Stribild

Quick links to important sections

Stribild

Method of action: Hiv Infection

Treatment option: Immunodeficiency, Infection

Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Stribild

Property Description
Active Ingredients Elvitegravir, Cobicistat, Emtricitabine, Tenofovir disoproxil fumarate
Form Film-coated tablet
Pharmacological Class Antiretroviral Combination (INSTI, NRTIs, PK Enhancer)
Common Use Comprehensive viral suppression
Origin Synthetic

Stribild: Definition and Identity as a Single-Tablet Regimen

Stribild is a fixed-dose combination (FDC) antiretroviral agent formulated as a complete single-tablet regimen (STR) intended for oral use. This synthetic medication, manufactured by Gilead Sciences, integrates four separate active substances into one film-coated tablet, a characteristic recognized for supporting patient adherence, compared to multi-pill regimens. The inherent design of the STR is to deliver all necessary components of a complete regimen in a single daily dose.

Composition and Pharmacological Classification

The tablet contains the four active compounds: elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate, as detailed in its prescribing information. These ingredients belong to three distinct pharmacological classes vital for viral suppression. Elvitegravir is an Integrase Strand Transfer Inhibitor (INSTI), while emtricitabine and tenofovir disoproxil fumarate are both Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs). Cobicistat is a Pharmacokinetic Enhancer, a component specifically included to manage the metabolism of elvitegravir, allowing for effective once-daily administration.

Primary Purpose: Multi-Targeted Viral Suppression

The primary purpose of Stribild is to achieve comprehensive viral suppression by simultaneously interrupting multiple, distinct stages of the Human Immunodeficiency Virus (HIV) replication cycle. This multi-class combination blocks the virus from integrating its genetic material into host cells while also stopping the production of viral DNA. This combination's efficacy is supported by pharmacological studies that confirm its durability in achieving sustained suppression. The pharmacokinetic enhancement provided by cobicistat ensures that elvitegravir maintains a necessary, sustained concentration in the bloodstream, which is critical to maintaining the efficacy of the overall antiretroviral treatment regimen.

Regulatory References

  1. clinically recognized for supporting patient adherence

What side effects are possible with Stribild?

Possible Side Effects and Safety Information

Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) carries a Boxed Warning regarding two serious risks: Lactic Acidosis/Severe Hepatomegaly with Steatosis and the risk of Acute Exacerbation of Hepatitis B (HBV) in patients co-infected with HIV-1 and HBV who discontinue the drug. Stribild is not approved to treat chronic HBV infection.

Clinically Significant Adverse Reactions

The most common adverse reactions reported in clinical trials (incidence ge 10%) were Nausea and Diarrhea. Other common side effects include headache, fatigue, vomiting, and flatulence.

Renal Effects: Stribild is associated with a risk of new onset or worsening renal impairment, including severe cases such as acute renal failure and Fanconi syndrome, due to the tenofovir DF component. Cobicistat, a pharmacokinetic enhancer in Stribild, causes an expected, small increase in serum creatinine and a decrease in creatinine clearance by inhibiting tubular secretion, which is generally not associated with true renal glomerular toxicity but requires careful monitoring.

Bone Effects: Decreases in Bone Mineral Density (BMD) have been reported in patients taking Stribild, along with rare cases of osteomalacia (softening of the bone) that may present as bone pain.

Immune Reconstitution Syndrome has been observed in some patients during the initial phases of combination antiretroviral treatment.

Safety Monitoring and Limitations

Routine monitoring of creatinine clearance, urine glucose, and urine protein is required before and during therapy. Stribild is contraindicated with numerous medications due to its potential for serious drug interactions mediated by the CYP3A enzyme. The drug should not be initiated in patients with a creatinine clearance below 70 mL/min and must be discontinued if creatinine clearance falls below 50 mL/min.

Overdose and Emergency Response

Overdose and When to Seek Help

A Stribild overdose requires immediate medical attention. If overdose is suspected, individuals must go to the nearest hospital emergency room or contact emergency services immediately. Urgent medical help is necessary when severe symptoms are present, such as collapse, seizure, difficulty breathing, or inability to be awakened, as explicitly noted in official guidance.

