— The federal warning that “Tenofovir . . . alone or in combination . . . may cause serious damage to the liver and . . . lactic acidosis”
— The manufacturer’s warning that “Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with . . . nucleoside analogs, including tenofovir”
— “increasing exposure to tenofovir was associated with a higher incidence of CKD [chronic kidney disease] . . . . and there are numerous studies . . . demonstrating that tenofovir is associated with impaired kidney function”.
“• Potential for renal impairment, including rare reports of Fanconi syndrome and acute renal insufficiency
• Potential for decrease in bone mineral density”
(as well as failure to suppress viral load when combined with nevirapine [!])
A couple of years ago I discussed the failure of TDF in a PrEP trial: “Pre-exposure prophylaxis: A flawed clinical trial that no one should take seriously”. The media descriptions of the evidence on which the FDA and its Advisory Panel approved Truvada for PrEP suggest that this evidence is again anything but trustworthy:
“The committee voted 19-3 in favor of approval for the prevention indication — PrEP for HIV-uninfected men who have sex with men and 19-2 with one abstention for HIV-uninfected partners in couples where the other partner is infected. The committee recommended by 12-8 with two abstentions in favor of approving the drug for individuals who engage in risky sexual behavior that could result in their contracting the virus” (Panel recommends approving Truvada to prevent HIV infection, Sandra Young, CNN, 10 May). Those votes mean that the panel judged it a greater risk when HIV-negative men have sex with men, or when the uninfected partner in a couple where the other is infected, than when “individuals . . . engage in risky sexual behavior that could result in their contracting the virus”? What possible basis could there be for such a comparative judgment?
“Committee members also heard concerns about the drug’s side effects, which can include nausea, vomiting, dizziness, loss of appetite and diarrhea, liver and kidney toxicity and loss of bone density”. Those committee members will not be able in the future to deny that they were voting to cause iatrogenic harm to healthy individuals who had other options for protecting themselves.
As history lauds in retrospect the FDA officer who held off from approving thalidomide, so in future we may look back approvingly on the attempt to block Truvada PrEP by one member of the committee:
“Dr. Lauren Wood of the National Cancer Institute said she voted against all preventive applications because clinical studies did not measure the dangers of drug-related renal problems among black people, who are among the hardest impacted by HIV infection and the most susceptible to kidney problems linked to AIDS drugs”.
“”Existing interventions have not reduced the number of new infections annually” (FDA panel backs Gilead’s Truvada to prevent HIV).
“Truvada first made headlines in 2010, when government researchers showed it could prevent people from contracting HIV. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 42 percent, when accompanied by condoms and counseling” (Truvada for HIV prevention backed by advisory panel, FDA may decide by June). That’s the study I debunked in “Pre-exposure prophylaxis: A flawed clinical trial that no one should take seriously
“[I]t would add to the armamentarium of proven prevention modalities.
Prevention for HIV is really a comprehensive, multifaceted group of prevention modalities that’s kind of a tool kit. This one can be potentially very effective. So if it’s approved and added to the recognized prevention modalities, it would be an important advance in making available for certain people a very effective way to prevent HIV infection.”