picture from http://iprexole.com
Data from iPrEx Open-Label Extension(OLE): Demonstrate High Interest in PrEP, Longer-term Evidence of Safety and Efficacy, and No Sign of Increased Risk Behavior Among PrEP Users
iPrEx OLE is the first PrEP demonstration project to report on its experience; results
presented as a late-breaker at AIDS 2014, published in Lancet Infectious Diseases
(Melbourne, Australia) – Oral HIV pre-exposure prophylaxis (PrEP) provides a high degree of protection against HIV infection, even for individuals who miss some daily doses, according to new data from iPrEx OLE, the first PrEP demonstration project to report outcomes. PrEP was first proven effective in the original iPrEx study in 2010, and approved by the US FDA in 2012.
A celebration of life: Jeff McConnell
February 7th, 2014. 3-6 pm Gladstone Institutes.
First floor conference room A/B - 1650 Owens street San Francisco.
On January 25, 2014, our dear friend and colleague Jeff McConnell died in his apartment in San Francisco at the age of 49. Jeff was one of the pillars of iPrEx which championed Pre-exposure prophylaxis, or PrEP. Jeff McConnell was sensitive to social goals and practices, willing to eschew conventional thinking, and had a relentless intention to stop AIDS. Under Jeff’s guidance, we have a pill that prevents HIV infection, and powerful information about the social and sexual networks of gay men and transgendered women on 4 continents: Asia, Africa, Latin America, and North America.
picture from http://zebracms.org
IPREX OLE ANNOUNCES FINAL STUDY VISIT
The final participant visit in the iPrEx OLE (Open Label Extension) study took place in Lima, Peru on December 13, 2013.
iPrEx OLE was the 72-week, open-label
continuation of the multinational iPrEx study -- known formally as Chemoprophylaxis for HIV Prevention in Men, the Pre-exposure Prophylaxis (PrEP) Initiative study.
The original iPrEx study was a phase III, double-blinded, placebo controlled clinical trial that took place at 11 sites in Brazil, Ecuador, Peru, South Africa, Thailand and the
United States. All participants from that study, which reported results in November 2010, were invited to participate in iPrEx OLE. Preliminary study results from iPrEx OLE will be released in the first quarter of 2014.
The final iPrEx OLE study visit marks the completion of the first human trial to show that the use of daily oral PrEP with the antiretroviral combination tenofovir/emtricitabine,
commercially known as Truvada®, prevents...
picture from http://zebracms.org
Circumcision effectively reduces the risk of HIV infection “in real life”
ANRS Project in Orange Farm, South Africa confirms
The ANRS-12126 “Bophelo Pele” Project implemented in the township of Orange Farm in South Africa has confirmed the effectiveness of a large-scale program of voluntary medical male circumcision in prevention of heterosexually acquired HIV infection. The follow-up of over 3300 men shows a 57% to 61% reduction in the rate of new HIV infections in circumcised men compared with uncircumcised men. This study, headed by Prof Bertran Auvert and his colleagues, also shows that a circumcision program can be rapidly and effectively implemented in African communities where circumcision is not a social norm. These results, published in PLoS Medicine, argue for accelerated roll-out of voluntary male circumcision programs on the African continent in order to improve prevention of HIV transmission...
picture from http://www.hptn.org
HPTN 073, a New PrEP Demonstration Project is currently enrolling
Study takes place in three US cities
HPTN 073: Pre-Exposure Prophylaxis (PrEP) Initiation and Adherence among Black Men who have Sex with Men (BMSM) is a demonstration study evaluating PrEP initiation and adherence among HIV-negative black men who have sex with men. The study aims to assess the initiation, acceptability, safety, and feasibility of PrEP for black men who have sex with men (BMSM) in three U.S. cities utilizing client-centered care coordination (C4) models. This open label Truvada PrEP study attempts to recruit an equal number of BMSMs under age 25 and over 25, for a total of 225 participants with 75 participants at each of the three sites. The study will take place at three of the US sites of the HIV Prevention Trials Network (HPTN); the University of North Carolina in Chapel Hill; in Washington, D.C., through George Washington University; and through the University of California at Los Angeles. A subset of study participants will also be recruited to participate in qualitative interviews about facilitators and barriers regarding PrEP. To learn more about the HPTN 073 study, please click here:
picture from http://www.ias2013.org/
iPrEx Participants Interested in Continuing HIV Pre-exposure prophylaxis
First PrEP demonstration project to present preliminary results.
A majority of participants in an extension of the iPrEx pre-exposure prophylaxis (PrEP) trial said they would like ongoing open-label access to Truvada for HIV prevention, researchers reported at the 7th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2013) this week in Kuala Lumpur...
picture from CDC
iPrEx Welcomes CDC’s Bangkok Tenofovir Study Showing Pre-Exposure Prophylaxis (PrEP) is Safe and Effective for HIV Prevention in Injection Drug Users
The following statement was released by iPrEx Protocol Chair Robert Grant, MD, MPH of the Gladstone Institutes and the University of California at San Francisco
Oral PrEP is a critically important HIV prevention tool that can play a significant role in reducing individual infection risk and helping to end the epidemic. Today’s news, that PrEP prevents HIV among people whose primary infection risk is injection drug use, adds to clear evidence from earlier studies that PrEP is safe and effective at preventing the sexual transmission of HIV in gay and bisexual men and in heterosexual women and men. With this new evidence we now know that PrEP, which was FDA-approved to prevent sexual transmission of HIV in 2012, can help HIV-uninfected people protect themselves from HIV regardless of the route of exposure...
picture from www.proud.mrc.ac.uk.
A New PrEP Study in Men Who Have Sex with Men is currently Recruiting Participants in England 500 MSM will be participating in this PrEP study.
The "PROUD study: Examining the impact on gay men of using Pre-Exposure Prophylaxis (PrEP)", is a new PrEP study that started enrollment of MSM participants in November of 2012 in six cities across England.