The documented clinical manifestations of a severe overdose align with the established toxicities of the active components. The severe adverse events of concern include Lactic Acidosis and Severe Hepatomegaly with Steatosis, which have been associated with fatal outcomes in the drug’s pharmacological class. Overdose exposure also carries the potential for serious impacts on the renal system, including Acute Renal Failure and Fanconi Syndrome.

Regulatory documentation confirms that no specific antidote is known for Stribild overdose. Consequently, management is symptomatic and supportive, aiming to maintain the patient's condition. Procedural steps may include measures to reduce the systemic exposure of the active substances. For instance, hemodialysis is documented as a method to remove the nucleoside components. Close clinical observation and laboratory follow-up are required to detect and manage potential life-threatening renal and hepatic complications.

Therapeutic Uses of Stribild

Stribild is commonly used for managing Human Immunodeficiency Virus type 1 (HIV-1) infection in relevant patient groups, including adults and adolescents. The medication supports the reduction of the amount of HIV-1 in the blood, which is applied in situations where supportive symptom management is appropriate. This therapeutic approach is generally considered relevant for addressing the chronic nature of HIV-1.

A key benefit of this therapy is that its use contributes to supporting immune function. By managing the viral load, the medication assists with supporting the body's protective immune cell count, which is key to easing the symptom burden related to immune weakness. It is commonly used across conditions presenting with acute episodes, such as starting treatment, and in conditions involving fluctuating manifestations, such as continuing viral management. This commonly applies to assist with both the initiation of treatment and the continuation of viral management.

Quick Fact: Relevant for Systemic Imbalance

Eligibility and Restrictions for Use

Eligibility Profile

Official regulatory documents define specific populations who can and cannot use Stribild (a fixed-dose combination of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate).

Who Can Use Stribild

Use is generally permitted for adults and pediatric patients aged 12 years and older weighing at least 35 kg. Patients must be either antiretroviral treatment-naïve or virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable regimen with no prior history of treatment failure or known resistance.


Who Must Not Use Stribild

Stribild is contraindicated for patients with a known hypersensitivity to any of its components. It is also strictly contraindicated with the coadministration of numerous medicinal products, particularly strong CYP3A inducers (e.g., rifampin, carbamazepine, St. John's wort) and certain other medicines that are highly dependent on CYP3A for clearance, as this can lead to loss of therapeutic effect or serious adverse events.

Eligibility Restrictions

  • Renal Function: The medicine must not be initiated in patients whose estimated creatinine clearance is less than 70 mL/ min. Treatment must be discontinued if creatinine clearance declines below 50 mL/ min.
  • Hepatic Function: It is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C).
  • Pregnancy: Initiation is not recommended during pregnancy due to significantly lower drug exposures.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The co-administration of Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir disoproxil fumarate) with numerous other products is subject to strict regulatory constraints based on pharmacokinetic interactions.

Documented Pharmacokinetic Mechanisms

The component Cobicistat functions as a potent mechanism-based inhibitor of the CYP3A enzyme and inhibits CYP2D6. Cobicistat also inhibits drug transporters, including P-glycoprotein (P-gp) and OATP1B1. These actions may lead to significantly altered plasma concentrations of co-administered medicines.

Contraindicated Combinations

Co-administration is formally contraindicated with medicines that are highly dependent on CYP3A for clearance, such as specific HMG-CoA Reductase Inhibitors (e.g., Lovastatin, Simvastatin) and certain Antiarrhythmics (e.g., Amiodarone, Quinidine), due to the risk of serious adverse events from elevated exposure. The combination is also prohibited with strong CYP3A inducers—including the herbal product St. John’s wort and anticonvulsants like Carbamazepine—as these may decrease Stribild component exposure and risk the loss of antiviral effect.

Administration Requirements

Administration requires separation from products containing polyvalent cations (e.g., Aluminum, Magnesium, or Iron-containing antacids). These products must be administered at least two hours before or two hours after Stribild to prevent reduced component exposure. Additionally, co-administration with current or recent use of nephrotoxic drugs is not recommended, as this can increase the concentrations of Emtricitabine and Tenofovir.

Mechanism of Action

How Stribild Works

Stribild's action results from the concerted activity of four components that target two essential enzymatic processes. Emtricitabine and tenofovir disoproxil fumarate function as nucleoside reverse transcriptase inhibitors (NRTIs).

