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MedChemExpress

Bictegravir (BIC)

Developer(s)

Gilead

Originator
https://www.gilead.com/

United States

Drug structure

Bictegravir chemical structure

Bictegravir chemical structure

MedChemExpress

Drug information

Associated long-acting platforms

Oral solid form

Administration route

Oral

Therapeutic area(s)

HIV

Use case(s)

Treatment

Use of drug

Ease of administration

Self-administered

User acceptance

Not provided

Dosage

Available dose and strength

various fixed dose combinations

Frequency of administration

once daily within regimen

Maximum dose

Not provided

Recommended dosing regimen

Not provided

Additional comments

Not provided

Dosage link(s)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210251s000lbl.pdf
https://www.ema.europa.eu/en/documents/product-information/biktarvy-epar-product-information_en.pdf

Drug information

Drug's link(s)

Not provided

Generic name

https://go.drugbank.com/drugs/DB11799

Brand name

One of the three compounds of Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide)

Compound type

Not provided

Summary

Bictegravir is an integrase inhibitor used to treat HIV infections. Alternative names are GS-9883 and GS-9883-01. Bictegravir is used in combination with tenofovir alafenamide and emtricitabine to treat human immunodeficiency virus-1 (HIV-1) infection.

Approval status

In the US, it may be used in treatment-naive patients weighing at least 14 kg. Alternatively, it may be used 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. In Europe, it is approved for use in patients 2 years of age and older with evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.

Regulatory authorities

Approved in many HICs and LMICs

Delivery device(s)

No delivery device

Scale-up and manufacturing prospects

Scale-up prospects

Not provided

Tentative equipment list for manufacturing

Not provided

Manufacturing

Not provided

Specific analytical instrument required for characterization of formulation

Not provided

Clinical trials

Not provided

Excipients

Proprietary excipients used

No proprietary excipient used

Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration

No novel excipient or existing excipient used

Residual solvents used

No residual solvent used

Patent info

There are either no relevant patents or these were not yet submitted to LAPaL

Supporting material

Publications

There are no publication

Additional documents

No documents were uploaded

Useful links

There are no additional links

Access principles

Collaborate for development

Consider on a case by case basis, collaborating on developing long acting products with potential significant public health impact, especially for low- and middle-income countries (LMICs), utilising the referred to long-acting technology

Not provided

Share technical information for match-making assessment

Provide necessary technical information to a potential partner, under confidentiality agreement, to enable preliminary assessment of whether specific medicines of public health importance in LMICs might be compatible with the referred to long-acting technology to achieve a public health benefit

Not provided

Work with MPP to expand access in LMICs

In the event that a product using the referred to long-acting technology is successfully developed, the technology IP holder(s) will work with the Medicines Patent Pool towards putting in place the most appropriate strategy for timely and affordable access in low and middle-income countries, including through licensing

Not provided

Comment & Information

Not provided