The PROUD trial is a two-year study that will recruit volunteers across England, who will be placed at random into one of two groups. One group will use PrEP from the start of the study, and the other group will receive PrEP after 12 months. Both groups will receive support to remain HIV negative throughout the study. The study medication used in this PrEP study is Truvada (which contains tenofovir and emtricitabine) the same medication that was used in the iPrEx study.
The trial will be recruiting 500 men who have sex with men in 14 study sites in England that include the following cities: London, Brighton, Birmingham, York, Manchester and Sheffield. Enrollment criteria includes:
• Be HIV negative
• 18 years of age or older
• Have had anal sex without a condom in the last three months.
• Be likely to do this again in the following three months.
• Be able to visit the study clinic for blood tests every three months.
This study is looking at a new way to reduce the risk of getting HIV. It will look at the impact of taking PrEP on how often men have sex; how often they use condoms; and whether they get other sexually transmitted infections. The study is sponsored by the UK Medical Research Council Clinical Trials Unit, and study drug and support for protocol specific procedures and laboratory tests have been provided by Gilead Sciences. For more information about the PROUD study, visit the following page:
picture from MTN
Results of a Major HIV Prevention Study in African Women Confirms that Pre-Exposure Prophylaxis is Effective Only When Used Consistently Young African Women Find Did Not Follow Daily Regimen
The following statement was released by iPrEx Protocol Chair Robert Grant, MD, MPH of the Gladstone Institute of Virology and Immunology and the University of California at San Francisco
ATLANTA, March 4, 2013 – Results of the VOICE trial indicated that none of the three products
evaluated in this study, oral tenofovir, oral Truvada® and tenofovir gel were effective in
protecting women from acquiring HIV. Most participants did not use them daily as
recommended, suggesting that this regimen does not appear to be the right approach for
preventing HIV in young, unmarried African women that enrolled in this study.
The VOICE study (Vaginal and Oral Interventions to Control de Epidemic) was designed to
evaluate whether antiretroviral drugs (ARV), used to treat people living with HIV,
picture from www.bhiva.org
The British HIV Association/British Association for Sexual Health and HIV Position Statement on pre-exposure prophylaxis in the UK
The intention of this Position Statement is to inform UK healthcare workers on the role of antiretroviral pre-exposure prophylaxis (PrEP) in the setting of the UK HIV epidemic, so that they can have an informed discussion with their patients. Recent results from clinical trials of PrEP have made it imperative to investigate whether this biomedical tool will have a useful part to play in HIV prevention in the UK. However, it is not possible to review the evidence for this biomedical intervention in isolation, as PrEP (systemic and topical) is one of several methods in the prevention package, and one of four biomedical tools available; the other three being medical male circumcision, postexposure prophylaxis following
picture from University of Washington
An open-label, pilot demonstration and evaluation project of antiretroviral-based HIV-1 prevention among high-risk HIV-1 serodiscordant African couples.
The Partners Demonstration Project
Antiretroviral-based HIV-1 prevention strategies – including antiretroviral treatment (ART) to reduce the infectiousness of HIV-1 infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons to prevent HIV-1 acquisition – are among the most promising new approaches for dramatically decreasing HIV-1 spread. A priority population for implementation of ART and PrEP for HIV-1 prevention is HIV-1 serodiscordant couples (i.e., one member is HIV-1 infected and the other uninfected).
Stable, heterosexual African HIV-1 serodiscordant couples face high risk of HIV-1 transmission, from within the partnership and from outside partners, and are a priority population for prevention interventions.
picture from www.projectprepare.net
Adolescent Medicine Trials Network (ATN) launches the PrEPare study
14 sites in the US are making part of it
The Adolescent Medicine Trials Network (ATN) will launch this early fall the PrEPare study, comprehensive HIV prevention study designed to obtain additional data on the safety and efficacy of FTC/TDF and to evaluate patterns of use, rates of adherence, and patterns of sexual risk behavior among young men who have sex with men (YMSM) who are provided with open label FTC/TDF to help to determine if pre-exposure prophylaxis (PrEP) could become a part of a comprehensive HIV prevention package for YMSM in the real world.
picture from www.thewarning.info
(PrEP) The ANRS-IPERGAY study should be discontinued
Prevention research in France is in disarray
Warning considers that, given the current international scientific consensus, the placebo arm of the IPERGAY study does not meet ethical standards and must be immediately interrupted in the interest of protecting the health of gay men participating in study. Warning also requests that a temporary authorization for the use of oral PrEP be granted in France by the medication regulatory body.
In what follow, Warning, a community health organisation, responds to the opinion issued by the independent monitoring committee  of the IPERGAY study as well as to the news release of the ANRS (the French Aids Research Agency) regarding IPERGAY where they announce that the trial will be continued as originally planned.
picture from ipergay
The Anrs decides to continue its Ipergay trial
And creates a new working group on HIV prevention
Last July the US Food and Drug Administration approved Truvada®, an antiretroviral drug, used as a continuous daily regimen to reduce the infection risk in seronegative subjects exposed to HIV. This decision prompted the Anrs to launch a consultation process regarding a trial it sponsors—Ipergay (cf. press release of 6 June 2012).
The Anrs Ipergay trial
Anrs Ipergay will yield crucial information on HIV prevention in gay and trans men. The pilot phase started in February 2012. The aim is to evaluate a hitherto unexplored approach to HIV prevention: provide all available prevention tools (condoms, frequent HIV screening, counseling, screening and treatment of other sexually transmitted diseases, use of post-exposure prophylaxis) and assess the additional benefit of Truvada® when used on demand, ie, according to sexual activity. In Anrs Ipergay, which is a randomized, double-blind placebo-controlled trial, all study participants have access...
picture from truvada.com
La pastilla antiretroviral Truvada es aprobada en el Ecuador para el tratamiento de la infección por VIH
Su costo podría ser tan bajo como US$ 1.50 al día
La combinación antiretroviral tenofovir/emtricitabina, comercialmente conocida como Truvada, que se usa como medicamento de primera línea para el tratamiento de la infección por VIH, acaba de ser aprobada para su comercialización por el Ministerio de Salud Pública del Ecuador.
