ARIA Study Shows Superior Efficacy of Triumeq® for Treatment-naïve Women Living with HIV (2)

- 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

CONTRAINDICATIONS 

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 <1% of subjects receiving TIVICAY(R) in Phase 3 clinical
trials
- Clinically, it is not possible to determine whether a hypersensitivity reaction with
Triumeq would be caused by abacavir or dolutegravir. Discontinue Triumeq and other
suspect agents immediately if signs or symptoms of hypersensitivity reaction develop

Effects on Serum Liver Biochemistries in Patients with Hepatitis B or C Co-infection: 

- Patients with underlying hepatitis B or C may be at increased risk for worsening
or development of transaminase elevations with use of Triumeq. In some cases the
elevations in transaminases were consistent with immune reconstitution syndrome or
hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was
withdrawn
- Appropriate laboratory testing prior to initiating therapy and monitoring for
hepatotoxicity during therapy with Triumeq are recommended in patients with underlying
hepatic disease such as hepatitis B or C  

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): 

- An observational study showed an increase in MI with abacavir; a sponsor-conducted,
pooled analysis did not show increased risk. In totality, the available data are
inconclusive
- The underlying risk of coronary heart disease should be considered when prescribing
antiretroviral therapies, including abacavir, and action taken to minimize all
modifiable risk factors (eg, hypertension, hyperlipidemia, diabetes mellitus, smoking)

Use With Certain Antiretroviral Products: Triumeq should not be administered concomitantly with other products containing abacavir or lamivudine.

ADVERSE REACTIONS: The most commonly reported (greater than or equal to2%) adverse reactions of at least moderate intensity in treatment-naive adults receiving Triumeq were insomnia (3%), headache (2%), and fatigue (2%).

DRUG INTERACTIONS 

- Co-administration of Triumeq with certain inducers of UGT1A and/or CYP3A may
reduce plasma concentrations of dolutegravir. Consult the full Prescribing Information
for Triumeq for more information
- Administer Triumeq 2 hours before or 6 hours after taking polyvalent cation-containing
antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or
buffered medications. Alternatively, Triumeq and supplements containing calcium or
iron can be taken with food

USE IN SPECIFIC POPULATIONS 

- Pregnancy Category C: Triumeq should be used during pregnancy only if the
potential benefit justifies the potential risk. An Antiretroviral Pregnancy Registry
has been established
- Nursing Mothers: Breastfeeding is not recommended due to the potential for HIV
transmission and the potential for adverse reactions in nursing infants
- Patients with Impaired Renal Function: Triumeq is not recommended in patients with
creatinine clearance <50 mL/min
- Patients with Impaired Hepatic Function: If a dose reduction of abacavir, a component
of Triumeq, is required for patients with mild hepatic impairment, then the individual
components should be used

Full US Prescribing Information for Triumeq is available at: https://www.gsksource.com/pharma/content...

About ViiV Healthcare 

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline and Pfizer 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-naive 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/factsheet...  Last accessed July 2016. 

3. UNAIDS, 2016-2021 Strategy On the Fast-Track to end AIDS. Available at: http://www.unaids.org/sites/default/file...  Last accessed July 2016. 

4. UNAIDS Factsheet - Adolescents, young people and HIV. Available at: http://www.unaids.org/sites/default/file... Last accessed July 2016. 

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. 

6. ClinicalTrials.gov (NCT01910402). Available at: https://clinicaltrials.gov/ct2/show/NCT0...  Last accessed June 2016. 

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. 

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