Adverse Reactions

The safety and tolerability of STRIBILD were established in 144-week studies of adults who had no antiretroviral treatment history and in 48-week studies of virologically suppressed adults who switched to STRIBILD.

Treatment-Naive Studies: Safety and tolerability profile through 144 weeks

The adverse reaction rates for STRIBILD are based on pooled data from 701 subjects in Study 102 and Study 103.

Study drug-related, treatment emergent adverse events (all severity grades) reported in ≥5% of subjects through 144 weeks1

STRIBILD adverse events

Studies 103 and 102 also assessed the proportion of subjects who discontinued treatment with STRIBILD vs ATV + RTV + FTC/TDF and EFV/FTC/TDF, respectively.

Treatment-Naive Studies: Discontinuation rates due to adverse events1


Discontinuation rates due to adverse events

Switch Studies: Safety and tolerability profile through 48 weeks

Switch Studies: Adverse reactions in patients who switched to STRIBILD


  • No new adverse reactions to STRIBILD through week 48 were identified in stably suppressed subjects switching to STRIBILD from a regimen containing an RTV-boosted protease inhibitor PI or an NNRTI1
  • The frequency of adverse reactions (all grades) was 24% in subjects switching to STRIBILD compared to 6% of subjects in either group who stayed on their baseline antiretroviral regimen1
  • Overall, most adverse reactions were grade 1 in severity; grade 2 to 4 adverse reactions were 5% in subjects who switched to STRIBILD and 1% in either group who stayed on their baseline ARV regimen2
  • Common adverse reactions that occurred in ≥2% of subjects switching to STRIBILD were nausea (4%), flatulence (2%), and headache (2%)1

Switch Studies: Discontinuation rates due to adverse events


Switch Study discontinuation rates


Important Safety Information

BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH
STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate (tenofovir DF), a component of STRIBILD, in combination with other antiretrovirals.
  • STRIBILD is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of STRIBILD have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued emtricitabine or tenofovir DF, components of STRIBILD. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue STRIBILD. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Indication

STRIBILD is indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen for ≥6 months with no history of treatment failure and no known resistance to any component of STRIBILD.

References:

  • STRIBILD [package insert]. Foster City, CA: Gilead Sciences, Inc; 2014.
  • Data on file, Gilead Sciences, Inc.

Please click here to view full Prescribing Information for STRIBILD, including BOXED WARNING

Important Safety Information

Warnings and precautions

  • New onset or worsening renal impairment:
    • Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir DF and STRIBILD.
    • In all patients, monitor estimated creatinine clearance (CrCl), urine glucose, and urine protein prior to initiating and during therapy. In patients with or at risk for renal impairment, additionally monitor serum phosphorus.
    • Do not initiate STRIBILD in patients with CrCl <70 mL/min. Discontinue STRIBILD if CrCl declines to <50 mL/min.
    • Cobicistat may cause modest increases in serum creatinine and modest declines in CrCl without affecting renal glomerular function; patients with an increase in serum creatinine >0.4 mg/dL from baseline should be closely monitored for renal safety.
    • Avoid concurrent or recent use with a nephrotoxic agent. Cases of acute renal failure, some requiring hospitalization and renal replacement therapy, have been reported after initiation of high dose or multiple NSAIDs in patients with risk factors for renal dysfunction; consider alternatives to NSAIDs in these patients.
    • Persistent or worsening bone pain, pain in extremities, fractures and/or muscular pain or weakness may be manifestations of proximal renal tubulopathy and should prompt an evaluation of renal function.
  • Other antiretroviral products: STRIBILD is a complete regimen for the treatment of HIV-1 infection. Do not coadminister with other antiretroviral products, including products containing any of the same active components; products containing lamivudine; products containing ritonavir; or with adefovir dipivoxil.
  • Drug interactions: Coadministration of STRIBILD and other drugs may result in known or potentially significant drug interactions; this may lead to loss of efficacy and development of resistance to STRIBILD or clinically significant adverse reactions from greater exposures of concomitant drugs. Consider the potential for drug interactions prior to and during STRIBILD therapy and monitor for adverse reactions.
  • Bone effects: Decreases in bone mineral density (BMD) and mineralization defects, including osteomalacia, have been seen in patients treated with tenofovir DF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss.
  • Fat redistribution and accumulation have been observed in patients receiving antiretroviral therapy.
  • Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
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