La aplicación para el registro de Truvada para el tratamiento de la infección por VIH en el Ecuador fue sometida por Gilead Sciences Inc., los productores de la medicación, en el año 2008 pero fue recién la semana pasada que el Ministerio de Salud Pública la aprobó para su comercialización en este país. Sin embargo...
picture from SFDPH
San Francisco AIDS Foundation (SFAF) launched a web site
The SF AIDS Foundation has just launched a website to provide community information about PrEP: www.prepfacts.org This is a great information resource for people interesting in finding out more about PrEP.
picture from SFDPH
SFDPH to Launch PrEP Demonstration Project for HIV Prevention
Demo Projects will take place in San Francisco and Miami
San Francisco, CA—The San Francisco Department of Public Health (SFDPH) is launching the city's first demonstration project to evaluate the delivery of pre-exposure prophylaxis (PrEP) in
STD clinics. PrEP is the use of a daily anti-HIV medication for HIV prevention. Called The Demo Project, the program will enroll up to 300 HIV-uninfected men who have sex with men
(MSM) and transgender women at the San Francisco City Clinic, the only municipal STD clinic in San Francisco, and an additional 200 participants at a Florida Department of Health STD clinic in Miami, Florida. This study is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Several recent clinical trials have demonstrated that the anti-HIV medication Truvada® can
prevent HIV infections in men and women at risk for acquiring HIV when used as part of a
comprehensive prevention package.
picture from cdc
PrEP Interim Guidance for PrEP in Sexually Active Heterosexual Adults
CDC released today
In the United States, an estimated 48,100 new human immunodeficiency virus (HIV) infections occurred in 2009 (1). Of these, 27% were in heterosexual men and women who did not inject drugs, and 64% were in men who have sex with men
(MSM), including 3% in MSM who inject drugs. In January
2011, following publication of evidence of safety and efficacy
of daily oral tenofovir disoproxil fumarate 300 mg (TDF)/
emtricitabine 200 mg (FTC) (Truvada, Gilead Sciences) as
antiretroviral preexposure prophylaxis (PrEP) to reduce the risk
for HIV acquisition among MSM in the iPrEx trial, CDC issued
interim guidance to make available information and important
initial cautions on the use of PrEP in this population. Those
recommendations remain valid for MSM, including MSM
who also have sex with women (2). Since January 2011, data
from studies of PrEP among heterosexual men and women have
become available, and on July 16, 2012, the Food and Drug
Administration (FDA) approved a label indication for reduction
of risk for sexual acquisition of HIV infection among adults,
including both heterosexuals and MSM.* This interim guidance
includes consideration of the new information and addresses
pregnancy and safety issues for heterosexually active adults at
very high risk for sexual HIV acquisition that were not discussed
in the previous interim guidance for the use of PrEP in MSM.
picture from who
World Health Organization issues first PrEP guidance
Guidance is issued after FDA approved Truvada for PrEP on July 16th
20 JULY 2012 | GENEVA / WASHINGTON DC - WHO has issued its first guidance to countries that are considering offering HIV medications, known as antiretrovirals (ARVs), to protect people who do not have the virus but who are at high risk of HIV infection.
Pre-exposure prophylaxis (PrEP)
The guidance is based on clinical trials indicating that a daily dose of oral antiretroviral medication, known as pre-exposure prophylaxis (PrEP), taken by HIV-negative people to reduce the risk of infection, is both safe for people to use and effective in preventing HIV. The iPrEX study shows that use of PrEP can reduce HIV infection by around 40% among men who have sex with men – and up to 73% among those who took the medicine regularly. The Partners PrEP study found 75% protection among serodiscordant couples (couples in which one person is HIV positive) in Kenya and Uganda.
picture from wikimedia commons
HPTN Launches NEXT-PrEP Trial
The study will evaluate the safety and tolerability of Maraviroc
July 18, 2012 - The HIV Prevention Trials Network (HPTN) announced today the initiation of the NEXT-PrEP study (Novel exploration of Therapeutics for PrEP or HPTN 069), the first clinical trial to test whether the drug maraviroc (brand name Selzentry) currently approved to treat HIV infection is also safe and tolerable when taken once daily by HIV-uninfected individuals to decrease their risk of acquiring HIV.
The trial involves a strategy known as pre-exposure prophylaxis, or PrEP, in which HIV-uninfected individuals who are at risk for contracting the virus take one or two HIV drugs routinely in an effort to prevent infection.
picture from Gladstone
FDA Approves New Indication of FTC/TDF for HIV Prevention
The following statement is released by Robert Grant, MD, MPH, of the Gladstone Institutes and the University of California San Francisco
San Francisco – On July 16, 2012 the US and Food and Drug Administration (FDA) approved Gilead's Truvada® for HIV prevention in uninfected adults at high risk of acquiring HIV through sex. This decision was based on the efficacy and safety results from the iPrEx study in 2,499 gay men, other men who have sex with men and transgender women (GMT) and the Partners PrEP study in 4,758 serodiscordant couples (where one is HIV positive and the other is not). Truvada is currently used as a treatment for HIV-infected individuals.
On May 10th, the FDA Antiviral Advisory Committee recommended the use of Truvada for pre-exposure prophylaxis (or PrEP) among sexually active adults who are potentially
exposed to HIV infection...
picture from iprexole.com
The iPrEx Study Closed Enrollment in OLE
Follow up will end in November 2013
San Francisco, June 2012 - The iPrEx Open Label Extension (iPrEx OLE) closed enrollment with 1,770 participants from Brazil, Ecuador, Peru, South Africa, Thailand and the United States. iPrEx OLE, an intervention that could be considered the first worldwide PrEP demonstration project in men who have sex with men and transgender women (MSM), will finish follow up by mid November 2013.
