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Triumeq HCP
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Clinical Trial Results

  • Trial Designs
  • Virologic Response
  • Resistance Results
  • Discontinuations Due to AEs
  • Adverse Drug Reactions

Risks and Side Effects

  • Risks and Side Effects

HLA-B✶5701 Screening

  • Importance of HLA-B✶5701
    Screening
  • HLA-B✶5701 Clinical Studies
  • PREDICT-1 HLA-B✶5701
    Clinical Study
  • ARIES HLA-B✶5701
    Clinical Study
  • SHAPE HLA-B✶5701
    Clinical Study
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Triumeq HCP

Clinical
Trial
Results

  • Trial Designs
  • Virologic Response
  • Resistance Results
  • Discontinuations
    Due to AEs
  • Adverse Drug Reactions

For HLA-B*5701-negative adult patients with HIV-1. See Full Indication.

Trial Designs

TRIUMEQ in the SINGLE Trial1

  • Baseline characteristics: Median age was 35 years, 84% of patients were male, 24% were of African American/African heritage, 68% were white, 32% had HIV-1 RNA >100,000 copies/mL, 53% had CD4+ T-cell counts <350 cells/mm3, 7% had hepatitis C virus co-infection,† and 4% were CDC Class C (AIDS)
  • Primary endpoint: Proportion of patients with HIV-1 RNA <50 copies/mL at Week 48 using FDA snapshot analysis with 10% noninferiority margin with prespecified tests for superiority

✶Patients received 1 dolutegravir 50-mg tablet and fixed-dose ABC/3TC. This regimen is bioequivalent to 1 TRIUMEQ tablet under fasted conditions.

†Hepatitis B virus co-infection was an exclusion criterion. 

CrCl=creatinine clearance; TDF/FTC=tenofovir/emtricitabine; CDC=Centers for Disease Control and Prevention; ABC/3TC=abacavir/lamivudine.

TRIUMEQ in the ARIA Trial2

  • Baseline characteristics: Median age was 37 years, 100% of patients were female, 42% were of African American/African heritage, 45% were white, 7% had hepatitis C virus co-infection,*4% were CDC Class C (AIDS), 27% had HIV-1 RNA >100,000 copies/mL, and 51% had CD4+ T-cell counts <350 cells/mm3
  • Primary endpoint: Proportion of patients with HIV-1 RNA <50 copies/mL at Week 48 using FDA snapshot analysis with 12% noninferiority margin with prespecified tests for superiority

✶Hepatitis B virus co-infection was an exclusion criterion.

CrCl=creatinine clearance; TDF/FTC=tenofovir/emtricitabine; CDC=Centers for Disease Control and Prevention.

Virologic Response

Statistically superior long-term result with TRIUMEQ vs efavirenz/TDF/FTC at week 1441,3

  • Treatment difference (8.3% [95% CI; 2.0%, 14.6%]) was driven primarily by rates of discontinuation due to adverse events (4% for TRIUMEQ vs 14% for efavirenz/TDF/FTC)

Booster-free TRIUMEQ showed a statistically superior virologic response at 48 weeks vs a regimen with atazanavir/ritonavir2,3

  • Treatment difference (10.5% [95% CI; 3.1%, 17.8%]) was driven primarily by a lower rate of virologic nonresponse (6% for TRIUMEQ vs 14% for atazanavir/ritonavir + TDF/FTC) and discontinuations due to adverse events or death (4% and 7%, respectively)
  • Direct comparisons across trials should not be made due to differing trial designs

Resistance Results

144-Week Results From the SINGLE Trial Support a High Barrier to Resistance With TRIUMEQ3

In SINGLE, no patients receiving TRIUMEQ had detectable decreases in susceptibility to the components of TRIUMEQ (dolutegravir, abacavir, or lamivudine) in the resistance analysis data set (n=11 with confirmed HIV-1 RNA >400 copies/mL at failure or last visit and having resistance data).

Number of patients with treatment-emergent INSTI, NNRTI, or NRTI substitutions with decreased susceptibility to ARVs studied based on the resistance analysis data set through 144 weeks3

INSTI=integrase strand transfer inhibitor; NNRTI=non-nucleoside reverse transcriptase inhibitor; NRTI=nucleoside reverse transcriptase inhibitor; ARV=antiretroviral.