Intracellularly, these molecules are converted into active triphosphate metabolites. These metabolites act as competitive substrates for the viral enzyme reverse transcriptase, causing their incorporation into the growing viral DNA strand in place of natural nucleosides. This incorporation results in DNA chain termination, which prevents the full transcription of the viral genome from its RNA template.

Elvitegravir acts as an integrase strand transfer inhibitor (INSTI). It specifically binds to and inhibits the active site of the HIV-1 integrase enzyme. This binding prevents the double-stranded viral DNA intermediate from being covalently inserted (integrated) into the host cell's DNA.

Finally, cobicistat functions as a pharmacokinetic enhancer. It selectively inhibits the human enzyme cytochrome P450 3A (CYP3A), which is involved in the metabolism of elvitegravir. This inhibition increases and sustains the plasma concentration of elvitegravir.

Dosage and Administration Information

General Principles of Administration

Stribild is administered via the oral route as a fixed-dose combination, film-coated tablet designed as a single-tablet regimen. The tablet must be taken once daily, a schedule supported by the presence of the pharmacokinetic enhancer, cobicistat.


Dosing and Contextual Requirements

The standard labeled dose for adults and pediatric patients weighing at least 35 kg is one tablet. Each tablet delivers the full fixed dosage of its four components. A critical instruction for proper use is the requirement to take the tablet with food to ensure optimal absorption of the medication. The tablet must be swallowed whole and should not be crushed or chewed, maintaining the integrity of the delivery system. The therapy is intended for continuous, long-term administration.


Procedural Constraints

Specific rules govern missed doses: if a dose is missed by less than 18 hours from the usual time, it should be taken immediately with food. If more than 18 hours have passed, the missed dose must be skipped, and the next scheduled dose resumed. Usage is also constrained by renal function: the drug is required to be discontinued if the patient's estimated creatinine clearance declines below 50 mL/min during the course of treatment.

Recent Clinical Evidence

Stribild: Overview of Clinical Research

Evidence for Antiretroviral Treatment Initiation

Research for Stribild was studied primarily in Randomized Controlled Trials (RCTs) involving adults and adolescents beginning treatment for the first time. These comparative trials explored the proportion of patients whose viral RNA concentration was measured below a specific threshold (virologic response) after a defined study period, and also monitored changes in immune status markers, such as CD4+ T-cell counts. The findings describe group patterns related to these measurements over the intermediate-term, with data extending up to 144 weeks in some extensions. Research has explored instances of virologic failure and the emergence of drug resistance mutations. These findings describe group patterns and do not determine whether an individual will respond similarly.


Evidence for Treatment Continuation and Research Gaps

Stribild was evaluated in randomized open-label trials that examined the effect of transitioning virologically suppressed adults from a stable existing regimen. The research reported the proportion of participants who maintained virologic response after the regimen was switched, describing the observed durability of the regimen. Studies have also explored outcomes in the adolescent population who were treatment-naïve.

A key limitation across the research program is the exclusion of patients with significant pre-existing renal impairment (typically CrCl < 70 mL/min). Therefore, data for this specific patient group remain insufficient, and the results apply only to the populations studied. Furthermore, long-term effects are not fully established beyond the intermediate follow-up periods documented in the pivotal trials.

Frequently Asked Questions (FAQ)

Common questions about Stribild (FAQ)


Q: What are the most common side effects people mention when they first start Stribild?

A: According to regulatory documents, the most common adverse reactions reported in clinical trials (occurring in 10% or more of patients) were nausea and diarrhea. Other common effects include headache, fatigue, vomiting, and flatulence. These figures reflect group patterns observed in studies.


Q: Does Stribild cause kidney problems over time?

A: Official information states that Stribild is associated with a risk of new onset or worsening renal impairment, including severe cases. This risk is primarily due to one of its components, and regular monitoring of renal function using blood and urine tests is an important part of treatment.


Q: Does Stribild affect bone density or cause bone thinning?

A: Yes, regulatory documents indicate that decreases in Bone Mineral Density (BMD) have been reported in patients taking Stribild. This loss of bone mass has also been associated with rare cases of osteomalacia (softening of the bone). Healthcare providers typically monitor for this possibility during the course of treatment.


