Following outrage by HIV advocates after UnitedHealthcare sent a rejection letter to a patient seeking Truvada — denying him due to his “high risk homosexual behavior” — the insurer announced Friday it is changing its policy for the daily HIV prevention pill “effective immediately.”
“We apologize for the insensitive language appearing in the letter and regret any difficulty it caused. We have corrected our letters, removed the prior authorization requirement for Truvada and members can fill their prescription at the network pharmacy of their choice,” a spokesperson for the company wrote in an email to NBC News Friday night.
Bottles of Truvada are displayed at Jack’s Pharmacy on November 23, 2010 in San Anselmo, California. Justin Sullivan / Getty Images
The monthlong controversy started with a pre-authorization denial letter sent to Thomas Ciganko, a New York man whose physician prescribed Truvada for Pre-Exposure Prophylaxis (PrEP). While the rejection came as a surprise, the stated reason was the real shock.
“The information sent in shows you are using this medicine for high risk homosexual behavior,” the letter, dated July 11, 2017, read. In the same paragraph, however, the letter listed an approved reason for taking the medication “to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.”
There’s a lot of research now regarding PrEP (Pre-Exposure Prophylaxis) and how taking this daily anti-viral medication can keep you from becoming infected with HIV. The problem is that most gay men don’t want to ask their doctor about it and don’t know how else they can get it.
But now you can use a free online tool called PrEP Locatorto find PrEP providers near you. The locator is a national directory of providers that you can search by entering your zip code. It’s also accessible on your smart phone as well as your computer.
Note too that in some cases, providers can also help with the cost of PrEP.
PrEP Locator is presented by Emory University, in partnership with M•A•C AIDS Fund.
If you live in the Pittsburgh area, you can also find local resources here.
The first large-scale clinical trial of a long-acting injectable drug for HIV prevention began today. The study, sponsored by the National Institutes of Health, will examine whether a long-acting form of the investigational anti-HIV drug cabotegravir injected once every 8 weeks can safely protect men and transgender women from HIV infection at least as well as the anti-HIV medication Truvada taken daily as an oral tablet. If injectable cabotegravir is found to be effective for HIV pre-exposure prophylaxis, also known as PrEP, it may be easier for some people to adhere to than daily oral Truvada, the only licensed PrEP regimen. Truvada consists of the two anti-HIV drugs emtricitabine and tenofovir disoproxil fumarate.
“We urgently need more HIV prevention tools that fit easily into people’s lives,” said Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH. “Although daily oral Truvada clearly works for HIV prevention, taking a daily pill while feeling healthy can be difficult for some people. If proven effective, injectable cabotegravir has the potential to become an acceptable, discreet and convenient alternative for HIV prevention.”
When Truvada was introduced four years ago as a way to prevent HIV, public health leaders didn’t welcome the drug with open arms. The head of the AIDS Healthcare Foundation panned the once-daily pill as a “party drug.” Other health officials claimed that taking Truvada would cause a wave of wild unprotected sex. Even members of the LGBTQ community parroted the criticism, with one gay journalist (regretfully) labeling some users “Truvada whores.”
But the last four years has seen a shift in attitude. More and more Americans are embracing pre-exposure prophylaxis (PrEP), the HIV prevention method that requires a daily dose of Truvada to reduce viral risk. And more and more prescriptions are being written for the antiretroviral drug. While PrEP is growing in popularity, a new study out of the University of California released last month suggests that the populations most at risk of HIV infection are not the ones benefitting from the prevention strategy.
In a survey of gay and bisexual men in California, only a handful of participants reported having taken PrEP. PrEP use was highest among young white men, at 13.9 percent. For young Latino men, that figure was cut by more than half, while young black men represented less than 10 percent of people who started PrEP.
“This is not reflective of the HIV epidemic at all,” says Shannon Weber, founder of Please PrEP Me, an online directory of over 230 clinics in California that provide PrEP. “It is reflective about access, and where and how people are getting that information.”
Researchers delivered ART to reduce the infectiousness of HIV-infected persons and PrEP to reduce susceptibility of their uninfected partners. PrEP was offered prior to ART initiation and for the first six months of ART, until the HIV-infected partner would have been expected to achieve viral suppression. Then PrEP was discontinued.
“Our primary goals were to evaluate this delivery model, but partway through the span of the study, it became clear that HIV transmission rates were considerably lower than would have been anticipated,” said lead author Dr. Jared Baeten, vice chair and professor of global health and professor of epidemiology at the School.
Researchers examined the feasibility and acceptability of a program in Kenya and Uganda to offer medications to 1,013 couples in which one member was HIV-positive and the other was HIV-negative. The findings, published online August 23 in PLOS Medicine, showed that the observed rates of HIV transmission were 96 percent lower than simulated rates of transmission in historic controls.
“We learned that the approach is desirable and highly cost-effective and could be delivered affordably to people in that setting,” Dr. Baeten said. Researchers also noted that this study does not include a concurrent comparison population for HIV transmission because it would not have been ethical to enroll a control population and not offer access to PrEP and ART.
