Long-term use of tenofovir disoproxil fumarate (Viread or TDF) is associated with an increased risk of the final stage of liver disease (ESLD) as well as hepatocellular carcinoma (CHC, the most common form of liver cancer) among people with HIV. Publication of the records of investigators who accompanied members of data collection on Adverse Drug Trials studies (D: A: D) until they experienced their first indication of ESLD or HCC who died within six months after of their last study visit, whose findings were published in the journal AIDS, D: A: D is a prospective cohort study, a collaboration initiated in 1999 that follows almost 50.000 HIV positive individuals in Europe, the United States and Australia. Participants in this analysis were followed up until January of 2014.
During an average follow-up of 8,4 years, 319 cases of ESLD (HCC) or HCC (Abbreviation in English for Treatment of Hepatitis C Cell Carcinoma Victims) occurred between the cohort, for an annual incidence of 0,101%. Those who had any 62,6% condition had a chance to die within a year.
After adjusting the data for several factors, the researchers found that every five years of exposure to several ARVs resulted in the following increased rates of ESLD or HCC for each drug: Zerit (stavudine or d4T), 46%; Videx (Didanosine or ddI), 32%; Viread, 46%; and Lexiva (fosamprenavir), 47 percent.
Viread is included in the combination of Atripla (efavirenz / TDF / emtricitabine) Complera (rilpivirine / TDF / emtricitabine) Stribild (elvitegravir / cobicistat / emtricitabine / TDF) and Truvada (TDF / emtricitabine).
The increased rate for ESLD or HCC associated with Videx Zerit will not begin to decline until the subjects have spent six years after they stopped taking any of these drugs.
As a result of the increased risk of liver disease associated with the four drugs, the researchers concluded that "strengthening liver function control should therefore be considered among all individuals exposed to these drugs for longer periods." While Zerit and Videx are rarely prescribed today, the researchers still said they should be avoided. They further concluded that the association of Viread with ESLD and HCC, related to viral hepatitis, and a call was made for further study.
With recent approval of Genvoya (elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide, or TAF), Gilead Sciences introduced the first tablet combination containing an upgraded, less toxic version of tenofovir. The Food and Drug Administration (FDA) is also reviewing Gilead applications for approval of a TAF-inclusive versions of Truvada and Complera.
Translated by Claudio Souza's original Viread (Tenofovir, TDF) Linked With Liver Disease and Cancer Reviewed by Mara Macedo at 15 / 01 / 2016