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Stribild (Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Disoproxil Fumarate) - Summary

 
 



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, a component of STRIBILD, in combination with other antiretrovirals [see Warnings and Precautions].

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 human immunodeficiency virus-1 (HIV-1) and have discontinued EMTRIVA or VIREAD, which are 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 [see Warnings and Precautions].

 

STRIBILD SUMMARY

STRIBILD is a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir DF for oral administration.

  • Elvitegravir is an HIV-1 integrase strand transfer inhibitor.
  • Cobicistat is a mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A family.
  • Emtricitabine is a synthetic nucleoside analog of cytidine. EMTRIVA is the brand name for emtricitabine.
  • Tenofovir DF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. VIREAD is the brand name for tenofovir DF.
Each tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 300 mg of tenofovir DF (equivalent to 245 mg of tenofovir disoproxil). The tablets include the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, sodium lauryl sulfate, and magnesium stearate. The tablets are film-coated with a coating material containing indigo carmine (FD&C Blue #2) aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.

STRIBILD® is indicated as a complete regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naïve.


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NEWS HIGHLIGHTS

Published Studies Related to Stribild (Elvitegravir / Cobicistat / Emtricitabine / Tenofovir)

A randomized double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: analysis of week 96 results. [2013]
We report week 96 results from a phase 3 trial of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF, n = 348) vs efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF, n = 352). At week 48, EVG/COBI/FTC/TDF was noninferior to EFV/FTC/TDF (88% vs 84%, difference +3.6%, 95% confidence interval: -1.6% to 8.8%)...

Elvitegravir: a once-daily, boosted, HIV-1 integrase inhibitor. [2012]
The development of HIV-1 integrase strand transfer inhibitors (INSTIs) has been a major therapeutic breakthrough in the management of HIV-1 infection. The first HIV-1 integrase inhibitor, raltegravir, was licensed in 2007 and was subsequently approved for use in treatment-naive patients... The in vitro activity, pharmacokinetic and pharmacodynamic properties, results of Phase I-III clinical trials, resistance profile and drug-drug interactions of EVG will be reviewed in this article.

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Clinical Trials Related to Stribild (Elvitegravir / Cobicistat / Emtricitabine / Tenofovir)

STRIBILD in Non-Nucleoside Resistant Patients (SINNR STUDY) [Recruiting]
The SINNR study will evaluate the virologic efficacy (viral load <50 copies/mL)and safety of STRIBILD administered for 48 weeks to HIV-infected current or recent illicit drug users.

Bioequivalence of Crushed Stribild With a Normal Breakfast or With Drip Feed Compared to the Whole Tablet [Completed]
Elvitegravir is an HIV-1 integrase inhibitor which is marketed in a fixed dose combination tablet with cobicistat, tenofovir and emtricitabine (Stribild«, referred to as STB). For patients with swallowing difficulties, administration of whole tablets can be problematic and tablets are cut or crushed to ease administration. In addition if HIV patients develop opportunistic infections, patients can become severely ill and may end up on the intensive care. Patients at the intensive care might not be able to swallow medication. Therefore it is useful to know if it is possible to administer STB through a different route, like a feeding tube. If STB can be crushed or dissolved and given through a catheter it is also useful to know if it can be given with drip feed. Currently there is no information about crushing STB tablets. "Crushing STB tablets into a liquid medium has not been studied and is not recommended" according to the SPC text. Depending on the biopharmaceutical characteristics of a drug formulation, crushing tablets can lead to altered pharmacokinetics of drugs. It is important to know whether pharmacokinetics are influenced by crushing of tablets as low concentrations are associated with virologic failure. Therefore higher doses might be needed. In addition, higher Cmax and/or exposure can lead to toxicity. As a result therapeutic drug monitoring is advised, or crushing the drug is a contra-indication based on the available data. It has been shown that simultaneous oral ingestion of antacids and elvitegravir gives a decrease in Cmax and AUC of elvitegravir. This interaction is not shown for co-ingestion with omeprazole. Which makes it unlikely that this interaction is caused by a pH-lowering effect influencing the absorption of elvitegravir. It is probably a local gastrointestinal complexation phenomenon, similar to what has been observed with other HIV integrase inhibitors. A possible pharmacokinetic interaction between elvitegravir and complexation formers may be expected. Especially considering the active binding sites of elvitegravir which bind magnesium metal ion cofactors. Although there is data that STB can be ingested with a protein rich drink, it is unclear if foods or liquids containing high amounts of magnesium or other cations can cause this same interaction. Therefore this study will be conducted to investigate whether crushed and suspended STB and crushed and suspended STB with drip feed are bioe-quivalent to taking STB as a whole.

Sleep and Cognition After Atripla to Stribild Switch [Recruiting]
Atripla and Stribild are two FDA-Approved one pill a day combination antiretroviral medications given for the treatment of HIV. Both drugs are reasonably well tolerated. However, efavirenz, a component of Atripla, is known to cause "mental" side effects. This proposal aims to assess whether a switch from Atripla to Stribild for 12 weeks will be associated with reversal of sleep and cognitive disturbances. Demonstrating changes upon withdrawal of drug and substitution of a drug regimen not known to have an impact on sleep and cognition may represent the best option to determine whether use of efavirenz is associated with effects on sleep and cognition beyond the immediate period following initiation of drug.

Atripla to Stribild Switch Study to Evaluate Sleep Disturbances [Active, not recruiting]
Switch patients from Atripla to Stribild will be evaluated to see if patients have less sleep disturbances.

Changes in Insulin Resistance in Healthy Volunteers on STRIBILD« Medication [Completed]
Changes in insulin resistance in healthy volunteers with normal body weight (BMI 18-25) after 14 days of STRIBILD«-, Truvada«/Kaletra« or Truvada«/Prezista«/Norvir« intake, measured by hyperinsulinemic euglycemic clamp.

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Page last updated: 2014-11-30

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