4 T-cell, CD4/CD8 ratio improvement and a general reduction in inflammatory biomarkers with low-level viremia (LLV) up to Week 192 with fostemsavir (FTR)-based regimens in individuals with multidrug-resistant (MDR) HIV-1 | V. Spagnuolo |
Encore Poster Presentation |
| Similar efficacy, safety and CD4 T-cell increase up to Week 96 observed with fostemsavir (FTR)-based regimens in the BRIGHTE study and dolutegravir (DTG)-based regimens in the VIKING-3 study in individuals with multidrug-resistant (MDR) HIV-1 | A. Castagna |
Encore Poster Presentation |
| Pipeline | ||
| Correlation of baseline phenotypic sensitivity with virologic response to VH3810109 (N6LS) in BANNER | M. Gartland |
Poster Presentation |
| VH3810109 (N6LS) administration dose-responsively enhances anti-HIV antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity in ex vivo models | M. Keegan |
Encore Poster Presentation |
| Additional Studies | ||
| Mortality and clinical outcomes after common cancers in people | A. Timiryasova |
Poster Presentation |
| The association between anticholinergic medication use and cognitive function in older people with HIV in the Pharmacokinetic and clinical Observations in PeoPle over fifty (POPPY) Study | S. Deb | Poster Presentation |
| Comparison of 4 frailty scores to predict adverse health outcomes and mortality in people living with HIV aged 70 years and more (ANRS EP66 SEPTAVIH study) | C. Allavena | Poster Presentation |
| The prevalence and factors associated with polypharmacy in participants with HIV in the Pharmacokinetic and clinical Observations in PeoPle over fiftY (POPPY) study over a 3-5 year period | L. Sukumaran | Poster Presentation |
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
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.
| ViiV Healthcare enquiries: | |||
| Media enquiries: | Rachel Jaikaran | +44 (0) 78 2352 3755 | (London) |
| Melinda Stubbee | +1 919 491 0831 | (North Carolina) | |
| Fundación Huésped | |||
| Media: | Guadalupe Di Palma | +54 9 11 3083-9726 | (Argentina) |
| GSK enquiries: | |||
| Media: | Tim Foley | +44 (0) 20 8047 5502 | (London) |
| Sarah Clements | +44 (0) 20 8047 5502 |
(London) | |
| Kathleen Quinn | +1 202 603 5003 | (Washington DC) | |
| Lyndsay Meyer | +1 202 302 4595 | (Washington DC) | |
| Alison Hunt | +1 540 742 3391 | (Washington DC) | |
| Investor Relations: | Annabel Brownrigg-Gleeson | +44 (0) 20 8047 5502 | (London) |
| James Dodwell | +44 (0) 20 8047 2406 | (London) | |
| Mick Readey | +44 (0) 7990 339653 | (London) | |
| Camilla Campbell | +44 (0) 7803 050238 | (London) | |
| Steph Mountifield | +44 (0) 7796 707505 | (London) | |
| Jeff McLaughlin | +1 215 751 7002 | (Philadelphia) | |
| Frannie DeFranco | +1 215 751 4855 | (Philadelphia) | |
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.
Registered in England & Wales:
GSK plc ViiV Healthcare Limited
No. 3888792 No. 06876960
Registered Office:
79 New Oxford Street ViiV Healthcare Limited
London GSK Medicines Research Centre
WC1A 1DG Gunnels Wood Road, Stevenage
United Kingdom
SG1 2NY
References:
- Data on file
- J. Thornhill, et al. Similar virologic outcomes and frequency of isolated viraemic events (blips, low-level viraemia and suspected virologic failure) between oral and long-acting antiretroviral therapy: a pooled analysis of phase 3/3b cabotegravir + rilpivirine long-acting studies. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland.
- M. 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.
- E. Cordova, et al. Efficacy of dolutegravir plus lamivudine in treatment-naïve people living with HIV without baseline drug-resistance testing available: 48-week results from the randomised D2ARLING study. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland.
- A. Adelakun, et al. Cost-effectiveness and public-health impact of cabotegravir long-acting injectable for HIV pre-exposure prophylaxis in Canada. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland.
- H. Wang, et al. Differences in oral PrEP use patterns and intention to use long-acting regimens among MSM between formal and informal PrEP provision pathways in 20 European countries: a latent class analysis. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland.
- K. Jonas, et al. Intention to use long-acting PrEP among heterosexual women and men in 20 European countries – results from the PROTECT survey. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland.
- P. Leone, et. al. VH3810109 (N6LS) Reduces Viremia Across a Range of Doses in ART-Naive Adults Living with HIV: Proof of Concept Achieved in the Phase IIa BANNER (207959, NCT04871113) Study. Presented at HIV Glasgow 2022.
- M. Gartland, et al. Correlation of baseline phenotypic sensitivity with virologic response to VH3810109 (N6LS) in BANNER. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland.
- M. Keegan, et al. VH3810109 (N6LS) administration dose-responsively enhances anti-HIV antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity in ex vivo models. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland.
Media contacts
For our corporate press office, email: Rachel Jaikaran
OR call +44 7823 523 755
For US-specific media enquiries, email: melinda.x.stubbee@viivhealthcare.com
OR call +1 919 491 0831
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the GSK Reporting Tool link https://gsk.public.reportum.com/. By reporting side effects, you can help provide more information on the safety of this medicine.
If you are from outside the UK, you can report adverse events to GSK/ ViiV by selecting your region and market, here.
