By Courtney McQueen
Published: Feb 15, 2012 9:11 am
Αποτελέσματα μεγάλης σύγχρονης μελέτης επιβεβαιώνουν οτι το Viread (βασικό φάρμακο αντιρετροϊκής θεραπείας) συστατικό επίσης των φαρμάκων truvada και Atripla προκαλεί νεφρική βλάβη στους ανθρώπους με HIV.
Τα αποτελέσματα της μελέτης αποτελούν επίσης ένδειξη οτι η νεφρική βλάβη είναι μη αναστρέψιμη.
Οι συγγραφείς συνιστούν οι ασθενείς να γνωρίζουν την κατάσταση λειτουργίας των νεφρών τους πριν την ένταξη του viread στη φαρμακευτική αγωγή τους.
Για τους ασθενείς που δεν έχουν κάποιο πρόβλημα νεφρικής βλάβης το φάρμακο μπορεί να χρησιμοποιηθεί.
Προηγούμενες μελέτες έχουν αναδείξει οτι τα άτομα με HIV έχσουν μεγαλύτερη πιθανότητα εμφάνισης νεφρικής βλάβης αφου τόσο τα αντιρετροϊκά όσο και και η ίδια η HIV λοίμωξη μπορούν να προκαλέσουν νεφρική βλάβη.
Viread Is Associated With Long-Term, Irreversible Kidney Damage
Results from a recent large study confirm that Viread, which is also a component of Truvada and Atripla, causes kidney damage in people with HIV.
The results also indicate that the kidney damage increases with each year of exposure and is irreversible.
Based on the results, the study authors recommended frequent kidney function monitoring for people who take Viread, Truvada, or Atripla.
They also suggested that people who already have kidney problems may need to consider other antiretrovirals.
“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,” said Dr. Michael Shlipak, a professor of medicine at University of California, San Francisco and lead author of the study, in a press release.
“For an otherwise healthy patient, the benefits of [Viread] are likely to exceed the risks, but for a patient with a combination of risk factors for kidney disease, [Viread] may not be the right medication,” he added.
“We do not know the long-term prognosis for… patients who stop [Viread] after developing kidney disease.”
Previous research has indicated that people with HIV are more prone to kidney disease than people without HIV, because both antiretrovirals and the HIV virus, which can infect and kill kidney cells, can damage the kidneys (for more information on kidney disease in people with HIV, see related AIDS Beacon news).
Viread (tenofovir), in particular, has been associated with loss of kidney function (see related AIDS Beacon news).
Viread is a nucleoside reverse transcriptase inhibitor that can be prescribed separately or as component of Atripla (efavirenz/emtricitabine/tenofovir) or Truvada (emtricitabine/tenofovir).
According to the study authors, Viread’s role in causing kidney disease is still controversial, as not all studies have found evidence that Viread causes kidney damage.
The authors hypothesized that this discrepancy may be due to varying patient populations (for example, patients with more or less pre-existing kidney damage) or other factors.
In this study, the researchers set out to definitively determine whether Viread use over time is associated with kidney damage. The study included 10,841 HIV-positive United States veterans who started antiretroviral therapy for the first time between 1997 and 2007.
The average participant age was 46 years old. Almost all participants (98 percent) were male and just under half (49 percent) were African-American.
Researchers measured participants’ kidney function and HIV-related outcomes, such as viral loads (amount of HIV in the blood) and CD4 (white blood cell) counts.
They also measured their blood pressure and blood glucose levels, since high blood pressure and diabetes can also lead to kidney damage.
Results showed that each year of Viread use was associated with a 30 percent higher risk of having abnormally high levels of protein in the urine, a sign of kidney damage. In addition, each year of Viread use increased the risk of a rapid decline in kidney function by 11 percent and increased the risk for chronic kidney disease by 33 percent.
Any exposure to Viread was associated with about a 50 percent increased risk of high levels of protein in the urine, rapid kidney function decline, and chronic kidney disease.
There was no evidence that taking Viread with protease inhibitors, non-nucleoside reverse transcriptase inhibitors, or the antiretroviral boosting agent Norvir (ritonavir) increased the risk of kidney damage.
Results also showed that stopping Viread did not decrease the risk of abnormal protein in the urine or rapid loss of kidney function, although it did slightly decrease the risk for chronic kidney disease.
The study authors concluded that damage caused by Viread is likely irreversible.
Various types of kidney damage were more or less likely after certain lengths of time taking Viread.
For example, risk of abnormally high levels of protein in the urine was higher in study participants who had taken Viread for more than three years, while risk of rapid decline in kidney function decreased after three years.
Traditional risk factors for kidney disease, such as high blood pressure and diabetes, did not increase the risk of Viread-induced kidney damage.
