GS-9350, or Cobicistat as it is now known, is an experimental(Of a drug) Not licensed for use in humans, or as a treatment for a particular condition. Experimental drugs are studied in clinical trials to determine their safety and efficacy, and are sometimes made available via Special Access Schemes prior to their approval. pharmacokineticReferring to the processes (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine. In clinical trials, measurements are made of the rate at which a drug is absorbed into the bloodstream and then excreted via the kidneys or liver, to determine the optimum dose of the drug. enhancer - a drug used to boost other medications in the blood to make them more effective. Currently, a small dose of ritonavir is often prescribed to perform this function.
The exact mechanism by which cobicistat boosts the blood levels of other drugs has not yet been revealed, though it is likely that the drug inhibits a liverA large organ, located in the upper right abdomen, which assists in digestion by metabolising carbohydrates, fats and proteins, stores vitamins and minerals, produces amino acids, bile and cholesterol, and removes toxins from the blood. enzyme called CYP3A4.
Cobicistat needs to be used in combination with other drugs. Clinical trials will evaluate its effect.
Update: A Phase 3A large clinical trial designed to establish whether a drug is effective and safe enough for widespread use. Phase III studies include expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. clinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. trial (Study 114) met its 48-week primary objective of non-inferiority to ritonavir. See link to company press release.
| Generic name: |
Cobicistat |
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| Also known as: | GS-9350 |
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| Drug class: | other |
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| Availability in Australia: | - Not available on the Pharmaceutical Benefits Scheme (PBS).
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Side effects
All drugs can produce side effects in some people. These may be mild, moderate or severe, so you should be aware of potential side effects before starting any drug, and speak to your doctor if you experience side effects that concern you.
- Common side effects may include nausea (upset stomach, feeling sick to the stomach), vomiting, diarrhea.
- Less common side effects may include kidney impairment.
It's unlikely you will experience all of these side effects, and you may not experience any side effects at all. Before starting any new drug, ask your doctor about side effects you might experience and discuss strategies for dealing with side effects if they do occur. If you experience any significant side effect you should continue taking your medicine and see your doctor as soon as possible.
Interactions with other drugs
Studies on potential interactions between cobicistat and other drugs have not yet been reported, but are planned and ongoing.
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The table below shows all the clinical trials in the database with the keyword cobicistat (GS-9350).
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