Business Wire

ViiV Healthcare presents long-term switch data for Dovato demonstrating non-inferior efficacy in adults with HIV-1 and zero cases of virologic failure versus continuation of a 3-drug TAF-based regimen

Share

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced 96-week data from the TANGO study at the HIV Glasgow 2020 congress showing that the 2-drug regimen (2DR) Dovato (dolutegravir/lamivudine) continued to demonstrate non-inferior efficacy compared to continuation of a tenofovir alafenamide fumarate (TAF)-based regimen of at least three drugs in virologically suppressed adults with HIV-1 who have not previously experienced virologic failure.1 Data from the study revealed that no participants on Dovato (0/369, 0%) and three participants (3/372, <1%) on the TAF-based regimen met protocol-defined virologic failure, and no participants developed resistance mutations upon failure.1

Professor Stéphane De Wit, M.D., Head, Infectious Diseases, Saint Pierre University Hospital, Brussels, and investigator for the TANGO study, said: “For physicians who have been waiting for long-term data on dolutegravir/lamivudine in virologically suppressed adults with HIV, the TANGO 96-week results show that it maintains the efficacy and resistance profile seen in earlier presentations of the study findings. It is also significant to see that in such a large pivotal study, no one experienced virologic failure in the two years that it has been running. These data help to build our understanding of dolutegravir/lamivudine as a complete regimen and expand its strong evidence base, providing clinicians with more confidence to switch from TAF-based 3-drug regimens to dolutegravir/lamivudine.”

Week 96 findings from the TANGO study showed that switching to Dovato was non-inferior to continuing a TAF-based regimen in the Intention to Treat-Exposed (ITT-E) analysis (defined as all participants randomised to the study), based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre (c/mL) at Week 96 (Snapshot virologic failure: <1% vs 1%; adjusted difference: -0.8% [95% CI: -2.0%, 0.4%]).1 In the Per-Protocol analysis (defined as participants who completed the study to 96 weeks), Dovato was shown to be superior to the TAF-based regimen arm (0% vs 1%; adjusted difference: -1.1% [95% CI: -2.3%, -0.0%]).1

The proportion of participants with plasma HIV-1 RNA <50 c/mL was high in both arms and demonstrated non-inferiority in 86% ([317/369] of participants in the Dovato arm vs 79% [294/372] in the TAF-based regimen arm; adjusted difference: 6.8% [95% CI: 1.4%, 12.3%]).1

Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: “Today’s findings from the TANGO study provide more evidence that people living with HIV can keep their virus under control with a dolutegravir-based 2-drug regimen, reflecting the consistent results that we’re seeing in real-world cohorts. Following on from the GEMINI 1 & 2 results presented earlier this week for treatment-naïve adults, these results continue to support the inclusion of Dovato as a recommended therapy in international HIV treatment guidelines.”

Overall adverse event (AE) rates were similar between the two study arms, with more drug-related grade 2-5 AEs in the Dovato arm (6% [21/369]) vs the TAF-based regimen arm (2% [7/371]). Rates of adverse events were similar between treatment arms at both Week 48 and Week 96.1 Fasting lipids were similar to findings seen at Week 48 and generally in favour of Dovato: total cholesterol (TC), low-density lipoprotein (LDL) and triglycerides showed significant differences favouring the Dovato arm, while high-density lipoprotein (HDL) cholesterol changes significantly favoured TAF-based regimens, with no difference in TC/HDL ratios between arms.1 The Week 96 findings also showed indications of better renal function outcomes in the Dovato arm; decreases in glomerular filtration rate (GFR) by cystatin-C* were observed in both arms, with a significantly smaller decrease in the Dovato arm.1 The clinical significance of these changes in biomarkers is unknown.

About TANGO 1,2

TANGO is a phase III, randomised, open-label, active-controlled, multicentre study to assess the antiviral efficacy and safety of switching to a 2-drug regimen (2DR) consisting of dolutegravir/lamivudine in HIV-infected adults who are virologically suppressed and stable on a TAF-based regimen.

Study participants were HIV-1 infected adults on a TAF-based regimen with HIV-1 RNA<50 c/mL for at least six months, without prior virologic failure, no historical nucleoside reverse transcriptase inhibitors (NRTI) or integrase inhibitor (INI) major resistance mutation, and no evidence of hepatitis B infection. Participants were randomised to switch to dolutegravir/lamivudine or continue on the TAF-based regimen through Week 148. The primary endpoint was the proportion of participants with a viral load of >50 c/mL at Week 48 (FDA Snapshot algorithm) for the ITT-E population.

About Dovato (dolutegravir/lamivudine) 3,4

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).

Dovato (dolutegravir 50 mg/ lamivudine 300 mg tablets) is authorised 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. In the US, Dovato is indicated as a complete regimen to treat HIV-1 infection in adults with no 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.

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.

Dovato is approved in the US, Europe, Japan and other countries worldwide. Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

Important Safety Information for Dovato

The following safety information 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.

WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HUMAN IMMUNODEFICIENCY VIRUS (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

DOSAGE AND ADMINISTRATION

  • Prior to or when initiating Dovato, test patients for HBV infection.
  • Pregnancy Testing: Perform pregnancy testing before initiation of Dovato in individuals of childbearing potential
  • One tablet taken orally once daily with or without food
  • The dolutegravir dose (50 mg) in Dovato is insufficient when coadministered with carbamazepine or rifampin. If Dovato is coadministered with carbamazepine or rifampin, take one tablet of Dovato once daily, followed by an additional dolutegravir 50-mg tablet, approximately 12 hours from the dose of Dovato

CONTRAINDICATIONS

  • Prior hypersensitivity reaction to dolutegravir or lamivudine
  • Coadministration with dofetilide

WARNINGS AND PRECAUTIONS

  • Hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury, have been reported with dolutegravir. Discontinue Dovato immediately if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction
  • Hepatotoxicity has been reported in patients receiving a dolutegravir-containing regimen. Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with Dovato. Monitoring for hepatotoxicity is recommended
  • Embryo-fetal toxicity may occur when used at the time of conception and in early pregnancy. An alternative treatment to Dovato should be considered at the time of conception through the first trimester of pregnancy due to the risk of neural tube defects. Counsel individuals of childbearing potential to use effective contraception
  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues
  • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy

ADVERSE REACTIONS

The most common adverse reactions (all grades) observed in ≥2% (in those receiving Dovato) were headache, nausea, diarrhea, insomnia, fatigue, and anxiety.

DRUG INTERACTIONS

  • Dovato is a complete regimen for the treatment of HIV-1 infection; therefore, coadministration with other antiretroviral drugs for the treatment of HIV-1 infection is not recommended
  • Refer to the full prescribing information for important drug interactions with Dovato

USE IN SPECIFIC POPULATIONS

  • Pregnancy: An alternative treatment to Dovato should be considered at the time of conception through the first trimester due to the risk of neural tube defects
  • Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission.
  • Females and males of reproductive potential: Pregnancy testing and contraception are recommended in individuals of childbearing potential
  • Renal Impairment: Dovato is not recommended in patients with creatinine clearance less than 50 mL/min
  • Hepatic Impairment: Dovato is not recommended in patients with severe hepatic impairment (Child-Pugh Score C)

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.

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 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 with a special purpose: to help people do more, feel better, live longer. For further information please visit https://www.gsk.com/en-gb/about-us/.

GSK enquiries:

 

 

 

Media enquiries:

Simon Steel

+44 (0) 20 8047 5502

(London)

 

Tim Foley

+44 (0) 20 8047 5502

(London)

 

Kristen Neese

+1 804 217 8147

(Philadelphia)

 

Kathleen Quinn

+1 202 603 5003

(Washington DC)

 

 

 

 

Analyst/Investor enquiries:

Sarah Elton-Farr

+44 (0) 20 8047 5194

(London)

 

Sonya Ghobrial

+44 (0) 7392 784784

(Consumer)

 

Danielle Morris

+44 (0) 20 8047 7562

(London)

 

James Dodwell

+44 (0) 20 8047 2406

(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 the company's Annual Report on Form 20-F for 2019 and as set out in GSK’s “Principle risks and uncertainties” section of the Q2 Results and any impacts of the COVID-19 pandemic.

Registered in England & Wales:
No. 3888792

Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS

* Monitoring GFR by cystatin-C is a measure of renal function


References

1 van Wyk J., 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 96 Weeks (TANGO Study). Presented at HIV Glasgow 2020.
2 Clinical trials.gov. Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO). Available at: https://clinicaltrials.gov/ct2/show/NCT03446573?term=TANGO+dolutegravir&rank=1. Accessed September 2020.
3 Dovato EU Summary of Product Characteristics. July 2019. Available at: https://www.medicines.org.uk/emc/product/10446/smpc. Accessed September 2020.
4 Dovato US Prescribing Information. Available at: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Dovato/pdf/DOVATO-PI-PIL.PDF. Accessed September 2020.

Contact information

ViiV Healthcare media enquiries:
Patricia O’Connor
+44 20 8047 5982 (UK)

Audrey Abernathy
+1 919 605 4521 (US)

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

PerkinElmer Launches Industry First No-Wash Immunoassay For Phospho Ubiquitin Ser65 to Help Drive Neuroscience Disease and Therapeutics Research Forward26.10.2020 22:05:00 EETPress release

PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today launched the life science industry’s first no wash Ubiquitin phosphorylation at Serine 65 immunoassay for studying defective mitophagy biological mechanisms that have been broadly associated with diseases such as Parkinson’s and Alzheimer’s. The new PerkinElmer Cisbio HTRF® Phospho-Ubiquitin (Ser65) Cellular Kit takes analysis efficiency and accuracy to the next level compared to existing techniques such as Western blot and is aimed at helping scientists discover new therapeutic candidates earlier in the disease cycle. The innovative assay leverages TR-FRET technology to bring high sensitivity across a wide range of analytes and greater study specificity to the Phospho-Ubiquitin (Ser65) intersection point that has been shown to play a key role in mitophagy dysfunction and breakdowns in the complex network between neurons and glial cells which can lead to neurodegenerative disease. Efficient and stre

