Virologic Response

STRIBILD demonstrated sustained and noninferior efficacy at week 1441-3

The efficacy of STRIBILD is based on the results from Study 103 and Study 102 – two randomized, double-blind, active-controlled trials in treatment-naive HIV-1 infected adults with baseline estimated creatinine clearance ≥70 mL/min.1 The primary endpoint of both noninferiority trials was the percentage of treatment-naive subjects with an HIV-1 viral load <50 copies/mL at week 48 using FDA snapshot analysis. Week 96 and week 144 analyses were secondary endpoints of the studies.1-3

In Study 103 (N=708), STRIBILD (n=353) was compared to ATV + RTV + FTC/TDF (n=355). The charts below show the primary endpoint data (snapshot analysis) and the intent-to-treat (ITT), missing = failure (M=F) analysis.

Study 103: virologic success (HIV-1 RNA <50 copies/mL) at week 1441,4,5

   
Study 103 – Snapshot Analysis

In Study 102 (N=700), STRIBILD (n=348) was compared to coformulated EFV/FTC/TDF (n=352).

Study 102: virologic success (HIV-1 RNA <50 copies/mL) at week 1441,6,7

   
Study 102 – Snapshot Analysis

Click here to review the study designs.

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.
  • DeJesus E, Rockstroh JK, Henry K, et al; for the GS-236-0103 Study Team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet. 2012;379(9835):2429-2438.
  • Sax P, DeJesus E, Mills A, et al; for the GS-US-236-0102 Study Team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus co-formulated efavirenz, emtricitabine, and tenofovir for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3 trial, analysis of results after 48 weeks. Lancet. 2012;379(9835):243-2448.
  • 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.
  • Data on file, Gilead Sciences, Inc.
  • Wohl DA, Cohen C, Gallant JE, et al; for the GS-US-236-0102 Study Team. A randomized, double-blind comparison of single-tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir DF versus single-tablet regimenefavirenz/emtricitabine/tenofovir DF for initial treatment of HIV-1 infection: analysis of week 144 results. J Acquir Immune Defic Syndr. 2014;65(3):e118-e120.
  • Wohl DA, Cohen C, Gallant JE, et al. elvitegravir/cobicistat/emtricitabine/tenofovir DF (STB) has durable efficacy and differentiated long-term safety and tolerability versus efavirenz/emtricitabine/tenofovir DF (ATR) at week 144 in treatment-naïve HIV patients. 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy. September 10-13, 2013; Denver CO; Abstract #H-672a.

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.
  • 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. In patients at risk of renal dysfunction who present with persistent or worsening bone or muscle symptoms, hypophosphatemia and osteomalacia secondary to proximal renal tubulopathy should be considered.
  • 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.

By following this link, you are now leaving www.STRIBILD.com/hcp. This site is not controlled by Gilead Sciences, Inc. Gilead Sciences, Inc. is not responsible for the site’s content or your use of the site.

Leave Site

Go Back