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Cost puts HIV-preventing PrEP out of reach for many

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The daily drug regimen known as PrEP is a nearly foolproof way to prevent HIV infection. But a new study suggests that many high-risk Americans may be giving the medication a pass because of cost.

The warning stems from a pricing analysis that tracked about 2.6 million PrEP prescriptions filled between 2014 and 2018.

The researchers found that during that time frame, PrEP prices — which were already high — shot up an average of 5% per year.

“Pre-exposure prophylaxis, or PrEP, is when people at risk for HIV take a medication to prevent HIV,” explained study author Dr. Nathan Furukawa. He is a medical officer in the division of HIV/AIDS prevention at the U.S. Centers for Disease Control and Prevention.

First introduced back in 2012, the regimen entails taking a single pill once a day (brand name Truvada), though the pill actually combines two antiretroviral drugs. According to the CDC, a second option — Descovy — is also approved for PrEP, though it is not yet clear whether it specifically protects women during vaginal intercourse.

But the bottom line is that “PrEP is highly effective at preventing HIV from sex or injection drug use when taken consistently,” stressed Furukawa. “If enough people at risk of HIV take PrEP, we can stop new HIV infections and end the HIV epidemic.”

Furukawa and his colleagues describe the widespread adoption of PrEP as “a foundational pillar” of the effort to rein in HIV among those most vulnerable, including gay and bisexual men, and drug users.

But only about 18% of Americans deemed at high-risk for HIV had embraced PrEP as of 2018. And the latest findings, said Furukawa, suggest that its prohibitive cost may be to blame.

The conclusion follows an examination of PrEP orders and prices compiled by the IQVIA prescription database. The database tracks more than nine in 10 medications dispensed by retail pharmacies in the United States, and between 60% and 86% of medications obtained online.

The investigators found that between 2014 and 2018, the number of Americans who began taking PrEP increased significantly, rising from about 20,000 to nearly 205,000.

Yet, at the same time, the cost of a month’s supply of 30 tablets rose from $1,350 to $1,638, the study authors noted.

But isn’t PrEP covered by insurance? Yes and no, Furukawa said.

“PrEP is covered by nearly all insurance plans, most state Medicaid plans and Medicare,” he noted. “However, out-of-pocket costs for patients who have not met their deductible may still be prohibitive.”

Out-of-pocket costs shot up by nearly 15% a year during the study period. That translates to an average out-of-pocket rise from $54 a month in 2014 to $94 a month by 2018, the findings showed.

“Even though insurers cover about 94% of PrEP medication costs, patients may still have difficulties paying the remaining out-of-pocket costs, since the cost of the medication is large,” Furukawa explained.

As for those who are underinsured or lack insurance altogether, state medication assistance programs and the manufacturer of Truvada (Gilead) may offer subsidies. (Furukawa directed those interested to the nonprofit PrEPcost.org website.)

Furukawa also acknowledged that there are other impediments to PrEP acceptance beyond cost, including lack of awareness and insufficient access to health care.

Still, he suggested that lowering the cost of the medication could be an important factor in getting more people on board.

That thought was seconded by Dr. Michael Horberg, associate medical director and director of HIV/AIDS and STD at the Kaiser Permanente Care Management Institute in Rockville, Md.

While drug assistance programs are available, “pharmacy costs are always a big concern in preventive medicine,” said Horberg.

But PrEP cost is likely to fall in the coming years, he said, as a cheaper generic version of Truvada comes to market. And PrEP is also now classified as a level “A” recommended drug by the U.S. Preventive Services Task Force. That designation should drive out-of-pocket costs down to as low as zero, Horberg added.

“Nonetheless, the pharmaceutical industry should aim to lower costs, and make this readily available to all U.S. citizens who would benefit from PrEP,” Horberg said.

The findings were published Sept. 8 in the Annals of Internal Medicine.

More information

There’s more on PrEP at the U.S. Centers for Disease Control and Prevention.

Copyright 2020 HealthDay. All rights reserved.



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‘Green prescriptions’ could cancel mental health benefits for some

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So-called “green prescriptions” may end up being counterproductive for people with mental health conditions, researchers say.

Spending time in nature is believed to benefit mental health, so some doctors are beginning to “prescribe” outdoor time for their patients.

That led researchers to investigate whether being in nature helps actually does help people with issues such as anxiety and depression. They collected data from more than 18,000 people in 18 countries.

The takeaway: Time in nature does provide several benefits for people with mental health conditions, but only if they choose on their own to visit green spaces.

While being advised to spend time outdoors can encourage such activity, it can also undermine the potential emotional benefits, according to the authors of the study published this month in the journal Scientific Reports.

The researchers said they were surprised to find that people with depression were spending time in nature as often as folks with no mental health issues, and that people with anxiety were doing so much more often.

While in nature, those with depression and anxiety tended to feel happy and reported low anxiety. But those benefits appeared to be undermined when the visits were done at others’ urging, the investigators found.

The more external pressure people with depression and anxiety felt to visit nature, the less motivated they were to do so and the more anxious they felt.

“These findings are consistent with wider research that suggests that urban natural environments provide spaces for people to relax and recover from stress,” said study leader Michelle Tester-Jones, a postdoctoral research associate at the University of Exeter in the United Kingdom.

But the findings also show that health care practitioners and loved ones should be sensitive about recommending time in nature for people who have mental health issues.

