AIDS drug Tenofovir linked to kidney damage, new study says |
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Seattle Gay News
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posted Friday, February 24, 2012 - Volume 40 Issue 08 AIDS drug Tenofovir linked to kidney damage, new study saysby Mike Andrew - SGN Staff Writer The antiretroviral drug tenofovir is associated with a significant risk of kidney damage and chronic kidney disease, according to a new study by researchers at the San Francisco VA Medical Center (SFVAMC) and the University of California San Francisco (UCSF). Tenofovir is currently the preferred first-line treatment for HIV because of its potency, overall low toxicity, and convenience of dosing. It is sold under a variety of names, by itself and in combination with other medications. The medication may still prove beneficial for HIV patients who are otherwise healthy, and patients who currently use tenofovir should not necessarily stop using it, researchers said. The study casts some doubt on the safety of PrEP therapies using truvada, since tenofovir is one of the drugs used in that combination. The study examined the medical records of 10,841 HIV-positive veterans in the national VA health care system who used tenofovir from 1997 to 2007. It was published online in the journal AIDS on February 9. The study found that for each year of exposure to tenofovir several markers of kidney disease also increased. Risk of protein in urine - an indicator of kidney damage - rose 34 percent, risk of rapid decline in kidney function rose 11 percent, and risk of developing chronic kidney disease (CKD) rose 33 percent. The risks remained statistically significant even after researchers controlled for other kidney disease risk factors such as age, race, diabetes, hypertension, smoking, and HIV-related factors. 'However, these numbers are based on the average risks in our study population, and patients with more risk factors for kidney disease would be put at proportionately higher risk,' said principal investigator Michael G. Shlipak, M.D., MPH, chief of general internal medicine at SFVAMC and professor of medicine and epidemiology and biostatistics at UCSF. The implications for patients already on or just starting antiretroviral therapy are 'mixed,' said Shlipak. Even with the increased risk, patients' overall chance of long-term kidney damage was fairly low. For example, patients who took tenofovir had a two-percent risk of developing chronic kidney disease after one year on the drug, compared with one percent for those who did not use the drug. 'Patients need to be aware of their kidney disease risks before they start therapy, and this should influence the medications that they choose in consultation with their doctor,' Shlipak said. 'For an otherwise healthy patient, the benefits of tenofovir are likely to exceed the risks, but for a patient with a combination of risk factors for kidney disease, tenofovir may not be the right medication.' 'The best strategy right now is to work with your health care provider to continually monitor for kidney damage. Early detection is the best way to determine when the risks of tenofovir begin to outweigh the benefit.' Shlipak added. 'Does this mean that all patients on tenofovir need to be stopped? No,' Dr. Michael Horberg, director of HIV/AIDS at Kaiser Permanente, agreed. 'What it does mean is you need to be monitoring these patients closely. You need to be checking kidney function, and if the signs are trending toward worsening function, consider alternatives.' For patients who develop kidney disease, stopping the medication may not result in quick improvement, the study showed. Patients were tracked for an average of 1.2 years after they stopped taking tenofovir. They remained at elevated risk for at least six months to one year compared with those who never took the drug, Shlipak said. 'We do not know the long-term prognosis for these patients who stop tenofovir after developing kidney disease,' he cautioned. The latest study indicated a stronger association between tenofovir and kidney damage than previous studies had. Lead author Rebecca Scherzer, Ph.D., a researcher and statistician at SFVAMC and UCSF, said that the current study was the largest and most conclusive indication so far of tenofovir's association with kidney damage. 'There have been a number of previous, smaller studies suggesting that this drug might be associated with kidney disease, but the results were mixed,' she said. 'Those studies may have missed this association because they were too small, lacked appropriate lab data, or excluded subjects with pre-existing renal impairment or risk factors for kidney disease.' Researchers who have been looking at tenofovir as a PrEP - or pre-exposure prophylaxis - medication note that studies so far have shown little increased risk of kidney damage in people who are not HIV-positive. The most recent PrEP study, involving 2,500 men who did not have HIV, was led by scientists at UCSF and the Gladstone Institutes. Only a handful of participants showed signs of kidney damage, and in all of their cases those signs went away once the drug was stopped. SFVAMC has the largest medical research program in the national VA system, with more than 200 research scientists, all of whom are faculty members at UCSF. UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. The study was supported by funds from the National Institutes of Health, the National Center for Research Resources, the American Heart Association and the Department of Veterans Affairs, some of which were administered by the Northern California Institute for Research and Education. |
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