Category: PrEP

Truvada going generic

From out.com…

Get PrEP-ared for generic Truvada in the next year, according to an official document that Gilead, the pharmaceutical company that manufactures the drug, released on their website.

According to a quarterly report filed to the Securities and Exchange Commission, Gilead announced that it reached an agreement to allow a generic version of Truvada to be manufactured in the United States on September 30, 2020.

In a statement, Aaron S. Lord, a physician and member of PrEP4All, called the decision a “victory for the LGBTQ+ community, for HIV activists, and for U.S. taxpayers,” and cautioned that the fight for widespread PrEP access is not over. Lord specifically pointed to the fact that only Teva will be allowed to manufacture generic PrEP.

“This will do little to reduce price in a way that will increase access and PrEP4All remains suspicious of the terms and lack of transparency surrounding the Teva settlement,” Lord wrote in the statement. “I have to ask, what’s to stop them — other than a desire for profit margins — from releasing the rights now?”

Read the full article.

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Study shows high HIV prevalence in Black, gay men taking PrEP

From thevitalvoice.com…

Black men who engage in sex with men have a 1 in 2 chance of getting HIV in their lifetime, according to the National Institutes of Health. This is unconscionable when a drug called PrEP (a once-a-day pill that prevents HIV) exists. However, as recently published in the Journal of AIDS, black men who have sex with men on PrEP had a higher incidence of HIV than those not on PrEP, due to poor adherence to the drug. The study suggests that PrEP alone is not enough to stop the spread of HIV. The study does not, however, challenge the efficacy of PrEP itself but rather the uptake of the surrounding preventative package including behavioral risk reduction support, STI treatment, and medication adherence counseling.

Two health technology startups, UrSure and Healthvana, have separately made enormous strides in reducing HIV. UrSure improves adherence to HIV medications with diagnostic tests, while Healthvana’s platform/app is being used by clinics and their 250,000 patients who are at high-risk for HIV or are HIV positive. Collaboratively, the two startups are now working to build the most technologically innovative PrEP programs in the 48 counties in the U.S. with the highest prevalence of HIV, as identified last week by HHS Secretary Azar.

Experts debate if HIV prevention pill contributes to rise in other STDs

Prevention program manager Adam Weaver talks about sexually transmitted diseases in the testing room at Palmetto Community Care in North Charleston

From postandcourier.com…

The STD explosion has led to a debate over a possible connection since the introduction of the HIV prevention pill.

PrEP is not a cure for HIV, and it also is not 100 percent effective, but, taken as directed at the same time once a day, it comes pretty close — up to 99 percent successful in preventing HIV, according to Palmetto Community Care, formerly Lowcountry AIDS Services, in North Charleston.

The drumbeat of safe sex practices hasn’t changed among health officials. Abstinence, using condoms and being in a monogamous relationship are still the best ways to help prevent STD infections.

But the naked truth is people don’t always follow that advice.

“After they start taking PrEP, we don’t see a great shift in risk behavior,” said Aaron O’Brien with Roper Hospital’s Ryan White Wellness Center.

Aaron O’Brien, quality and development manager of Roper Hospital’s Ryan White Wellness Center.

He puts condom users into two groups: those who use them regularly and those who don’t, and, based on his talks with patients, that doesn’t change much once they start taking the pill.

Adam Weaver, prevention program manager at Palmetto Community Care, agrees with O’Brien.

“What we are finding is that the people we are putting on PrEP aren’t changing their condom use,” he said.

They also don’t believe PrEP’s introduction, in and of itself, contributed to the explosion in STDs.

They say it has more to do with better reporting since people taking PrEP must check in with their doctor or provider every three months or so for regular testing.

Read the full article.

New study finds 4% of HIV-negative gay/bi men using PrEP

From OUT Magazine online…

A mere 4% of gay and bisexual men reported using Truvada as PrEP in a new study, recently published in PLOS ONE.

Led by Psychology Professor Phillip Hammack of the University of California Santa Cruz, the study examined HIV testing and use, familiarity, and attitudes toward pre-exposure prophylaxis (PrEP) among HIV-negative gay and bisexual men in the United States.

