Safety and Effectiveness Analyses of Dolutegravir/Lamivudine in Patients with HIV: 2-Year Report of Post-Marketing Surveillance in Japan.

Introduction: Since 2019, for the first time, a two-drug regimen with dolutegravir/lamivudine (DTG/3TC) has been recommended for HIV treatment as initial and subsequent therapy in the international guidelines. However, safety and efficacy data of DTG/3TC in Japanese people living with HIV (PLHIV) in clinical trials are limited and have not been evaluated in clinical practice. In this report, we evaluated safety and effectiveness of DTG/3TC in Japanese PLHIV through post-marketing surveillance.