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Author Topic: Doubt cast on link between (TDF) tenofovir disoproxil and bone fractures  (Read 414 times)

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Online JimDublin

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Have not had the chance to fully read this, will do later but this study found taking multiple factors into account no robust association between the risk of fracture and exposure to TDF and PIs

Quote

aidsmap:

TDF is a component of Truvada and Atripla and their generic equivalents, as well as Eviplera and Stribild. TAF is a component of Odefsey, Genvoya, Symtuza, Descovy and Biktarvy.

Protease inhibitor (PI) therapy has also been associated with an increased risk of fracture but the authors were unable to establish a robust link between any antiretroviral, protease inhibitors included, and elevated fracture rates.

“We found no evidence of an excess risk of fracture after exposure to TDF and PIs,” comment the authors. “This has important implications for the debate concerning tenofovir alafenamide versus generic TDF.”

People with HIV have lower bone mineral density (BMD) and an increased risk of fractures compared to age- and sex-matched HIV-negative controls. BMD drops after starting antiretroviral therapy (ART), especially with TDF-containing regimens and treatment based on a PI.

Ten studies have examined the links between specific antiretroviral drugs and the risk of fracture. Their methodology differed considerably, including the definition of fracture. Moreover, few of the studies took into account the full range of traditional risk factors for low BMD and fractures.

Investigators used data from the French Hospital Database on HIV to design a study in order to more thoroughly examine the potential link between individual antiretroviral drugs and fracture risk.

Their study population consisted of 254 people who experienced a low-impact fracture between 2000 and 2010 who were enrolled in the database before starting antiretroviral treatment. These patients were matched with 376 age- and sex-matched HIV-positive fracture-free controls who were likewise recruited while antiretroviral naïve.

The association between ART exposure and individual drugs was studied using various models that took into account any exposure and cumulative use.

The investigators considered a range of potential confounders. The following traditional risk factors were explored: region of geographical origin, body mass index (BMI), smoking, alcohol consumption, use of systemic glucocorticoids, and menopausal status for women. Numerous HIV-related factors were also included in the investigators’ modelling, including year of HIV diagnosis, HIV transmission group, year of ART initiation, AIDS status, nadir and current CD4 cell count, viral load and hepatitis C virus antibody status. Information was also gathered on kidney function, a possible pathway for the posited link between TDF therapy and increased fracture risk.

Median age was 49 years and 67% of patients were men. Almost three-quarters of the cases were diagnosed with HIV before 1997.  Median and nadir CD4 cell counts for the cases were 436 cell/mm3 and 172 cells/mm3, respectively. Two-thirds of cases had an undetectable viral load.

All fractures were low impact and at sites potentially associated with osteoporosis. Over-three quarters of cases (79%) experienced only one fracture, 14% had two fractures, 4% had three fractures and 2% had four fractures. The most common fracture sites were the vertebrae, hip and wrist.

At the time of fracture diagnosis, 49% of cases had ever been treated with  TDF and 82% with a PI. The median duration of exposure was 2.5 years for TDF and 4.3 years for PIs.

In both the univariate nor multivariate models, and regardless of how ART use was defined, no association was found between TDF use and risk of fracture. After adjustment for confounders, there was no association in the “ever-exposed” model (OR = 1.21; 95% CI, 0.61-2.39) or the cumulative exposure model (OR = 1.04; 95% CI, 0.86-1.27).

Therapy with the protease inhibitor atazanavir was associated with increased fracture risk in some models, but this finding was far from robust and ceased to be significant in a sensitivity analysis that took into account other risk factors. Nor did the investigators find any evidence of an interaction between TDF and atazanavir to increase fracture risk
.

In full:
https://www.aidsmap.com/Doubt-cast-on-link-between-tenofovir-disoproxil-and-bone-fractures/page/3398708/
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Online JimDublin

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Re: Doubt cast on link between (TDF) tenofovir disoproxil and bone fractures
« Reply #1 on: December 13, 2018, 01:37:32 pm »
poz.com write-up:

13-Dec 2018
https://www.poz.com/article/older-tenofovir-may-tied-fracture-risk

Quote
Older Tenofovir May Not Be Tied to Fracture Risk After All

Gilead has based its entire HIV drug portfolio on updating tenofovir, ostensibly to make it safer for bones and kidneys.

Here is the earlier POZ feature article (May 2018) that questions the benefit of TAF over TDF. Is Gilead’s Entire HIV Enterprise Built on a False Promise?

https://www.poz.com/article/gileads-entire-hiv-enterprise-built-false-promise
HIV 101 - Everything you need to know
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Transmission and Risks:
HIV Transmission and Risks
Read more about Testing here:
HIV Testing
Read about Treatment-as-Prevention (TasP) here:
HIV TasP
You can read about HIV prevention here:
HIV prevention
Read about PEP and PrEP here
PEP and PrEP

Offline geobee

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Re: Doubt cast on link between (TDF) tenofovir disoproxil and bone fractures
« Reply #2 on: December 13, 2018, 08:06:14 pm »
"These investigators found that TAF was indeed associated with improved kidney and bone toxicities in trials that compared TAF and TDF. But such benefits were largely seen only when the drugs were used with so-called boosting agents, including Norvir (ritonavir) and Tybost (cobicistat), "

Doesn't everyone take tenofovir with a booster?  So there actually is a real benefit?

 


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