Viread Gets FDA Nod
December 2001/January 2002
The Food and Drug Administration has approved Viread (tenofovir disoproxil fumarate), the twentieth medication used to treat HIV infection. Made by Gilead Sciences, Viread is a nucleotide analog, which works to stop reverse transcriptase.
Since it is a different type of medication, Viread may have the opportunity to be effective because of its resistance profile. In clinical trials, resistance occurred in 3 percent of the participants.
Side effects to Viread include nausea, diarrhea, vomiting and flatulence. Viread did, however, receive a black box warning, which stated, "Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals." Lactic acidosis is a metabolic disorder that is characterized by weight loss, fatigue, malaise, nausea, diarrhea, abdominal pain and shortness of breath. It is associated with mitochondrial toxicity, which has been attributed to nucleoside analogs. Severe hepatomegaly with steatosis refers to liver enlargement associated with an over-accumulation of fat.
Viread was approved for use in individuals with HIV infection and based upon clinical trial data from participants who had previously used other FDA approved medications. Information used to approve Viread was not collected from individuals who had not previously used other antiretrovirals. The question remains whether there will be long-term inhibition of HIV for people who have never used any of these medications before.
Gilead is investigating the use of Viread in treatment-naive individuals.
This article was provided by AIDS Project Los Angeles. It is a part of the publication Positive Living.