For more information, please see the study in the journal AIDS (abstract) or the press release from the University of California, San Francisco.
ΔΙΚΑ ΜΑΣ ΣΧΟΛΙΑ:
Το viread της φαρμακευτικής εταιρείας GILEAD, φαίνεται πως παρά την επιτυχία του και τα πολλά κέρδη που προσέφερε στην εταιρεία παραγωγής του,
έχει μια αμαρτωλή προϊστορία.
Μελέτη με 1.000 εκδιδόμενα άτομα είχε ξεκινήσει στην Καμπότζη από ερευνητές του πανεπιστημίου της Καλιφόρνια Σαν Φραντσίσκο με χρηματοδότηση του Eθνικου Ινστιτούτου Υγείας (ΝΙΗ) των ΗΠΑ και του πανεπιστημίου της Νεας Ν. Ουαλίας.
Οι μισές από τις γυναίκες θα έπαιρναν Viread και
οι άλλες μισές ένα πλασματικό φάρμακο (placebo).
Ενα χρόνο αργότερα οι ερευνητές θα συνέκριναν (ανερυθρίαστα) τις δύο ομάδες.
Μελη των τοπικών ομάδων εκδιδομένων γυναικών αρνήθηκαν να συμμετάσχουν.
Ακτιβιστές στο Παγκόσμιο Συνέδριο AIDS στην Μπαγκόνγκ διαμαρτυρήθηκαν επίσης λέγοντας πως οι εκδιδόμενες ήταν αντικείμενα εκμετάλλευσης.
Οι διαδηλωτές καθοδηγούμενοι από την ACT UP PARIS κατηγόρησαν τους ερευνητές για σκόπιμη ανεπαρκή εκπαίδευση των εθελοντών προκειμένου να εξυπηρετηθεί η μελέτη.
Δέστε το σχετικό δημοσίευμα της εποχής:
Tue, Aug. 03, 2004
Cambodia Prime Minister Opposes Testing Anti-HIV Drug
by KER MUNTHIT, Associated Press
PHNOM PENH, Cambodia - Prime Minister Hun Sen said Tuesday he opposes the testing of drugs on Cambodians, a position that could derail a planned trial for an anti-AIDS medicine here.
His remarks seemed directed at a test, partially funded by the Bill and Melinda Gates Foundation, of the drug Tenofovir DF by the California-based biotech company Gilead Sciences Inc.
"Please, don't use Cambodians for (any drug) trial," Hun Sen said at a groundbreaking ceremony for a hospital, noting that his country had been selected to test AIDS medication. "If a trial is needed, please do it on animals, and don't use Cambodians."
Hun Sen did not single out any project, but his remarks come amid a controversy on the ethics of testing Tenofovir, called Viread DF by Gilead Sciences Inc., in Cambodia.
The study, which seeks to recruit almost 1,000 sex workers, is being conducted by researchers from the University of California San Francisco with funding from the U.S. National Institutes of Health, and the University of New South Wales.
Half those volunteers in the Cambodia experiment will be given Viread, and the others will take a placebo. A year later, researchers will compare the two groups to determine if significantly fewer volunteers taking Viread were infected with HIV than those receiving the dummy pill.
Members of a local sex workers' rights group, Women Network for Unity, said in March they would refuse to participate, citing a lack of insurance against potential side effects.
Activists at last month's International AIDS conference in Bangkok also protested the test, saying the prospective participants were being exploited.
The protesters, led by the AIDS activist group Act Up, accused the researchers of purposely providing insufficient prevention education to the volunteers because it needs infection data to analyze Viread's potential to protect against the virus.
The protesters also demanded that the company take care of the lifetime medical needs of any volunteers who contract AIDS during the experiment - partially funded by the Bill and Melinda Gates Foundation.
The study was approved by the ethics council of Cambodia's Health Ministry last year, but has not yet formally started, said Khol Vohith, a research officer at Cambodia's National Center for HIV/AIDS, Dermatology and Sexually Transmitted Diseases.
Saphonn Vonthanak, a chief of the center's research unit, said he heard about Hun Sen's remarks but was unable to comment on them or say if the Cambodian leader was referring to the Viread study. He said the center would seek clarification.
Cambodia's current HIV infection rate is 2.6 percent among people of 15-49 age group, the highest in Southeast Asia.
Women Network for Unity welcomed Hun Sen's remarks, saying he was "defending the interests of the Cambodian people."
"I'm very glad with what the prime minister has said. I wish for the study to fail, and I will get our girls together to celebrate when it actually fails," said Sou Sotheavy, one of the group's leaders.
from ACT UP/Paris