  • While there were no detectable decreases in susceptibility to the components of TRIUMEQ (abacavir, dolutegravir, or lamivudine), 2 patients with virologic failure assigned to TRIUMEQ had treatment-emergent G/D/E193D and G193G/E integrase substitutions at Week 84 and Week 108, respectively, and 1 subject with 275 copies/mL HIV-1 RNA had a treatment-emergent Q157Q/P integrase substitution detected at Week 24

48-Week Results From the ARIA Trial Support a High Barrier to Resistance With TRIUMEQ3

In ARIA, no patients receiving TRIUMEQ had detectable decreases in susceptibility to the components of TRIUMEQ (abacavir, dolutegravir, or lamivudine) in the resistance analysis data set (n=6 with 2 consecutive assessments of plasma HIV-1 RNA ≥400 copies/mL at failure or last visit and having resistance data).

Number of patients with treatment-emergent INSTI, PI, or NRTI substitutions with decreased susceptibility to ARVs studied based on the resistance analysis data set through 48 weeks3

INSTI=integrase strand transfer inhibitor; PI=protease inhibitor; NRTI=nucleoside reverse transcriptase inhibitor; ARV=antiretroviral.

  • Direct comparisons across trials should not be made due to differing trial designs

Discontinuations Due to AEs

Proportion of patients who discontinued due to adverse events1,3

Proportion of patients who discontinued due to adverse events2,3

  • Direct comparisons across trials should not be made due to differing trial designs

Adverse Drug Reactions (ADRs)

Grades 2 to 4 treatment-emergent ADRs (≥2% frequency)3

Grade 1 insomnia rates: 

  • 7% and 4% in patients receiving TRIUMEQ and efavirenz/TDF/FTC, respectively

‡Includes pooled terms: rash, rash generalized, rash macular, rash maculopapular, rash pruritic, and drug eruption.

Grades 2 to 4 treatment-emergent ADRs (≥2% frequency)3

†Includes rash, rash generalized, rash maculopapular, rash papular; and rash pruritic.

  • Direct comparisons across trials should not be made due to differing trial designs

Please see full Prescribing Information, including Boxed Warning and Medication Guide, for TRIUMEQ.

References

  1. Walmsley S, Baumgarten A, Berenguer J, et al. Dolutegravir plus abacavir/lamivudine for the treatment of HIV-1 infection in antiretroviral therapy-naive patients: week 96 and week 144 results from the SINGLE randomized clinical trial. J Acquir Immune Defic Syndr. 2015;70(5):515-519.
  2. Orrell C, Hagins DP, Belonosova E, et al; on behalf of the ARIA Study Team. Fixed-dose combination dolutegravir, abacavir, and lamivudine versus ritonavir-boosted atazanavir plus tenofovir disoproxil fumarate and emtricitabine in previously untreated women with HIV-1 infection (ARIA): week 48 results from a randomised, open-label, non-inferiority, phase 3 study. Lancet HIV. 2017;4(12):e536-e546.
  3. Data on file. ViiV Healthcare group of companies. Research Triangle Park, NC.

DALWCNT190006

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contact ViiV Healthcare at
1-877-844-8872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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©2021 ViiV Healthcare or licensor. DALWCNT210014 April 2021 Produced in USA.

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INDICATION

TRIUMEQ is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients weighing at least 40 kg.

Limitations of Use:

TRIUMEQ alone is not recommended in patients with resistance-associated integrase substitutions or clinically suspected integrase strand transfer inhibitor (INSTI) resistance because the dose of dolutegravir in TRIUMEQ is insufficient in these subpopulations. See full prescribing information for TIVICAY (dolutegravir).