The randomized phase of the iPrEx trial finished in February of 2011 and started rolling out participants into the open label extension in June of that year at the San Francisco Department of Public Health in the United States. Enrollment closed on June 22nd of 2012 at Investigaciones Medicas en Salud (INMENSA), the iPrEx study site in Lima, Peru.
picture from article
Southern African guidelines for the safe use of pre-exposure prophylaxis in men who have sex with men who are at risk for HIV infection
Southern African Journal of HIV Medicine, Vol 13, No 2 (2012)
Background. The use of oral antiretrovirals to prevent HIV infection among HIV-negative men who have sex with men (MSM) has been shown to be safe and efficacious. A large, randomised, placebo-controlled trial showed a 44% reduction in the incidence of HIV infection among MSM receiving a daily oral fixed-dose combination of tenofovir disoproxil fumarate and emtricitabine (Truvada) in combination with an HIV prevention package. Improved protection was seen with higher levels of adherence.
Aim. The purpose of this guideline is to: (i) explain what pre-exposure prophylaxis (PrEP) is; (ii) outline current indications for its use; (iii) outline steps for appropriate client selection; and (iv) provide guidance for monitoring and maintaining clients on PrEP.
Method. PrEP is indicated for HIV-negative MSM who are assessed to be at high risk for HIV acquisition and who are willing and motivated to use PrEP as part of a package of HIV prevention services (including condoms, lubrication, sexually transmitted infection (STI) management and risk reduction counselling).
picture from BBC News
BBC News: Interview with Robert Grant. PrEP and its potential after FDA Advisory Committee Meeting
HIV prevention pill Truvada backed by US expertsA panel of US health experts has for the first time backed a drug to prevent HIV infection in healthy people.
The panel recommended US regulators approve the daily pill, Truvada, for use by people considered at high risk of contracting the Aids virus.
The US Food and Drug Administration (FDA) is not required to follow the panel's advice, but it usually does.
Some health workers and groups active in the HIV community have opposed the approval of the drug.
However, correspondents say the move could prove to be a new milestone in the fight against HIV/Aids...
picture from AVDAC meeting webcast May 10, 2012
FDA Antiviral Drugs Advisory Committee Recommends New Indication of
FTC/TDF for HIV Prevention
The following statement is released by Robert Grant, MD, MPH, of the Gladstone Institutes and the University of California San Francisco
In a public hearing at the FDA White Oak Campus, the FDA Antiviral Drugs Advisory Committee voted in favor of recommending the change in indication of the antiretroviral
drug combination emtricitabine/tenofovir disoproxil fumarate (Truvada®) for the prevention of HIV infection in adults as pre-exposure prophylaxis.
On December 15th, 2011, Gilead Sciences Inc., the manufacturer of Truvada, filed a "supplemental new drug application (sNDA)" with the US Food and Drug Administration
(FDA) proposing a change in its indication based on the efficacy and safety results from the iPrEx and Partners PrEP studies. Truvada is currently used as a treatment for HIVinfected individuals.
As part of this process, Gilead Sciences, iPrEx and Partners PrEP have been providing the FDA with all the necessary information so that the FDA can make an evidencebased decision regarding the prevention use of Truvada. For advice, and to help make
a decision, the FDA convened an Antiviral Drugs Advisory Committee comprised of experts in the field as well as a consumer representative. This committee reviews the data and formulates recommendations, however, the final decision will be made by the FDA.
picture from www.stockvault.net
iPrEx and the Supplemental New Drug Application of Truvada for Pre-Exposure Prophylaxis
What is an Investigational New Drug Application (IND)?
An IND is a request for authorization from the US Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population. An IND application includes animal pharmacology and toxicology study data, manufacturing information and clinical protocols and investigator information.
Yes, the iPrEx study has an IND filing with the FDA. The study sponsor, the National Institute of Allergies and Infectious Diseases (NIAID)/Division of AIDS (DAIDS), holds the IND. By filing an IND, the IND holder commits to keeping the FDA informed about the conduct of the study. That is, evaluating the drug and reporting any adverse experiences or changes in the study conduct.
Was the study medication used in iPrEx, tenofovir disoproxil fumarate and emtricitabine (Truvada®), filed as an IND with the FDA?
picture from www.fda.gov
Leading AIDS Advocates Support FDA Approval of Pre-Exposure Prophylaxis (PrEP),
a Promising New HIV Prevention Method, for Men and Women
Written Comments to FDA Advisory Committee Cite Compelling Evidence for PrEP and
Urgent Need for Every Available Tool to End AIDS
New York, May 1, 2012 – In public comments submitted this week, a group of 14 leading HIV/AIDS and health organizations stated their support for Food and Drug Administration (FDA) approval of emtricitabine/ tenofovir disoproxil fumarate (TDF/FTC or Truvada®) as pre-exposure prophylaxis (PrEP) to prevent HIV infection in adult men and women. Their comments, submitted in advance of a May 10 FDA Advisory Committee meeting, pointed to compelling evidence on the efficacy of TDF/FTC as PrEP and highlighted the unique potential of this intervention to help slow the HIV epidemic in the US.
picture from www.californiaaidsresearch.org
University of California launches initiative to test an HIV prevention pill in California
11.8 million dollars granted
On April 17, the California HIV/AIDS Research Program (CHRP) of the University of California announced that it has awarded grants totaling $11.8 million to three teams of investigators to test a potential HIV prevention pill among high-risk HIV-uninfected persons in California. The studies also will examine new strategies to engage and retain HIV-infected persons in care and treatment. These combined strategies are expected to help curb the HIV epidemic in California.
Two of the research teams will offer the HIV prevention pill – part of an intervention known as PrEP (pre-exposure prophylaxis with antiretroviral drugs) – to an estimated 700 uninfected men who have sex with men (MSM) and to transgender women (male to female transgendered persons) at high-risk in Los Angeles, San Diego and Long Beach over the next four years. PrEP also includes the provision of risk reduction counseling and other services.
picture from www.fda.gov
The United States Food and Drug Administration (FDA) Finalizes Audits at Global iPrEx Sites in South America.
The FDA auditor found no critical issues in the implementation of the study in either study site.
