The Food and Drug Administration (FDA) recently announced the approval of Dovato, the first complete two-drug HIV treatment regimen for people who previously have not been on antiretroviral therapy.
The new drug is for people who have no known or suspected resistance to the therapy, according to
Right now, the therapy for HIV-positive people who have not been previously receiving antiretroviral treatment has been a three-drug regimen.
Why is Dovato significant?
It offers the potential for these people to take their two-drug regimen in one single tablet. ViiV Healthcare developed the drug.
“Having a drug-sparing treatment available that uses fewer drugs is beneficial to patients who may have issues taking multiple medications over a long period of time,” said Dr. Debra Birnkrant, director of the FDA’s division of antiviral products, in the release.
However, this isn’t the first HIV single two-drug treatment ever developed. Seventeen months ago, the FDA approved Juluca.
Juluca was the first successful, single two-drug therapy option, but unlike Dovato, it was geared to people who had already been receiving treatment. (Think of it as a maintenance regimen for those who achieved an undetectable viral load, which is when a person cannot transmit the virus to HIV-negative sexual partners, according to the Centers for Disease Control and Prevention (
Dr. Alan Taege, an infectious disease expert at Cleveland Clinic, said that the new drug announcement underscores the gradual improvement in HIV treatment options over the years.
He said that drugs available in the earlier years of the HIV-AIDS epidemic were “not as potent” as those developed in recent years.
Over time, once the medical community learned that therapies involving fewer pills could be effective with fewer and more palpable side effects than early drugs, the current three-drug standard became the norm.
Now, more two-drug therapies can make treatment potentially more manageable for people living with HIV.
What does that mean for patients?
“Any time a medication’s chance of side effects decreases, if two-drug regimens seem to be extremely well tolerated with minimal-to-no side effects — with the bigger picture meaning you have very safe, very effective, and extremely well-tolerated treatments — the hope is this will make it easier to take these treatments,” Taege told Healthline.
Taege also pointed out that while we currently don’t know how the medication will be priced, this new treatment may cost less than other drugs currently on the market.
“It is all about simplicity, tolerability, and hopefully this will ultimately come at less cost,” Taege said.
Dovato contains a boxed warning that people with both HIV and hepatitis B should incorporate added treatment for their hepatitis B or possibly consider taking a different regimen, according to the release.
The FDA announced that common “adverse reactions” to the drug in clinical trials included headaches, diarrhea, nausea, insomnia, and fatigue.
Taege said if the two-drug regimen proves to be as powerful as believed then there might be a shift in this direction. However, he said that is still yet to be seen.
“New treatment is good news. Hopefully, it leads to increased adherence than older medications so more people stay controlled, so that there is less chance that people will progress with disease and less chance of new cases showing up,” he said.
The need for continually improved treatments for people who are HIV positive is certainly great.
The CDC reports that there are about
Within this number, about 15 percent don’t even know they are infected, according to the U.S. Department of Health and Human Services.
The new drug announcement also dovetails with the pledge by the U.S. government to eradicate new cases of HIV and AIDS by 2030. This includes an emphasis on treatment as prevention initiatives, like the use of pre-exposure prophylaxis (PrEP), a daily regimen of two medications in one pill taken by people who are HIV-negative but at risk for contracting HIV.
Dr. Hyman Scott, MPH, the clinical research medical director at Bridge HIV and an assistant clinical professor of medicine at the University of California, San Francisco (UCSF), told Healthline that we are living in a time where people with HIV are living to a much higher life expectancy than ever before.
“I think this is exciting as we move into new options for people living with HIV, and it’s really a sign of how well some of the newer regimens of drugs work for treating HIV. I think it’s a testament to how much the advocacy for scientific advancements and understanding of HIV has informed the development of these new treatment options,” Scott said. “This awareness can lead to breakthroughs that have real implications for people, and new targets keep being investigated for treatment that are novel.”
He said the continued development of new and better treatment “holds potential” that, in the future, could “change some of the paradigms we have for treatment for HIV.”
Both Taege and Scott stressed that you should always consult your doctor about what treatment makes the most sense for you and emphasized that this new drug is just the first of its kind for people who previously have not received therapy and who have no known resistance to the treatment. Time will tell where this will lead in regard to the approval of future, similar regimens down the line.
The Food and Drug Administration
The new drug is meant only for people who have no known or suspected resistance and who have not previously been on antiretroviral treatments.
HIV experts suggest that this — along with a similar two-drug therapy for people who have undetectable viral loads from past antiretroviral treatment — could lead to more accessible drug regimens with progressively less side effects down the line.