DOVATO

What it is

Dovato is a fixed-dose combination of dolutegravir and lamivudine indicated for the treatment of Human Immunodeficiency Virus-1 (HIV-1) infection in antiretroviral treatment-naïve adults and adolescents from 12 years of age weighing at least 40 kg who have no known or suspected resistance to either antiretroviral component.

Approved indications

— Treatment of Human Immunodeficiency Virus-1 (HIV-1) infection in antiretroviral treatment-naïve adults and adolescents from 12 years of age weighing at least 40 kg with no known or suspected resistance to either component.

Dosing overview

Dovato contains dolutegravir 50 mg and lamivudine 300 mg per tablet.

Key safety warnings

Hypersensitivity reactions have been reported with both dolutegravir and lamivudine, components of Dovato. Hypersensitivity to lamivudine is a multi-organ clinical syndrome which can occur at any time during treatment, but most often occurs within the first 6 weeks of therapy. Signs or symptoms usually present in two or more of the following groups: fever; rash; gastrointestinal symptoms including nausea, vomiting, diarrhoea or abdominal pain; constitutional symptoms including generalised malaise, fatigue or achiness; or respiratory symptoms including dyspnoea, cough or pharyngitis. Discontinue Dovato as soon as a hypersensitivity reaction is suspected. If a hypersensitivity reaction is suspected, Dovato must be stopped without delay, even in the absence of the HLA-B*5701 allele. Delay in stopping treatment after the onset of hypersensitivity may result in life-threatening hypotension and death. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of antiretroviral nucleoside analogues either alone or in combination, including lamivudine. A majority of these cases have been in women. Clinical features which may be indicative of the development of lactic acidosis include generalised weakness, anorexia, and sudden unexplained weight loss, gastrointestinal symptoms and respiratory symptoms. Caution should be exercised when administering Dovato particularly to those with known risk factors for liver disease. Treatment with Dovato should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis with or without hepatitis.

Contraindications

Dovato is contraindicated in patients with known hypersensitivity to dolutegravir or lamivudine, or to any of the excipients.

PBS listing

Dovato is listed on the PBS for the treatment of HIV infection in treatment-naïve patients who meet certain conditions. The August 2019 PBAC recommendation was based on cost-effectiveness if cost-minimised against individual components, with grandfather restriction recommended for patients transitioning from concomitant dolutegravir and lamivudine to the fixed-dose combination. A streamlined Authority Required restriction applies under the Highly Specialised Drugs Program community access listing.

Regulatory history

Dovato (50 mg dolutegravir / 300 mg lamivudine tablets) was first listed on the ARTG on 12 September 2019. Dovato was approved by the TGA on 11 September 2019 for the treatment of Human Immunodeficiency Virus-1 (HIV-1) infection. In August 2019, PBAC recommended Dovato for the treatment of HIV infection in treatment-naïve patients who meet certain conditions.