An Overview of GS-7340
October 24, 2012
Other Names: Prodrug of tenofovir
What is GS-7340?
GS-7340 is an investigational drug for the treatment of HIV infection. It is also being studied in HIV-uninfected participants for use in the treatment of chronic hepatitis B.
What is an investigational drug?
An investigational drug is one that is under study and is not approved by the U.S. Food and Drug Administration (FDA) for sale in the United States. Medical research studies are conducted to evaluate the safety and effectiveness of an investigational drug. These research studies are also called clinical trials. Once an investigational drug has been proven safe and effective in clinical trials, FDA may approve the drug for sale in the United States.
How are clinical trials of investigational drugs conducted?
Clinical trials are conducted in "phases." Each phase has a different purpose and helps researchers answer different questions.
An investigational drug must be proven safe and effective in a Phase III clinical trial to be considered for traditional approval by the FDA for sale in the United States. Some drugs go through the FDA's accelerated approval process and are approved before a Phase III clinical trial is complete. After a drug is approved by the FDA and made available to the public, researchers track its safety in Phase IV trials to seek more information about the drug's risks, benefits, and optimal use.
In what phase of testing is GS-7340?
GS-7340, as part of fixed-dose combination tablets, is currently being studied in Phase II clinical trials.
What have recent studies shown about GS-7340?
In a recent early-phase study, three different doses of GS-7340 taken once daily were compared with placebo and with TDF (given at the standard dose) in HIV-infected participants. Study participants did not receive additional anti-HIV drugs as part of their background regimens. (A background regimen is a combination of drugs that are not being studied as the investigational drug[s] in the clinical trial, but are being given to help control a participant's HIV infection.)
In HIV treatment-naive and treatment-experienced adults, GS-7340 (at the two higher doses studied: 25 mg and 40 mg) proved more effective than TDF at lowering viral load. In this study, GS-7340 resulted in higher TFV-DP levels inside cells and lower tenofovir concentrations in the blood than TDF did. In terms of safety, there were no reports of significant laboratory abnormalities or serious side effects related to GS-7340 use.
Additional Phase II trials involving GS-7340, as part of fixed-dose combination tablets, are under way in treatment-naive adults.
More information on testing of GS-7340 is available from these sources:
Where can I get more information about clinical trials studying GS-7340?
More information about GS-7340-related research studies is available from the AIDSinfo database of ClinicalTrials.gov study summaries. Click on the title of any trial in the list to see the ClinicalTrials.gov trial summary and more information about the study.
I am interested in participating in a clinical trial of GS-7340. How can I find more information about participating in a clinical trial of an investigational drug?
Clinical trials involve benefits and risks. Before deciding to participate in a clinical trial, talk to your health care provider. For more information on participating in clinical trials, visit NIH Clinical Research Trials and You.
This article was provided by AIDSinfo. Visit the AIDSinfo website to find out more about their activities and publications.
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