The Food and Drug Administration (FDA) lately declared the approval of Dovato, the first complete two-drug HIV treatment program for folks that previously haven’t been on antiretroviral treatment.
The new drug is for people that don’t have any known or suspected resistance to the treatment, based on a press release trusted source. Currently, the treatment for HIV-positive people who haven’t been receiving antiretroviral therapy has been a three-drug regimen.
Why is Dovato Important?
It provides the potential for these individuals to take their two-drug regimen in one particular 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 only two-drug treatment ever invented. Seventeen months ago, the FDA supported Juluca.
Juluca was the first prosperous single two-drug treatment opportunity, but unlike Dovato, it was provided to folks who had been already getting treatment. (Think of it as a support regimen for people who achieved an undetectable viral load, which is when someone can’t transmit the virus to HIV-negative intimate partners, according to the Centers for Disease Control and Prevention (CDC Trusted Source).
Dr. Alan Taege, a transmissible disease expert at Cleveland Clinic, said that the new drug statement underscores the slow improvement in HIV treatment choices through the years.
He stated that medication available in the earlier years of this HIV-AIDS epidemic were “less potent” as those developed in recent years.
Over time, when the medical community learned that ancient drugs could not be successful with fewer and more noticeable side effects than early medications, the new three-drug model became the standard.
Now, more two-drug therapy can make treatment seemingly more flexible for individuals living with HIV.
What Does This 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 pointed out that while we do not know how the medication will be priced, this treatment may cost less than other drugs on the market.
“It is all about simplicity, tolerability, and hopefully this will ultimately come at less cost,” Taege said.
Dovato includes a boxed warning that people with HIV and hepatitis B must incorporate added treatment for their hepatitis B or consider taking a different regimen, according to the release.
The FDA declared that common “adverse reactions” to the drug in clinical trials included nausea, diarrhea, headaches, insomnia, and fatigue.
Could Single HIV Therapies Be The Standard In The Future?
Taege said if the two-drug regimen determines to be as strong as believed, then there might be a shift in this direction. However, he said that is still 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 requirement for continuously improved treatments for people who are HIV positive is undoubtedly great.
The CDC reports that there are nearly 1.1 million people Trusted Source currently living with the virus in America. Within this amount, about 15 percent do not even know they’re infected, according to the U.S. Department of Health and Human Services.
The new medication announcement also dovetails with the pledge from the U.S. government to eliminate new cases of AIDS and HIV by 2030. This includes an emphasis on therapy as prevention initiatives, such as using pre-exposure prophylaxis (PrEP), a daily regimen of two drugs in one pill taken by those that are HIV-negative but at risk for contracting HIV.
Dr. Hyman Scott, MPH, the clinical study medical director at Bridge HIV and an assistant clinical educator of medicine at the University of California, San Francisco (UCSF), advised Healthline that we’re living in a period where people with HIV are living to a 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 treatments that are novel.”
He said the continuing development of new and improved treatment “holds possible” that, in the long run, could “change a few of the standards we have for treatment for HIV.”
Both Taege and Scott emphasized that you should regularly ask your physician about what treatment is the most suitable to you and stressed that this new medication is simply the first of its kind for folks that previously have not received treatment and who have no known resistance to the treatment. Time will tell where this will point to the approval of similar, future regimens down the road.
Ending the HIV Epidemic
In the State of the Union Address in February 2019, Donald J. Trump declared his Administration’s goal to stop the HIV epidemic in America within 10 years. To attain this goal and handle the continuing public health crisis of HIV, the projected Ending the HIV Epidemic: A Plan For America will use the compelling tools and data currently available to reduce new HIV infections in the USA by 75 percent in five years and by 90% by 2030.
HIV has cost America too much for years and persists a substantial public health issue:
- Over 700,000 American lives are lost to HIV since 1981.
- Over 1.1 million Americans are presently living with HIV, and many more are at chance of getting HIV infection.
- While new HIV diagnoses have weakened significantly from their peak, an improvement on further reducing them has delayed with an estimated 40,000 Americans being newly diagnosed every year. Over ten years, another 400,000 Americans will be diagnosed without intervention regardless of the tools that are available to prevent diseases.
- The U.S. government pays $20 billion in annual direct health expenditures for HIV prevention and care.
- There’s a real threat of HIV resurgence due to many circumstances, including injection drug use and diagnostic contentment among healthcare agencies.