Overshadowed by the Zika epidemic, concerns about terrorism and security, and the US presidential election, the global HIV/AIDS pandemic persists, with 2.1 million new HIV infections and 1.1 million deaths worldwide in 2015 (http://bit.ly/2ambo2P). The 21st International AIDS Conference in Durban, South Africa, in July highlighted the remarkable progress since 2000, when the conference was last held in Durban and very few people in Africa received antiretroviral therapy.
At present, 3.4 million people in South Africa are being treated for HIV infection, more than in any other country in the world; between 2005 and 2015 overall life expectancy at birth in South Africa increased from 53.5 years to 62.5 years (http://bit.ly/1swJbPo). In 2000, 490 000 new HIV infections occurred among children throughout the world; in 2010 the figure decreased to 290 000 and in 2015 to 150 000 (http://bit.ly/2ambo2P). Unlike the $10 000 annual cost of HIV treatment in 2000, the price tag for some first-line antiretroviral regimens now is only $100 per year.
The recent conference aimed to catalyze the work that remains—further scientific advances, addressing stigma, discrimination and other structural barriers within society, and securing the political commitment, including financial resources for prevention, diagnosis and treatment (http://bit.ly/2960ttk). However, fewer people may have been listening than in the past. Among the more than 15 000 participants from 153 countries, including 800 media delegates, few journalists from a US newspaper or television network were on-site in Durban. Although the conference was covered from afar, it was relatively underreported in the United States.
Speaking to a meeting on pre-exposure prophylaxis (PrEP) yesterday, ahead of the 21st International AIDS Conference (AIDS 2016), Chris Beyrer, president of the International AIDS Society, reminded delegates that the last time the conference was held in Durban, South Africa, in the year 2000, the event was notable for drawing attention to the enormous gap in access to HIV treatment between rich and poorer countries. That conference began the treatment access era.
“Now is really the time to start the PrEP access era,” Beyrer said.
The questions about whether PrEP works have been resolved. But a host of questions about the best way to implement PrEP remain, including who to offer PrEP to, where to provide it and how to stimulate demand.
To help health services and countries answer those questions, the World Health Organization (WHO) will soon issue implementation guidance, outlined to the meeting by Rachel Baggaley of WHO and Robert Grant of the University of California. The document is designed to be practical, addressing in separate chapters the needs and interests of political leaders, medicines regulators, community educators, public health officials, clinic administrators, clinicians, counsellors, testing providers, pharmacists, and monitoring and evaluation staff. A specific chapter addressed to individuals taking PrEP will answer their frequently asked questions.
The Centers for Disease Control and Prevention are working to inform patients and health care providers of a new, anti-viral pill that they estimate can drastically reduce the risk of infection. Here to tell us more about this treatment and discuss why it hasn’t been adopted by clinicians in the region are Dr. Ken Ho, an HIV specialist at the University of Pittsburgh and Jason Herring, director of programs and communications at the Pittsburgh AIDS Task Force.
The increasing demand for pre-exposure prophylaxis (PrEP) is likely to increase the likelihood that some marginalised individuals living with HIV sell some of their prescribed medication to pill brokers and drug dealers, according to a study presented to the Conference of the Association for the Social Sciences and Humanities in HIV in Stellenbosch, South Africa last week.
Steven Kurtz told the conference that several reports have documented street markets for diverted antiretrovirals (ARVs) in the United States. His own research focuses on south Florida, where he recruited 147 HIV-positive men who have sex with men (MSM) who regularly use cocaine, crack or heroin. He purposively sampled (over-recruited) individuals who had sold or traded their antiretrovirals, so that he could better understand the factors associated with doing so.
Economic vulnerability is the key explanation. Within this sample, men who had recently sold ARVs were more likely to have an income below $1000 a month, to have traded sex for money or drugs and to be dependent on drugs. Age, race and education were not relevant factors. Unsurprisingly, men who had sold their HIV treatment had poor levels of adherence to it.
The number of people usingTruvadafor pre-exposure prophylaxis (PrEP) in the US is increasing and a growing proportion of users are men, according to an analysis of data from approximately half of American pharmacies presented this week at theHIV Drug Therapy Glasgow conference.
PrEP refers to the use of antiretroviral medications to prevent HIV infection. Gilead Sciences’Truvada(tenofovir + emtricitabine) taken once daily was shown to be effective in the iPrEx study of mostly gay and bisexual men, reducing the risk of HIV infection by 42% overall, rising to 92% among participants with blood drug levels indicating regular use. A mathematical model suggested that takingTruvadafour times per week would provide 99% protection, and in an open-label extension of iPrExnone of the men who tookTruvadaat least this often became infected.
The US Food and Drug Administration (FDA) approved once-dailyTruvadafor PrEP in July 2012. In May of this year, the US Centers for Disease Control and Prevention (CDC) recommended that people at ‘substantial risk’ should consider PrEP to prevent HIV infection, and the World Health Organization (WHO) has also recommended PrEP as an option for at-risk gay men.
Yet uptake ofTruvadaPrEP has not been as widespread as many had hoped, facing barriers such as lack of awareness among people at risk for HIV, resistance from some medical providers and inconsistent insurance coverage.