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Viread associated with increased fracture risk in patients with HIV
Viread, in contrast with other antiretroviral medications, was associated with an increased risk for bone fractures in people with HIV in a recent study.
Patients who had used or were currently using Viread (tenofovir disoproxil fumarate, Gilead Sciences; TDF) had significantly more fractures. An association with cumulative use of the drug, however, was insignificant in the study, which was published in Clinical Infectious Diseases.
“Our study supports cautious use of TDF among HIV–positive persons at fracture risk initiating ART as recommended by current guidelines and expert panels,” study researchers wrote. They added that other factors increase the risk for fractures and osteonecrosis, or bone tissue death.
“Host factors, HIV–specific variables and comorbidities contribute to the risk of these bone events,” they explained.
The study involved 11,820 patients with HIV. They were among the more than 20,000 enrolled in the EuroSIDA study — a long-term follow-up of such patients undergoing care in 35 European countries, Israel and Argentina.
Of those involved in the study, 496 patients suffered 619 fractures. Seventy-three patients developed 89 cases of osteonecrosis of the femoral head, which is the top portion of the femur.
The researchers compared the incidence of bone events for patients on TDF with that of patients using any of five other antiretrovirals — Videx (didanosine, Bristol-Myers Squibb), Crixivan (indinavir, Merck), Invirase (saquinavir, Hoffmann La Roche), Norvir (ritonavir, AbbVie) and Kaletra (lopinavir/ritonavir, AbbVie).
Patients who had ever used TDF (adjusted incidence rate ratio [aIRR] = 1.4/1,000 person years of follow-up [PYFU]), along with those who were using it at the time of the study (aIRR = 1.25/1,000 PYFU), “had a significantly increased incidence of fractures,” the researchers reported.
There was no difference in the risk for fractures in those using TDF without a boosted protease inhibitor or those using a boosted protease inhibitor without TDF compared with those using both.
Meanwhile, TDF and the other five antiretrovirals included in the study — for those patients who had ever used them — were all associated with a nonsignificant increased risk for osteonecrosis of the femoral head.
Because TDF, indinavir and saquinavir are not often used anymore, researchers did not have enough data on the risk of current use for fractures.
The researchers found no association between cumulative exposure to any of the drugs and osteonecrosis.
The study also included associations between fracture risk and factors like age, race, IV drug use, HCV coinfection and others. – by Joe Green
Disclosures: Please see full the study for a list of all authors’ relevant financial disclosures.