Truvada

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    Truvada Criteria

    • Took any of the following medications for the treatment and/or prevention of HIV & hepatitis
      • Viread
      • Truvada
      • Truvada for PrEP
      • Atripla
      • Stribild
      • Complera
      • AccessPak w/ Kaletra
      • AccessPak w/ Viracept
      • Cimduo
    • Suffered any of the following injuries after consistent usage
      • Kidney complications, side effects or diagnosed injuries
      • Bone-related complications, side effects or diagnosed injuries
    • None of the injuries suffered were preexisting conditions
    • No legal representation

    Gilead Background Information

    Issues

    Viread et al. are prodrugs (taken orally) used to treat and manage HIV and Hepatitis “C”. Viread is a billion-dollar blockbuster drug that is the backbone of the HAART treatment strategy. for HIV patients. Gilead developed two separate delivery systems, TDF and TAF, the former delivered the drug in a much higher dosage (even though Gliead had already developed the TAF delivery system, which delivered the drugs in much smaller dosage), which has resulted in a myriad of kidney issues including CKD, end stage renal disease, and fatal renal insufficiency as well as loss of bone density issues including Falconi Syndrome, Osteoporosis with pathological fracture and bone necrosis among others.

    California Ruling

    2/13/1019 – In the Superior Court of California, Judge Carolyn B Kuhl ruled that Plaintiffs’ allegations had merit and Gilead may be accountable for kidney and bone injuries that occurred in patients who were using their antiretroviral medications. Gilead will have to defend itself against Plaintiffs claiming that they failed to warn patients of the damaging side effects of TDF and actively misrepresenting TDF’s efficacy/risks, all the while knowing the safer alternative existed: tenofovir alafenamide (TAF).

    FDA Warnings

    5/1/2001 – During the Clinical Pharmacology and Biopharmaceutics Review for the NDA application, FDA notes that Gilead Science “did not evaluate Tenovir DF in individuals with renal insufficiency” and “did not determine specific active secretion pathways” for the drug. DFA recommended human studies and made clear that Gilead must properly examine and disclose side effects TDF would have on kidneys and whether it would build up toxic levels in the body. FDA sent warning letters in 2002 and 2003 regarding Gilead’s marketing practices.

    Manufacturer

    Gilead Sciences

    Antiretroviral TDF (tenofovir disoproxil fumarate) Delivery Drugs

    Viread, Truvada, Atripla, Complera, Striblid

    TDF (tenofovir disoproxil fumarate) dosage = 300mg TAF (tenofovir alafenamide) dosage = 25mg
    Viread (tdf)
    October 2001
    Vemlidy (taf)
    November
    Truvada (tdf + emtricitabine)
    August 2004
    Descovy (taf + emtricitabine)
    April 2016
    Truvada PrEp (tdf + emtricitabine)
    July 2012
    Descovy (taf + emtricitabine)
    September 2019 for PrEP
    Complera (tdf + emtricitabine, rilpivirine)
    August 2011
    Odefsey (taf + emtricitabine, rilpivirine)
    March 2016
    Stribild (tdf + emtricitabine, elvitegravir, cobicistat)
    August 2012
    Genvoya (taf + emtricitabine, elvitegravir, cobicistat)
    November 2015
    Atripla (tdf + emtricitabine, efavirenz)
    July 2006
    Biktarvy (taf + Bictegravir, emtricitabine) **Not identical
    February 2018

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