IMPORTANT SAFETY INFORMATION

BOXED WARNING: HYPERSENSITIVITY REACTIONS AND EXACERBATIONS OF HEPATITIS B VIRUS (HBV)

Hypersensitivity Reactions:

  • Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir-containing products
  • 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 abacavir-containing product

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

  • Do not use TRIUMEQ in patients who have the HLA-B✶5701 allele
  • Do not use TRIUMEQ in patients with previous hypersensitivity reaction to abacavir, dolutegravir, or lamivudine
  • Do not use TRIUMEQ in patients receiving dofetilide
  • Do not use TRIUMEQ in patients with moderate or severe hepatic impairment

Warnings and precautions

Hypersensitivity Reactions:

  • Hypersensitivity reactions have been reported with dolutegravir and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury
  • Clinically, it is not possible to determine whether a hypersensitivity reaction with TRIUMEQ would be caused by abacavir or dolutegravir
  • Discontinue TRIUMEQ immediately if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated

Hepatotoxicity:

  • Hepatic adverse events have been reported, including cases of hepatic toxicity (elevated serum liver biochemistries, hepatitis, and acute liver failure), in patients receiving a dolutegravir-containing regimen without pre-existing hepatic disease or other identifiable risk factors
  • Patients with underlying hepatitis B or C or marked elevations in transaminases prior to treatment 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
  • Drug-induced liver injury leading to liver transplant has been reported with TRIUMEQ
  • Monitoring for hepatotoxicity is recommended

Lactic Acidosis and Severe Hepatomegaly With Steatosis:

Fatal cases have been reported with the use of nucleoside analogues, including abacavir and lamivudine. Discontinue TRIUMEQ if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Embryo-Fetal Toxicity:

  • Assess the risks and benefits of TRIUMEQ and discuss with the patient to determine if alternative treatments should be considered at the time of conception through the first trimester of pregnancy due to the risk of neural tube defects
  • Pregnancy testing is recommended before use of TRIUMEQ. Adolescents and adults of childbearing potential should be counseled on the consistent use of effective contraception

Adverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of TRIUMEQ and other drugs may occur (see Contraindications and Drug Interactions).

Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of TRIUMEQ.

Myocardial Infarction (MI):

  • Several observational studies have reported an association with the use of abacavir and the risk of MI; meta-analyses of randomized controlled clinical trials did not show increased risk. To date, there is no established biological mechanism to explain a potential increase in risk. In totality, the available data show inconsistency; therefore, evidence for a causal relationship between abacavir and the risk of MI is 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)

Adverse reactions

The most common adverse reactions (incidence ≥2%, Grades 2-4) in treatment-naïve adults receiving TRIUMEQ were insomnia (3%), headache (2%), and fatigue (2%).

Drug interactions

  • Consult the full Prescribing Information for TRIUMEQ for more information on potentially significant drug interactions
  • Drugs that induce or inhibit CYP3A or UGT1A1 may affect plasma concentrations of dolutegravir
  • Administer TRIUMEQ 2 hours before or 6 hours after taking antacids, polyvalent cation-containing products 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: There are insufficient human data on the use of TRIUMEQ during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage. An Antiretroviral Pregnancy Registry has been established. Advise adolescents and adults of childbearing potential of the potential risk of neural tube defects. Assess the risks and benefits of TRIUMEQ and discuss with the patient to determine if an alternative treatment should be considered at the time of conception through the first trimester of pregnancy or if pregnancy is confirmed in the first trimester
  • Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant
  • Females and Males of Reproductive Potential: Pregnancy testing is recommended before initiation of TRIUMEQ. Counsel adolescents and adults of childbearing potential taking TRIUMEQ on the consistent use of effective contraception
  • Impaired Renal Function: TRIUMEQ is not recommended for patients with creatinine clearance <30 mL/min. Patients with a sustained creatinine clearance between 30 and 49 mL/min should be monitored for hematologic toxicities, which may require a dosage adjustment of lamivudine as an individual component
  • Impaired Hepatic Function: If a dose reduction of abacavir is required for patients with mild hepatic impairment, then the individual components of TRIUMEQ should be used

INDICATION

TRIUMEQ is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients weighing at least 40 kg.

Limitations of Use:

TRIUMEQ alone is not recommended in patients with resistance-associated integrase substitutions or clinically suspected integrase strand transfer inhibitor (INSTI) resistance because the dose of dolutegravir in TRIUMEQ is insufficient in these subpopulations. See full prescribing information for TIVICAY (dolutegravir).

Please see full Prescribing Information, including Boxed Warning and Medication Guide, for TRIUMEQ.


DALWCNT210018