ViiV Healthcare Announces FDA Approval of Dovato, the First Two-Drug Fixed-Dose Combination for Treatment-Naïve HIV Patients

On April 8, VCBeat (WeChat Official Account: vcbeat) learned that Dovato (dolutegravir and lamivudine), an antiretroviral therapy from ViiV Healthcare, a company specializing in HIV treatment and care, has received FDA approval as a complete regimen for the treatment of HIV-infected patients who have never previously received antiretroviral therapy. Notably, this is the first FDA-approved two-drug, fixed-dose complete regimen for adult patients with HIV who are antiretroviral-naïve.

ViiV Healthcare was jointly established by GlaxoSmithKline and Pfizer in November 2009, with a commitment to providing advanced treatment and care for people living with HIV. The company aims to deepen and broaden its focus on HIV and AIDS, delivering effective novel antiretroviral therapies and supporting communities affected by HIV.

To date, approximately 1.1 million people in the United States are living with HIV, and about 15% of them are unaware of their infection status. Antiretroviral "cocktail therapy" can effectively reduce the level of HIV in the blood, prevent disease progression, and enable patients to lead healthier lives. Individuals with HIV who receive long-term antiretroviral therapy can suppress their viral load to levels that are not transmissible to others.

Dovato is a fixed-dose combination tablet comprising dolutegravir (DTG) and lamivudine, developed by ViiV Healthcare. DTG is a next-generation HIV integrase inhibitor, while lamivudine is a nucleoside reverse transcriptase inhibitor. The efficacy and safety of Dovato (administered as one tablet once daily) have been demonstrated in two randomized, double-blind, active-controlled clinical trials involving a total of 1,433 individuals with HIV infection. The trials indicated that the two-drug regimen consisting of DTG and lamivudine achieved similar reductions in HIV viral load in the blood compared to the three-drug regimen comprising DTG, emtricitabine, and tenofovir.Treatment is considered successful if the patient maintains low levels of HIV RNA (below 50 copies/mL) in their blood for at least 48 weeks.

The most common adverse reactions to Dovato are headache, diarrhea, nausea, insomnia, and fatigue. In May 2018, the FDA issued a drug safety communication regarding neural tube birth defects in infants born to women taking DTG for treatment. Due to the known risk of neural tube defects associated with DTG, patients in the first trimester of pregnancy should avoid using Dovato.

Dovato labeling includes a boxed warning: Patients co-infected with HIV and hepatitis B virus (HBV) should consider alternative antiretroviral regimens or additional treatment for HBV. In patients co-infected with HIV and HBV who receive lamivudine-containing products, HBV variants associated with resistance to lamivudine have emerged. Upon discontinuation of lamivudine-containing drugs, severe acute exacerbations of hepatitis B, including hepatic decompensation and liver failure, may occur. Therefore, patients co-infected with HIV and HBV who discontinue Dovato should be closely monitored by their healthcare provider.

“Currently, the standard of care for treatment-naïve patients is a three-drug combination regimen. This approval provides these patients with the option of using a two-drug fixed-dose combination tablet. It can help eliminate adverse effects and potential drug interactions associated with the third drug,” said Dr. Debra Birnkrant, Director of the Division of Antiviral Products at the FDA. “Reducing medication burden by eliminating one drug may benefit certain patients who have concerns about long-term use of multiple medications.”

Deborah Waterhouse, CEO of ViiV Healthcare, stated: “Powered by DTG, Dovato is based on our innovative drug portfolio. DTG is an antiretroviral medication included in various combination therapies and is the most widely used integrase inhibitor worldwide. ViiV Healthcare is delivering what patients have been asking for: treating HIV-1 infection with as few medications as possible. This also represents a significant step forward in HIV treatment.”

Notably, in February 2019, the U.S. Department of Health and Human Services announced a new initiative, “Ending the HIV Epidemic: A Plan for America.” This is regarded as a rare opportunity to eliminate HIV infection in the United States. The initiative will provide additional expertise, technology, and resources to the most heavily affected communities to address local HIV epidemics, with a focus on specific geographic hotspots. Its goal is to reduce new infections by 75% within five years and by 90% within ten years, thereby preventing more than 250,000 HIV infections during this period.

(Compiled by Li Chengping)