The FDA Has Given Its Approval To The First HIV Preventive Injection

  • The Food and Drug Administration (FDA) has authorized the first injectable HIV pre-exposure prophylaxis therapy, giving at-risk persons another choice for preventing sexually transmitted HIV. According to the FDA, Aperture will be available to at-risk adults and adolescents who weigh at least 77 pounds and have previously tested negative for HIV.

According to the FDA’s approval, patients can now receive injectable medicine instead of daily HIV prevention oral medications like Truvada. Apretude, on the other hand, needs two one-month apart starting injections, followed by two monthly doses.

Participants who took the injectable treatment following the oral pill cabotegravir were 69 percent less likely to become infected with HIV in a study of over 4,500 cisgender males and transgender women who had sex with men. The other trial, which included almost 3,200 cisgender women at risk of contracting HIV, found that those who used Apretude with cabotegravir had a 90% lower chance of contracting HIV than those who took Truvada.

“By providing the first non-daily HIV prevention option, today’s approval adds a critical tool to the effort to address the HIV pandemic,” said Debra Birnkrant, director of the FDA’s Center for Drug Evaluation and Research’s Division of Antivirals.

The FDA expects that the injectable alternative would increase uptake among high-risk populations, such as young men who have sex with males and those suffering from drug use disorders, depression, or poverty, who are less likely to take their prescription regularly.

The uptake of HIV pre-exposure prophylaxis drugs has “considerable potential for improvement,” with just a quarter of the 1.2 million persons who were eligible receiving prescriptions last year. Nonetheless, officials noted “significant progress” since 2015, when just 3% of eligible patients obtained drugs.

According to a press statement, ViiV Healthcare, which is majority-owned by GlaxoSmithKline, will begin selling Apretude to distributors in the United States early next year. The United States is the only country that has authorized Apretude thus far. Approximately 1.7 million new HIV infections are discovered each year. Those who get HIV while using Apretude are encouraged to begin HIV therapy as soon as possible.

The year 2021 is on pace to exceed 2020 as the deadliest in the United States:

Health professionals in the United States predict that 2021 will be even deadlier than last year. Because all of the November and December death reports won’t be in for several weeks, it’s too early to determine for sure. According to Robert Anderson, who manages the Centers for Disease Control and Prevention’s mortality statistics, it appears probable that 2021 will beat last year’s record number of fatalities by at least 15,000, based on existing data.

The FDA Has Given Its Approval To The First HIV Preventive Injection
The FDA Has Given Its Approval To The First HIV Preventive Injection

In fact, according to a CDC analysis issued on Wednesday, 2020 was much worse than the agency had initially predicted. According to the study, there were around 3.384 million deaths last year, nearly 25,000 higher than tentative data provided earlier this year.

According to Anderson, provisional and final statistics often fluctuate. Still, the discrepancy in 2020 was more prominent than usual due to a lag in death records from several states that moved to new computerized reporting systems.

This week, the Centers for Disease Control and Prevention updated its life expectancy projection for 2020. Life expectancy was 77 years at birth, down 1.8 years from 2019. The agency had previously estimated that the decrease would take 1.5 years. In 2021, more than 3.4 million people will die in the United States, according to Anderson. Other experts anticipate that the number of fatalities this year will be similar to or even higher than in 2020.

COVID-19, which hit the United States hard around March 2020 and became the country’s No. 3 cause of death after heart disease and cancer, is one of the main reasons. According to Anderson, the figure is already at 356,000 this year, with a final tally of 370,000 possible.

Experts also believe that the figures in 2021 will be influenced by a drug overdose crisis that is anticipated to reach 100,000 deaths for the first time in a calendar year. It’s pretty uncommon for annual mortality rates to rise. The annual count climbed by approximately 16,000 from 2018 to 2019 before COVID-19.

On the other side, the coronavirus has had a significant influence. According to Kenneth Johnson of the University of New Hampshire, between July 2020 and July 2021, the United States saw the lowest population growth rate in history, mainly owing to COVID-19 deaths.

COVID-19 immunizations were thought to lower the number of fatalities, according to officials. Immunizations were made available in phases this year, with just 7 million people fully vaccinated by the end of January and 63 million by March.

Many Americans have refused to be immunized since then. According to the CDC, 204 million Americans are completely vaccinated, accounting for nearly 65 percent of the five and above population who are eligible for vaccinations.

Indeed, despite the availability of effective vaccinations, Mokdad believes that COVID-19 mortality might rise. He noted that the emergence of new, more transmissible coronavirus types exacerbated the situation.

As the epidemic enters its third year, life expectancy and population growth in the United States are declining:

According to government statistics, the United States’ population growth will reach a new low in 2020, while life expectancy will drop most since World War II, reflecting the pandemic’s impact on mortality and immigration.

According to the Census Bureau, the country’s population rose by 392,665 people, or 0.1 percent, between July 2020 and July 2021. According to the study, this was the first time the country’s population expanded by fewer than 1 million people since 1937. Covid-19 became the third-leading cause of mortality in the United States, after heart disease and cancer, with an average predicted life expectancy of 77, down 1.8 years from 2019.

The Census Bureau attributes the low population increase to various causes, including the pandemic and reduced birth rates. The coronavirus contributed to increased mortality, but travel limitations imposed by the pandemic kept fewer individuals from traveling to the United States.
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