“It could be helpful to encourage them to spend more time in places that people already enjoy visiting, so they feel comfortable and can make the most of the experience,” Tester-Jones said in a university news release.

More information

For more on the benefits of green spaces, go to the National Recreation and Park Association.

Copyright 2020 HealthDay. All rights reserved.



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Study: Nearly half of ‘essential workers’ in U.S. at risk for severe COVID-19

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Nov. 9 (UPI) — Nearly half of those classified as “essential workers” in the United States are at increased risk for severe COVID-19, according to an analysis published Monday by JAMA Internal Medicine.

This means that more than 74 million workers and those with whom they live could be at risk for serious illness, based on disease risk guidelines developed by the U.S. Centers for Disease Control and Prevention, the researchers said.

“Many parts of the country face high and rising infection rates, [and] we should not think about work exposure and health risks in isolation, given that workers and persons at increased risk often live in the same households,” study co-author Thomas M. Selden told UPI.

“Insofar as we can reduce the prevalence of COVID-19 in our communities, we can reduce the extent to which policymakers have to choose between the economy and keeping the population safe,” said Selden, an economist with the U.S. Department of Health and Human Services’ Agency for Healthcare Research and Quality.

Since the COVID-19 pandemic spread to the United States in March, states and cities across the country have instituted lockdown measures designed to limit the spread of the disease.

Many of these measures entailed closing schools and non-essential businesses, with only banks, grocery stores, pharmacies and other businesses deemed to provide vital services allowed to stay open.

For this study, Selden and his colleagues analyzed data on the U.S. workforce to examine how many people were in essential jobs, how often they were able to work at home, their risk for severe COVID-19 and the potential health risks for their household members.

Of the more than 157 million workers across the country, 72% are in jobs deemed essential — based on U.S. Department of Homeland Security criteria — and more than three-fourths of all essential workers are unable to work at home, Selden said.

Essential workers include those in the medical and healthcare, telecommunications, information technology systems, defense, food and agriculture, transportation and logistics and energy, water and wastewater industries, as well as those in law enforcement and public works, the DHS criteria stipulates.

The study notes that up to 60% of these workers have underlying health issues, placing them at increased risk for severe COVID-19 if they get infected, as defined by U.S. Centers for Disease Control and Prevention guidelines.

Those with diabetes, heart disease, high blood pressure and chronic respiratory conditions like asthma are considered to be at high risk for serious illness, the CDC says.

Based on these findings, between roughly 57 million and 74 million adults working in on-site essential jobs — and their families — are at increased risk for serious illness, Selden and his colleagues estimated.

“Policymakers face important decisions about how to balance the economic benefits of keeping workers employed and the public health benefits of protecting those with increased risk of severe COVID-19,” Selden said.

“These issues arise in the context of decisions to close segments of the economy and decisions about how to distribute vaccines, which will initially be available only with limited supply, [and] become all the more difficult when the prevalence of infection rises in parts of the country,” he said.



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Study: Hydroxychloroquine no better than placebo for hospitalized COVID-19 patients

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Nov. 9 (UPI) — COVID-19 patients treated with hydroxychloroquine showed no signs of significant improvement in “clinical status” compared with those given a placebo, a study published Monday by JAMA found.

Patients given a five-day course of the drug were scored as “category six” based on the World Health Organization’s seven-category COVID Ordinal Outcomes Scale, the same as those given a placebo, the researchers said.

Also, 28 days after they started treatment, 10.4% of those treated with hydroxychloroquine died, just slightly lower than the 10.6% fatality rate in the placebo group.

“The results show that hydroxychloroquine did not help patients recover from COVID-19,” study co-author Dr. Wesley H. Self told UPI.

“In the study, patients treated with hydroxychloroquine and those treated with a placebo had nearly identical outcomes, [so] I do not foresee any role for hydroxychloroquine in acutely ill patients hospitalized with COVID-19,” said Self, an infectious disease specialist at Vanderbilt University Medical Center.

Hydroxychloroquine is an immunosuppressive and anti-parasitic drug that is used to treat malaria.

Early in the COVID-19 pandemic, it was touted by President Donald Trump and others as a potential treatment for the virus, despite the lack of any scientific data supporting its use.

Given its effectiveness helping those sickened with malaria — a mosquito-borne infection — to recover, “there was a strong rationale for why hydroxychloroquine may have been beneficial for patients with COVID-19,” according to Self.

However, in July, the U.S. Food and Drug Administration warned against the drug’s use in the treatment of those infected with the new coronavirus, due to potentially serious heart-related side effects.

For this study, Self and his colleagues treated 433 COVID-19 patients at 34 hospitals across the United States with either the drug or a placebo for a period of five days.

Patients assigned to the hydroxychloroquine group received 400 milligrams of the drug in pill form twice a day for the first two doses and then 200 mg. in pill form twice a day for the next eight doses, for a total of 10 doses over the five days.

All of the patients were then assessed based on the WHO’s COVID Ordinal Outcomes Scale, which categorizes those infected according to disease severity.

Most of the patients in both the hydroxycholorquine group and the placebo group were in “category six,” meaning they were hospitalized and receiving extracorporeal membrane oxygenation or invasive mechanical ventilation to maintain their breathing, the researchers said.

“Our results, especially when combined from other studies conducted in the United Kingdom and Brazil, are good evidence that hydroxychloroquine does not provide benefit for patients hospitalized with COVID-19,” Self said.



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