FDA Approves Generic Truvada for HIV Treatment and PrEP
America’s Hidden H.I.V. Epidemic
Published by Poz June 9, 2017
By Benjamin Ryan
In a move that has taken HIV advocates by surprise and stewed considerable confusion, the U.S. Food and Drug Administration (FDA) has approved a generic formulation of Gilead Sciences’ blockbuster antiretroviral (ARV) Truvada (tenofovir disoproxil fumarate/emtricitabine). This decision could have major implications for the future cost of Truvada, to insurers and consumers alike.
However, Gilead insisted in a statement, “A generic version of Truvada will not be immediately available. It’s important to note that there are a number of factors involved in commercialization that are not tied directly to FDA approval.”
In Vivo Excision of HIV-1 Provirus by saCas9 and Multiplex Single-Guide RNAs in Animal Models
Published by the New York Times June 6, 2016
By Linda Villarosa
Why do America’s black gay and bisexual men have
a higher H.I.V. rate than any country in the world?
Early on a balmy morning last October, Cedric Sturdevant began his rounds along the bumpy streets and back roads of Jackson, Miss. Sturdevant, 52, has racked up nearly 300,000 miles driving in loops and widening circles around Jackson in his improvised role of visiting nurse, motivational coach and father figure to a growing number of young gay men and transgender women suffering from H.I.V. and AIDS. Sturdevant is a project coordinator at My Brother’s Keeper, a local social-services nonprofit. If he doesn’t make these rounds, he has learned, many of these patients will not get to the doctor’s appointments, pharmacies, food banks and counseling sessions that can make the difference between life and death.
HIV Activist Peter Staley Talks PrEP
Published by Science Direct on May 3rd, 2017
By Chaoran Yin, Ting Zhang, Xiying Qu, Yonggang Zhang, Raj Putatunda, Xiao Xiao, Fang Li, Weidong Xiao, Huaging Zhao, Shen Dai, Xuebin Qin, Xianming Mo, Won-Bin Young, Kamel Khalili, Wenhui Hu
CRISPR-associated protein 9 (Cas9)-mediated genome editing provides a promising cure for HIV-1/AIDS; however, gene delivery efficiency in vivo remains an obstacle to overcome. Here, we demonstrate the feasibility and efficiency of excising the HIV-1 provirus in three different animal models using an all-in-one adeno-associated virus (AAV) vector to deliver multiplex single-guide RNAs (sgRNAs) plus Staphylococcus aureus Cas9 (saCas9).
Outbreak of Serogroup C Meningococcal Disease Primarily Affecting Men Who Have Sex with Men — Southern California, 2016
What if PrEP has long-term health effects that we’ve yet to discover? Or if it leads to a significant decrease in condom use and an increase in STI transmissions? If we let our guards down, couldn’t another virus come along that’s just as devastating as HIV? Is PrEP just setting us up for history to repeat itself?
“If you have those kinds of fears, you shouldn’t be riding in cars,” says veteran HIV and gay rights activist Peter Staley, from his home in New York. “You should be very scared about the next swine flu virus and be taking precautions right now. It doesn’t make a whole lot of sense to live a life of fear based on a future unknown.”
Then why are there people doing just that? In the United States an estimated 44,073 people were diagnosed with HIV in 2014. At-risk populations show a moderate level of adherence to PrEP, according to one study, but we nevertheless had a tool that could have protected most of these people with 99 percent effectiveness. Yet we saw some of the leading voices in HIV and AIDS advocacy peddling such fears rather trying to reduce the diagnosis numbers.
Oral Sex and HIV Risk: CDC Updated Fact Sheet 5/23/16
Published by the CDC September 2, 2016
Srinivas Nanduri, MD; Chelsea Foo, MPH; Van Ngo, MPH; Claire Jarashow, PhD; Rachel Civen, MD; Ben Schwartz, MD; John Holguin, MPH; Eric Shearer, MPH; Matt Zahn, MD; Kathleen Harriman, PhD; Kathleen Winter, PhD; Cecilia Kretz, PhD; How Yi Chang, PhD; Sarah Meyer, MD; Jessica MacNeil, MPH (View author affiliations)
During March 4–August 11, 2016, 25 outbreak-associated cases of meningococcal disease, including two deaths (8% case-fatality ratio), were reported in Southern California. Twenty-four of the cases were caused by serogroup C Neisseria meningitidis (NmC) and one by N. meningitidis with an undetermined serogroup (Figure). On June 24, 2016, in response to this increase in NmC cases, primarily among men who have sex with men (MSM) in Los Angeles County, the city of Long Beach, and Orange County, the California Department of Public Health (CDPH) issued a press release and health advisory, declaring an outbreak of NmC in Southern California (1).
Half of Gay Black Men Are Projected to Get HIV
Published by Center For Disease Control
May 23, 2016
Oral Sex and HIV Risk May 2016 Fast Facts
• There is little to no risk of getting or transmitting HIV from oral sex. • Other STDs and hepatitis can be transmitted during oral sex.
• Latex barriers and medicines to prevent and treat HIV can further reduce the very low risk of getting HIV from oral sex.
Oral sex involves using the mouth to stimulate the penis (fellatio), vagina (cunnilingus), or anus (anilingus).
