ViiV Healthcare announces phase III study meets primary endpoint, demonstrating the ability to control HIV-1 with a 2-drug regimen of dolutegravir plus lamivudine in virally suppressed patients switching from a TAF-containing, 3-drug regimen

Week 48 results from the TANGO study will be presented this month at 10th International AIDS Society Conference on HIV Science (IAS 2019)

LONDON, UK I July 10, 2019 I ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced positive Week 48 results from its phase III TANGO study. The TANGO study was conducted to assess whether adults living with HIV-1 who had maintained viral suppression for at least six months on a tenofovir alafenamide fumarate (TAF)-containing regimen of at least three drugs, were able to maintain similar rates of viral suppression after switching to the 2-drug regimen (2DR) of dolutegravir plus lamivudine in a fixed dose combination, compared to continuing the TAF-containing regimen.

The study met its primary endpoint for non-inferiority, based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre (c/mL) using the FDA Snapshot algorithm at Week 48. No patients met confirmed virologic withdrawal criteria or developed treatment resistance in the dolutegravir plus lamivudine arm of the study. The safety results for the 2DR of dolutegravir plus lamivudine were consistent with the product labelling for the medicines.1

Full results from the study will be presented at the 10th International AIDS Society Conference on HIV Science (IAS 2019), to be held from 21-24 July in Mexico City.

Kimberly Smith, M.D., Head of Global Research & Medical Strategy at ViiV Healthcare, said:
“When we developed the TANGO study, we asked if virally suppressed people living with HIV could reduce the number of medicines in their HIV treatment regimen while maintaining viral suppression. These Week 48 data clearly indicate that they can – individuals who are already on treatment can maintain viral suppression if they switch from a 3-drug, TAF-containing regimen to a 2-drug regimen of dolutegravir plus lamivudine.”

The single-pill, 2DR of dolutegravir plus lamivudine, was authorised in the United States earlier this year for the treatment of HIV-1 infection in adults with no antiretroviral treatment (ARV) history and with no known resistance to either dolutegravir or lamivudine.2 It was also authorised in Europe in July 2019 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 integrase inhibitor (INI) class, or lamivudine.3

About TANGO
TANGO is a phase III, randomised, open-label, active-controlled, multicentre study to assess the antiviral efficacy and safety of switching to a 2DR consisting of dolutegravir plus lamivudine in HIV-infected adults who are virally suppressed and stable on a TAF-containing regimen. 4

Study participants were HIV-1 infected adults on a TAF-containing regimen with HIV-1 RNA<50c/mL for at least six months, without prior virologic failure, no historical nucleoside reverse transcriptase inhibitors (NRTI) or INI major resistance mutation, and no evidence of hepatitis B infection. Participants were randomised to switch to dolutegravir plus lamivudine or continue on the TAF-containing 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 Intention To Treat-Exposed (ITT-E) population.4

About dolutegravir and lamivudine
Dolutegravir is an INI for use in combination with other antiretroviral agents for the treatment of HIV.5 INIs block 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. Dolutegravir is authorised in over 100 countries across North America, Europe, Asia, Australia, Africa and Latin America.

Lamivudine, commonly known as 3TC, is a nucleoside analogue used in combination with other antiretroviral agents for the treatment of HIV infection. Lamivudine is available in branded (Epivir®) and generic forms.6

Dolutegravir plus lamivudine is a once-daily, single-pill, 2-drug regimen that combines the INI dolutegravir (Tivicay, 50 mg) with the NRTI lamivudine (Epivir, 300 mg).2 The fixed dose combination of dolutegravir plus lamivudine 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,3 and in the US for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either dolutegravir or lamivudine.2

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

Important Safety Information for 50mg dolutegravir/300mg lamivudine tablets in the EU
The following Important Safety Information is based on the Summary of Product Characteristics for dolutegravir plus lamivudine. Please consult the full Summary of Product Characteristics for all the safety information.

Dolutegravir plus lamivudine (50mg dolutegravir/300mg lamivudine)
Dolutegravir plus lamivudine is indicated for the treatment of Human Immunodeficiency Virus type 1 (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 integrase inhibitor class, or lamivudine.

The recommended dose of dolutegravir plus lamivudine in adults and adolescents is one 50 mg/300 mg tablet once daily.

Method of administration

Oral use. Dolutegravir plus lamivudine can be taken with or without food.

Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Dose adjustments

A separate preparation of dolutegravir is available where a dose adjustment is indicated due to drug-drug interactions (e.g. rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St. John’s wort, etravirine (without boosted protease inhibitors), efavirenz, nevirapine, or tipranavir/ritonavir. In these cases the physician should refer to the individual product information for dolutegravir.

Missed doses

If the patient misses a dose of dolutegravir plus lamivudine, the patient should take dolutegravir plus lamivudine as soon as possible, providing the next dose is not due within 4 hours. If the next dose is due within 4 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.

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 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.

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 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2018.

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 www.gsk.com.

References


1 ViiV Healthcare: TANGO headline results. Data on file.

2 Dolutegravir plus lamivudine Prescribing Information. U.S. Approval 8 April 2019. Available at: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Dovato/pdf/DOVATO-PI-PIL.PDF Accessed July 2019

3 Dovato EU Summary of Product Characteristics. July 2019. Available at: https://www.medicines.org.uk/emc/product/10446/smpc Accessed July 2019.

4 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 July 2019

5 Tivicay (dolutegravir) European Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/tivicay-epar-product-information_en.pdf. Accessed July 2019.

6 European Medicines Agency. Epivir (lamivudine) European Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/epivir-epar-product-information_en.pdf Accessed June 2019.

SOURCE: ViiV HealthCare

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