Risks and Side Effects

Contraindications:

TIVICAY is contraindicated in patients:

  • with previous hypersensitivity reaction to dolutegravir
  • receiving dofetilide (antiarrhythmic)

Hypersensitivity Reactions

  • 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 in Phase 3 clinical trials
  • Discontinue TIVICAY and other suspect agents immediately if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. Monitor clinical status, including liver aminotransferases, and initiate appropriate therapy if hypersensitivity reaction is suspected

Hepatotoxicity:

  • Patients with underlying hepatitis B or C 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reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn
  • Cases of hepatic toxicity, including elevated serum liver biochemistries, hepatitis, and acute liver failure, have also been reported in patients receiving a dolutegravir-containing regimen who had no pre-existing hepatic disease or other identifiable risk factors. Drug-induced liver injury leading to liver transplant has been reported with TRIUMEQ (abacavir, dolutegravir, and lamivudine)
  • Monitoring for hepatotoxicity is recommended

Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:

The 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.

SINGLE, SPRING-2, and FLAMINGO—Grades 2 to 4 treatment-emergent adverse drug reactions (≥2% frequency)1

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.

Grade 1 insomnia rates:

  • 1% and <1% in patients receiving TIVICAY and raltegravir, respectively
  • These events were not treatment limiting

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

Grade 1 insomnia rates:

  • 1% and 2% in patients receiving TIVICAY and darunavir/ritonavir, respectively1
  • These events were not treatment limiting

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

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


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

SAILING—Grades 2 to 4 treatment-emergent adverse drug reactions

  • At 48 weeks, 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 raltegravir 400 mg twice daily + BR

BR was investigator selected and consisted of up to 2 agents including at least 1 fully active agent.

BR=background regimen.

Please see full Prescribing Information for TIVICAY.

Reference

  1. Data on file. ViiV Healthcare group of companies. Research Triangle Park, NC.