Risk of HIV
The chance an HIV-negative person will get HIV from oral sex with an HIV-positive partner is extremely low. However, it is hard to know the exact risk because a lot of people who have oral sex also have anal or vaginal sex. The type of oral sex that may be the riskiest is mouth-to-penis oral sex. But the risk is still very low, and much lower than with anal or vaginal sex. Though the risk of HIV transmission through oral sex is low, several factors may increase that risk, including sores in the mouth or vagina or on the penis, bleeding gums, oral contact with menstrual blood, and the presence of other sexually transmitted diseases (STDs).
HIV PrEP drug Truvada as safe as aspirin, study finds
Published by Bloomberg Business, February 23, 2016
By John Tozzi
If you’re a white American woman, your risk of being diagnosed with HIV is pretty small, lower than the odds of dying in a car crash. If you’re a gay black man, the chances of getting an HIV diagnosis are closer to a coin flip.
About 43 percent of black men who have sex with men will be diagnosed with HIV in their lifetimes if the epidemic’s current trends hold, according to research being presented on Tuesday by the Centers for Disease Control. For Hispanic men who have sex with men, the rate is 22 percent. For white men who have sex with men, it’s about 10 percent.
The latest report is a staggering reminder that gay men of color bear the brunt of the HIV crisis. That fact has been evident for years in the data on HIV, but it has often gone unmentioned as public health campaigns focus on broad-based prevention strategies.
Daily Pre-Exposure Prophylaxis for HIV Indicated for Over 1.2 Million Americans
Published by United Press International, January 20, 2016
By Stephen Feller
LOS ANGELES, Jan. 20 (UPI) -- Pre-exposure prophylaxis, or PrEP, a drug taken daily to prevent HIV, was shown in a new study to be as safe for users as taking aspirin.
PrEP is a combination of the drugs emtricitabine and tenofovir, marketed as the drug Truvada, that can be taken by HIV-negative people at risk for contracting the virus.
Studies since at least 2011 have shown the efficacy of the drug at stopping the spread of HIV, and none of the people at high risk for HIV using PrEP in a 2.5-year study in San Francisco contracted the virus.
The lack of significant side effects, which were shown in the new study to be comparable to those of taking aspirin every day, may help the Centers for Disease Control and Prevention raise awareness and use of PrEP.
San Francisco Is Changing Face of AIDS Treatment
By Amy Orciari Herman
Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
Roughly a quarter of men who have sex with men (MSM) should receive daily pre-exposure prophylaxis (PrEP) to lower their risk for HIV acquisition, according to a CDC analysis in Vital Signs.
Insurer Says Clients on Daily Pill Have Stayed H.I.V.-Free
Published by the New York Times
By DONALD G. McNEIL Jr. OCT. 5, 2015
SAN FRANCISCO — It wasn’t his first broken condom, so Rafael didn’t worry. But three weeks later, the man he’d met in a bar called to say that he had “probably been exposed” to H.I.V.
Rafael, a muscular, affable 43-year-old, went to a clinic and within 45 minutes learned he was infected. Although it was already closing time, a counselor saw him immediately and offered him a doctor’s appointment the next day.
At Ward 86, the famous H.I.V. unit at San Francisco General Hospital, the doctor handed him pills for five days and a prescription for more. Because he was between jobs, she introduced him to a counselor who helped him file for public health insurance covering his $30,000-a-year treatment.
“They were very reassuring and very helpful,” said Rafael, who, like several other men interviewed for this article, spoke on condition that only his first name be used to protect his privacy. “They gave me the beautiful opportunity to just concentrate on my health.”
Daily pill Truvada cuts spread of HIV by 86%, study shows
Published by the New York Times September 2, 2015
By DONALD G. McNEIL Jr.
Demonstrating that taking a daily pill to prevent H.I.V. infection can work in the real world, San Francisco’s largest private health insurer announced Wednesday that not one of its 657 clients receiving the drug had become infected over a period of more than two years.
That outcome contradicted some critics’ predictions that so-called pre- exposure prophylaxis, or PrEP, would lead to less condom use and more H.I.V. infections.
A study published in Clinical Infectious Diseases found that the San Franciscans on PrEP, almost all of whom were gay men, did use fewer condoms — and contracted several other venereal diseases as a result. But none got H.I.V.
San Francisco Official Says He Takes Truvada to Prevent H.I.V., and More Gay Men Should, Too
Published by The Guardian, February 24th 2015
By Sarah Bosley
A daily pill can effectively protect gay men against infection with HIV, a UK trial has shown, which experts say now offers hope of reversing the virus’s spread.
Taking the drug, called Truvada, could become a daily routine for men who have sex with men in the same way that the contraceptive pill is for women, some believe. NHS England will now study the results to determine whether it is cost effective to provide it for men at risk of infection.
Published by the New York Times September 17th 2014
By Josh Barro
Scott Wiener, a member of the San Francisco Board of Supervisors, made an unusual public announcement on Wednesday: He takes Truvada, a daily antiviral pill, to greatly reduce his risk of contracting H.I.V.
Taking the pills is a practice known as pre-exposure prophylaxis, or PrEP, and some researchers believe it may reduce the risk of infection by 99 percent if patients take their medication daily as prescribed. Approved by the Food and Drug Administration in 2012, PrEP has increasingly been embraced by public health authorities and is one of three planks of Gov. Andrew Cuomo’s plan in New York to sharply cut new H.I.V. infections.