Dovato Receives Expanded Indication for HIV

August 6, 2020 – The U.S. FDA has approved an expanded indication for Dovato® (dolutegravir/lamivudine) oral tablets, manufactured by ViiV Healthcare. The drug is now approved as a complete treatment regimen to replace the current antiretroviral (ARV) regimen in adults 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 the individual components of Dovato. Previously, the product was only approved for use in adults who had no ARV treatment history.

Approximately 1.2 million people in the United States live with HIV-1 infection, though an estimated 1 in 7 are unaware they are infected. Thanks to advances in treatment, many patients are able to live long, healthy lives. The goal of treatment is often to suppress the virus, keeping its numbers low in the body to prevent complications and disease progression.

In a clinical study, adults who had maintained virologic suppression of HIV-1 for at least six months on a regimen of at least three drugs were able to maintain similar rates of virologic suppression after switching to Dovato.

Recommended dosing is one tablet per day. Each tablet contains 50mg of dolutegravir and 300mg of lamivudine. If Dovato is used concurrently with carbamazepine or rifampin, patients should take an additional 50mg of dolutegravir approximately 12 hours after taking Dovato.

A black box warning cautions that there is a risk of hepatitis B virus (HBV) exacerbation and emergency of lamivudine-resistant HBV in patients who use Dovato and are coinfected with HBV and HIV-1. All patients should be tested for HBV before starting treatment with Dovato.

Dovato first received FDA approval in 2019.