The Department of Justice has launched a review of a government patent for use of a drug that prevents HIV infection, according to a retired Centers for Disease Control scientist who was among scientists who spoke with a department lawyer last week.
Thomas Folks said a Justice Department lawyer visited the CDC in Atlanta on April 16 to question government scientists who pioneered the use of the drug Truvada for prevention.
Reporting chronic kidney diseases and major bone fractures, more than 50 patients treated with human immunodeficiency virus antiretroviral drugs filed a lawsuit against the Foster City-based Gilead Sciences this month with claims the biopharmaceutical company put profits before patient safety in the marketing and availability of drugs expected to stem the spread of a life-threatening disease.
As consumers of the prescription drugs Viread, Truvada, Atripla, Complera and Stribild, the more than 50 individuals listed as plaintiffs in the suit were exposed to significant safety risks to patients’ bones and kidneys that studies have shown accompany treatment with drugs containing tenofovir disoproxil fumarate, or TDF, according to the suit filed April 10 in San Mateo County Superior Court.
The On-Demand Approach to PrEP, the HIV-Preventing Drug Regimen, Is Becoming More Popular. But Is It Safe?
An Australian man recently made headlines as the seventh reported case, worldwide, of a failure of PrEP (Pre-Exposure Prophylaxis), the groundbreaking drug regimen shown to be 99 percent effective at preventing HIV infection with daily adherence. While understandably disconcerting for users, PrEP failures are major news because they are so rare—and Truvada (tenofovir disoproxil fumarate/emtricitabine), the drug used for PrEP, is unquestionably one of the best tools we have for stopping the spread of HIV.
One notable detail of this case is that the individual, Steve Spencer (who is already undetectable and noninfectious with treatment and still an advocate for PrEP), was following what is known as an “on-demand” version of the regimen. This prescribed schedule is also known as event-driven PrEP, or PrEP 2-1-1. Essentially, when someone knows they are going to have condomless anal sex, they take a double dosage of PrEP between 2–24 hours before the encounter, and then a single pill each over the following two days. Official guidelines in Europe and Australia allow the on-demand approach, while the U.S. Food and Drug Administration has not yet approved it. Even so, some American doctors and health centers are already recommending the regimen to gay and bisexual men. While we don’t know the specific circumstances that precipitated Spencer’s seroconversion, it’s fair to ask: Is on-demand PrEP safe? And if so, who should consider using it?
Pharmaceutical giant Gilead Sciences is being sued for “intentionally withholding” a safer HIV treatment drug, reported PinkNews.
The company has Tenofovir Disoproxil Fumarate (TDF), an antiretroviral drug sold as part of the routine medications taken by people affected by HIV, patented. However, the lawsuit, filed in the U.S. Supreme Court on Saturday (November 17), claims the company is withholding a safer version of TDF – with fewer side-effects– with the goal of exploiting patent laws.
Lawyers for the AIDS Healthcare Foundation (AHF) filed personal injury and class action suits against Gilead on Tuesday, alleging the company stalled the development of a safer alternative to their highly-profitable HIV drug tenofovir disoproxil fumarate (TDF) for nearly two decades.
The personal injury action was filed on behalf of two Southern California men, both living with HIV, who claim they suffered bone and kidney damage from taking TDF at the doses prescribed. Behind the class action suit are two different Southern California men, who are also living with HIV and claim similar side effects from TDF.
Two Southern California men filed suit against Gilead Sciences on Tuesday, saying they were harmed when the drug company intentionally delayed development of a safer version of a crucial HIV medicine so that it could continue to profit from its lucrative monopoly.
The lawsuit — and a similar case that seeks class-action status — says that Gilead executives knew as early as 2000 that the company's scientists had developed a less toxic form of its HIV medicine tenofovir that was less harmful to patients' kidneys and bones.
Gilead Sciences is no stranger to furious patients and advocates, many of whom have said over the years that the company puts shareholder interests over their own. Now, two patients allege that the drugmaker shelved better HIV treatments in favor of monopoly sales and at the detriment of their health.
Gilead's Viread, or tenofovir disoproxil fumarate (TDF), won FDA approval in 2001. The plaintiffs, California residents Michael Lujano and Jonathan Gary, allege that the company knew the compound carried serious health risks, but hid that info and secretly advanced research on better drugs.