Showing posts with label PrEP. Show all posts
Showing posts with label PrEP. Show all posts

Wednesday, August 5, 2015

2020 Vision: Our Updated National HIV/AIDS Strategy

 Posted by Valerie Jarrett on July 30, 2015. Reposted at http://keystothecloset.blogspot.com,
Today, the Obama Administration is releasing the National HIV/AIDS Strategy: Updated to 2020 (“Updated Strategy”). Since we released the nation’s first comprehensive HIV/AIDS strategy in 2010, we’ve made tremendous progress in the fight against HIV/AIDS. More people living with HIV know their status and are linked to care. We have better medications to treat the disease and better tools to prevent its transmission, like pre-exposure prophylaxis (“PrEP”) —a daily pill that can reduce a person’s risk of acquiring HIV by more than 90 percent when taken consistently.

Yet, despite this progress, there is still an HIV epidemic in the U.S. Not only has there been a recent HIV outbreak among injection drug users in Indiana, there has also been a national increase in the number of diagnoses of HIV infection among young gay and bisexual men. This disease is preventable and if a person is infected, there are ways to drastically minimize transmission to others. Too many people living with HIV are unaware of their status or are diagnosed late. Many people may not realize that while being HIV-positive may once have been a death sentence, they can now live long, healthy lives with HIV if they are diagnosed and treated.

There is a great discrepancy between the number of people who are diagnosed with HIV and those who are in care. Of the 1.2 million people living with HIV in the U.S., 87% (or about 1 million) of them know they have HIV, yet only 39% are engaged in care. This means that the majority of folks with HIV are not consistently getting the care they need to stay healthy and decrease their chances of transmitting HIV to others.

Groundbreaking research is unlocking new tools and methods to help keep people in care, prevent and treat the disease, and find a cure. A critical part of making the best use of current investments and maximizing impact is to focus attention and resources on persons living with HIV infection and those who are at greatest risk for acquisition. That’s why the Updated Strategy’s update calls for a focus on the right people, the right places, and the right practices…right now.

Our efforts under the Updated Strategy will prioritize the groups most affected by HIV: gay and bisexual men of all races/ethnicities (especially young Black gay and bisexual men), Black women and men, Latinos and Latinas, people who inject drugs, youth aged 13 to 24 years, and transgender women (particularly Black transgender women). We will also focus on the areas with the highest burden of disease, such as the Southern United States.

Learn about the five major changes to the strategy since 2010 here.
In 2015, we know what works, and to make a significant impact on the epidemic, the Updated Strategy calls for a focus on the following actions that will move us toward the 2020 goals:
  • Widespread testing and linkage to care, enabling people living with HIV to access treatment early.
  • Broad support (from housing and transportation to treatment adherence) for people living with HIV to remain engaged in comprehensive care.
  • Universal viral suppression among people living with HIV.
  • Full access to comprehensive pre-exposure prophylaxis (PrEP) services for those whom it is appropriate and desired.
Obtaining health care coverage is an important step to keep ourselves and our families healthy. More than 16 million people have taken this step since the passage of the Affordable Care Act, contributing to the largest reduction in the nation's uninsured rate in four decades. But we only realize the full value of that coverage when we use it to access the types of preventive services that will keep us healthy. The ACA provides access to precisely those services. Thanks to the ACA, most private plans, Medicare, and Medicaid coverage offer HIV testing without requiring a co-pay or deductible. PrEP is also covered by many insurance programs. Promoting testing, linkage to and staying in care, having the support services to achieve viral suppression, and using PrEP, are all parts of how the Updated Strategy encourages Americans be their healthiest selves.

Still, too many people lack either the health insurance coverage or the financial resources to obtain treatment and care. The Ryan White HIV/AIDS Program helps to fill that gap. It provides critical coverage completion services to nearly half of all Americans living with HIV and remains an essential part of our national response to HIV.

I encourage all Americans to take advantage of the preventive services available to them, get tested for HIV if they haven’t been, and consider using PrEP if they are at substantial risk of contracting the disease. With the release of our Updated Strategy, let’s all commit to double down on our efforts, and focus our HIV outreach on the right people, in the right places, with the right practices, right now. We’ve made great progress, but there’s more work to be done. The Updated Strategy will enable our nation to become a place where new HIV infections are rare, and where every affected person will have access to life-extending care, regardless of their circumstances, and live free from stigma and discrimination.

