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EFFICACY AND RESISTANCE

GILEAD-SPONSORED TRIAL—STUDY 1490: SEE HOW A DOLUTEGRAVIR-BASED REGIMEN COMPARED WITH A BICTEGRAVIR-BASED REGIMEN1,2

A randomized, double-blind, multicenter, active-controlled, noninferiority trial in 645 treatment-naïve (≥18 years) patients with HIV-1. Study 1490 was designed to assess whether BIC/FTC/TAF was noninferior to DTG+FTC/TAF

Baseline characteristics
Mean age was 37 years; 88% of patients were male, 31% were of African American/African heritage, 59% were white, 12% had HIV-1 RNA >100,000 copies/mL, 12% had CD4+ T-cell counts <200 cells/mm³, 4% had hepatitis B and/or C virus coinfection, and 8% were CDC Class C (AIDS)

Primary endpoint
Proportion of participants with plasma HIV-1 RNA <50 copies/mL at Week 48, with a prespecified noninferiority margin of –12%

Virologic Response

noninferior RESULT

BIC/FTC/TAF vs DTG + FTC/TAF at 96 weeks in treatment-naїve patients3

TREATMENT DIFFERENCE (–2.3% [95% CI; –7.9%, 3.2%])3

*As of December 2019, data from the 144 week timepoint have been collected, but have not yet been published in a peer-reviewed journal.

Virologic Response in Patients
With High Baseline Viral Load3

Subgroup analysis

Virologic response (HIV-1 RNA <50 copies/mL) stratified by baseline viral load

Virologic Response in Patients
With low Baseline Viral Load3

Subgroup analysis

Virologic response (HIV-1 RNA <50 copies/mL) stratified by baseline viral load

Resistance Results

High barrier to resistance with dolutegravir is supported by 96-week results in STUDY 14903

In Study 1490, no patients in either treatment arm had treatment-emergent resistance to study drugs in the resistance analysis data set with confirmed HIV-1 RNA ≥200 copies/mL at failure or study drug discontinuation.

Number of patients with treatment-emergent INSTI substitutions based on the resistance analysis data set through 96 weeks³

BIC=bictegravir; CDC=Centers for Disease Control and Prevention; CI=confidence interval; DTG=dolutegravir; FTC=emtricitabine; INSTI=integrase strand transfer inhibitor; NRTI=nucleoside reverse transcriptase inhibitor; TAF=tenofovir alafenamide.

References: 1. Sax PE, Pozniak A, Montes ML, et al. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380–1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet. 2017;390(10107):2073-2082. 2. BIKTARVY [package insert]. Foster City, CA: Gilead Sciences, Inc; 2018. 3. Stellbrink H-J, Arribas JR, Stephens JL, et al. Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019;6(6):e364-e372.

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IMPORTANT SAFETY INFORMATION

Contraindications

Do not use TIVICAY or TIVICAY PD in patients with previous hypersensitivity reaction to dolutegravir
Do not use TIVICAY or TIVICAY PD in patients receiving dofetilide

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IMPORTANT SAFETY INFORMATION

Contraindications

Do not use TIVICAY or TIVICAY PD in patients with previous hypersensitivity reaction to dolutegravir
Do not use TIVICAY or TIVICAY PD in patients receiving dofetilide

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
Discontinue dolutegravir immediately if signs or symptoms of hypersensitivity reaction 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 dolutegravir. 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
Monitoring for hepatotoxicity is recommended

Embryo-Fetal Toxicity:

Assess the risks and benefits of TIVICAY and TIVICAY PD 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 due to the risk of neural tube defects
Pregnancy testing is recommended before use of TIVICAY or TIVICAY PD. 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 dolutegravir 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 dolutegravir

Different Formulations Are Not Interchangeable:
TIVICAY and TIVICAY PD are not bioequivalent and are not interchangeable on a milligram-per-milligram basis. If a patient switches from one formulation to the other, the dose must be adjusted

Adverse reactions

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

Drug interactions

Consult the full Prescribing Information for more information on potentially significant drug interactions
Drugs that induce or inhibit UGT1A1 and/or CYP3A may affect plasma concentrations of dolutegravir
Administer TIVICAY or TIVICAY PD 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, TIVICAY 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 dolutegravir 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 continuing TIVICAY and TIVICAY PD 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 TIVICAY or TIVICAY PD. Counsel adolescents and adults of childbearing potential taking TIVICAY or TIVICAY PD on the consistent use of effective contraception

indication-target

INDICATION

TIVICAY and TIVICAY PD are human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitors (INSTIs) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced, but INSTI-naïve) aged ≥4 weeks and weighing ≥3 kg

TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for ≥6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent

Please see full Prescribing Information for TIVICAY and TIVICAY PD.

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To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at
1-877-844-8872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

GILEAD is a trademark of Gilead Sciences, Inc.
All other trademarks are owned

by or licensed to the ViiV Healthcare group of companies. This site is funded and developed by ViiV Healthcare. This site is intended for US healthcare professionals only. ©2021 ViiV Healthcare or licensor. DLTWCNT200012 January 2021 Produced in USA.

EFFICACY AND RESISTANCE

GILEAD-SPONSORED TRIAL—STUDY 1490: SEE HOW A DOLUTEGRAVIR-BASED REGIMEN COMPARED WITH A BICTEGRAVIR-BASED REGIMEN1,2

Virologic Response

Virologic Response in Patients With High Baseline Viral Load3

Virologic Response in Patients With low Baseline Viral Load3

Resistance Results

High barrier to resistance with dolutegravir is supported by 96-week results in STUDY 14903

Number of patients with treatment-emergent INSTI substitutions based on the resistance analysis data set through 96 weeks3

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Virologic Response in Patients
With High Baseline Viral Load3

Virologic Response in Patients
With low Baseline Viral Load3

Number of patients with treatment-emergent INSTI substitutions based on the resistance analysis data set through 96 weeks³