- If you are an adult with hepatitis C, there may be research trials you can join.
- When you take part in a clinical study, you can learn more about your condition, take an active role in your own healthcare, and sometimes gain access to new treatments sooner.
- With recent advances in hepatitis C treatment, most people can now be cured.
Clinical studies improve our medical knowledge with the help of human volunteers. Clinical studies test possible outcomes by observing and controlling variables, such as the dosage of a medication or the effects of a new medication or changing the dose of a medication, for example.
There are two types of clinical studies.
- Observational studies. These studies are organized according to a research plan. Researchers don’t assign any treatment, so there is no independent variable. Participants can follow treatment prescribed by their doctor, but the study doesn’t change this treatment plan. Instead, researchers group similar participants into categories and record what they see, such as the effects of exercise on cardiac health, or health outcomes from tobacco use.
- Interventional studies. Also known as clinical trials, these studies have an independent variable controlled by the research team. This might be a new drug, device, procedure, or lifestyle change.
If you’re in a clinical trial, the research team might assign you a regular dose of a medication or give you instructions about a medical device. You might be in a placebo group or a control group that receives no intervention.
Clinical trials help to improve future disease outcomes. Participation may give you access to new and improved treatments before the general population and enable you to treat your condition sooner than if you had to wait.
There are some risks, too. You might get the standard treatment for hepatitis C or a placebo, instead of the new treatment. Many trials are blinded, meaning that neither the researchers nor you will know which treatment you’re getting. It’s important to understand the potential risks before agreeing to take part in a clinical study.
If you’re interested in taking part in a clinical trial, the first step is to talk with your doctor to see if they know about any studies that might be a good match for you.
You can also visit the U.S. National Library of Medicine website at ClinicalTrials.gov to find trials that are currently recruiting participants. On the home page, scroll down to “Find a study” and enter “hepatitis C” under “Condition or disease.” You can narrow down your search further by adding information under “Other terms” and “Country,” but those fields are not required.
Another website that publishes information about clinical trials that are actively recruiting is CenterWatch. Here, you can also search for trials taking place near you or within a specific range of distance (from within 10 miles to worldwide).
There are several criteria that must be considered in order for someone to be eligible to take part in a clinical study. This can include criteria related to eligibility or exclusion, as well as practical issues.
Each description of a specific study will outline the eligibility criteria required to participate. These factors are in place to make the study as safe and as accurate as possible. These criteria may include:
- age
- sex
- type and stage of disease
- body mass index
- health indicators not related to the diagnosis being studied
There are also reasons a person may not participate, called exclusion criteria. Even if you meet all the eligibility criteria, you won’t be able to join a study if an exclusion criteria item applies to you.
Exclusion criteria exist because of safety, practical, and error issues that can occur. If potential adverse effects can outweigh the benefits, you may be excluded from a trial. Examples where this might occur can include:
- pregnancy
- breastfeeding
- age
- presence of multiple chronic conditions
- organ dysfunction
- drug allergy
- substance use
- organ transplant
Practical issues make participation difficult. They increase the chance of missed sessions or treatments, which affects trial accuracy. Examples include:
- how far you live from the trial location
- your financial stability, if you need time off from work to participate
- your access to reliable transportation
- whether you require caregiver help
Sometimes exclusion criteria are designed to reduce random error. If a group of participants doesn’t have enough in common, their differences can make test results more difficult to interpret. For this reason, study participants are often grouped, and therefore excluded, according to:
- age
- sex
- type of disease
- stage of disease
Location is important when deciding if you should apply for a clinical trial. Usually, if you are taking part in a study, you will need to report regularly to a specific physical location for treatment or to report on your experiences with treatment.
The U.S. National Library of Medicine website has interactive maps that let you search for clinical trials by location. You can use this map function to search for hepatitis C studies that are currently recruiting, or for any study currently taking place.
The National Institute of Allergy and Infectious Diseases (NIAID) supports and conducts hepatitis research. There are five hepatitis viruses in total: A, B, C, D, and E, and all five are studied by NIAID. Hepatitis B and C receive the most coverage because of the level of medical impact they impose, including their link to liver cirrhosis and cancer.
There are five hepatitis C cooperative research centers in the United States and NIAID supports all of them. They study the immune system response to an infection with the hepatitis C virus (HCV). They’re also looking at using biomarkers to predict the progression from hepatitis C to liver cancer.
NIAID researchers are working toward a vaccine for hepatitis C since HCV continues to spread. This is because many people don’t know they have an infection, so they don’t seek treatment or take steps to avoid virus transmission. Undetected, hepatitis C can eventually lead to liver cirrhosis or cancer. A vaccine can prevent this by reducing asymptomatic transmission, as well as re-infections in people who have been cured of hepatitis C.
Recent years have seen rapid advancements in hepatitis C treatment. Patients who seek diagnosis and treatment are cured at a rate of more than
The latest medications for hepatitis C are taken by mouth, in pill form, and they have fewer side effects than previous options. Treatment generally lasts between 8 weeks to 6 months, depending on the medication.
On the other hand, interferon injections, which used to be one of the most common treatments, must be taken for 6 and 12 months, but only cured hepatitis C in about
Before you agree to take part in a clinical trial, it’s important to involve your doctor in order to make an informed decision.
If you find a trial that interests you, bring the information to your next doctor’s appointment. Weigh the pros and cons of participating, and discuss important factors such as potential side effects, what can happen to your condition when the trial ends, and whether it will include follow-up care.
Clinical studies depend on human volunteers, and their participation adds to medical knowledge. There are two types of studies: observational, where no changes are made by the research team, and interventional (clinical trials), in which you’re assigned a treatment to try.
To qualify for a trial, you must meet inclusion criteria and must not have any exclusion criteria. This is for reasons of safety, practicality, and error prevention.
NIAID supports and conducts current hepatitis C research, including immune system response, cancer prediction markers, and the development of a vaccine. If you want to participate in a trial, talk with your doctor to determine the potential benefits and risks.