New fixed-dosed two-drug regimen approved for HIV—reducing patient exposure and potential drug interactions compared to usual pills containing three or more medicines
The TGA has approved Dovato (dolutegravir and lamivudine), a new once-daily, single-tablet, two-drug regimen for treatment-naïve adults and adolescents with human immunodeficiency virus infection type 1 (HIV-1).
Studies show that that Dovato, containing only two antiretroviral medicines, demonstrates non-inferior efficacy compared with a traditional dolutegravir-based three-drug regimen over 48 weeks (primary endpoint) and 96 weeks.
Meanwhile it also reduces patient exposure to the number of medicines from the start of treatment.
“This is the first generation of people being diagnosed with HIV that will have access to a two-drug regimen – representing a paradigm shift in how HIV is managed in Australia,” said Professor Mark Boyd, Chair of Medicine, University of Adelaide Medical School.
The TGA announcement is based on evidence from two large clinical trials which show that HIV can be effectively controlled and sustained with two drugs instead of three or more, “giving people who are diagnosed with HIV and their clinicians a new option of avoiding additional toxicity and potential drug interactions from a third medicine,” said Professor Boyd.
The approval is based on the global GEMINI clinical studies (GEMINI-1 and GEMINI-2) of 1441 participants with HIV-1 infection, in which Dovato achieved non-inferior efficacy compared to a dolutegravir-based, traditional, three-drug regimen through a 48 week (primary endpoint) and 96 week period.
At week 48, more drug-related adverse events occurred with the three-drug regimen than with the two-drug regimen (169 [24%] of 717 vs 126 [18%] of 716); few participants discontinued because of adverse events (16 [2%] in the three-drug regimen and 15 [2%] in the two-drug regimen).
Two deaths were reported in the two-drug regimen group of GEMINI-2, but neither was considered to be related to the study medication.
Meanwhile week 96 discontinuations for adverse events or death stood at 3% in both study arms. The drug-related adverse event rate was slightly lower with two drugs than with three: 20% versus 25%.
These trials were funded by ViiV Healthcare, a global specialist HIV company and the manufacturer of Dovato.
Most recent data from the Kirby Institute shows there are about 27,545 Australians living with HIV, with nearly 1,000 new diagnoses in 2017.
A submission for the medicine has been made to the Pharmaceutical Benefits Advisory Committee (PBAC) for a Section 100 (Highly Specialised Drugs Program – Community Access) Authority Required (STREAMLINED) listing on the PBS for the treatment of patients with HIV infection.
Physicians and pharmacists treating people living with HIV can contact manufacturer ViiV Healthcare for information on how to access Dovato prior to the reimbursement on the PBS.