Patient Profiles | DOVATO (dolutegravir/lamivudine)

DOVATO Can Benefit a Range of Patients With Diverse Backgrounds

Consider who may be appropriate for DOVATO. Help patients explore their treatment options.

Malcolm

42 Years Old
On ART for 7 years

Oscar

36 Years Old
Treatment-Naïve

Dave

54 Years Old 
On ART Regimens for 15 Years

Anne

49 Years Old
Has Tried 3 Different
ART Regimens

Malcolm

42 Years OldOn ART for 7 Years

HIV Treatment History

Currently suppressed on a 3DR containing ABC
Has been on 1 ART treatment over the course of 7 years

Current Concerns

Has a family history of renal issues
Has been frequently discussing his change in weight with his doctor

Future Considerations

Curious about the difference between a 2DR and 3DR
Concerned about the long-term impact of treatment and wants guidance on options

Explore DOVATO vs a 3DR

Scenarios and patients are fictive and only to illustrate concept.

What are patients thinking about when considering HIV medication?

See Patients’ Answers

2DR=2-drug regimen; 3DR=3-drug regimen; ABC=abacavir; ART=antiretroviral therapy; BMI=body mass index; CV=cardiovascular.

PMUS-DLLWCNT240046 January 2025

INDICATION

DOVATO is indicated as a complete regimen to treat HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of DOVATO.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HIV-1: EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV

INDICATION

IMPORTANT SAFETY INFORMATION

BOXED WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND 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. If DOVATO is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen.

Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of DOVATO. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment.

Contraindications

Do not use DOVATO in patients with previous hypersensitivity reaction to dolutegravir or lamivudine
Do not use DOVATO in patients receiving dofetilide

Warnings and precautions

Hypersensitivity Reactions:

Hypersensitivity reactions have been reported with dolutegravir and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury
Discontinue DOVATO immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated

Hepatotoxicity:

Hepatic adverse events have been reported, including cases of hepatic toxicity (elevated serum liver biochemistries, hepatitis, and acute liver failure), in patients receiving a dolutegravir-containing regimen without pre-existing hepatic disease or other identifiable risk factors
Patients with underlying hepatitis B or C or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations with use of DOVATO. In some cases, the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn
Monitoring for hepatotoxicity is recommended

Lactic Acidosis and Severe Hepatomegaly With Steatosis:
Fatal cases have been reported with the use of nucleoside analogs, including lamivudine. Discontinue DOVATO if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Adverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of DOVATO and other drugs may occur (see Contraindications and Drug interactions).

Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of DOVATO.

Adverse reactions

The most common adverse reactions (incidence ≥2%, all grades) with DOVATO were headache (3%), nausea (2%), diarrhea (2%), insomnia (2%), fatigue (2%), and anxiety (2%).

Drug interactions

Consult full Prescribing Information for DOVATO for more information on potentially significant drug interactions
DOVATO is a complete regimen. Coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
Drugs that induce or inhibit CYP3A or UGT1A1 may affect the plasma concentrations of dolutegravir
Administer DOVATO 2 hours before or 6 hours after taking polyvalent cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, DOVATO and supplements containing calcium or iron can be taken with food

Use in specific populations

Pregnancy: There are insufficient human data on the use of DOVATO during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage. An Antiretroviral Pregnancy Registry has been established
Lactation: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant
Renal Impairment: DOVATO is not recommended for patients with creatinine clearance <30 mL/min. Patients with a sustained creatinine clearance between 30 and 49 mL/min should be monitored for hematologic toxicities, which may require a dosage adjustment of lamivudine as an individual component
Hepatic Impairment: DOVATO is not recommended in patients with severe hepatic impairment (Child-Pugh Score C)

Please see full Prescribing Information, including Boxed Warning, for DOVATO.

PMUS-DLLWCNT240058 January 2025

To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at www.gsk.public.reportum.com or 1-877-844-8872, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

BIKTARVY and GENVOYA are trademarks of Gilead Sciences, Inc. All other trademarks are owned by or licensed to the ViiV Healthcare group of companies.

This site is funded and developed by ViiV Healthcare.
This site is intended for US healthcare professionals only.
©2025 ViiV Healthcare or licensor.
PMUS-DLLWCNT240055 February 2025
Produced in USA.

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As They Look to Their Future,

Patients Are Considering How Treatment Fits Into Their Overall Health

“To what extent do you agree or disagree with each of the following statements about taking HIV medication?”

Percentage of US respondents living with HIV (n=400) who “strongly agree” or “agree” with each statement

Data are not specific to DOVATO patients or indicative of DOVATO clinical trials

Treat ahead by addressing your patients’ current needs

DOVATO Can Benefit a Range of Patients With Diverse Backgrounds

Malcolm

Oscar

Dave

Anne

Malcolm

HIV Treatment History

Current Concerns

Future Considerations

What are patients thinking about when considering HIV medication?

See Patients’ Answers

INDICATION

IMPORTANT SAFETY INFORMATION

INDICATION

IMPORTANT SAFETY INFORMATION

Contraindications

Warnings and precautions

Adverse reactions

Drug interactions

Use in specific populations

As They Look to Their Future,

Patients Are Considering How Treatment Fits Into Their Overall Health

“To what extent do you agree or disagree with each of the following statements about taking HIV medication?”

Percentage of US respondents living with HIV (n=400) who “strongly agree” or “agree” with each statement

Data are not specific to DOVATO patients or indicative of DOVATO clinical trials

Treat ahead by addressing your patients’ current needs

DOVATO Can Benefit a Range of Patients With Diverse Backgrounds

Malcolm

Oscar

Dave

Anne

Malcolm

HIV Treatment History

Current Concerns​​

Future Considerations

What are patients thinking about when considering HIV medication?

See Patients’ Answers

INDICATION

IMPORTANT SAFETY INFORMATION

INDICATION

IMPORTANT SAFETY INFORMATION

Contraindications

Warnings and precautions

Adverse reactions

Drug interactions

Use in specific populations

Current Concerns