What is the dosage of Biktarvy?

Biktarvy is available in 2 dosages, including 30-120-15 mg Tab and 50-200-25 mg Tab

What does Biktarvy treat?

Biktarvy treats HIV Infections and Chronic Hepatitis B

What is Biktarvy made of?

Biktarvy contains bictegravir / emtricitabine / tenofovir alafenamide which is a Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor

How is Biktarvy administered?

Biktarvy is administered as a Oral Pill

What is Biktarvy mechanism of action?

Biktarvy mechanism of action is Nucleoside Reverse Transcriptase Inhibitors

Dosage & Administration Drug label Prior authorization Financial assistance

Patient education

Biktarvy

(bictegravir / emtricitabine / tenofovir alafenamide)

bictegravir 30 MG / emtricitabine 120 MG / tenofovir alafenamide 15 MG Oral Tablet [Biktarvy]bictegravir 50 MG / emtricitabine 200 MG / tenofovir alafenamide 25 MG Oral Tablet [Biktarvy]

BLACK BOX WARNING

Dosage & administration

* Testing: Prior to or when initiating BIKTARVY test for hepatitis B virus infection. Prior to or when initiating BIKTARVY, and during treatment, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, also assess serum phosphorus.
* Recommended dosage in adults and pediatric patients weighing at least 25 kg: One tablet containing 50 mg BIC, 200 mg FTC, and 25 mg TAF taken once daily with or without food.
* Recommended dosage in pediatric patients weighing at least 14 kg to less than 25 kg: One tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food.
* Renal impairment: BIKTARVY is not recommended in patients with estimated creatinine clearance of 15 to below 30 mL/min, or below 15 mL/min who are not receiving chronic hemodialysis, or below 15 mL/min who have no antiretroviral treatment history.
* Hepatic impairment: BIKTARVY is not recommended in patients with severe hepatic impairment.

drug label

Biktarvy prescribing information

Have more Biktarvy questions?

Submit MSL Request

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Need to report a Biktarvy issue?

ONLINE FORMReport adverse event

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prior authorization

Biktarvy Prior authorization resources

NOT PROVIDED BY BRANDComplete Letter of Medical Necessity

NOT PROVIDED BY BRANDCoverage Authorization Request

NOT PROVIDED BY BRANDCoverage Authorization Appeals

Prior Authorization Checklist

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Benefits investigation

Gilead Advancing Access Enrollment Form

Gilead Advancing Access Enrollment Form - Online

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Reimbursement help (FRM)

NOT PROVIDED BY BRANDReimbursement help (FRM) resources

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financial assistance

Biktarvy Financial assistance options

Co-pay savings program

commercial only

Gilead Advancing Access Enrollment Form

Gilead Advancing Access Enrollment Form - Online

Enroll in Patient Savings Program

Activate Co-Pay Card (if already have one)

Replace Co-Pay card (if lost one)

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Overview

Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs)

Patient benefit

A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max

Patient eligibility

Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs)
Generally, must have commercial insurance (rarely, may permit uninsured patients to use)
May never be used with government insurance

How to sign up

Cards may be downloadable digital cards or hard copies
Some pharmacos offer debit cards with pre-loaded copay benefit
Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form)
Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form

Bridge program

commercial only

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Overview

Provide patient immediate access to therapy during an insurance delay (typically new starts; some may cover change in insurance)
Limited time/ fill (typically 7-30 days; some may offer additional fill for continued delay up to certain limit)

Patient benefit

100% free (outside of insurance)

Patient eligibility

HCP must enroll patient
May be limited to commercially insured patients (i.e., no government beneficiaries); some programs may allow government beneficiaries

How to sign up

Typically HCP assisted enrollment (via form)

Foundation programs

under insured

no insurance

goverment insurance

65+

Gilead Advancing Access Enrollment Form

Gilead Advancing Access Enrollment Form - Online

Patient Assistance Program

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Overview

Charitable 501(c)(3) organizations provide direct cost-sharing and other support (e.g., travel, counseling) through disease-state funds to indigent patients on first-come first-served basis
These organizations may receive financial contributions from drug manaufacturers for particular disease-state funds that cannot provide funds directly to patients - the foundation must be independent/unaligned

Patient benefit

Patients apply for grants that cover a portion (or all) of their out-of-pocket costs (deductibles and co-pays) until the grant is exhausted

Patient eligibility

Patients must apply and meet eligibility criteria including income level (typically a multiple of federal poverty line), specific diagnosis, insurance status, etc.

How to sign up

Patients submit proof of out-of-pocket drug costs to charities for reimbursement

patient education

Biktarvy Patient education