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Dolutegravir/Lamivudine

    Brands

    DEA Class; Rx

    Common Brand Names; Dovato

    • HIV, ART Combos

    Combination of an integrase strand transfer inhibitor and a nucleoside reverse transcriptase inhibitor
    Complete regimen for treatment of HIV-1 infection in adults who are treatment-naive or virologically suppressed and on a stable antiretroviral regimen
    Black Box Warning for exacerbations of hepatitis B infections

    Indicated as a complete 2-drug regimen for treatment of HIV infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (ie, HIV-1 RNA <50 copies/mL) on a stable ARV regimen and no history of treatment failure and no known substitutions associated with resistance

    Hypersensitivity to dolutegravir or lamivudine

    Coadministration with dofetilide

    • Headache (3%)
    • Nausea (2%)
    • Diarrhea (2%)
    • Insomnia (2%)
    • Fatigue (2%
    • Dizziness
    • Blood and lymphatic systems disorders: Anemia, neutropenia, thrombocytopenia
    • Gastrointestinal disorders: Abdominal discomfort, abdominal pain, flatulence, upper abdominal pain, vomiting
    • General: Fever
    • Hepatobiliary disorders: Hepatitis
    • Immune system disorders: Hypersensitivity, immune reconstitution syndrome
    • Musculoskeletal disorders: Myositis
    • Nervous system disorders: Somnolence
    • Psychiatric disorders: Anxiety; abnormal dreams; depression; suicidal ideation, attempt, behavior, or completion; these events were observed primarily with preexisting history of depression or other psychiatric illness
    • Renal and urinary disorders: Renal impairment
    • Skin and subcutaneous tissue disorders: Pruritus, rash

    Safety and efficacy of lamivudine have not been established for treatment of chronic HBV in patients dually infected with HIV-1 and HBV; emergence of HBV variants associated with resistance to lamivudine reported

    Severe acute HBV exacerbations reported in patients coinfected with HIV-1 and HBV who have discontinued lamivudine

    Hypersensitivity reactions reported with dolutegravir; reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury

    Hepatic adverse events reported with dolutegravir; patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations; in some cases, the elevated transaminases were consistent with immune reconstitution syndrome or HBV reactivation, particularly in the setting where antihepatitis therapy was withdrawn

    Preliminary data from an observational study suggest dolutegravir is associated with increased risk of neural tube defects when administered at the time of conception and in early pregnancy

    Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with nucleoside analogues, including lamivudine; female sex and obesity may be risk factors

    Breastfeeding is not recommended because of potential for HIV-1 transmission from mother to infant

    Adults

    1 tablet/day PO (dolutegravir 50 mg/day PO; lamivudine 300 mg/day PO); dolutegravir 100 mg/day PO when coadministered with certain drugs.

    Geriatric

    1 tablet/day PO (dolutegravir 50 mg/day PO; lamivudine 300 mg/day PO); dolutegravir 100 mg/day PO when coadministered with certain drugs.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    dolutegravir/lamivudine

    dolutegravir 50mg/ lamivudine 300mg