New Covid Booster Guidelines Set by the FDA for Healthy Adults Under 65
The FDA will require new clinical trials for approval of the annual COVID-19 booster in healthy Americans under the age of 65.
The Food and Drug Administration approved Gilead’s HIV preventive drug Lenacapavir on Wednesday. This is a twice-injectable drug therapy that shows that clinical trials will prevent new infections.
The drug is sold under the name Yeztugo and sells for an annual price of $28,218 or $14,109 per injection. Gilead said the price is comparable to existing HIV preventative drugs and the company will work with insurance companies to obtain broad coverage for the drug.
Advocates say long-acting drugs are promising as they are more convenient than existing HIV preventive drugs that must be taken daily.
Carl Schmid, executive director of the HIV+ Hepatitis Policy Institute, said providing people with options that can be injected twice a year is a “game changer not just in the US, but around the world.”
Gilead officials praised the FDA’s approval of Lenacapaville, which has been researched and developed for nearly 20 years.
“There is currently a very realistic opportunity to end the HIV outbreak,” said Daniel O’day, chairman and CEO of Gilead Sciences. “Renacapavil has been shown to be extremely effective and should only be given twice a year. This represents an entirely new way to prevent HIV.”
How does Renacapavir compare to other HIV preventive drugs?
Pre-exposure prevention, or preparation, medicines are sold as daily tablets under the brand names Truvada and Descovy as well as Generic versions. Another injectable drug, Apretude, is taken every two months after the first shot of two months is taken for a month.
The vast majority of prep users film daily versions, but “it’s difficult to take the pill every day for prevention,” said Johanna Mercier, Chief Commercial Officer of Gilead. “We therefore believe that compliance levels are low, between 50% and 55%,” he says, not providing adequate protection to at-risk groups.
People are more likely to take the medication if they only need to take it twice a year, rather than oral daily doses. Mercier said.
Dr. Paul Sachs, clinical director of the Department of Infectious Diseases at Brigham and Women’s Hospital, said the daily pills and the two-month prep version are suitable for people who take them consistently.
Sachs said that the shots twice a year may appeal to people who are unable or unable to take the daily pill.
“The key is to have people (preparation) and make sure they do that,” Sachs said.
What did the study of Renacapaville show?
In one study of women and adolescent girls in sub-Saharan Africa and Ugandan, renacapavir was 100% effective in preventing HIV infection.
The second study reported that two injections per year reduced HIV infection rates by 96% in groups of Cisgender men and gender divers in the US, Argentina, Brazil, Mexico, Peru, South Africa and Thailand.
Schmidt said the study shows that people are much more likely to take the medication, as recommended when administered twice a year compared to daily pills.
“This makes it very easy and improved for people who have other challenges in their lives, such as compliance, mental health issues, work, and stigma,” Schmidt said.
Will the insurance company cover the costs of the Renacapaville?
Gilead said the company will work with insurance companies, healthcare systems and other payers.
Out-of-pocket costs for uninsured patients taking Truvada and Descovy sold by Gilead range from $22,000 to $30,000 per year, according to an analysis by GoodRx, which provides drug pricing information for pharmacies.
The US Preventive Services Task Force, an independent advisory board of national experts assessing medical processing and services, assigned a “A” rating for PREP drugs when prescribed to adolescents and adults due to their high risk of HIV.
Under the Affordable Care Act, that means that insurance companies must cover the full cost of the medication as preventive care.
Still, activists say insurance companies have charged out-of-pocket or other cost sharing from required lab tests and medical visits. People need to test negative for HIV before starting the medication. During treatment, they must undergo routine testing for HIV, other sexually transmitted diseases, and kidney health.
Sax said Lenacapaville insurance coverage is key for people taking the medication.
Some insurance companies are likely to cover the common version of daily prep medication, and these generics can “be very cheap” compared to branded versions, Sax said.
More than 1 million new cases of HIV each year
According to the World Health Organization, more than one million new cases of HIV worldwide each year.
Around 10 million people around the world said they need to prepare to meet global HIV prevention goals. Approximately 2.5 million people said they would take the prep.
More than 39,000 US residents were diagnosed with HIV in 2023, according to the Centers for Disease Control and Prevention. More than 4,700 deaths in 2023 were attributed to HIV, a virus that weakens the immune system and causes AIDS, the CDC said.
A study in June estimated that as many as 2.2 million Americans could benefit from HIV preventive medications.
According to the CDC, men account for nearly 80% of new cases in which gay or bisexual men are primarily involved.
Research shows that despite the less likely white patients to contract HIV, white patients are far more likely to take PREP than black and Latino counterparts.
Geographically, the south accounts for more than half of new HIV cases.
“We hope to reduce these numbers and reach the day when zero infections are reported,” Mercier said.