Truvada is a daily pill that reduces the likelihood of acquiring HIV by almost 100%. Currently, it is the only FDA-approved form of pre-exposure prophylaxis, or PrEP, which is recommended by the Centers for Disease Control and Prevention (CDC) for those at high risk of HIV/AIDS.

“The extremely low rate of PrEP use, while not surprising given barriers to access in various parts of the country, is disappointing,” said Hammack.

The study used a national probability sample of 470 men ages 18-59. Participants completed the survey between March, 2016 and March, 2017.

Other key results of the study included:

— The majority of gay/bi men between the ages of 18-25 are not tested for HIV annually, as recommended by the CDC.

— 25% of young men in the same age group have never been tested for HIV.

— Approximately 8% of men over 25 had never been tested for HIV.

— Visiting an LGBT health clinic and searching online for LGBT resources were associated with greater likelihood of PrEP use.

— Bisexual and non-urban men were less familiar with PrEP compared to gay-identified and urban men.

— Attitudes were positive among most men (68.4%) who were familiar with PrEP, despite low usage of the drug.

“I worry especially about younger men who didn’t grow up with the concerns of HIV that men of older generations did,” said Hammack. “The low rate of HIV testing probably reflects a degree of complacency and cultural amnesia about AIDS.”

Principal investigator Ilan H. Meyer said of the study, “Our findings suggest that health education efforts are not adequately reaching sizable groups of men at risk for HIV infection. It is alarming that high-risk populations of men who are sexually active with same-sex partners are not being tested or taking advantage of treatment advances to prevent the spread of HIV.”

Why don’t more Americans use PrEP?

From the New York Times…

Truvada was approved by the Food and Drug Administration in 2012. But over six years later, the United States is failing miserably in expanding its use. Less than 10 percent of the 1.2 million Americans who might benefit from PrEP are actually getting it. The major reason is quite clear: pricing. With a list price over $20,000 a year, Truvada, the only PrEP drug available in the United States, is simply too expensive to become the public health tool it should be.

[…] The disparities in PrEP access are astounding: Its use in black and Hispanic populations is a small fraction of that among whites. In the South, where a majority of H.I.V. infections occur, use is half what it is in the Northeast. Women use PrEP at drastically lower rates than men, and while there’s no national data on PrEP and transgender Americans, it’s almost certainly underused. The issue of PrEP access has become an issue of privilege.

The ability of PrEP to greatly reduce new H.I.V. infections is no longer in question. In New South Wales, Australia, a program providing free access to PrEP led to a drop in H.I.V. diagnoses in the most vulnerable communities by a third in just six months, one of the fastest declines recorded since the global AIDS crisis began.

Read the full article on New York Times online.

Most doctors would give HIV prevention drugs to teens

From Reuters Health…

Last month U.S. regulators said a pill that helps prevent infection with HIV is safe for use by adolescents, and a study suggests most physicians would be willing to prescribe this medicine to teens.

So-called pre-exposure prophylaxis (PrEP) with Truvada, a daily pill combining the medicines tenofovir and emtricitabine, can lower the risk of getting HIV from sex by up to 90 percent, according to the U.S. Centers for Disease Control and Prevention. Truvada has long been used to treat HIV and as a prevention strategy for adults.

The current study was conducted between October 2016 and January 2017, before the U.S. Food and Drug Administration approved PrEP for teens who weigh at least 35 kg (77 pounds).

Researchers surveyed 162 doctors who worked with adolescents and young adults. While 93 percent of the clinicians had heard of PrEP, only 35 percent had prescribed it.

About 65 percent of the survey participants said they would be willing to prescribe PrEP to adolescents, and another 19 percent were willing to refer teens to another clinician for the prescription.

Among those who were unwilling to prescribe it themselves, about two-thirds said they would prescribe it for teens if it had FDA approval for these patients.

“Everyone, including adolescents, should know whether they could benefit from PrEP,” said lead study author Dr. Geoffrey Hart-Cooper, a pediatrician at Stanford Children’s Health and a HIV prevention specialist at the San Francisco Department of Public Health.

