For HIV-1. See Full Indication.

RISK AND SIDE EFFECTS OF TIVICAY

Contraindications:

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

Hypersensitivity Reactions:

  • Hypersensitivity reactions have been reported with dolutegravir and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury
  • Discontinue TIVICAY 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 TIVICAY. 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reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn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

Embryofetal Toxicity:

  • Alternative treatments to TIVICAY should be considered at the time of conception through the first trimester of pregnancy due to the risk of neural tube defects
  • Perform pregnancy testing before use of TIVICAY and counsel that consistent use of effective contraception is recommended while using TIVICAY in adolescents and adults of childbearing potential

Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of TIVICAY and other drugs may result in known or potentially significant drug interactions (see Contraindications or Drug Interactions).

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

TREATMENT-NAÏVE STUDIES

ADVERSE DRUG REACTIONS

SINGLE

SPRING-2

FLAMINGO

STUDY 1490

Grades 2 to 4 treatment-emergent ADRs
(≥2% frequency in either treatment arm)1,2

Grade 1 insomnia rates
7% and 4% in patients receiving TIVICAY and efavirenz/TDF/FTC, respectively
These events were not treatment limiting 

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

Grades 2 to 4 treatment-emergent ADRs2,3*

Grade 1 insomnia rates
1% or <1% in patients receiving TIVICAY and raltegravir, respectively
These events were not treatment limiting 

*From table 3 of the full PI for TIVICAY

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

Grades 2 to 4 treatment-emergent ADRs
(≥2% frequency in either treatment arm)2

Grade 1 insomnia rates2
1% and 2% in patients receiving TIVICAY and darunavir/ritonavir, respectively
These events were not treatment limiting 

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

Adverse reactions (all Grades)
(≥2% frequency in either treatment arm) through 96 weeks5,6

DISCONTINUATIONS DUE TO AEs

Proportion of patients who discontinued due to
AEs in treatment-naïve trials1-5

Treatment-Experienced Study

ADVERSE DRUG REACTIONS

SAILING—Grades 2 to 4 treatment-emergent
adverse drug reactions (≥2% frequency) through 48 weeks2,7

The only treatment-emergent adverse drug reaction of moderate to severe intensity with at least 2% frequency in either treatment group was diarrhea, 2% (6 of 354) in patients receiving TIVICAY 50 mg once daily + BR and 1% (5 of 361) in patients receiving
RAL 400 mg twice daily + BR

DISCONTINUATIONS DUE TO AEs
THROUGH 48 WEEKS

Proportion of patients who discontinued due to AEs
in a treatment-experienced, INSTI-naïve trial7

BR was investigator selected and consisted of up to 2 agents including at least 1 fully active agent. Most common BRs: darunavir/r + TDF, lopinavir/r + TDF, darunavir/r + etravirine, lopinavir/r, atazanavir/r + TDF, darunavir/r + maraviroc.

ADRs=adverse drug reactions; ABC=abacavir; 3TC=lamivudine; TDF=tenofovir disoproxil fumarate; FTC=emtricitabine; TAF=tenofovir alafenamide; DTG=dolutegravir; BIC=bictegravir; AEs=adverse events; BR=background regimen; INSTI=integrase strand transfer inhibitor.

References1. 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. Data on file, ViiV Healthcare. 3. Raffi F, Jaeger H, Quiros-Roldan E, et al; on behalf of 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. 4. Molina J-M, Clotet B, van Lunzen J, et al. Once-daily dolutegravir versus darunavir plus ritonavir for treatment-naive adults with HIV-1 infection (FLAMINGO): 96 week results from a randomized, open-label, phase 3b study. Lancet HIV. 2015;2(4):e127-e136. 5. 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. 6. BIKTARVY [package insert]. Gilead Sciences, Inc.; Foster City, CA: February 2018. 7. Cahn P, Pozniak AL, Mingrone H, et al; on behalf of the extended SAILING Study Team. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet. 2013;382(9893):700-708.

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