In response to the recent news article: FDA GIVES PRIORITY REVIEW OF TRUVADA AS PREP
AHF Challenges FDA Move to Fast Track Gileads HIV Prevention Drug
Decision to grant expedited review of drug application comes just days after release of study showing the drug, Truvada, is associated with significant risk of kidney damage and disease that increases over time.
AIDS Healthcare Foundation (AHF), the nation’s largest HIV/AIDS nonprofit medical provider, today expressed its disappointment and dismay at the Food and Drug Administration’s (FDA) decision to grant an expedited review for Gilead Sciences’ application for expanded use of its blockbuster AIDS drug, Truvada, as a means of preventing HIV infection in non-infected people. AHF has long voiced concerns that such a use would actually increase HIV infections, and the announcement comes just days after researchers reported that a component of Truvada (which is a combination containing two Gilead drugs—tenofovir DF + emtricitabine—in one tablet), is linked to a significant risk of kidney disease and damage. Most alarmingly, the risk remains even after people stop taking the drug.
Click HERE to read the full article on aidshealth.org
As seen on NSWP.org:
The World Health Organization (WHO) is developing guidelines for evidence-based interventions for the prevention and treatment of HIV and other sexually transmitted infections (STIs) in low- and middle-income countries.
The Global Network of Sex Work Projects (NSWP) oversaw a civil society consultation of sex workers commissioned by the WHO to gather feedback on the proposed guidelines and produced this report, entitled: ‘Female, Male and Transgender Sex Workers’ Perspectives on HIV & STI Prevention and Treatment Services: a global sex worker consultation.’
This report summarises the findings from that consultation as follows:
- Sex workers identified the following barriers to accessing HIV and STI related services: criminalisation, penalisation and repression of sex work, same-sex activity and gender expression; mandatory testing; discrimination and mistreatment within the health sector; exclusion of male and transgender sex workers; inappropriate and inadequate services; and funds diverted to programmes that have no evidence-base.
- Sex workers identified the following necessary steps to improve access to HIV and STI prevention and treatment: decriminalisation, depenalisation and non-repressive policy; HIV interventions in line with human rights standards; collective empowerment; recognition of sex work as work; comprehensive programmes; and sex worker-led strategies.
- Sex workers unanimously supported: condom promotion for sex workers; periodic voluntary
screening for STIs; voluntary counselling and testing; and ARV treatment according to guidelines that apply to the general adult population. - Sex worker strongly supported: condom promotion for clients.
- Sex workers strongly rejected: mandatory testing, periodic presumptive treatment for STIs (PPT) and provider-Initiated testing.
You can read or download this 22 page PDF report: 
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Thank you AIDSmeds for this interesting article!
New mathematical modeling conducted by the U.S. Centers for Disease Control and Prevention and Johns Hopkins researchers underscores how important it is to get all people unknowingly living with HIV in the United States tested and into care. According to a brief report published online ahead of print by the journal AIDS, roughly half of new HIV infections originate with the 20 percent of people living with the virus and are unaware of their infection.
Click here to read the full article.
S.Africa, Swiss firm Lonza in $211 mln drug JV
South Africa will establish its first pharmaceutical plant to manufacture the main chemicals used in HIV drugs in an effort to lower the prices of antiretroviral (ARV) drugs, Reuters reports. The $211 million joint venture with Swiss chemical and biotechnology company Lonza Group will enable the country to produce Active Pharmaceutical Ingredients (API), components that account for about 75 percent of the finished drug dosage. The plant is a step toward producing ARVs in the country by 2016 to support the nearly 5.7 million people with HIV in South Africa.
As seen on POZ.com. To read the Reuters article, click here.
U.S. FDA Grants Priority Review for Truvada® for Reducing the Risk of Acquiring HIV Infection
The U.S. Food and Drug Administration (FDA) has accepted Gilead Sciences’ application to give priority review of Truvada (emtricitabine and tenofovir) as pre-exposure prophylaxis (PrEP), according to a Gilead statement. This PrEP is when an HIV-negative person takes a daily dose of Truvada as a means to lower the chance of contracting the virus during sex. The FDA grants fast-track appraisal to drug applicants that demonstrate major advances in treatment or provide a treatment where no adequate or current therapy exists. Approval of the supplemental New Drug Application (sNDA) will be discussed at the FDA Antiviral Drugs Advisory Committee in May. The target review date is June 15.
To read the Gilead statement, click here.
HIV Experts Propose New Pathway for Conducting Phase 3 Drug Trials
New Approach Intended to Remove Barriers to Innovation in Drug Development
WASHINGTON, DC (February 7, 2012) – As the war on HIV/AIDS begins its fourth decade, medical researchers, pharmaceutical manufacturers, patient advocates and government regulators face a new and unexpected scientific challenge: how to demonstrate the safety and efficacy of promising new antiretroviral drugs when the two traditional study designs – the superiority trial and the non-inferiority trial – are no longer useful in showing improvements in both “treatment experienced” patients and those who have never received drug therapy (treatment-naïve patients).
CLICK HERE FOR COMPLETE ARTICLE
Now that three studies have shown that circumcising adult heterosexual men is one of the most effective “vaccines” against AIDS— reducing the chances of infection by 60 percent or more — public health experts are struggling to find ways to make the process faster, cheaper and safer.
A closer look at what was done to cure two patients of chronic lymphocytic leukemia with a novel gene therapy (using a form of the HIV virus) — which may be useful against other cancers.
Hi, all- A film crew will be in Los Angeles in February to film a handful of folks talking about their personal connection to accidental drug overdose & why they believe California could & should be doing more (Narcan, Good Sam 911, more education about OD to young people, etc.) Each mini-film will be about 2 minutes long & will be used on a website being created to serve as part of a public awareness campaign. If you know someone who would really want to be involved with this, please let me know so I can get in touch with them. If you have any questions, please just ask me! Thanks!
Meghan Ralston | Harm Reduction CoordinatorDrug Policy Alliance3470 Wilshire Blvd. Suite 618 | Los Angeles, CA 90010 Cell: 323.681.5224 www.drugpolicy.org
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