On March 23rd, 2012 the US Food and Drug Administration (FDA) finalized a two-week audit visit at two South American sites of the "Chemoprophylaxis for HIV Prevention in Men"
clinical trial, also known as Global iPrEx, to evaluate data quality and integrity, the study conduct, and compliance with good clinical practice and good laboratory practice. The FDA
audits took place at Asociacion Civil Impacta Salud y Educacion (Impacta), a Lima-based research institution in Peru, and the Fundacion Ecuatoriana Equidad Medical Institute (Equidad), a community-based organization working in civil rights for men who have sex with men (MSM) and transgender women in Guayaquil, Ecuador. These audits took place as part of the supplemental New Drug Application (sNDA) of oral daily Truvada® for HIV prevention, that Gilead Sciences, filed with the FDA last December. The FDA auditor found no critical
issues in the implementation of the study in either study site.
picture from www.equidadglbt.com
La Administraci6n de Alimentos y Drogas de los Estados Unidos (FDA) realiza visita de
inspección al lnstituto Medico de Ia Fundaci6n Ecuatoriana Equidad- Sede Guayaquil.
Para auditar el estudio "Quimioprofilaxis para Ia Prevenci6n del VIH en Hombres" (iPrEx Global)
Entre el 19 y 23 de marzo del 2012, Ia Fundacion Ecuatoriana Equidad recibió la visita de la inspectora del FDA en su sede de Guayaquil para revisar la conduccion de Ia fase aleatorizada del
estudio "Quimioprofilaxis para Ia Prevencion del VIH en Hombres" (iPrEx Global) e indicó que no tenía ninguna observación verbal o escrita sobre la ejecución de la investigación, lo que significa que la sede del estudio en Ecuador cumplió a cabalidad con todas las regulaciones y rigurosidad exigidas para la conducción de dicho ensayo clínico en términos de buenas práticas de investigación clínica, buenas prácticas de laboratorio, control y aseguramiento de la calidad de los datos y la protección a sujetos humanos en investigacion.
U.S. FDA Grants Priority Review for Truvada(r) for Reducing the Risk of Acquiring HIV Infection
The Supplemental New Drug Application is Based on Results from iPrEx and Partners PrEP
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the
U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) and granted a six-month Priority Review for once-daily Truvada® (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection among
uninfected adults. Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and is currently the most prescribed antiretroviral treatment in the United States.
Launch of first pre-HIV exposure prevention trial for gay men in Europe
IPERGAY is a French ANRS initiative
The ANRS (French National Agency for Research on AIDS and Viral Hepatitis) is about to launch in Europe the first pre-HIV exposure prevention trial in men who have sex with men.
This phase III trial—ANRS IPERGAY—will start at the end of January 2012, in Paris (Hôpital Saint-Louis, Professor Jean-Michel Molina and Hôpital Tenon, Professor Gilles Pialoux) and Lyon (Hôpital de la Croix-Rousse, Dr Laurent Cotte), and later in Montreal in Quebec (CHUM Hôpital Hôtel Dieu, Dr Cécile Tremblay). The trial will include 300 volunteers in the pilot phase and ultimately 1900 in total.
FDA ASKED TO APPROVE NEW HIV PREVENTION METHOD
Gilead submitted supplemental New Drug Application (sNDA).
An application from Gilead Sciences, Inc. has been filed with the U.S. Food and Drug Administration to approve an HIV antiretroviral therapy to reduce the risk of HIV infection among uninfected men who have sex with men (MSM) and heterosexual
women and men. The application to approve the new HIV prevention method called preexposure prophylaxis, or PrEP, is based partly on data from the Global iPrEx study, the first human efficacy study to prove that PrEP reduces HIV infection risk in people.
VOICE DSMB Recommends Stopping Tenofovir Gel Arm
NIAID has made a public on November 25, 2011.
The National Institute of Allergies and Infectious Diseases (NIAID) and the Microbicide Trials Network (MTN) announced today that the Data Safety Monitoring Board (DSMB) for VOICE (an independent committee that oversees the study) has recommended that the tenofovir gel arm of the trial be stopped because it concluded that there was no possibility that daily use of tenofovir gel would show efficacy in preventing HIV in the context of the VOICE trial.
This was the final DSMB meeting for VOICE. NIAID has just made a public announcement about the DSMB's recommendation to.....
CDC "Project T" Participants to Join iPrEx
iPrEx OLE will invite 279 additional participants from the US Centers for Disease Control and Prevention (CDC)'s long-term PrEP safety study, Project T (http://helpfighthiv.org/projt.htm), to join the roll over phase of the iPrEx study.
Project T sites in in San Francisco and Boston will contact participants and host information sessions to explain the iPrEx study results and inform Project T participants of their eligibility to enroll in iPrEx OLE (Open Label Extension). Adding Project T participants will strengthen iPrEx OLE while providing HIV-negative Project T participants who chose to enroll with an additional 72 weeks of access to PrEP with Truvada (emticitabine/tenofovir). Truvada PrEP has proven to be up to 92% effective in preventing HIV infection in men who have sex with men (MSM) with regular use.
Project T tested the long-term safety of tenofovir, a frequently prescribed HIV therapy, in HIV-negative men MSM over a two-year period. Study results, first presented in July of 2010 at the XVIII International AIDS Conference in Vienna, Austria found no significant safety concerns with taking a daily tenofovir pill. The study also found that men in the trial did not take more risks sexually while taking tenofovir.
The study was conducted by the U.S. CDC in collaboration with the San Francisco Department of Public Health, AIDS Research Consortium of Atlanta and Fenway Health in Boston.
Unblinding iPrEx Participants and Enrolling iPrEx OLE
iPrEx study sites have been unblinding participants since June of 2011. Unblinding is the process of sharing with participants which arm of the iPrEx study (active drug or placebo) they were assigned to, and informing them of their eligibility to participate in the iPrEx Open Label Extension (iPrEx OLE.) To date, 288 of the 2,499 participants from the original iPrEx study have enrolled in iPrEx OLE. Enrollment is currently underway at nine of the 11 original iPrEx sites. Many more participants from the randomized study are expected to enroll in iPrEx OLE in the weeks and months ahead....
