Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women Who Have Sex With Men - Full Text View - Primary Outcome Measures: Number of documented incident HIV infections in Steps 1 and 2 [ Time Frame: Measured through participant's last study visit, up to 4.5 years after study entry ] [ Designated as safety issue: Yes ] Number of Grade 2 or higher clinical and laboratory adverse events [ Time Frame: Measured through participant's last study visit, up to 4.5 years after study entry ] [ Designated as safety issue: Yes ] The purpose of this study is to evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW).
This study will enroll HIV-uninfected MSM and TGW at risk for acquiring HIV infection. Participants will remain in the study between 1.5 years to 4.5 years, depending on when they enroll in the study. This study will take place in three steps. Participants will be randomly assigned to one of two arms: Arm A: Arm B: Mobile.aidsmap. A case report of a man in Toronto who became infected with a multi-drug-resistant strain of HIV despite apparently very consistent adherence to PrEP was presented at the CROI 2016 conference in Boston today. Dr David Knox, a doctor at Toronto’s Maple Leaf Medical clinic, said the patient was a 43-year-old gay man who had been on PrEP for two years. He had an HIV-positive partner who was undetectable on antiretroviral therapy, but also had casual sex contacts involving the risk of HIV exposure. He was a regular attender at the clinic and tested for HIV on average every three months.
It was suggested to him that he start Truvada PrEP in April 2013 and he appeared to have good adherence to it on the basis of the frequency of pharmacy refills. Two years later in April 2015 he started having symptoms after a period of exposure to HIV with multiple partners. The other needs explanation. There was an indirect way, however. No New HIV Infections in San Francisco Community PrEP Clinic.
December 17, 2015, Emily Newman A trailblazing pre-exposure prophylaxis (PrEP) program by the San Francisco AIDS Foundation sexual health center Magnet was lauded at the 2015 HIV Prevention Conference. The PrEP health program began as a pilot program in November, 2014 and will continue to expand when it moves into a new health and wellness center, Strut, in San Francisco’s Castro neighborhood. In early December, Magnet director Steve Gibson, MSW, shared lessons learned about the PrEP health program—which has seen no new HIV infections—at the conference in Atlanta, Georgia.
Steve Gibson, MSW (Photo: Liz Highleyman) With an increasing number of community and health groups interested in scaling up PrEP access programs, practitioners across the country had the opportunity to learn about Magnet’s model of care and how the center has been able to successfully enroll and retain people in the program. Some of the results presented at the conference appear below. Who’s enrolling in the PrEP Program?
Adding vitamin D and calcium to a new HIV regimen curbs bone loss in the hip | Project Inform. By Alan McCord, Director of Education In a presentation at the 2014 CROI (Conference on Retroviruses and Opportunistic Infections) in Boston, taking high-dose vitamin D and calcium every day reduced the loss of hip bone mass in people who started on a regimen of efavirenz (Sustiva) + tenofovir/emtricitabine (Truvada). Studies have shown that bone mineral density, or BMD, is reduced 2–6% in people who start an HIV regimen. Although this phenomenon tends to even out after about a year, it may lead to fractures or breaks especially if the person has other risk factors for bone loss, such as age or lack of exercise.
Given the low levels of vitamin D seen in people with HIV, finding ways to prevent this bone loss is an area of current research. The 48-week ACTG 5280 study enrolled 165 people new to treatment into two groups. The average age was 34 years, 9 out of 10 were men, about a third were White and another third were Black. SOURCE: ET Overton, et al. PrEP Flow Chart. PrEP (Pre-Exposure Prophylaxis) | Project Inform. NEW! PrEP Flow Chart: This health care tool can help consumers and navigators with working through the process for finding a clinician, getting a prescription and covering the costs of PrEP. It’s laid out on a legal-sized sheet of paper, so feel free to print it on a desktop printer. ( PrEP/PEP point-of-care awareness cards: Order form: PrEP/PEP medication and patient assistance programs and copay programs:Click on the links at the bottom of that page at the Fair Pricing Coalition.
April/May #195 : Against All Odds - by Trenton Straube. PrEP - Benjamin RyanJournalist. The Danger in Comparing the HIV-Prevention Pill to Condoms. On Monday, August 3, I tested positive for HIV. That night, I sat on the sofa in my friend’s high-rise apartment in downtown Miami, peering down at the grainy, sodium-vapor-lit sprawl. I related the story of an older friend who’d tried to console me by saying HIV-positive people stay healthy. His words, while well-intentioned, only served to amplify the generational difference between us: Gay millennials, when they think of HIV, think more about dating than about death. On my way over, I’d seen couples walking together and thought about how I’d likely never have that—so many people I might have coupled with, all lost opportunities now. For men in America with access to healthcare, HIV isn’t usually fatal. I didn’t cry. When I’d gone to the AIDS Healthcare Foundation clinic near my home in South Beach, I wasn’t intending to take an HIV test—I’d been taking PrEP for months, but knew I was still at risk for other sexually transmitted infections.
