Hep B Clinical Trial

16 01 2013

When babies are infected with hepatitis B, chances are they’ll stay infected for life. It becomes a chronic condition.

Some live long lives and their deaths are unrelated to their hep B infection.

Others develop cancer or their liver gives out. And then there are those who have minor symptoms, such as jaundice or fatigue.

You never know what or when or if something’s going to happen.

There’s no wonder drug for this disease. The available treatments are anemic at best, and few get favorable results.

My daughter, who was infected as an infant, has lived with hep B for 13 years. We’ve waited a long time for drugs that might work for her stage of the disease.

Hope has just peeked over the horizon.

NIH is running a clinical trial through a few centers in the US and Canada on children whose hep B infection is at a certain stage.

They’re using a combination of entecavir and pegylated interferon. They’re not looking for a cure, but rather hoping to slow it down. Even the best results wouldn’t remove the hep b virus from the cells. It’s integrated now, and there’s no work being done that’s close to getting it out of the cells it’s infected.

But, if the stars align and results are better than expected, it could be that those who respond to this treatment can relax, knowing hep B needn’t remain on their worry list.

That’s what we want. We all want our kids to live long, happy, healthy lives.

We flew to San Francisco yesterday for blood work and to sign forms. Lots of forms. Dr. Phil Rosenthal is running the trial and Shannon Fleck, the clinical research coordinator at UCSF Benioff Children’s Hospital, is assisting. I’ve known Phil for nearly 20 years and was delighted to see how optimistic he is about this drug combo.

This first step is to determine if my daughter is eligible for participation in the study. Her lab results have to match the criteria set for the trial.

If she is eligible, we fly back down within 30 days and her name goes into a computer, which then spits back out her placement. She’ll either be in the control group (no treatment) or the treatment group.

If she’s in the control group and the study is proving successful, she’ll be allowed compassionate use of the drugs, but that won’t be for two or three years.

That’s where we are—not even past the first hurdle.

I know people who’ve been infected with hep B in their adult years and have died from the disease. And I know people who’ve had cancer or liver transplants, or both—all because of this infection.

There are lots of ways to become infected. The easiest way to prevent infection is to get vaccinated. You, your siblings, your parents, your kids . . . ask your healthcare provider about it.

You can’t fix this with an aspirin.

By Hep B Mom





Microbes R Us

14 06 2012

Well, they’ve finally done it. Researchers have mapped the microbes living on humans.

Seems like they wouldn’t be hard to find, since they’re all over and in the body, but they are little—hence the “micro” part. And there are trillions of them on each of us. But, they are accountable for only 1 to 3 percent of the body’s mass. So if you weigh 180 pounds, the microbes make up between 1.8 and 5.4 pounds. Imagine. Trillions of anything weighing just 1.8 pounds.

If you think about it too much, it’ll give you the willies. Tiny critters in your nose, on your eyelashes, on your mouth, on your skin, on your lips . . . you get the idea.

Humans do have mutually beneficial relationships with some of these microorganisms. The microbes in the gut are famous for being helpful. We give them a place to live and they give us the ability to digest certain foods and produce vitamins and anti-inflammatories.

Other microbes, called pathogens, can and do cause illness in some of us. Yet many healthy people carry pathogens that don’t cause disease. Go figure.

The National Institutes of Health organized a group of researchers to map out the “normal microbial makeup of healthy humans (in the Western population).” The results of this mapping will be a bumper crop of hypotheses followed by a flood of studies which will, it’s hoped, move infectious disease research considerably further down the road.

NIH shares a bit of what’s already come out of this mapping:

CLINICAL APPLICATIONS

As a part of HMP, NIH funded a number of studies to look for associations of the microbiome with diseases and several PLoS papers include medical results. For example, researchers at the Baylor College of Medicine in Houston compared changes in the vaginal microbiome of 24 pregnant women with 60 women who were not pregnant and found that the vaginal microbiome undergoes a dramatic shift in bacterial species in preparation for birth, principally characterized by decreased species diversity. A newborn is a bacterial sponge as it populates its own microbiome after leaving the sterile womb; passage through the birth canal gives the baby its first dose of microbes, so it may not be surprising that the vaginal microbiome evolved to make it a healthy passage.

Researchers at the Washington University School of Medicine in St. Louis examined the nasal microbiome of children with unexplained fevers, a common problem in children under 3 years of age. Nasal samples from the feverish children contained up to five-fold more viral DNA than children without fever, and the viral DNA was from a wider range of species. Previous studies show that viruses have ideal temperature ranges in which to reproduce. Fevers are part of the body’s defense against pathogenic viruses, so rapid tests for viral load may help children avoid inappropriate treatment with antibiotics that do not kill the viruses but may harm the child’s healthy microbiome.

These are among the earliest clinical studies using microbiome data to study its role in specific illnesses. NIH has funded many more medical studies using HMP data and techniques, including the role of the gut microbiome in Crohn’s disease, ulcerative colitis and esophageal cancer; skin microbiome in psoriasis, atopic dermatitis and immunodeficiency; urogenital microbiome in reproductive and sexual history and circumcision; and a number of childhood disorders, including pediatric abdominal pain, intestinal inflammation, and a severe condition in premature infants in which the intestine actually dies.

All good news, but the scope of the mass of microbes on and in me still gives me the willies.

By Trish Parnell

Image courtesy of NIH





Is Chronic Fatigue Syndrome Infectious?

16 09 2010

A couple of studies written up over the past year suggest that chronic fatigue syndrome (CFS), may be an infectious disease.

Hold your horses, said CDC this summer.  They did their own study and found no such result.   The retroviruses, or virus gene sequences, other researchers have found to be common in a significant number of CFS+ study participants were not found by CDC in their study.

Talk about “conflicted findings!”  Which study is accurate?

If CFS in an infectious disease, then how do we treat and prevent it?

Until we know what causes CFS, prevention is nearly impossible.  Treatment options are all over the board and will likely remain so until causative agents are identified, and in most cases, physicians are managing rather than treating the illness.  CDC recommends the following options for CFS patients:

  • Professional Counseling
  • Cognitive Behavioral Therapy (CBT)
  • Graded Exercise Therapy (GET)
  • Symptomatic Treatment
  • Alternative Therapies
  • Support Groups
  • Pharmacologic Therapy
  • Sleep Hygiene
  • Pain Therapy
  • Orthostatic Instability Treatment
  • Antidepressants

Another thing to consider: If CFS may be an infectious disease, what about our blood supply?  CFS is hard to diagnose, so how many potential blood donors rolling up their sleeves can be accurately identified and stopped from giving blood?  Or should they be stopped?  If CFS isn’t infectious, then probably not, but if it is, then probably so!

Dr. Harvey Alter at the NIH is the scientist to watch on this.  He’s a superstar in the world of viral hepatitis, and it looks like CFS might be his next big thing.

There’s too much conflicting information right now as to the cause of CFS, but to be affected by (or infected with) CFS is not easy.  The millions of people living with it deserve our attention.  We need to tip the scale so that we have more answers than questions.