Participantes de iPrEx se enrolan en iPrEx OLE
Las sedes de iPrEx han procedido a develar el ciego a los participantes del estudio. La develación del ciego es el proceso en el que se informa a los participantes a qué brazo del estudio (medicación activa o placebo) fueron asignado así como informarles sobre su elegibilidad para participar en la Extensión de Etiqueta Abierta del iPrEx (iPrEx OLE). Hasta la fecha se han enrolado 288 de los 2,499 participantes de la fase aleatorizada del iPrEx en el iPrEx OLE. El enrolamiento continúa en nueve de las 11 sedes del iPrEx. Se espera que en los siguientes meses se enrolen muchos más participantes...
PrEP Demonstration Project in San Francisco, California
San Francisco will be the first city in the United States to implement a pre-exposure prophylaxis (PrEP) demonstration project in men who have sex with men (MSM).
With support from the US National Institutes of Health (NIH), the San Francisco Department of Public Health is planning to launch a demonstration project of PrEP for HIV prevention using the ARV combination tenofovir/emtricitabine, commercially known as Truvada®. This is the same medication used in the iPrEx trial that proved to be up to 92% effective in the prevention of HIV infection in MSM in the iPrEx study.
Pending final approval, this pilot intervention will enroll 300 MSM at sites that include the City Clinic and Magnet, a gay men's health center in the Castro neighborhood.
The San Francisco Department of Public Health has been an important site in the iPrEx trial. The Department of Health was the first site to open enrollment in iPrEx OLE, a 72 week Open Label Extension of the iPrEx study designed to collect additional information about long-term safety and efficacy of PrEP and sexual behavior of participants taking the daily HIV prevention pill.
NEW iPrEx DATA CONFIRM THE LONG-TERM EFFICACY AND SAFETY OF PRE-EXPOSURE PROPHYLAXIS (PrEP) TO PREVENT
HIV INFECTION IN PEOPLE
Eleven New Analyses from the iPrEx Study Will Be Presented at the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention
(Rome, Italy) -- Eleven new research studies examining the durability of responses to pre-exposure prophylaxis, or PrEP, the safety of the intervention and ways to evaluate HIV risk to better target PrEP will be presented here by researchers from the iPrEx study, the first clinical trial to demonstrate the efficacy of PrEP for HIV prevention in people.
The iPrEx study found that daily PrEP with the antiretroviral drug Truvada® (FTC/TDF) reduced HIV infections by an average of 44% in men and transgender women who have sex with men (MSM). PrEP efficacy was 73% among those who reported using...
OPEN-LABEL EXTENSION OF IPREX HIV PRE-EXPOSURE PROPHYLAXIS (PrEP) STUDY BEGINS AT 11 SITES IN SIX COUNTRIES
iPrEx OLE to Build on News that PrEP Slows HIV Infections Significantly in Both Men Who Have Sex with Men and Heterosexual Women and Men
The iPrEx Open-Label Extension Study (iPrEx OLE), the next phase of the first human study to report efficacy results on pre-exposure prophylaxis (PrEP) to prevent HIV infection, has begun at clinical trial sites around the world. Approximately 2,000 men and transgender women who have sex with men are expected to participate in the 72-week iPrEx OLE study (http://www.iprexole.com/). Study sites in the United States and South Africa are enrolling participants now, as other study sites finalize the regulatory approval process.
In PrEP, antiretroviral medications that are usually used to treat HIV are taken by uninfected people to reduce their risk of infection. The iPrEx study found that men and transgender women who have sex with men (MSM) who took a single daily tablet containing the HIV medications emtricitabine and tenofovir (FTC/TDF), known commercially as Truvada®, experienced an average of 44% fewer HIV infections than those who received a placebo (blank pill). HIV infection rates in the iPrEx study dropped by 90% among those who used PrEP consistently enough to have detectable drug in the body. The HIV risk reduction benefits of PrEP were in...
Two Major Studies Prove HIV Pre-Exposure Prophylaxis (PrEP) Works in Heterosexual Women and Men; Build on iPrEx Data Showing PrEP Reduces HIV Infections in Men Who Have Sex with Men
Download full statement
The following statement was released by iPrEx Protocol Chair Robert Grant, MD, MPH of the Gladstone Institutes and the University of California at San Francisco
"Today's news from the Partners PrEP and CDC Botswana (TDF2) studies detailing the safety and effectiveness of PrEP in heterosexual women and men is a major step forward in HIV prevention research with global implications for helping to end the AIDS epidemic.
PrEP involves uninfected people taking antiretroviral medications, which are usually used to treat HIV, to reduce their chances of HIV infection. With 2.6 million people worldwide newly infected by HIV each year, the compelling evidence presented by the iPrEx, Partners PrEP and TDF 2 studies -- that PrEP greatly reduces the risk of HIV infection both in heterosexual men and women and among men who have sex with men -- makes it increasingly clear that PrEP can play an important role in helping to slow the global epidemic in multiple populations at ...
The FACTS 001 tenofovir gel study
• Follow-on African Consortium for Tenofovir Studies
Young women bear the brunt of the HIV epidemic in South Africa. The historic clinical trial, CAPRISA004 showed that tenofovir gel when used before an after sex was 39% effective in preventing HIV infection in women. The reduction in risk reached 54% among woman who reported using the product most consistenly. The study also demostrated a reduction in the risk of becoming infected with the Herpes Simple Virus2 (HSV-2) by 51%. CAPRISA 004 was designed to show proof of concept that the gel could protected against HIV, but the study was no longer enough on its own to sopport registration of ...
Intermittent PrEP. HPTN 067 about to be launched
• Science Speaks: HIV & TB News
Ready to launch: "ADAPT" study looks at intermittent dosing of PrEP
Investigators at the HIV Prevention Trials Network (HPTN) Annual Meeting Monday received an update on a study looking to ease the pill burden on those wishing to benefit from pre-exposure prophylaxis (PrEP).
Inspired by studies of non-human primates over the past seven years at the Centers for Disease Control and Prevention, the HPTN 067 "ADAPT" study (Alternate Dosing to Augment PrEP Tablet-taking) is a behavioral study looking at how adherence can be improved by lowering the frequency and potency of each dose, while achieving "comparable" efficacy in preventing HIV infection.
The primate studies, "…Encourage us that daily doses might not be necessary, and easier dosing that is better adaptable to people may be possible," said Bob Grant, MD, of the Gladstone Institute of Virology and Immunology in San Francisco, who presented on the study. The idea of adapting PrEP regimens to the patients' needs was well-received by the audience, and Grant said it was a key concept to improving adherence, "especially in terms of people whose lives are not defined by a disease they don't have."
30 years into the epidemic
• The Economist: Thirty years of a disease
The end of AIDS?
Thirty years on, it looks as though the plague can now be beaten, if the world has the will to do so
• The Lancet: Towards an improved investment approach for an effective response to HIV/AIDS
Substantial changes are needed to achieve a more targeted and strategic approach to investment in the response to the HIV/AIDS epidemic that will yield long-term dividends.
• Unites Nations: High Level Meeting on AIDS 2011
Thirty years into the AIDS epidemic, and 10 years since the landmark UN General Assembly Special Session on HIV/AIDS, the world will come together to review progress and chart the future course of the global AIDS response at the 2011 UN General Assembly High-Level Meeting on AIDS from 8–10 June 2011 in New York.
• UNAIDS: AIDS at 30: Nations at the crossroads
This report provides evidence of how much we have achieved and weighs that against our vision for the future.
Statement from the iPrEx Pre-Exposure Prophylaxis Study on Results of the HPTN 052 HIV Prevention Study
The following statement was issued today by iPrEx Protocol Chair Robert Grant, MD, MPH of the Gladstone Institutes and the University of California at San Francisco:
“iPrEx congratulates the participants and researchers involved in HPTN 052. This important study proves that providing early antiretroviral treatment significantly improves health among people living with HIV and dramatically reduces new HIV infections in their partners.
HPTN 052 adds another piece of compelling evidence that the HIV epidemic can be slowed and one day stopped. In less than two years, we have seen significant new discoveries supporting the use of treatment as prevention, including early treatment of HIV infected persons, oral pre-exposure prophylaxis (PrEP) for uninfected men who have sex with men (MSM), and topical pre-exposure prophylaxis for uninfected heterosexual women. In the previous few years, we learned that heterosexual men can be durably protected by male circumcision, and injection drug users are protected by clean needles. Mother to infant transmission has nearly vanished in places where antiretroviral therapy is available for pregnant women. An HIV vaccine candidate showed promising preliminary results. The risk behavior of participants in these studies became consistently safer overtime, signaling the compatibility of each of these prevention approaches with behavioral risk reduction strategies.
Never before have so many effective HIV prevention tools and strategies been available. The challenge before funders and policy makers now is to increase investments to make new HIV treatment and prevention tools available to everyone who needs them, along with standard prevention methods such as male and female condoms, HIV testing and counseling, STD treatment and support for behavioral prevention approaches.
Investments to date in HIV prevention research have brought tremendous results. HIV can be slowed and one day stopped if we use this new information. The funds required to fight and win the war on HIV are substantial, although in line with other investments made to assure public safety and relieve widespread human suffering. Increasing investment in HIV prevention will save millions of lives, increase productivity and savings and build stronger and safer communities. Now is the time to invest in a future without AIDS.”
iPrEx Statement on the Discontinuation of the FEM-PrEP HIV Prevention Study
The Independent Data Monitoring Committee (IDMC) overseeing the FEM-PrEP study of oral pre-exposure prophylaxis (PrEP) (http://www.fhi.org) has recommended that the study be
stopped because it will not be able to answer the question of whether the HIV antiretroviral drug Truvada can decrease HIV infection risk in heterosexual women.
In November 2010, results from the Global iPrEx study (http://www.iprexnews.com) showed robust and highly statistically significant evidence that daily use of the same medication does reduce HIV infection risk among men who have sex with men (MSM). PrEP with Truvada in the iPrEx study reduced HIV infection risk among all MSM by an average of 44%. HIV infection rates were 90% lower among those who used Truvada consistently enough to have detectable drug in the body.
In addition, the effectiveness of a vaginal topical formulation of one of the component drugs of Truvada, tenofovir, was also demonstrated in a study of heterosexual women in Africa,
CAPRISA 004, which announced results in July 2010. The topical formulation of tenofovir is known to achieve high levels of drug in the vagina when used consistently by women.
The evidence that oral PrEP with Truvada significantly reduces HIV infection risk in MSM is clear. More study, including analysis of drug levels and adherence among study participants, is
needed to understand the results of FEM-PrEP. Whether the difference in results between studies is attributable to differences in the biological activity of the drug in men and women, its
effectiveness at reducing infection risk based on different routes of HIV exposure or other factors such as pill use are yet to be determined. These questions will be a central focus of inquiry for the HIV prevention research community moving forward, and the answers will help us understand the best and most appropriate uses for oral PrEP as HIV prevention. The VOICE
and Partners PrEP trials being conducted in African women and men are also expected to provide important additional information on the safety and efficacy of PrEP in heterosexual
Worldwide, 2.6 million people were infected with HIV last year alone. MSM are 19.3 times more likely to become infected with HIV than non-MSM, pointing out the need for effective new
strategies to reduce HIV infection risk among MSM.
A multi-country open label extension of the iPrEx study called iPrEx OLE is beginning in MSM the coming months in the United States, Peru, Ecuador, Brazil, Thailand and South Africa. All participants in iPrEx OLE will be able to receive Truvada in tablet form, in addition to other proven HIV prevention tools such as condoms, treatment for sexually transmitted infections and HIV testing and counseling. In addition to gathering more safety data on PrEP, iPrEx OLE will focus on strategies to help participants take PrEP consistently.