Q: Can Stribild interact with birth control pills?

A: Yes, Stribild contains an ingredient that can act as an enzyme inhibitor, which may alter the concentration of certain hormonal contraceptives (birth control pills). This interaction could affect the effectiveness of the birth control. If hormonal contraceptives are used, official product information recommends consulting a healthcare provider to determine the most appropriate birth control methods.


Q: Are there any foods or drinks to strictly avoid while taking Stribild?

A: The critical instruction for administration is the requirement to take the tablet with food to ensure the medication is properly absorbed into the body. Official dosing instructions do not strictly prohibit specific foods or drinks, apart from the general requirement to take with a meal or snack.


Q: What should I do if I vomit after taking my Stribild pill?

A: Official patient information generally advises that if vomiting occurs within approximately 1 hour of taking the dose, another tablet may be taken to ensure the full dose is received. If vomiting occurs more than 1 hour after the dose, the standard procedure is usually to not take another dose and wait for the next scheduled dose.


Q: Can women who are pregnant or planning to be pregnant use Stribild?

A: Regulatory information indicates that initiating Stribild is generally not recommended during pregnancy due to the possibility of reduced drug levels that could affect treatment effectiveness. Women who are exposed to the drug while pregnant are encouraged to enroll in a Pregnancy Registry to track outcomes, as documented in the product information.


Q: Is Stribild the same as the older HIV meds, or is it a new type?

A: Stribild is a single-tablet regimen (STR), which is a modern approach that combines four different antiretroviral components into one pill. It includes an integrase strand transfer inhibitor (INSTI), which is a newer class of drug, along with older, established classes of drugs like nucleos(t)ide reverse transcriptase inhibitors (NRTIs).


Q: How quickly does Stribild start working to lower the viral load?

A: Stribild is designed to reduce the amount of virus in the body (viral load). Clinical studies report the proportion of patients who achieved virologic suppression (viral load below detectable levels) after a specific period, such as 48 weeks of treatment.


Q: Is weight gain a known side effect of Stribild?

A: Weight gain is not explicitly listed as a common adverse reaction in the official product information for Stribild. However, regulatory documents mention that changes in body fat distribution, known as lipodystrophy, have been observed with combination antiretroviral therapies in general.


Q: Does Stribild interact with common over-the-counter pain relievers?

A: Official product information advises caution when taking Stribild with certain common over-the-counter medications that can affect kidney function. This includes non-steroidal anti-inflammatory drugs (NSAIDs, like ibuprofen), due to a potential increased risk of kidney-related side effects.


Q: Can Stribild affect my sleep?

A: Yes, official reports from clinical trials list certain sleep-related issues as possible adverse reactions. These include insomnia (difficulty falling or staying asleep) and abnormal dreams. If these issues persist or become bothersome, they should be discussed with a healthcare provider.


Q: Is it normal to feel tired when you first start taking Stribild?

A: Yes, fatigue (a feeling of tiredness or low energy) is listed as a common adverse reaction, occurring in a significant number of patients during clinical trials. Feeling tired is one of the more frequently reported side effects associated with the drug.


Q: Can Stribild still work if my HIV is already resistant to other medications?

A: Stribild is specifically indicated for patients who are either new to treatment or who have an already suppressed viral load with no known history of treatment failure or known resistance to any of its four components. The presence of resistance may lead to loss of antiviral effect and treatment failure, as noted in the product information.


Q: How often do people taking Stribild need blood tests?

A: Official safety monitoring requires routine checks of blood test results, specifically for creatinine clearance, and also urine tests for glucose and protein. These tests are required before and during therapy to monitor for potential kidney effects. The exact frequency of monitoring is determined by the patient's healthcare provider.


Q: Are there any long-term effects of Stribild that doctors monitor closely?

A: While the very long-term effects of Stribild are not fully established, doctors closely monitor for potential issues noted in trials. The primary concerns include the worsening of renal (kidney) function, potential decreases in Bone Mineral Density (BMD), and the possibility of drug resistance developing.


Q: Does Stribild cause changes in cholesterol levels?

A: Official product information states that clinical trials reported changes in blood test results related to lipids. Specifically, elevated cholesterol and triglycerides (fats in the blood) have been observed as potential effects in patients taking the medication.


