Two medicines, side by side
Bictegravir/emtricitabine/tenofovir alafenamide vs dolutegravir/lamivudine
Bictegravir/emtricitabine/tenofovir alafenamide and dolutegravir/lamivudine are both labeled for HIV. Drugs@FDA records approvals of bictegravir/emtricitabine/tenofovir alafenamide since 2018 and of dolutegravir/lamivudine since 2019. Pharmacies paid $136.73 per Biktarvy 50-200-25 mg tablet and $105.22 per Dovato 50-300 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, bictegravir/emtricitabine/tenofovir alafenamide is a hepatitis b virus nucleoside analog reverse transcriptase inhibitor and dolutegravir/lamivudine a human immunodeficiency virus integrase strand transfer inhibitor.
Check it at the source: the bictegravir/emtricitabine/tenofovir alafenamide FDA label on DailyMed (effective April 30, 2024); the dolutegravir/lamivudine FDA label on DailyMed (effective October 29, 2025).
Highlights of the bictegravir and emtricitabine and tenofovir alafenamide record
Bictegravir and emtricitabine and tenofovir alafenamide (Biktarvy) · label of April 30, 2024
POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and 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 who are coinfected with HIV-1 and HBV and discontinue BIKTARVY.
Used for
From the label: indicationsBIKTARVY 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: who have no antiretroviral treatment history 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. […]
On the market
- Earliest approval on file
- February 7, 2018
- Generic labelers
- none listed
- Pharmacy cost
- $136.73 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Highlights of the dolutegravir and lamivudine record
Dolutegravir and lamivudine (Dovato) · label of October 29, 2025
PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV-1): EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported.
Used for
From the label: indicationsDOVATO is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DOVATO. […]
On the market
- Earliest approval on file
- April 8, 2019
- Generic labelers
- none listed
- Pharmacy cost
- $105.22 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Source: FDA drug labels via openFDA (Bictegravir/emtricitabine/tenofovir alafenamide label of April 30, 2024, Dolutegravir/lamivudine label of October 29, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do bictegravir/emtricitabine/tenofovir alafenamide and dolutegravir/lamivudine differ on the record?
In FDA's classes, bictegravir/emtricitabine/tenofovir alafenamide is a hepatitis b virus nucleoside analog reverse transcriptase inhibitor and dolutegravir/lamivudine a human immunodeficiency virus integrase strand transfer inhibitor.
How each works, in its label's words: Bictegravir/emtricitabine/tenofovir alafenamide, “BIKTARVY is a fixed dose combination of antiretroviral drugs bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF) [see Microbiology (12.4) ].”; Dolutegravir/lamivudine, “DOVATO is a fixed-dose combination of the HIV‑1 antiretroviral agents, dolutegravir and lamivudine [see Microbiology ( 12.4 )].”
Both labels carry a boxed warning; the records quote them.
| Bictegravir/emtricitabine/tenofovir alafenamide | Dolutegravir/lamivudine | |
|---|---|---|
| Labeled for | HIV | HIV |
| Pharmacologic class | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor, Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor |
| How it works (label) | BIKTARVY is a fixed dose combination of antiretroviral drugs bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF) [see Microbiology (12.4) ]. | DOVATO is a fixed-dose combination of the HIV‑1 antiretroviral agents, dolutegravir and lamivudine [see Microbiology ( 12.4 )]. |
| Half-life (label) | Note that the active metabolite of TAF, tenofovir diphosphate, has a half-life of 150–180 hours within PBMCs. | n/a |
| Earliest approval on file (Drugs@FDA) | February 7, 2018 | April 8, 2019 |
| First generic approved | none | none |
| Generic labelers (NDC) | none listed | none listed |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $136.73 per tablet (Biktarvy 50-200-25 mg tablet) | $105.22 per tablet (Dovato 50-300 mg tablet) |
| 12-month price change | no change | +5% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 0 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | n/a | 3,529 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to bictegravir/emtricitabine/tenofovir alafenamide
- every medicine labeled for the same conditions