HIV is transmitted differently in different populations and settings, and effective HIV prevention will never be a "one size fits all" model. FEM-PrEP demonstrates the importance of studying promising HIV prevention interventions in different populations. The study will add valuable information that will help determine the best use of PrEP as an important new tool to slow the global HIV epidemic. We commend everyone involved in the FEM-PrEP study – most importantly the women who participated – on their work to advance HIV prevention research,
and look forward to working closely with them to better understand the results of this study.
iPrEx presented new data at the Conference on Retroviruses and Opportunistics Infections 2011
Over 4,000 leading researchers and clinicians from around the world will convene in Boston, Massachusetts from February 27 through March 2, 2011 for the 18th Conference on Retroviruses and Opportunistic Infections (CROI). CROI is a scientifically focused meeting of the world’s leading researchers working to understand, prevent, and treat HIV/AIDS and its complications. The goal of CROI is to provide a forum for translating laboratory and clinical research into progress against the AIDS epidemic.
iPrEx abstracts presented at the 18th CROI
Following are the abstracts of new iPrEx study data presented at the 18th Conference on Retroviruses and Opportunistic Infections. A webcast of the study presentations will be available at the conference website (http://www.retroconference.org) beginning at approximately 8 p.m. EST on Tuesday, March 1, 2010.
92. Pre-exposure Chemoprophylaxis for Prevention of HIV among Trans-women and MSM: iPREx Study
Robert Grant*1, J Lama2, D Glidden3, and iPrEx Study Team
1Gladstone Inst of Virology and Immunology, San Francisco, CA, US; 2Investigaciones Medicas en Salud, Lima, Peru; and 3Univ of California, San Francisco, US
94LB. Effects of FTC/TDF on Bone Mineral Density in Seronegative Men from 4 Continents: DEXA Results of the Global iPrEx Study
Kathleen Mulligan*1, D Glidden1, PGonzales2, M-E Ramirez-Cardich3, A Liu1,4, S Namwongprom5, PChodacki6, L Mendonc¸a7,VMcMahan8, R Grant1,8, and iPrEx Study Team
1Univ of California, San Francisco, US; 2Investigaciones Medicas en Salud, Lima, Peru; 3Assn Civil Impacta Salud y Ed, Lima, Peru; 4San Francisco Dept of Publ Hlth, CA, US; 5Chiang Mai Univ, Thailand; 6Desmond Tutu HIV Fndn, Cape Town, South Africa; 7Federal Univ of Rio de Janeiro, Brazil; and 8Gladstone Inst of Virology and Immunology, San Francisco, CA, US
95LB. Adherence Indicators and PrEP Drug Levels in the iPrEx Study
Rivet Amico*1, A Liu2, VMcMahan3, PAnderson4, J Lama5, J Guanira5, J-H Zheng4, D Glidden6, and R Grant3
1Univ of Connecticut, Storrs, US; 2San Francisco Dept of Publ Hlth, CA, US; 3Gladstone Inst of Virology and Immunology, San Francisco, CA, US; 4Univ of Colorado Denver, Aurora, US; 5Investigaciones Medicas en Salud, Lima, Peru; and 6Univ of California, San Francisco, US
96LB. Interpreting Detection Rates of Intracellular FTC-TP and TFV-DP: The iPrEx Trial
Peter Anderson*1, J Lama2, S Buchbinder3, J Guanira4, O Montoya5, M Casapia6, L Bragg7, L Bushman1, D Glidden8, R Grant7,8, and iPrEx Study Team
1Univ of Colorado Denver, Aurora, US; 2Investigaciones Medicas en Salud, Lima, Peru; 3San Francisco Dept of Publ Hlth, CA, US; 4Assn Civil Impacta Salud y Ed, Lima, Peru; 5Fndn Ecuatoriana Equidad, Guayaquil-Guayas, Ecuador; 6Assn Civil Selva Amazonica, Iquitos, Maynas, Peru; 7Gladstone Inst of Virology and Immunology, San Francisco, CA, US; and 8Univ of California, San Francisco, US
97LB. Drug Resistance and Minor Drug Resistant Variants in iPrEx
Teri Liegler*1, M Abdel-Mohsen1, R Atchison2, M Mehotra2, T Schmidt1, C Eden2, D Glidden1, S Buchbinder1,3, J Lama4, R Grant1,2, and iPrEx Study Team
1Univ of California, San Francisco, US; 2Gladstone Inst of Virology and Immunology, San Francisco, CA, US; 3San Francisco Dept of Publ Hlth, CA, US; and 4Investigaciones Medicas en Salud, Lima, Peru
1002. Oral TDF and Its Impact in HSV-2 Acquisition and Clinical Expression
Javier Lama*1, K Mayer2, M Schechter3, E Kallas4, L-G Bekker5, S Chariyalertsak6, S Shiboski7, R Grant7,8, and iPrEx Study Team
1Investigaciones Medicas en Salud and Assn Civil Impacta Salud y Ed, Lima, Peru; 2Fenway Hlth, Boston, MA, US; 3Federal Univ of Rio de Janeiro, Brazil; 4Univ of Sao Paulo Sch of Med, Brazil; 5Desmond Tutu HIV Ctr, Univ of Cape Town, South Africa; 6Res Inst for Hlth Sci, Chiang Mai Univ, Thailand; 7Univ of California, San Francisco, US; and 8Gladstone Inst of Virology and Immunology, San Francisco, CA, US
Interim Guidance: Pre-exposure prophylaxis (PrEP) for the prevention of HIV infection in men who have sex with men
CDC issues interim guidance to health care providers on the use of PrEP as an HIV prevention strategy among men who have sex with men (MSM). In November 2010, the National Institutes of Health announced trial results providing the first evidence that daily oral use of an antiretroviral drug (TDF/FTC, brand name Truvada) used to treat HIV can also help to prevent sexually-acquired HIV among MSM when delivered as a part of comprehensive HIV prevention services. To help ensure safe and effective use of PrEP, CDC is currently leading national efforts to develop formal U.S. Public Health Service guidelines on its use among MSM. Until those more detailed guidelines are available, CDC is providing interim guidance to help inform clinical practice. CDC underscores the importance of targeting PrEP to MSM at high-risk for HIV acquisition and delivering it as a part of comprehensive HIV prevention services, which should include risk-reduction and medication adherence counseling, condoms, and testing and treatment for other sexually-transmitted infections. The guidance stresses the need to ensure any MSM who may be prescribed PrEP are confirmed to be HIV negative prior to use, as well as the need for regular monitoring of HIV status, side effects, adherence, and risk behavior among those taking PrEP. The guidelines only apply to MSM, as no data are available on its effectiveness among other populations.