You tested positive, she said. Why not? The Questions About PrEP | PrEP. Maybe you’re not completely sold on this new HIV prevention strategy. You think it’s a hard pill to swallow and not all it’s cracked up to be. Here are the most common questions we’ve heard so far about PrEP: You are currently not using PrEP and are interested in learning more about this new HIV prevention strategy. Who is this strategy meant for and how does it prevent HIV? You are considering using PrEP and you want to know how to prepare and learn about how you can get it. You are already taking Truvada (or other approved anti-HIV medication) for PrEP and have some pressing questions about this HIV prevention strategy. Here you'll find everything you need to inform yourself about PrEP and talking about it with your patients as a potential option to reduce their risk for HIV. If you have any questions that are not addressed here, please feel free to contact us at firstname.lastname@example.org. Hitting Bottom: Finding My Comfort With Sex Without Condoms :: HIV Equal.
The World Health Organization’s recommendation that HIV negative gay men consider using PrEP has set off another dramatic maelstrom of controversy in the HIV prevention world. Immediately, these new guidelines were distorted in media articles claiming all gay men “should” get on medications. My PrEP Facts Facebook Group immediately filled up with angry debates about who “should” take PrEP, who “should not”, whether it’s 92% or 99% effective, the evils of Big Pharma, upsets that PrEP doesn’t solve global warming or world hunger, and a general tone of hostility and attack. All I could do was hopelessly witness the shredding and think to myself, “All this arguing about butt sex? If only they knew what it meant to be HIV negative and have sex without fear.”
My own “spring awakening” popped wide open in the summer of 1985, much thanks to the incredible slew of hairy hunks on NBC’s daytime line-up. By the late 1980s, it was clear that consistent use of condoms could prevent HIV transmission. Daily Pill Can Prevent HIV | VitalSigns. Preexposure prophylaxis (PrEP) is a medicine taken daily that can be used to prevent getting HIV. PrEP is for people without HIV who are at very high risk for getting it from sex or injection drug use. People at high risk who should be offered PrEP include about 1 in 4 sexually active gay and bisexual men*, 1 in 5 people who inject drugs, and 1 in 200 sexually active heterosexual adults.
When taken every day, PrEP is safe and highly effective in preventing HIV infection. PrEP is even more effective if it is combined with other ways to prevent new HIV infections like condom use, drug abuse treatment, and treatment for people living with HIV to reduce the chance of passing the virus to others. Many people who can benefit from PrEP aren't taking it.
If more health care providers know about and prescribe PrEP, more HIV infections could be prevented. Health care providers can: Test patients for HIV as a regular part of medical care. Top of Page. Dr. Robert Grant: What Does Ipergay Tell Us About PrEP and ‘Seasons of Risk’? March 12, 2015, Emily Newman Much-anticipated efficacy results from a French study of intermittent PrEP were announced at the 2015 Conference on Retroviruses and Opportunistic Infections (CROI) at the end of February. Although PrEP experts do not have enough information from this relatively small study of men to advise or recommend intermittent PrEP use, Ipergay does add to clinical knowledge about one important issue: how to stop using PrEP if it’s no longer needed. Dr. Robert Grant (photo: Liz Highleyman) Robert Grant, MD, of the Gladstone Institutes, the University of California at San Francisco and chief medical officer of San Francisco AIDS Foundation, is excited to discuss the implications of the Ipergay study, which he says will be even more exciting and relevant when the discussion includes informed PrEP users who are ultimately in charge of how PrEP is used.
At this point, he’s focusing on one implication of Ipergay relevant to men now taking PrEP. PrEP demonstration project: Modest bone density loss observed among young men. November 2, 2015, Liz Highleyman Most young men participating in a pre-exposure prophylaxis (PrEP) demonstration project saw a small but significant amount of bone loss after starting Truvada, researchers reported at the 15th European AIDS Conference last week in Barcelona. Men who had the most highly protective levels of tenofovir in their blood, consistent with at least four doses per week, saw the largest decreases in bone density. “Although the BMD losses were generally modest [in this study], their occurrence before attainment of peak bone mass in young men who already have low bone mass may increase their risk of fragility in adulthood,” the researchers said.
Tenofovir—one of the two drugs in the Truvada combination pill—was approved in 2001 and is one of the most widely used antiretrovirals for HIV treatment. Tenofovir is generally safe and well-tolerated. ATN 110 enrolled 200 at-risk HIV-negative young men who have sex with men, ages 18 to 22, in 12 U.S. cities. Print Rebate Welcome.
