Treatment-experienced trial _ tivicay® (dolutegravir) 50 mg tablets

• What is the most important information I should know about TIVICAY?

• What should I tell my healthcare provider before taking TIVICAY?

• General information about the safe and effective use of TIVICAY

• Baseline characteristics: Median age was 43 years; 68% of patients were male, 42% were of African American/African heritage, 50% were white, 20% had HIV-1 RNA >100,000 copies/mL, 72% had CD4 +T-cell counts <350 cells/mm 3, 16% had hepatitis B and/or C virus co-infection, and 46% were CDC Class C (AIDS)

• Primary endpoint: Proportion of patients with HIV-1 RNA <50 copies/mL at Week 48 (FDA snapshot analysis with 12% noninferiority margin with prespecified tests for superiority)

• Baseline resistance prior to ART: 100% of patients had at least 2-class resistance and 49% were resistant to ≥3 classes

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

†Four patients were excluded from the efficacy and safety analyses: 3 from the arm receiving TIVICAY and 1 from the raltegravir arm due to good clinical practices noncompliance at one site.

INSTI=integrase strand transfer inhibitor; BR=background regimen; CDC=Centers for Disease Control and Prevention; ART=antiretroviral therapy; r=ritonavir; TDF=tenofovir.

You are encouraged to report negative side effects of prescription drugs to the FDA.

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The makers of these brands are not affiliated with and do not endorse the ViiV Healthcare group of companies or its products.

TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 30 kg.

• Use of TIVICAY in INSTI-experienced patients should be guided by the number and type of baseline INSTI substitutions. Women’s health associates columbia mo The efficacy of TIVICAY 50 mg twice daily is reduced in patients with an INSTI-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions including T66A, L74I/M, E138A/K/T, G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R

• Hypersensitivity reactions have been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. Health care premium 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. Health insurance help Monitor clinical status, including liver aminotransferases, and initiate appropriate therapy if hypersensitivity reaction is suspected

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 TIVICAY. Healthcare journal 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 TIVICAY are recommended in patients with underlying hepatic disease such as hepatitis B or C

• Coadministration of TIVICAY with certain inducers of UGT1A and/or CYP3A may reduce plasma concentrations of dolutegravir and require dose adjustments of TIVICAY

• Administer TIVICAY 2 hours before or 6 hours after taking polyvalent cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Comprehensive health care Alternatively, TIVICAY and supplements containing calcium or iron can be taken with food

• Consult the full Prescribing Information for TIVICAY for more information on potentially significant drug interactions, including clinical comments

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