Welcome to Ruane Medical, the private medical clinic specializing in Hepatitis C drug trials with the newest Hepatitis C medications. Located in the heart of Los Angeles, we have 30 years of experience in treating people with infectious diseases like Hepatitis C.
In any of these cases you will find valuable answers browsing through our site that is focused entirely on new Hepatitis C drug trials. What you need to know before you enroll in a trial, what you can expect if you enroll, and what steps you need to take to participate. Answers to questions about safety, commitment, charges, biopsies are all here.
If you are wondering about the financials involved: there is no cost to the patient in a trial and we provide a stipend to assist you with travel, time and parking. You don't need medical insurance to participate.
A new combination pill Harvoni® that has been in trials at our site and at other sites in the US is now approved for treatment of Genotype 1 Hepatitis C. Ruane Medical is proud to have been part of the effort to bring this important drug to market and delighted that we can now prescribe Harvoni for patients outside of clinical trials.
How can you access Harvoni outside clinical trials?
Using your insurance benefits, you can make an appointment with Dr Ruane to see you as a private patient and receive treatment with Harvoni or other approved medications using your prescription benefits. Please call the medical office at 323.954.1072 to assess your insurance, and schedule an appointment with Dr Ruane and his physician assistant Bruce Hinton.
Failing liver update:
Due to the recent and rapid progress in Hepatitis C treatment, Dr. Ruane's research department is now able to offer access to trials to patients with Hepatitis C and "failing" livers.
What is a "failing liver"?
Patients with failing livers typically already have cirrhosis but develop complications such as fluid accumulation in the abdomen (ascites). Fluid accumulates because of disturbances of blood flow and drainage through the liver. Previously patients at this stage of disease could not be treated because use of interferon was hazardous. The newer drugs have a different mechanism of action than interferon and thus appear safer.
Failed treatment update:
We can also offer trials to those patients who previously failed treatment with some of the newer therapies like HCV protease inhibitors, telaprevir, boceprevir and/or simeprevir. For patients who are considered advanced transplant candidates, we may be able to offer referrals for treatment / research at other sites as liver transplant trials are not performed here at Ruane Medical.
You have a question not listed here? Send us your questions and we will get back to you and may also add it to our list here.
We are working with the major companies that have Hepatitis C drugs in advanced trials. We have trials with Abbvie, BMS, Gilead Sciences, Merck and Idenix Pharmaceuticals.
New Hepatitis C drugs recently approved include Sofosbuvir/SOVALDI and Harvoni.
The trials are very competitive, meaning that they fill quickly. Some of the Hepatitis C trials involve only 8 weeks of therapy so they are over quickly and are replaced by new ones.
We cannot guarantee that you will be cured but we can tell you that in the most recent studies, we were able to cure over 95% of patients. In other trials with more complicated cases, it has been over 80%. New regimens are all-oral, well tolerated and much simpler than older, interferon based regimens.
In general, we are doing trials that seek to improve over existing options and it is our hope that with these new Hepatitis C drugs coming we will be able to cure everybody in a few years.
Whether your Hepatitis C is cured with one drug or another combination can depend on your genotype, the state of your liver and the types and combinations of drugs you receive.
The trials are being designed to create the best combination for each person.
Drugs used in Hepatitis C treatment trials may or may not be FDA approved. The primary purpose of the trial is to test their effectiveness and safety. Already approved drugs may be studied in trials to test for safety and effectiveness when used for a different clinical purpose, for a shorter or longer duration, or in a new combination.
The drugs we have in trials at Ruane Medical are mostly in Phase 2B-3 meaning that they have already been taken safely by many patients in Phase 1 and early phase 2 trials and so far show to be safe and effective compared to the current standard of care.
Phase 3 studies are the final studies that can lead up to FDA approval. For every trial, there is a document we will read through with you that details all the important information we have that you need to know about the drug and the trial.
We call this document "Informed Consent" and it tells you everything that will be asked of you in the trial; it is usually 25 pages long. Before you agree to be in the trial, you should take the document home to read at your leisure and discuss with your advisors and your doctor.
Some Hepatitis C trials have an initial placebo arm to identify side effects patients on active drug have versus patients on placebo. This is to determine side effects that are likely related to the study drug versus side effects that are not related to the study drug. Patients initially assigned to a placebo arm will receive active medication after the conclusion of the initial study arm.
In all our interferon free Hepatitis C studies, patients receive active medications.
No, you don't have to have a liver biopsy to be in a Hepatitis C clinical trial. But you may need a special test of your liver called a Fibroscan. A Fibroscan is like an ultrasound. Instead of needles into the liver, we use the Fibroscan to send sound waves and the information back tell us the condition of your liver: whether it is soft and floppy like a normal healthy liver or less flexible like we see in conditions like cirrhosis.
The test is easy to perform and we do it right here in the office. It takes about 10 minutes to do and is painless. The Fibroscan is new to the US and because of this, we rarely need biopsies anymore.
No you do not pay anything to be in an interferon free clinical trial. In a clinical trial, the medications and procedures you need for the trial are provided at no charge.
When you are in a Hepatitis C clinical trial, there are frequent office visits especially at the beginning of the trial. In the first three months of many trials, there can be as many as 9 visits.
Once you are on the trial, each visit takes about an hour. Most trials provide a stipend or payment to the patient to assist with the cost of travel, such as gas, taxi or parking. The stipends vary from study to study but are typically $50 per visit.
We give reloadable cards, much like a pre-paid Visa or MasterCard, to provide stipends to study patients. Funds usually take up to 5 days to load following each paid visit, so it is important patients make financial arrangements to cover travel costs until stipend funds are available. Unscheduled visits are sometimes required throughout studies to re-test labs that were not able to be processed or have abnormal results. Unscheduled visits
do not provide compensation.
We are a clinical research center with many trials so we can often get people in pretty quickly. But the Hepatitis C trials are very popular, meaning we often have more patients who want to be in trials than there are spaces available. The best way to get a spot is to get in contact with us soon and be assessed.
The first thing we will do is help you get copies of all your existing medical records. There are other particulars that affect how soon you can get into a trial. For example: the type of Hepatitis C you have ( "genotype"): some trials focus on Genotype 1, 2 or 3. You may have other medical conditions that can affect whether you can be enrolled.
Some people have both HIV and Hepatitis C. Fortunately, there are now trials available for patients who have both HIV and Hepatitis C. In general, the trials are getting more flexible because we no longer use Interferon.
We are located in a major medical building across the street from Olympia Medical Center in Los Angeles. Our building is located on Olympic Blvd. between Fairfax Ave and La Brea Blvd. There is a parking structure ($8 daily maximum) and valet parking right next to the building. We are also easily accessible by public transportation.