Men and women deprived of HIV infection using pre-exposure prophylaxis (PrEP) based on relevant tenofovir have significant reductions in renal function but not in accordance with the data observed in the larger study results.
The reduction has not progressed in patients who showed PrEP during the 36 months and the treatment did not increase the risk of clinically significant reductions in glomerular filtration rate (GFR), discovered the Dr.Jared Baeten of the University of Washington in Seattle and colleagues.
"These data confirm the safety of pre-exposure prophylaxis based on tenofovir for use in healthy people with HIV-negative," said Dr.Baeten Reuters Health in a telephone interview. "These data are the largest data sets to see if these medications can caussar liver problems in people who do not have HIV, and the results should be extremely relievers for both prescribers and patients."
Tenofovir is related to the reduction of GFR in patients infected with HIV, as observed Dr. Baeten and his team report published online in JAMA Internal Medicine of December 22, but there is little infromação about how drugs can affect renal activity when used for Prep.
The new data comes from a security protocol analysis of the study of PrEP 2008-2012 Partners conducted with HIV-negative partners of people with HIV.
The study included daily 1.548 patients with tenofovir, 1.545 with tenovofir- entricitabine and 1.547 placebo. At baseline, the average was 130 ml / min / 173m2.
After monitoring (an average of 18 months) patients with placebo, while the decrease was 1.59mL / min / 1.73m2 in patients with combinations of the two drugs. The differences emerged after patients who were taking the drug for a month, remained stable for a year, and then, "seemed languish," the researchers said.
Among the people in the group receiving tenofovir, 1,3% had the twelfth month a reduction of 25% or greater in eGFR compared to the baseline, while 1.8% did so in the twenty-fourth month. Among patients with tenofovir / emtricitabine, 1,2% had 25% or maoir reduced by one year. These values were not statistically different from that observed reduction in patients receiving placebo.
"For a drug to be used in an attempt to keep people healthy, the security level is possibly even greater than it is for treatment," said Dr. Baeten.
It is very important to have strict developments such as those presented in this paper to demonstrate the safety of this strategic medication.
In an editorial, Dr. Mitchell Katz, Department of Health Services Los Angeles agreed that the results are relievers.
While this is good news, it is important to note that the monitoring lasted an average of 18 months; people can take these medications for years, wrote Dr. Michelle Katz in the editorial. "And in that sense, it is possible that other adverse effects to tenofovir may become evident with the use of long term."
Source: JAMA Intern Med 2014
By Anne Harding
New York (Reuters Health) -