PharmaRadar360

PharmaRadar360

Infectious DiseaseDrug intelligence

Biktarvy

Bictegravir/Emtricitabine/Tenofovir Alafenamide

Fixed-dose combination of an HIV-1 integrase inhibitor and two nucleoside reverse transcriptase inhibitors. Developed by Gilead. Clinical, regulatory, and source evidence are connected below.

Company
Gilead
Target / MOA
HIV-1 integrase · HIV-1 reverse transcriptase
Aliases
Biktarvy
Signals
21
Clinical trials
8
Approvals
0
Evidence sources
21

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1

Phase 2 · RECRUITING · Gilead Sciences

clinical trialClinicalTrials.gov

Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment

Phase 2 · RECRUITING · Gilead Sciences

clinical trialClinicalTrials.gov

Study on Retention in Care and on Clinical Chracteristics of HIV-infected Women Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIKWO).

N/A · NOT_YET_RECRUITING · Ente Ospedaliero Ospedali Galliera

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 21, 2026.

United States (FDA label)

Biktarvy · NDA210251 · label version 26, effective Sep 9, 2026 · DailyMed

Label section 1

1 INDICATIONS AND USAGE BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg: • with no antiretroviral treatment history, or • with an antiretroviral treatment history and not virologically suppressed, with no known or suspected substitutions associated with resistance to the integrase strand inhibitor class, emtricitabine, or tenofovir, or • to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir [see Dosage and Administration (2.4) , and Use in Specific Populations (8.1) ].

European Union (EMA)

Biktarvy · EMEA/H/C/004449 · Authorised, authorised Jun 21, 2018 (Commission decision C(2018) 4019) · EPAR

Biktarvy is indicated for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults and paediatric patients at least 2 years of age and weighing at least 14 kg i without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.(see section 5.1)

EMA's summary; the full indication is in the product information on the EPAR page.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 21, 2026.

United States

NDA210251 · GILEAD SCIENCES INC · first approved Feb 7, 2018

8 efficacy supplements approved

European Union

  • Biktarvy: Authorised since Jun 21, 2018

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 21, 2026.

NDA210251 (Orange Book)

11 listed patents, latest expiry Nov 8, 2036
  • US 8754065 · expires Aug 15, 2032 · drug substance, drug product, U-257
  • US 9296769 · expires Aug 15, 2032 · drug substance, drug product, U-257
  • US 8754065*PED · expires Feb 15, 2033 · no claim type flagged
  • US 9296769*PED · expires Feb 15, 2033 · no claim type flagged
  • US 9216996 · expires Dec 19, 2033 · drug substance, drug product
  • US 9732092 · expires Dec 19, 2033 · drug substance, drug product
  • US 10385067 · expires Jun 19, 2035 · U-257
  • US 9708342 · expires Jun 19, 2035 · drug substance, drug product
  • US 10548846 · expires Nov 8, 2036 · drug product · listed for some products only: BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE
  • US 11744802 · expires Nov 8, 2036 · drug product · listed for some products only: BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE
  • US 12594244 · expires Nov 8, 2036 · drug product, U-257

Exclusivity: I-942 until Feb 23, 2027; M-305 until Apr 24, 2027 (some products only: BIKTARVY EQ 50MG BASE;200MG;EQ 25MG BASE); ODE-378 until Oct 7, 2028 (some products only: BIKTARVY EQ 30MG BASE;120MG;EQ 15MG BASE); ODE-468 until Feb 23, 2031; ODE-540 until Jul 30, 2032 · Orange Book entry

Generics and biosimilars

The Orange Book lists no approved generic (ANDA).

*PED is FDA's mark for a patent's period extended by six months of pediatric exclusivity.

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 21, 2026.

Boxed warning

Biktarvy label

WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients with HIV-1 and HBV who have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients with HIV-1 and HBV who discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ] .

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies · 8 linked records.

Phase 2RECRUITINGNCT07645287

A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1

Gilead Sciences · Updated Oct 15, 2026

Phase 2RECRUITINGNCT07708727

Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment

Gilead Sciences · Updated Oct 13, 2026

N/ANOT YET RECRUITINGNCT07859904

Study on Retention in Care and on Clinical Chracteristics of HIV-infected Women Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIKWO).

Ente Ospedaliero Ospedali Galliera · Updated Oct 9, 2026

Phase 2ACTIVE NOT RECRUITINGNCT02881320

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1

Gilead Sciences · Updated Sep 24, 2026

Phase 1ACTIVE NOT RECRUITINGNCT07055451

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV

Gilead Sciences · Updated Aug 26, 2026

Phase 1COMPLETEDNCT07532304

A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Participants (MK-4646)

Merck Sharp & Dohme LLC · Updated Aug 25, 2026

Regulatory timeline

Approvals and agency activity

Verified regulatory records in reverse chronological order.

No regulatory event is available in this snapshot.

Related intelligence

Connected drugs

Records connected through the current intelligence graph.

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial · Latest Oct 21, 202620
Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.