FDA approves Dovato for virologically suppressed adults with HIV
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The FDA has approved an expanded indication for Dovato, making it available for adult patients with HIV-1 who are virologically suppressed.
Dovato (ViiV Healthcare) — a combination of dolutegravir 50 mg and lamivudine 300 mg — became the first FDA-approved two-drug HIV regimen when it was approved last year for patients with no history of ART and no known resistance to either drug.
The new approval of means Dovato, a single tablet that is taken once daily, can replace the current antiretroviral regimen for virologically suppressed patients with HIV.
“The approval of Dovato as a treatment option for virologically suppressed patients living with HIV provides clinicians with the ability to offer a switch to a single-tablet regimen containing fewer antiretrovirals — allowing these patients the opportunity to reduce the number of medications they take every day while still maintaining durable viral suppression,” Charlotte-Paige Rolle, MD, MPH, director of research operations at the Orlando Immunology Center, told Healio.
Dovato’s approval for virologically suppressed adults was based on results from a phase 3 trial that showed virologically suppressed patients taking a three-drug regimen containing tenofovir alafenamide fumarate maintained similar rates of virologic suppression after switching to Dovato.
ViiV noted that patients should be tested for hepatitis B virus before initiating Dovato due to reports of lamivudine-resistant HBV variants association with antiretroviral regimens containing the drug, and severe exacerbations of HBV among patients coinfected with HIV who discontinued lamivudine.
Perspective
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Paul A. Volberding, MD
HIV drug development has been aimed at creating ever more potent drugs that suppress viral replication and prevent the selection of drug-resistant mutations. Another goal has been reducing toxicity while improving convenience. Since 1996, a persisting dogma has held that effective therapy demands the combination of three separate drugs, so-called "triple therapy." As we have made progress in discovering improved drugs, however, that belief has been challenged.
To avoid as much toxicity as possible, several combinations of two drugs have been shown effective and have gained FDA approval. These typically are based on one of the newer integrase inhibitors, given their potency and high resistance barrier. The newest of these two-drug, once-daily regimens is the combination of the integrase inhibitor dolutegravir with one of our oldest HIV drugs, lamivudine, or 3TC. Two caveats are in order.
Because this combination has been tested in few with extremely high HIV viral loads (above 500,000 copies/mL), it should be avoided in these patients. More importantly perhaps is that it should not be used in those with chronic HBV infection. Because 3TC alone is insufficiently active against HBV, its use without a second active drug like tenofovir disoproxil fumarate or tenofovir alafenamide fumarate can allow for the selection of HBV-resistant mutants. Also, in those with chronic HBV infection, stopping 3TC therapy can cause a flare in HBV infection, which can be serious. Nevertheless, the dolutegravir/lamivudine combination could be an attractive choice to further simplify HIV therapy.
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