Q: Is Stribild an option for HIV prevention (PrEP)?

A: No. Official regulatory documents clearly state that Stribild is indicated only for the treatment of HIV-1 infection. It has not been approved or studied for use as pre-exposure prophylaxis (PrEP) to prevent HIV infection.


Q: What is the experience of people switching to Stribild from another regimen?

A: Clinical studies included trials that evaluated adults who were already successfully suppressed on a different stable regimen and then switched to Stribild. These studies primarily focused on showing that patients were able to maintain their virologic response (stay suppressed) after making the switch.


Q: How does the drug combination in Stribild minimize the pill burden?

A: Stribild is a single-tablet regimen (STR). Its combination of four different active antiretroviral components into one pill, which is taken only once daily, is designed to minimize the number of pills a person needs to take compared to multi-pill regimens.


Q: Does Stribild have a risk of drug-induced rash?

A: Yes, official reports indicate that skin rash is listed as a common adverse reaction in patients studied during clinical trials. If a rash develops, consultation with a healthcare provider is necessary for evaluation.


Q: Is it okay to take vitamins with Stribild?

A: Official patient information advises patients to tell their healthcare provider about all medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. This allows for the consideration of any potential interactions.


Q: Can Stribild cause mood changes or depression?

A: Yes, regulatory documents list depression as a common adverse reaction reported in clinical trials. Furthermore, the product information mentions that suicidal thoughts or actions have been reported, making mood monitoring an important part of treatment.


Q: Does Stribild have a maximum age limit for use?

A: Regulatory information indicates that specific dose adjustment is not typically required for patients aged 65 and older. However, caution is advised when prescribing to this age group because of the generally higher frequency of reduced organ function (like kidney or liver) that occurs with age.


Q: Do people on Stribild need to worry about drug resistance developing?

A: Yes, official regulatory documents state that resistance to the components of Stribild can potentially develop. High adherence to the prescribed regimen is considered critical to minimize the potential for drug resistance to emerge.


Q: Can Stribild affect fertility in men or women?

A: According to the official product information, there is no adequate data available on the effects of Stribild’s individual components on human fertility. Any concerns about fertility should be directed to a healthcare professional.


Q: How is Stribild helping to improve immune system function?

A: Stribild works by suppressing the HIV virus, which allows the immune system to recover. Clinical studies measure this effect by tracking changes in CD4+ T-cell counts, which are key markers of immune status. An increase in CD4+ counts is a measure of improved immune function.


Q: What happens if I forget to take Stribild for a few days?

A: The official missed dose rules only address doses missed by less than 18 hours. If more than 18 hours have passed since the last dose, the official advice is to skip the missed dose and wait to take the next scheduled dose at its regular time. Missing doses for an extended period increases the risk of loss of viral suppression and potential treatment failure.


Q: Is Stribild known to cause issues with blood sugar control?

A: Yes, official reports from clinical trials mention that changes in blood test results, including elevated blood sugar (hyperglycemia), have been reported in patients taking Stribild. This means that blood sugar levels are an element monitored by healthcare providers.


Q: Is feeling dizzy a common experience after taking Stribild?

A: Yes, dizziness is listed in the regulatory documents as a common adverse reaction reported in the clinical trials that studied Stribild. Persistent or severe dizziness should be discussed with a healthcare provider.


Q: Unused or expired Stribild tablets must be disposed of properly.

A: For safety and environmental protection, unused or expired Stribild tablets must be disposed of properly in accordance with local requirements for pharmaceutical waste. Proper disposal helps protect the environment and prevent accidental exposure.

How should Stribild be stored and disposed of?

Storage and Handling Requirements

Stribild tablets must be stored according to official regulatory specifications to maintain product integrity. The required storage temperature is 25°C (77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). The medication must be kept and dispensed only in its original container, which must be kept tightly closed. The container includes a silica gel desiccant for moisture control, and the seal over the bottle opening must be intact before initial use. The medicine is supplied with a child-resistant closure and must be stored out of the reach and sight of children.


Disposal

Unused or expired Stribild tablets must be disposed of properly. Official instructions state that any unused medicinal product or waste material should be discarded in accordance with local requirements for pharmaceutical waste.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Available in countries:

Equivalent of Stribild found in:

A-Z Index: