An Overview of Elvucitabine
January 4, 2017
Other Names: CH-126443, ELV, L-F-D4C, beta-L-Fd4C, l(−)Fd4C
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.
To learn more about investigational drugs, read the AIDSinfo What is an Investigational HIV Drug? fact sheet.
What Is Elvucitabine?
Elvucitabine is an investigational drug that is being studied for the treatment of HIV infection.
Elvucitabine belongs to a class (group) of HIV drugs called nucleoside reverse transcriptase inhibitors (NRTIs).2 NRTIs block an HIV enzyme called reverse transcriptase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking reverse transcriptase, NRTIs prevent HIV from multiplying and can reduce the amount of HIV in the body.
Elvucitabine's chemical structure is similar to the structure of the FDA-approved NRTIs lamivudine (brand name: Epivir) and emtricitabine (brand name: Emtriva).5However, in vitro studies have suggested that elvucitabine may work on certain HIV strains against which other NRTIs, such as lamivudine and emtricitabine, no longer work.6 (In vitro studies are studies done in test tubes or other laboratory equipment and not on animals or humans.)
Studies have also suggested that elvucitabine may be effective against hepatitis b virus (HBV) infection.6-8
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.9
In most cases, an investigational drug must be proven effective and must show continued safety in a Phase III clinical trial to be considered for approval by FDA for sale in the United States. Some drugs go through FDA's accelerated approval process and are approved before a Phase III clinical trial is complete. After a drug is approved by 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.9 (Some clinical trials are categorized as "a" or "b," such as "Phase Ia" or "Phase IIb." These different subphases typically mean that a study is researching certain types of information or using a certain type of participant population.)
In What Phase of Testing Is Elvucitabine?
Elvucitabine has been studied in Phase II clinical trials.2The company developing elvucitabine reported that it is out-licensing elvucitabine and looking to work with partner companies to focus elvucitabine's development in regions outside the United States. Through a partner company, elvucitabine is being developed in China, Hong Kong, and Taiwan.3,4
This article was provided by AIDSinfo. Visit the AIDSinfo website to find out more about their activities and publications.
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