NetApp Brings Optimization and Enterprise Data Services to the Cloud26.10.2020 19:00:00 EETPress release

Global, cloud-led, data-centric software company NetApp® (NASDAQ: NTAP) today unveiled a groundbreaking serverless and storageless solution for containers from Spot by NetApp, a new autonomous hybrid cloud volume platform, and cloud-based virtual desktop solutions. NetApp’s new capabilities help simplify and optimize multicloud management for the highest performance at a low cost, offering true portability for data-rich cloud applications and delivering comprehensive workplace solutions across hybrid cloud environments. “To thrive in the new normal, digital transformation has become a business imperative. To succeed, businesses need to optimize their hybrid multicloud IT architectures,” said NetApp CEO George Kurian. “No matter where customers are on their transformation journey, NetApp can help them build a data fabric to maximize the value of their data, ensure applications are running optimally, and unlock the best of cloud.” The new features and capabilities that NetApp introduced

omni:us Welcomes Insurance Veteran Antonio Derossi to Drive Growth Across US and Europe26.10.2020 18:00:00 EETPress release

omni:us, the insurance claims AI solution provider, welcomes Antonio Derossi as a member of the omni:us Senior Executive Advisory board. Mr. Derossi, with 20+ years of experience in various roles across insurance, consulting, and venture capital, will function as a key advisor on go-to-market and product optimization strategies for the North American and European insurance markets. omni:us seeks to fortify its position as global pioneer of insurance claims transformation with the expert support of Mr. Derossi. Both parties see automation as a defining element of future claims management systems. Mr. Derossi’s understanding of the intricacies of the American and European insurance space will support increased market penetration for the Berlin-based omni:us. He will also act as an effective liaison to insurance companies, solution providers and consulting partners across both continents. Derossi was born in Trieste, Italy. He holds a Laurea degree in physics from Trieste University, and

Dahua Sponsors Omdia Webinars on Next Generation Network Cameras26.10.2020 16:45:00 EETPress release

Dahua Technology, a world-leading video-centric smart IoT solution and service provider, has sponsored one white paper and two webinars hosted by Omdia. The theme of the webinars held on October 22nd is Solving security challenges: Next-generation network cameras. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201026005466/en/ (Photo: Business Wire) Omdia is the new global technology research powerhouse, established in 2019 with the combination of the Informa Tech’s research brands (Ovum, Heavy Reading, and Tractica) and the acquired IHS Markit technology research portfolio. Collaborating with Dahua Technology, the comprehensive webinar has attracted about 1200 registrations. Audiences are experts from various industries such as energy, finance, education, government, retail, etc. With webinar events experts from Omdia, Dahua Technology’s Senior Project Sales Manager Simon Nash and Omdia’s analysts Josh Woodhouse and Tommy Z

26th Yiwu Fair Concludes with Success, Reaching Deals Worth Millions in Small Commodities26.10.2020 16:36:00 EETPress release

The 26th China Yiwu International Commodities (Standards) Fair concluded in Yiwu on October 25, 2020. As the first large-scale foreign trade exhibition presented both online and offline in China amid regular epidemic prevention and control, Yiwu Fair 2020 provided more than 3,400 standard booths with an exhibition area of ​​100,000 square meters at the Yiwu International Expo Center, and attracted nearly 2,000 companies from 19 domestic provinces, municipalities and autonomous regions, covering categories of hardware, electromechanical facilities, electronic & electrical appliances, daily necessities, crafts & ornaments, stationery & office goods, toys, sporting & outdoor products, knitwear, and gift packaging. The Fair attracted a total of 106,000 offline visitors and 160 million online views. Seven overseas online matchmaking sessions were held targeting the United Kingdom, Malaysia, Chile, etc., and achieved an intended turnover of $4.66 million. While expanding the international ma

Interactive Brokers Launches Innovative Sustainable Investing Tool26.10.2020 16:18:00 EETPress release

Interactive Brokers Group (Nasdaq: IBKR), a global brokerage firm, today unveiled an innovative, interactive Impact Dashboard designed to help clients evaluate and invest in companies that align with their values. The dashboard, which is free for all clients to use, sets a new standard for tools that can be used for sustainable, socially responsible, and values-based investing. The launch comes as interest in Environmental, Social and Governance (ESG) investing is soaring. ESG assets are expected to top $53 trillion by 2022, according to research released in September by Celent. “The future of sustainable investing begins with the Impact Dashboard, which allows investors to align their portfolios with their values,” said Will Peterffy, ESG Director at Interactive Brokers. “In a world lacking transparency, the dashboard quickly analyzes and grades your stock portfolio based on your values and presents your holdings through a personalized ‘impact lens’. You can then decide whether to kee

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom