Resistance Profile

STRIBILD resistance profile through 144 weeks in Studies 103 and 1021,2

701 subjects randomized to receive STRIBILD -> 35 were viremic and analyzed for resistance mutations - > 18 developed 1 or more resistance mutations

*Viremic subjects defined as having HIV-1 RNA >400 copies/mL at virologic failure, week 144, or time of study discontinuation. Viremic subjects who received at least 8 weeks of treatment and had evaluable genotypic data were included in this analysis.

Development of Drug Resistance (Combined Results of Studies 103 and 102)1-3


Most common drug resistance mutations (combined results from Studies 103 and 102)

  • The most common resistance-associated substitutions that emerged in subjects taking STRIBILD were:1
    • RT: M184V/I (n = 17), K65R (n = 5)
    • IN: E92Q (n = 9), N155H (n = 5), Q148R (n = 3), T66I (n = 2), and T97A (n =1)a
  • All subjects with evaluable data for RT and IN and who developed integrase substitutions associated with EVG resistance (n = 14) also developed the M184V/I RT substitutions, conferring reduced susceptibility to both EVG and FTC

aIn isolates with primary EVG resistance substitutions, additional substitutions in integrase associated with resistance to EVG were H51Y, L68I/V, G70R, 173V, G140C, S153A, E157Q, and G163R (pooled analysis).

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 single-tablet regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naive.

References:

  • STRIBILD [package insert]. Foster City, CA: Gilead Sciences, Inc; 2014.
  • Cohen C, Post F, Winston J, et al. Week 144 renal safety of elvitegravir/ cobicistat/emtricitabine/tenofovir DF (STB) from two phase 3 randomized controlled trials. 20th International AIDS Conference; July 20-25, 2014; Melbourne, Australia. Abstract #WEPE063.
  • Clumeck N, Molina JM, Henry K, et al; GS-236-0103 Study Team. A randomized, double-blind comparison of single-tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus emtricitabine/tenofovir DF for initial treatment of HIV-1 infection: analysis of week 144 results. J Acquir Immune Defic Syndr. 2014;65(3):e121-e124.

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

Important Safety Information

Dosage and administration

  • Adult dosage: One tablet taken orally once daily with food.
  • Renal impairment: Do not initiate in patients with CrCl below 70 mL/min. Discontinue in patients with CrCl below 50 mL/min.
  • Hepatic impairment: STRIBILD is not recommended in patients with severe hepatic impairment.
  • Testing prior to initiation: Test patients for HBV infection and document baseline CrCl, urine glucose, and urine protein.

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