The new initiative seeks to lessen the number of HIV infections in the U.S. by 90 percent over ten years, for an estimated 250,000 total HIV infections averted.
Right Data & Right Tools
Today we’ve got the tools available to end the HIV epidemic. Landmark biomedical and experimental study progress have contributed to the evolution of several successful HIV therapy regimens, prevention strategies, and increased care for persons living with HIV.
- Data inform us that many new infections occur in a limited number of counties and among particular populations.
- Thanks to improvements in antiretroviral therapy, the medication used to treat HIV, people with HIV who take their medication as prescribed and, because of this; keep an undetectable viral load can live long, healthy lives and have effectively no chance of sexually transmitted HIV to a partner.
- We’ve proven models of successful HIV prevention and care based on more than two years of expertise in engaging and retaining patients in effective care.
- Pre-exposure prophylaxis (PrEP), a regular regimen of two oral antiretroviral drugs in one pill, has been demonstrated to be very effective in preventing HIV infection for people at high risk, lowering the chance of getting HIV by up to 97 percent.
- New laboratory and epidemiological techniques let us pinpoint where HIV infections are spreading most quickly so health officials can react swiftly with resources to halt the further spread of new infections.
With these powerful tools and data, the Administration sees a once-in-a-generation opportunity to end the epidemic.
This action will leverage significant scientific advances in HIV prevention, diagnosis, treatment, and care by coordinating the highly effective applications, resources, and infrastructure of many HHS agencies and offices, including the:
- National Institutes of Health (NIH)
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Indian Health Service (IHS)
- Centers for Disease Control and Prevention (CDC)
- Office of the HHS Assistant Secretary for Health
- Health Resources and Services Administration (HRSA)
The HHS Office of the Assistant Secretary for Health is organizing this cross-agency program.
Besides the coordination of federal agencies, critical elements for the success of this initiative will be active partnerships with county, city, tribal and state public health agencies, local and regional clinics and health care departments, clinicians, advocates, professional associations, providers of medication-assisted treatment for opioid use disorder, community- and faith-based associations, and academic and research institutions.
President Trump suggested $291 Million in the FY2020 HHS funding start his Administration’s multi-year initiative centered on ending the HIV disease in the United States by 2030.
Period I: Geographic Focus
Most new HIV infections in America are highly intense in particular geographic hotspots. Over 50% of new HIV diagnoses in 2016 and 2017 happened in 48 counties, San Juan, Puerto Rico, and Washington, DC. Also, we understand that seven states have a disproportionate incidence of HIV in rural zones. For the first five years (Phase I), the lead will concentrate on a quick infusion of new resources, experience, and technology into these areas of the nation today most affected by HIV.
Phases II and III
In Phase II, attempts will be more widely disseminated throughout the country to decrease new infections by 90% by 2030. In Phase III, the intensive case strategy will be implemented to keep the number of new infections at fewer than 3,000 each year.
Despite the transforming developments in HIV prevention and treatment tools, not everyone is benefiting from such approaches. New infections are highly intense amongst men who have sex with men; minorities, notably African Americans, American Indians, and Alaska Natives; and people who reside in the southern United States.
Further, new analysis from CDC indicates the vast majority (roughly 80%) of new HIV infections in the U.S. in 2016 were transmitted by the almost 40 percent of individuals with HIV who either unaware that they had HIV or who were diagnosed but weren’t receiving HIV care. These data underscore the effects of untreated and undiagnosed HIV as well as the crucial requirement to expand HIV diagnosis and treatment in the United States.
And stigma–that can be a debilitating obstacle preventing people living with, or at risk for, HIV from getting the health care, assistance, and respect they want and deserve—yet tragically encircles HIV. Responding to HIV isn’t only a biomedical subject, but also a social challenge.
Effective medications have driven the number of new HIV infections down to approximately 40,000 per year–the lowest level ever. However, recent statistics show that our progress reducing the amount of new HIV infections has risen. Today, there are new threats to the advancement we have made, the most important being the opioid emergency: One in 10 new HIV infections occur among individuals who intake drugs.
The Bottom Line
The Food and Drug Administration announced Trusted Source the approval of Dovato, a new single two-drug treatment program for HIV-positive people.
The new drug is meant just for people that do not have any known or suspected resistance and that haven’t previously been on antiretroviral treatments.
HIV experts indicate that this — combined with a related two-drug treatment for people who have undetectable viral loads from earlier antiretroviral treatment — could lead to more available drug regimens with progressively fewer side effects down the line.