Welcome to McKesson's Patient Rebate Online Portal! McKesson Patient Relationship Solutions is pleased to provide you with this fast, reliable means to obtain patient savings. It is designed to assist you in obtaining a refund for the discount amount you paid when you presented your co-pay card. After answering a few simple questions to validate eligibility, you will be able to download your personalized form which, along with a label and receipt, can be mailed back to McKesson for reimbursement. In most cases, checks are issued within 2-4 weeks of eligibility verification. We aim to make this process as simple as possible.
Should you have any questions or concerns completing the following steps, you may call our Patient Support Hotline or "Click to Talk" for one of our dedicated contact center support staff. This option will be available in the upper right-hand corner during our regular business hours once you get started. PrEP: Your Burning Questions Answered. April 17, 2014, Megan Canon, MPH Dr. Albert Liu We know people have a lot of questions and concerns around PrEP. We enlisted Albert Liu, MD, MPH, from Bridge HIV at the San Francisco Department of Public Health, to answer common PrEP questions we’ve heard and help sort out what we know and what we don’t know about this new HIV prevention strategy. What are the side effects from Truvada for PrEP? Truvada is a safe and well-tolerated drug. A small number of people had a decrease in kidney function that returned to normal when they stopped taking PrEP. With all medications, it’s important to weigh potential side effects with potential benefits from taking the medication.
If I start PrEP, can I stop using condoms? Condoms have been and continue to be an effective tool in reducing HIV risk. For people who do not use condoms every time they have sex, PrEP can provide an effective layer of protection against HIV. Won’t people start having “riskier sex” when they begin taking PrEP? Here’s What We Actually Know About The Pill That Prevents HIV. Co-Pay Assistance. If you’re concerned about how you will pay for your HIV therapy, start by talking to your healthcare provider. He or she may be able to help you apply for assistance.
If you have insurance Gilead HIV Co-pay Assistance Coupon Card You may be able to save on the co-pay for your TRUVADA prescription, with a GILEAD HIV Co-pay Coupon Card. Visit www.GileadCoPay.com or call for more information and to see if you are eligible If you don’t have insurance Gilead U.S. Partnership for Prescription Assistance (PPA) Program This program is designed to help uninsured Americans get the prescription medicines they need at no or low cost.
Call toll-free 1-888-4PPA-NOW (1-888-477-2669).Know the names of the medicines you take.A trained specialist will answer your questions and help you apply. Help may also be available through: What is TRUVADA? TRUVADA is a prescription medicine used in 2 different ways: to treat HIV-1 infection in adults and teenagers (12 and older). TRUVADA can cause serious side effects: Side Effects. What is TRUVADA? TRUVADA is a prescription medicine used in 2 different ways: to treat HIV-1 infection in adults and teenagers (12 and older). When used for the treatment of HIV-1 infection, TRUVADA is always used together with other HIV-1 medicines. To help reduce the risk of getting HIV-1 infection when used together with safer sex practices. TRUVADA does not cure HIV-1 infection or AIDS. What is the most important information I should know about TRUVADA?
TRUVADA can cause serious side effects: Too much lactic acid in your blood (lactic acidosis), which is a serious medical emergency. If your healthcare provider has prescribed TRUVADA to help reduce the risk of getting HIV-1 infection, you should also know: You must be HIV-negative before you start taking TRUVADA to reduce the risk of getting HIV-1. Who should not take TRUVADA? Do not take TRUVADA if you also take: Medicines containing emtricitabine or tenofovir disoproxil fumarate (ATRIPLA, COMPLERA, EMTRIVA, STRIBILD, VIREAD). Huffingtonpost. Truvada prevents HIV infection in high-risk individuals! A clinical success built on animal research.
Insight Into HIV Transmission Risk When the Viral Load Is Undetectable and No Condom Is Used - Resource Center on Keeping Up With Your HIV Meds. PrEP | HIV Basics | HIV/AIDS. The Case for PrEP, or How I Learned to Stop Worrying and Love HIV-Positive Guys. Mobile.aidsmap. IRMA. Does Taking PrEP Encourage Risky Behavior?
After 2.5 Years, No One in Large SF PrEP Group Contracts HIV - by Benjamin Ryan. HIV-preventing drug holds up under study - SFGate. UNC researchers: Drug cocktails can stop sexual transmission of HIV | News. Here’s What We Actually Know About The Pill That Prevents HIV. Condom effectiveness for HIV prevention by consistency of use among men who have sex with men in the United States. PrEP | HIV Basics | HIV/AIDS. To Prevent HIV Infection, Couples Try Testing Together. Putting a number on it: The risk from an exposure to HIV.
Partners PrEP: Up to 90% Fewer Infections in Mixed-Status Hetero Couples - by Tim Horn. Mobile.aidsmap.