Issued: London, UK
\nViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today presented three-year results from the phase III GEMINI 1 & 2 studies at the HIV Glasgow 2020 congress. Findings showed that the 2-drug regimen (2DR) of dolutegravir plus lamivudine continued to offer non-inferior efficacy, a high genetic barrier to resistance and a comparable safety profile versus a 3-drug regimen of dolutegravir plus two nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), in treatment-naïve adults with HIV-1.[1]
\nPedro Cahn, M.D., Scientific Director, Fundación Huésped, Professor of Infectious Diseases, Buenos Aires University Medical School, and principal investigator for the GEMINI study programme, said: “These long-term data confirm that dolutegravir-based 2-drug regimens have a rightful place in the HIV treatment compendium. Dolutegravir plus lamivudine continues to demonstrate long-term non-inferior efficacy compared to dolutegravir plus TDF/FTC with benefits beyond viral suppression. While overall adverse event rates were similar across the study arms, we saw fewer drug-related adverse events with dolutegravir plus lamivudine. Clinicians who wanted proof that a dolutegravir-based 2-drug regimen works long-term in treatment-naïve adults with HIV now have evidence to show that it does.”
\nA pooled analysis of the two studies showed that dolutegravir plus lamivudine demonstrated non-inferiority, with 82% (584/716) of participants in the Snapshot analysis – Intention to Treat-Exposed (ITT-E) population having HIV-1 RNA <50 copies per millilitre (c/mL) at Week 144, compared with 84% (599/717) of participants receiving a 3-drug regimen of dolutegravir plus TDF/FTC (adjusted difference: -1.8 [95% CI: -5.8%, 2.1%]).[1] Safety and tolerability findings were consistent with previous data.[1],[2]
\nKimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: “Globally, the number of people living with HIV aged 50 and over is increasing and that’s testament to the success of antiretroviral therapy, which has transformed HIV into a chronic condition. However, living longer with HIV can mean taking multiple medications for many years, and we know that many people living with HIV have a preference to take as few medicines as possible, as long as their HIV remains under control. The momentum behind 2DRs is growing: Dovato has now shown sustained efficacy and tolerability through three years of treatment, with people able to maintain viral suppression with fewer medicines than a 3-drug regimen.”
\nDolutegravir plus lamivudine continued to demonstrate a high genetic barrier to treatment-emergent resistance. The percentage of individuals with protocol-defined confirmed virologic withdrawal (CVW) was 1.7% (12/716) in the dolutegravir plus lamivudine arm and 1.3% (9/717) in the dolutegravir plus TDF/FTC arm.[1] None of these participants developed treatment-emergent resistance mutations. One non-CVW participant receiving dolutegravir plus lamivudine with reported non-adherence to treatment developed M184V and R263R/K resistance mutations before discontinuing the study.[1]
\nOverall adverse event (AE) rates were similar between the study arms, with lower rates of drug-related AEs in participants receiving dolutegravir plus lamivudine compared with those receiving dolutegravir plus TDF/FTC (20% [146/716] vs 27% [192/717], respectively).[1] Four deaths occurred (3/716 for dolutegravir plus lamivudine vs 1/717 for dolutegravir plus TDF/FTC), all of which were considered unrelated to the study drug regimen.[1] The study findings showed potential for long-term bone and renal health outcomes, with post-baseline changes in markers of bone and renal function continuing to favour dolutegravir plus lamivudine compared to dolutegravir plus TDF/FTC through Week 144.[1]
\nAbout GEMINI 1 & 2[1],[2],[3],[4]
\nGEMINI 1 (204861) & GEMINI 2 (205543) are duplicate, phase III, randomised, double-blind, multicentre, parallel group, non-inferiority studies, and part of ViiV Healthcare’s innovative clinical trial programme. These studies evaluate a 2-drug regimen of dolutegravir plus lamivudine compared with a 3-drug regimen of dolutegravir plus TDF/FTC in HIV-1 infected, antiretroviral treatment-naïve adult participants with baseline HIV-1 viral loads between 1,000 and 500,000 c/mL. The studies were designed to demonstrate the non-inferior efficacy at Week 48, as well as the safety and tolerability of once-daily dolutegravir plus lamivudine compared to once-daily dolutegravir plus the fixed-dose combination of TDF/FDC in HIV-1-infected, antiretroviral treatment-naïve adult participants. The primary endpoint was the proportion of participants with HIV-1 RNA plasma <50c/mL at Week 48; secondary endpoints included the proportion of participants with HIV-1 RNA plasma <50c/mL at Weeks 24, 96 and 144.
\nFor more information please search for NCT02831673 (GEMINI 1) or NCT02831764 (GEMINI 2) on www.clinicaltrials.gov.
\nAbout Dovato (dolutegravir/lamivudine)[5],[6]
\nDovato 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).
\nDovato (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.
\nLike 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.
\nDovato is approved in the US, Europe, Japan and other countries worldwide. Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
\nImportant 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
\nDOSAGE AND ADMINISTRATION
\nCONTRAINDICATIONS
\nWARNINGS AND PRECAUTIONS
\nADVERSE 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
\nUSE IN SPECIFIC POPULATIONS
\nPlease 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.
\nAbout ViiV Healthcare
\nViiV 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.
\nFor more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.
\nAbout GSK
\nGSK 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/.
\nReferences
\n[1] Cahn P., Sierro Madera J., Arribas J, et al. Durable efficacy of dolutegravir (DTG) plus lamivudine (3TC) in antiretroviral treatment-naïve adults with HIV-1 infection – 3-year results from the GEMINI studies. Presented at HIV Glasgow 2020.
\n[2] Cahn P., Sierro Madera J., Arribas J, et al. Durable efficacy of dolutegravir (DTG) plus lamivudine (3TC) in antiretroviral treatment-naïve adults with HIV-1 infection - 96-week results from the GEMINI studies. Presented at the 10th International AIDS Conference on HIV Science (IAS 2019), 21-24th July 2019, Mexico City, Mexico.
\n[3] Clinical trials.gov. An efficacy, safety, and tolerability study comparing dolutegravir plus lamivudine with dolutegravir plus tenofovir/emtricitabine in treatment naïve HIV infected subjects (Gemini 1). NCT02831673. Available at https://clinicaltrials.gov/ct2/show/NCT02831673?term=204861&rank=1. Accessed September 2020.
\n[4] Clinical trials.gov. An efficacy, safety, and tolerability study comparing dolutegravir (DTG) plus lamivudine (3TC) with dolutegravir plus tenofovir/emtricitabine in treatment naïve HIV infected subjects (Gemini 2). NCT02831764. Available at https://clinicaltrials.gov/ct2/show/NCT02831764?term=NCT02831764&rank=1. Accessed September 2020.
\n[5] Dovato EU Summary of Product Characteristics. July 2019. Available at: https://www.medicines.org.uk/emc/product/10446/smpc. Accessed September 2020.
\n[6] 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.
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