LONDON, England and DURBAN, South Africa, July 18, 2016 /PRNewswire/ --
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"Women account for over half of the almost 35 million adults living with HIV worldwide, yet unfortunately they are consistently under-represented in HIV clinical trials," said John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare. "For this reason, we are committed to ensuring that the specific treatment needs of women are investigated. This trial not only provides physicians with important additional information about Triumeq, it also builds on the strong body of evidence supporting the efficacy of dolutegravir-based regimens in a broad range of patient populations."
The safety profile of dolutegravir/abacavir/lamivudine was favourable compared to ATV/r plus TDF/FTC, with fewer drug-related AEs reported on the dolutegravir/abacavir/lamivudine arm (33% vs 49%); there were also fewer AEs leading to discontinuation compared to those in the ATV/r plus TDF/FTC arm (4% vs 7%).
Drug-related AEs reported in the dolutegravir/abacavir/lamivudine arm included, nausea (31 individuals / 13%), diarrhoea (12 / 5%), headache (5 / 2%) and dyspepsia (4 / 2%). In the ATV/r plus TDF/FTC group, drug-related AEs included nausea (35 / 14%), diarrhoea (18 / 7%), ocular icterus (18 / 7%), dyspepsia (15 / 6%), headache (14 / 6%) and jaundice (13 / 5%).
There were fewer subjects meeting virologic non-response criteria (VL >50c/mL) in the dolutegravir/abacavir/lamivudine arm (6%) compared to the other group (14%) at week 48. Of the women that met protocol-defined virologic withdrawal criteria, none on the dolutegravir/abacavir/lamivudine arm had treatment-emergent resistance mutations to the components of dolutegravir/abacavir/lamivudine, compared with one in the comparator group.
HIV stands for the Human Immunodeficiency Virus. Unlike some other viruses, the human body cannot get rid of HIV, so once someone has HIV they have it for life. There is no cure for HIV, but effective treatment can control the virus so that people with HIV can enjoy healthy and productive lives.
About HIV in women
Globally, HIV/AIDS is the leading cause of death for women of reproductive age (15-44 years old) and infection rates in young women (aged 15-24) are twice as high as those seen in young men. Despite the scale of the challenge, women are routinely under-represented in HIV clinical trials. This may be in part due to lack of child-care services, exclusions from study protocols due to the potential for pregnancy and lack of support in the home. As a result there are gaps in our knowledge about issues regarding antiretroviral treatments that are particular to women.
ARIA study design
ARIA is a phase IIIb randomised, open-label, international, multi-centre study designed to demonstrate the non-inferior antiviral activity of fixed-dose dolutegravir/abacavir/lamivudine (Triumeq) compared with atazanavir boosted with ritonavir (ATV/r) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in treatment-naïve adult women over 48 weeks. While ARIA is a non-inferiority study, there was a pre-specified analysis for superiority. ARIA also evaluated the safety and tolerability of dolutegravir/abacavir/lamivudine compared to ATV/r plus TDF/FTC arm. 495 treatment-naïve adult women were enrolled in the study.
Triumeq is a once-daily dolutegravir-based regimen, containing the un-boosted integrase strand transfer inhibitor (INSTI) dolutegravir and the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine.
Two essential steps in the HIV life cycle are replication - when the virus turns its RNA copy into DNA - and integration - the moment when viral DNA becomes part of the host cell's DNA. These processes require two enzymes called reverse transcriptase and integrase. NRTIs and INSTIs interfere with the action of the two enzymes to prevent the virus from replicating. This decrease in replication will lead to less virus being available to cause subsequent infection of uninfected cells.
The latest data for Triumeq, including the ARIA data presented at IAC 2016, build on existing clinical trial data demonstrating that dolutegravir-based regimens are efficacious and generally well-tolerated in a broad range of people living with HIV (PLHIV), including treatment-naïve, treatment-experienced and those who have developed resistance to multiple HIV drugs.,,,,
Triumeq is a registered trademark of the ViiV Healthcare group of companies.
Important Safety Information (ISI) for Triumeq® (abacavir, dolutegravir, and lamivudine) tablets
Note: this is taken from the US label and local variations apply. Please refer to applicable local labelling.