There's an overview of everything you need to know about the Update Strategy, at https://www.whitehouse.gov/blog/2015/07/30/2020-vision-our-updated-national-hivaids-strategy



Friday, July 20, 2012

FDA Approves PrEP Drug Truvada

On July 16, 2012, the US Food and Drug Administration (FDA) approved Truvada, the first drug approved to reduce the risk of HIV infection in uninfected individuals. Taken daily, Truvada is intended as a pre-exposure prophylaxis (PrEP) for HIV-uninfected individuals who are at high risk of infection. According to the FDA press release, a PrEP indication means Truvada is approved for use as part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling and regular HIV testing.

Posted at GLMA Health update, reposted at http://www.keystothecloset.blogspot.com See FDA Press release below.

FDA approves first drug for reducing the risk of sexually acquired HIV infection

Evidence-based approach enhances existing prevention strategies

Today, the U.S. Food and Drug Administration approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually-acquired HIV infection in adults at high risk.

The FDA previously approved Truvada to be used in combination with other antiretroviral agents for the treatment of HIV-infected adults and children 12 years or older.

As part of PrEP, HIV-uninfected individuals who are at high risk will take Truvada daily to lower their chances of becoming infected with HIV should they be exposed to the virus. A PrEP indication means Truvada is approved for use as part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing.

"Today’s approval marks an important milestone in our fight against HIV," said FDA Commissioner Margaret A. Hamburg, M.D. "Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country."

As a part of this action, the FDA is strengthening Truvada’s Boxed Warning to alert health care professionals and uninfected individuals that Truvada for PrEP must only be used by individuals who are confirmed to be HIV-negative prior to prescribing the drug and at least every three months during use. The drug is contraindicated for PrEP in individuals with unknown or positive HIV status. The FDA strongly recommends against such use.

Truvada for PrEP is being approved with a Risk Evaluation and Mitigation Strategy (REMS) to minimize the risk to uninfected individuals of acquiring HIV infection and to reduce the risk of development of resistant HIV-1 variants. The central component of this REMS is a training and education program to assist prescribers in counseling individuals who are taking or considering Truvada for PrEP. The training and education program will not restrict distribution of Truvada but will provide information about the importance of adhering to the recommended dosing regimen and understanding the serious risks of becoming infected with HIV while taking Truvada for the PrEP indication.

"The REMS for Truvada for the PrEP indication is aimed at educating health care professionals and uninfected individuals to help ensure its safe use for this indication without placing an unnecessary burden on health care professionals and patients," said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

Truvada’s safety and efficacy for PrEP were demonstrated in two large, randomized, double-blind, placebo-controlled clinical trials. The iPrEx trial evaluated Truvada in 2,499 HIV-negative men or transgender women who have sex with men and with evidence of high risk behavior for HIV infection, such as inconsistent or no condom use during sex with a partner of positive or unknown HIV status, a high number of sex partners, and exchange of sex for commodities. Results showed Truvada was effective in reducing the risk of HIV infection by 42 percent compared with placebo in this population. Efficacy was strongly correlated with drug adherence in this trial.

The Partners PrEP trial was conducted in 4,758 heterosexual couples where one partner was HIV-infected and the other was not (serodiscordant couples). The trial evaluated the efficacy and safety of Truvada and tenofovir versus placebo in preventing HIV infection in the uninfected male or female partner. Results showed Truvada reduced the risk of becoming infected by 75 percent compared with placebo.

No new side effects were identified in the clinical trials evaluating Truvada for the PrEP indication. The most common side effects reported with Truvada included diarrhea, nausea, abdominal pain, headache, and weight loss. Serious adverse events in general, as well as those specifically related to kidney or bone toxicity, were uncommon.

As a condition of approval, Truvada’s manufacturer, Gilead Sciences, Inc., is required to collect viral isolates from individuals who acquire HIV while taking Truvada and to evaluate these isolates for the presence of resistance. Additionally, the company is required to collect data on pregnancy outcomes for women who become pregnant while taking Truvada for PrEP and to conduct a trial to evaluate drug adherence and its relationship to adverse events, risk of seroconversion, and resistance development in seroconverters. Gilead has committed to provide national drug utilization data in order to better characterize individuals who utilize Truvada for a PrEP indication and to develop an adherence questionnaire that will assist prescribers in identifying individuals at risk for low compliance.

Gilead Sciences, Inc. is based in Foster City, Calif.

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