Read the full article.

Gilead Sciences will begin airing television ads for PrEP

From NBC News…

In a major shift, pharmaceutical giant Gilead Sciences will begin airing television ads for PrEP, its HIV prevention medication. The company said the ads, which will start in June and run through August, are “designed to encourage candid conversations around sexual health and promote public awareness of HIV prevention.”

PrEP, or pre-exposure prophylaxis, involves taking a daily pill to prevent HIV transmission. Major clinical trials have shown that PrEP — also known by its brand name, Truvada — is safe and effective at preventing HIV if taken daily. The pill is also recommended by the Centers for Disease Control and Prevention for at-risk groups.

Since the Food and Drug Administration (FDA) approved Truvada for HIV prevention in 2012, Gilead has leaned on public health agencies to promote the drug. New York City has for years placed advertisements on subways and buses to promote PrEP, and the District of Columbia’s health department aired its own racy HIV PrEP television ad earlier this year.

Read the full article.

State-level PrEP utilization data now available from AIDSVu

From HIV.gov…

Since PrEP is one of the newer HIV prevention tools, understanding more about who is using it is important to better tailoring HIV prevention efforts at the national, state, and community levels. PrEP, or pre-exposure prophylaxis, is when people at high risk for HIV take HIV medicine daily to lower their chances of getting infected with HIV. AIDSVu has released the first-ever publicly available data and interactive maps of PrEP use by state from 2012 through 2016, stratified by sex and age.

 

The new maps from AIDSVu show more than 77,000 people were prescribed PrEP in 2016, with an average 73 percent increase year over year in persons using PrEP across the U.S. from 2012 – when the drug TDF/FTC was approved by the FDA for use as PrEP – to 2016. However, approximately 1.1 million people in the U.S. are at substantial risk for HIV exposure and could benefit from PrEP, according to analysis presented by the Centers for Disease Control and Prevention (CDC) at CROI 2018 earlier this year.

The data presented on AIDSVu reveal that the growth and distribution of PrEP use has been inconsistent across different sexes, age groups, and geographic regions. For example, the Southern U.S. accounted for more than half (52 percent) of all new HIV diagnoses in 2016 but represented only 30 percent of all PrEP users in 2016. That same year, women comprised 19 percent of all new HIV diagnoses but made up only seven percent of all PrEP users.

Read the full article.

Many at-risk men still don’t take HIV prevention pill

From The Associated Press…

From gritty neighborhoods in New York and Los Angeles to clinics in Kenya and Brazil, health workers are trying to popularize a pill that has proven highly effective in preventing HIV but which — in their view — remains woefully underused.

Marketed in the United States as Truvada, and sometimes available abroad in generic versions, the pill has been shown to reduce the risk of getting HIV from sex by more than 90 percent if taken daily. Yet worldwide, only about a dozen countries have aggressive, government-backed programs to promote the pill. In the U.S., there are problems related to Truvada’s high cost, lingering skepticism among some doctors and low usage rates among black gays and bisexuals who have the highest rates of HIV infection.

“Truvada works,” said James Krellenstein, a New York-based activist. “We have to start thinking of it not as a luxury but as an essential public health component of this nation’s response to HIV.”

A few large U.S. cities are promoting Truvada, often with sexually charged ads. In New York, “Bare It All” was among the slogans urging gay men to consult their doctors. The Los Angeles LGBT Center — using what it called “raw, real language” — launched a campaign to increase use among young Latino and black gay men and transgender women.

“We’ve got the tools to not only end the fear of HIV, but to end it as an epidemic,” said the center’s chief of staff, Darrel Cummings. “Those at risk have to know about the tools, though, and they need honest information about them.”

In New York, roughly 30 percent of gay and bisexual men are using Truvada now, up dramatically from a few years ago, according to Dr. Demetre Daskalakis, a deputy commissioner of the city’s health department.

However, Daskalakis said use among young black and Hispanic men — who account for a majority of new HIV diagnoses — lags behind. To address that, the city is making Truvada readily available in some clinics in or near heavily black and Hispanic neighborhoods.

Read the full article on Newsday.com.