Our team is conducting one of the largest studies to date in Europe, and the first ever in the UK, looking at how the menopause affects the health and wellbeing of women living with HIV.
02 December 2016 | National Institute for Health Research
Has President-elect Donald Trump put a bull’s-eye on the Food and Drug Administration? The agency is facing post-election upheaval. Public health advocates are bracing for a seismic shift: a surrender of the agency’s rules for off-label promotion of drugs; the importation of more drugs from other countries; and fewer requirements for clinical trials.
22 November 2016 | STAT
Fact sheet explaining the background to the DISCOVER trial
17 November 2016 | AIDS Foundation of Chicago
A group of U.S., Canadian, and European community advocates and HIV NGO workers have written a letter exrpesing "deep dismay" that Gilead Sciences have proceeded with the DISCOVER trial PrEP"without engaging stakeholders in a substantial or meaningful way.". DISCOVER will compared Gilead's new comination pill, Descovy against Truvada as PrEP. In 2007, the HIV/AIDS field adopted Good Participatory Practice (GPP), a formal set of guidelines approved by UNAIDS for stakeholder engagement in HIV prevention clinical trials.
"It is astonishing," says the letter, "that Gilead has failed to follow GPP guidelines in the design and implementation of DISCOVER, since GPP was developed partly as a response to the failure of previous prevention trials involving tenofovir."
17 November 2016 | HIV Prevention Justice Alliance
Gilead is not following the accepted standard for community engagement in its new pre-exposure prophylaxis (PrEP) trial, and we are among a coalition of HIV activists and organizations from Europe and North America calling them out on their bad corporate behavior. We root our criticism in the Good Participatory Practice (GPP) guidelines that were inspired, in part, by controversies in earlier PrEP trials.
17 November 2016 | The Body
Gilead Sciences released this statement after considerable interest and concerns abut the forthcoming study of their new tenofovir formulation, TAF, for use in PrEP. The TAF/FTC pill is called Descovy(R). "Gilead Sciences is sponsoring a clinical trial, known as the DISCOVER study, to test whether a combination of emtricitabine and tenofovir alafenamide (F/TAF) is as safe and effective as Truvada® (emtricitabine and tenofovir disoproxil fumarate, F/TDF) at reducing the risk of HIV infection when used as pre-exposure prophylaxis (PrEP). F/TAF was recently approved for HIV treatment, but it is not yet known whether it is effective as PrEP...."
16 November 2016 | Gilead Sciences
I recall when a colleague told me in 2014 that some transgender women advocates were unhappy with iPrEx. I was surprised and disappointed.
08 September 2016 | Robert Grant (blog)
In pointed remarks, Germany’s cost-effectiveness watchdog has criticised an effort by European regulators to accelerate approval for new medicines by limiting its requirements for evidence. The concerns raised by the agency come as regulators on both side of the Atlantic increasingly look to such approaches to get new drugs to patients with unmet medical needs. At issue is a proposal called adaptive pathways, a term used to describe a method for jumpstarting drug approvals for select patient populations. Two years ago,an EMA pilot programme was launched to compare initial data used for approval with so-called “real world” data, which is subsequently gathered after the medicines are in use.
18 August 2016 | STAT
Exclusive: The NHS is stopping participants in a major study into the drug Truvada from having further access to it – a move which Britain’s biggest HIV charity said would lead some to become infected.
29 July 2016 | Buzzfeed
EMA has proposed changes to its guideline on clinical trials of direct acting antiviral hepatitis C drugs. The revisions are intended to ensure the guideline reflects the dramatic changes that have happened in the hepatitis C sector since Gilead introduced its blockbuster Sovaldi (sofosbuvir).
17 July 2016 | Regulatory Affairs Professionals Society