09/22/2021 | Press release | Distributed by Public on 09/22/2021 01:07
London, 22 September 2021 - ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced the presentation of 13 abstracts from its diverse portfolio of innovative pipeline prevention options and licensed HIV treatments, including 2-drug and long-acting regimens, at the 2021 Infectious Disease Society of America (IDSA) IDWeek, being held virtually 29 September - 3 October.
Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: "The breadth of data we're presenting at IDWeek 2021 illustrates our commitment to understanding and addressing the variety of evolving needs and challenges faced by people living with or affected by HIV. These new data address specific questions that providers have been asking and we believe will provide increased confidence in the long-term efficacy and high barrier to resistance of our integrase inhibitor-based, 2-drug regimens. We look forward to sharing these findings with the HIV community at IDWeek."
Key abstracts to be presented by ViiV Healthcare at IDWeek 2021:
144-week findings from the TANGO study evaluate switching to the fixed-dose combination of Dovato (dolutegravir/lamivudine) compared to the continuation of tenofovir alafenamide (TAF) -based regimens of at least three drugs in virologically suppressed people living with HIV: The three-year findings to be presented at IDWeek 2021 will include efficacy, safety and tolerability data for dolutegravir/lamivudine and build on the growing body of evidence for this 2-drug regimen. [1]
48-week subgroup analysis of the STAT study investigating the safety and efficacy of dolutegravir/lamivudine for the treatment of HIV-1: Secondary analysis of treatment-naïve adults living with HIV was designed to build on previous 24-week feasibility, efficacy and safety outcomes of dolutegravir/lamivudine as a first-line regimen in a test-and-treat setting through 48 weeks. Findings to be presented at IDWeek 2021 will provide further insights into virologic outcomes among study participants by baseline viral load.[2]
Pregnancy and birth outcomes following maternal dolutegravir (DTG) use: The Antiretroviral Pregnancy Registry was designed to monitor for early warning signals of ARV effects on neonatal health. Findings to be presented at IDWeek 2021 will provide additional information about pregnancy outcomes among women exposed to DTG.[3]
Findings from the Positive Perspectives survey reported treatment outcomes and perceptions among people living with HIV following the global U=U educational campaign: The U=U campaign was designed to improve the well-being of people living with HIV and recalibrate HIV-related social norms. The findings to be presented at IDWeek 2021 examine the effects of U=U on treatment outcomes and satisfaction, mental health and sexual health among people living with HIV in North America and also provide further insight into the impact of provider relationships on quality of life.[4]
Results analysing the impact of COVID-19 on HIV treatment and care among ongoing BRIGHTE trial participants: Rukobia (fostemsavir), in combination with other ARV therapies, was evaluated in heavily treatment-experienced adults with advanced HIV and COVID-19. Findings to be presented at IDWeek 2021 from the ongoing analysis characterise reported cases and outcomes of COVID-19 among study participants.[5]
Real-world findings from the retrospective study examining usage patterns among people receiving tenofovir-based therapy as pre-exposure prophylaxis (PrEP) in the US: The retrospective study was designed to identify adults newly initiated on tenofovir-based therapy as daily PrEP and monitor persistence. Findings to be presented at IDWeek 2021 will examine consistency of use on daily oral PrEP in the real-word setting in comparison to recent PrEP clinical trials.[6]
The full list of ViiV Healthcare data to be presented at IDWeek 2021 is outlined below:
Abstract title |
First Author |
Presentation |
Dolutegravir |
||
High rates of virologic suppression with DTG/3TC in newly diagnosed adults with HIV-1 infection and baseline viral load >500,000 c/mL: 48-week subgroup analysis of the STAT study |
CP Rolle |
Oral Presentation |
Maternal Dolutegravir (DTG) Use, and Pregnancy and Birth Outcomes: The Antiretroviral Pregnancy Registry (APR) |
V Vannappagari |
Oral Presentation |
Switching to DTG/3TC fixed-dose combination (FDC) is non-inferior to continuing a TAF-based regimen (TBR) in maintaining virologic suppression through 144 weeks (TANGO study) |
O Osiyemi |
E-Poster |
Efficacy and tolerability of DTG+3TC in clinical practice: evidence from real world data |
LA Evitt |
E-Poster |
The Impact of the COVID-19 Pandemic on Clinical Follow-up, Monitoring and Regimen Discontinuation for People Living with HIV in the US |
G Pierone |
E-Poster |
Cabotegravir |
||
Efficacy and safety of long-acting cabotegravir + rilpivirine in participants with HIV/HCV co-infection: ATLAS-2M 48-week results |
R D'Amico |
E-Poster |
Indirect Treatment Comparison of 48-Week Efficacy and Safety of Cabotegravir + Rilpivirine Long-Acting every 8 weeks to Bictegravir/ Emtricitabine/ Tenofovir alafenamide in Suppressed HIV-1 Infected Persons |
S Snedecor |
E-Poster |
Pregnancy Outcomes and Pharmacokinetics in Pregnant Women Living with HIV Exposed to Long-Acting Cabotegravir and Rilpivirine in Clinical Trials |
P Patel |
E-Poster |
North American Phase 3/3b Experience with Long-Acting Cabotegravir and Rilpivirine: Efficacy, Safety, and Virologic Outcomes |
BO Taiwo |
E-Poster |
Qualitative Patient-Participant Perspectives on Implementation of Monthly Cabotegravir and Rilpivirine Long Acting (CAB+RPV LA) Injectable in the United States (CUSTOMIZE) |
C Garris |
E-Poster |
Real-World Persistency of Patients Receiving Tenofovir-Based Pre-Exposure Prophylaxis for the Prevention of HIV Infection in the US |
A Oglesby |
E-Poster |
Fostemsavir |
||
Characterization of Heavily Treatment Experienced HIV-1 Infected Clinical Trial Participants infected with SARS-CoV-2 COVID 19: Fostemsavir BRIGHTE Phase 3 Clinical Trial |
S Chabria |
E-Poster |
General |
||
Effects of the "Undetectable = Untransmittable" ("U=U") Educational Campaign on Treatment Outcomes and Perceptions among People Living with HIV in North America |
F Spinelli |
Oral Presentation |
Important Safety Information for Dovato (50mg dolutegravir/300mg lamivudine) Tablets
INDICATION
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.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HIV-1: EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV
All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If DOVATO is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen.
Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of DOVATO. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment.
Contraindications
Warnings and precautions
Hypersensitivity Reactions:
Hepatotoxicity:
Embryo Fetal Toxicity:
Lactic Acidosis and Severe Hepatomegaly with Steatosis:
Adverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of DOVATO and other drugs may occur (see Contraindications and Drug interactions).
Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of DOVATO.
Adverse reactions
The most common adverse reactions (incidence ≥2%, all grades) with DOVATO were headache (3%), nausea (2%), diarrhea (2%), insomnia (2%), fatigue (2%), and anxiety (2%).
Drug interactions
Use in specific populations
Please refer to the full European Summary of Product Characteristics for Dovato for full prescribing information, including contraindications, special warnings and precautions for use. For the US, please refer to the US Prescribing Information, including Boxed Warning.
Important Safety Information for Cabenuva (cabotegravir 200 mg/mL; rilpivirine 300 mg/mL) extended release injectable suspensions
Cabenuva is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
Post-Injection Reactions:
Hepatotoxicity:
Depressive Disorders:
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
Long-Acting Properties and Potential Associated Risks with Cabenuva:
ADVERSE REACTIONS
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
Please see full Prescribing Information for Cabenuva.
Important Safety Information for Rukobia (fostemsavir), 600 mg extended-release tablets
INDICATIONS AND USAGE
Contraindications
Warnings and precautions
Elevations in Hepatic Transaminases in Patients with Hepatitis B or C Virus Co-infection:
Adverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of RUKOBIA and other drugs may occur (see Contraindications and Drug Interactions).
Adverse reactions
Drug interactions
Use in specific populations
Please see full Prescribing Information for Rukobia
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (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 becoming infected with HIV. Shionogi joined as a shareholder in October 2012. The company's aims are to take a deeper and broader interest in HIV/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 www.viivhealthcare.com.
About GSK
GSK is a science-led global healthcare company. For further information please visit www.gsk.com/about-us.
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 in the Company's Annual Report on Form 20-F for 2020, GSK's Q1 Results and any impacts of the COVID-19 pandemic.
References
[1]Osiyemi O, Ajana F, Bisshop F, et al. Switching to DTG/3TC Fixed-Dose Combination (FDC) Is Non-inferior to Continuing a TAF-Based Regimen (TBR) in Maintaining Virologic Suppression through 144 Weeks (TANGO Study). Presented at IDWeek 2021.
[2]Rolle CP, Berhe M, Singh T, et al. High Rates of Virologic Suppression with DTG/3TC in Newly Diagnosed Adults with HIV-1 Infection and Baseline Viral Load >500,000 c/mL: 48-Week Subgroup Analysis of the STAT Study. Presented at IDWeek 2021.
[3]Vannappagari V, Albano JD, Ragone L, et al. Maternal Dolutegravir (DTG) Use, and Pregnancy and Birth Outcomes: The Antiretroviral Pregnancy Registry (APR). Presented at IDWeek 2021.
[4]Spinelli F, Richman, B, del los Rios P, et al. Effects of the "Undetectable = Untransmittable" ("U=U") Educational Campaign on Treatment Outcomes and Perceptions among People Living with HIV in North American Countries. Presented at IDWeek 2021.
[5]Chabria S, De Wit S, Pierce A, et al. Characterization of Heavily Treatment Experienced HIV-1 Infected Clinical Trial Participants infected with SARS-CoV-2 COVID 19: Fostemsavir BRIGHTE Phase 3 Clinical Trial. Presented at IDWeek 2021.
[6]Ogelsby A, Germain G, Laliberté F, et al. Real-World Persistency of Patients Receiving Tenofovir-Based Pre-Exposure Prophylaxis for the Prevention of HIV Infection in the US. Presented at IDWeek 2021.