LONDON, England and DURBAN, South Africa, July 18, 2016 /PRNewswire/ --
ViiV Healthcare today presented 48-week data from the phase IIIb, open-label, international, multi-centre ARIA study which showed superior efficacy for Triumeq(R) (dolutegravir/abacavir/lamivudine) compared with atazanavir boosted with ritonavir (ATV/r) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in 495 treatment-naive women living with HIV. Results show statistically superior viral suppression (HIV-1 RNA 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-naive 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-naive 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-naive, 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(R) (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:
- Current or past history of resistance to any components of Triumeq
- Resistance-associated integrase substitutions or clinically suspected INSTI resistance
because the dose of dolutegravir in Triumeq is insufficient in these subpopulations.
See full prescribing information for dolutegravir
BOXED WARNING: HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, and EXACERBATIONS OF HEPATITIS B VIRUS (HBV):
- Serious and sometimes fatal hypersensitivity reactions have occurred with
- Hypersensitivity to abacavir is a multi-organ clinical syndrome
- Patients who carry the HLA-B*5701 allele are at a higher risk of experiencing a
hypersensitivity reaction to abacavir; although, hypersensitivity reactions have
occurred in patients who do not carry the HLA-B*5701 allele
- Triumeq is contraindicated in patients with a prior hypersensitivity reaction to
abacavir and in HLA-B*5701-positive patients. All patients should be screened for the
HLA-B*5701 allele prior to initiating therapy or reinitiation of therapy with Triumeq,
unless patients have a previously documented HLA-B*5701 allele assessment
- Discontinue Triumeq as soon as hypersensitivity reaction is suspected. Regardless of
HLA-B*5701 status, permanently discontinue Triumeq if hypersensitivity cannot be ruled
out, even when other diagnoses are possible
- Following a hypersensitivity reaction to Triumeq, NEVER restart Triumeq or any other
Lactic Acidosis and Severe Hepatomegaly with Steatosis:
- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases,
have been reported with the use of nucleoside analogues
Exacerbations of Hepatitis B:
- Severe acute exacerbations of HBV have been reported in patients who are
co-infected with HBV and HIV-1 and have discontinued lamivudine, a component of
Triumeq. Monitor hepatic function closely in these patients and, if appropriate,
initiate anti-hepatitis B treatment
Triumeq is contraindicated in patients:
- who have the HLA-B*5701 allele
- with prior hypersensitivity reaction to abacavir, dolutegravir, or lamivudine
- receiving dofetilide (antiarrhythmic)
- with moderate or severe hepatic impairment
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions to Dolutegravir:
- Hypersensitivity reactions have been reported and were characterized by rash,
constitutional findings, and sometimes organ dysfunction, including liver injury. The
events were reported in