FDA Indications and Usage: Triumeq is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Limitations of Use:
Triumeq alone is not recommended in patients with:
BOXED WARNING: HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, and EXACERBATIONS OF HEPATITIS B VIRUS (HBV):
Lactic Acidosis and Severe Hepatomegaly with Steatosis:
Exacerbations of Hepatitis B:
Triumeq is contraindicated in patients:
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions to Dolutegravir:
Effects on Serum Liver Biochemistries in Patients with Hepatitis B or C Co-infection:
Use With Interferon- and Ribavirin-based Regimens: Hepatic decompensation, some fatal, has occurred in HIV-1/hepatitis C virus (HCV) co-infected patients receiving combination antiretroviral therapy and interferon alfa with or without ribavirin. Patients receiving interferon alfa with or without ribavirin and Triumeq should be closely monitored.
Immune Reconstitution Syndrome: including the occurrence of autoimmune disorders with variable time to onset, has been reported.
Fat Redistribution or accumulation has been observed in patients receiving antiretroviral therapy.
Myocardial Infarction (MI):
Use With Certain Antiretroviral Products: Triumeq should not be administered concomitantly with other products containing abacavir or lamivudine.
ADVERSE REACTIONS: The most commonly reported (?2%) adverse reactions of at least moderate intensity in treatment-naïve adults receiving Triumeq were insomnia (3%), headache (2%), and fatigue (2%).
USE IN SPECIFIC POPULATIONS
Full US Prescribing Information for Triumeq is available at: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Triumeq/pdf/TRIUMEQ-PI-MG.PDF
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. Shionogi (TYO: 4507) joined in October 2012. The company's aim is 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 new HIV medicines, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit http://www.viivhealthcare.com
1. C. Orell et al. Superior efficacy of dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) fixed dose combination (FDC) compared with ritonavir (RTV) boosted atazanavir (ATV) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in treatment-naïve women with HIV-1 infection (ARIA Study). Presented at the International AIDS Conference (IAC), 18-22 July 2016, Durban, South Africa. Abstract #10215.
2. World Health Organization (WHO). 2016. HIV/AIDS media fact sheet. Available at: http://www.who.int/mediacentre/factsheets/fs360/en/ Last accessed July 2016.
3. UNAIDS, 2016-2021 Strategy On the Fast-Track to end AIDS. Available at: http://www.unaids.org/sites/default/files/media_asset/20151027_UNAIDS_PCB37_15_18_EN_rev1.pdf Last accessed July 2016.
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5. Curno, J. Mirjam et al. A Systematic Review of the Inclusion (or Exclusion) of Women in HIV Research: From Clinical Studies of Antiretrovirals and Vaccines to Cure Strategies. Journal of Acquired Immune Deficiency Syndromes (JAIDS). 2016 Feb 1;71(2):181-8.
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7. Raffi F, Jaeger H, Quiros-Roldan E, Albrecht H, Belonosova E, Gatell JM, Baril J-G, Domingo P, Brennan C, Almond S, Min S, for the SPRING-2 Study Group. Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral-naive adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, non-inferiority trial. Lancet Infect Dis. 2013;13(11):927-935.
8. Walmsley S, Baumgarten A, Berenguer J, et al. Brief Report: Dolutegravir plus abacavir/lamivudine for the treatment of HIV-1 infection in Antiretroviral therapy-naïve patients: Week 96 and Week 144 Results from the SINGLE randomized clinical trial. Journal of Acquired Immune Deficiency Syndromes (JAIDS). 2015;70(5):515-519.
9. Molina J, et al. Once-daily dolutegravir versus darunavir plus ritonavir for treatment-naive adults with HIV-1 infection (FLAMINGO): 96 week results from a randomised, open-label, phase 3b study. Lancet HIV. 2015;2:e127-136.
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11. Castagna S, et al. Dolutegravir in antiretroviral-experienced patients with raltegravir- and/or elvitegravir-resistant HIV-1: 24-week results of the Phase III VIKING-3 study. J Infect Dis. 2014;210:354-62.
12. Triumeq® (dolutegravir/abacavir/lamivudine) US prescribing information. Available at: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Triumeq/pdf/TRIUMEQ-PI-MG.PDF
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