To find a hepatitis C testing event near you, check out this interactive map from the CDC.

Who Should Get Tested for Hepatitis C?

Anyone age 40 and older should be screened for the hepatitis C virus. This new age-based recommendation aims to identify more of the 4 million cases of hepatitis C in the U.S., since an estimated 1.6 million of these remain undiagnosed.

Unlike many other infections, the hepatitis C virus can remain symptomless for up to 20 years. During this time, however, the infection creates numerous health problems and can eventually lead to cirrhosis, liver failure, and liver cancer.

In addition to the age-based screening recommendation, there are other indicators that a person should get tested for hepatitis C infection:

• History of IV drug use
• Blood transfusion before 1992
• Unprotected sex with person known to be infected with hepatitis C or any questionable sexual encounter
• Needle stick from a potentially unsterile needle
• History of nasal drugs (even if it was only one time 20 years ago)
• Anyone who has lived with someone who has hepatitis C 

If confidentiality concerns give anyone pause for getting tested, keep in mind that donating blood is a confidential way to find out hepatitis infection status. Since 1992, all donated blood has been tested for the hepatitis C virus. The donation center alerts affected individuals that their donated blood contains the virus.

Diagnosis is so important because it leads to treatment. And the great news about treatment is that there has never been a better chance of a cure than there is today. New treatments now available bring about a meaningful cure for up to 70 percent of those infected with hepatitis C.

Stephen C Vogt, PharmD
President and CEO BioPlus SP

www.bioplusrx.com

Recombinant factor quickly gained popularity after it became available in 1992 for hemophilia A and is used by most people with hemophilia, in part because this form of clotting factor significantly decreases any chance of blood-borne infection. However, the risk of a hemophilia complication called “inhibitors” may still be present even with the use of recombinant factor.

With traditional plasma-derived clotting factor, some people develop an immune reaction that essentially targets the clotting factor as foreign. The immune system sends out “inhibitors” that interfere with the clotting factor’s function. This results in less effective treatment and more bleeding, pain, and joint damage for the patient. About 25 percent of those with severe hemophilia A develop inhibitors.

To better understand the comparative risk of inhibitors from plasma-derived and recombinant clotting factor, researchers examined inhibitor development in 574 children with severe hemophilia A. This study, published in the New England Journal of Medicine, found a higher than expected risk of inhibitors with recombinant factor in hemophilia A – basically the risk was the same with recombinant factor and plasma-derived factor. However, there was a difference between second-generation recombinant products and third-generation products: the third-generation products had a lower risk of leading to inhibitors in the young hemophilia A patients, according to these study results.

So is recombinant factor really no different than plasma-derived factor for patients?

Several additional experts have weighed in with opinions on this issue. For example, in a letter to the editors in the New England Journal of Medicine responding to the original study, Alfonso Iorio, M.D., Ph.D., Mark W. Skinner, J.D., and Mike Makris, M.D. wrote that they believe the risk from recombinant factor was overstated in the study.

“We anticipate obvious concerns in the hemophilia community regarding the unexpected finding of a higher rate of inhibitor development for second-generation recombinant factor VIII, and we would like to comment on the strength of the association,” notes Dr. Iorio and his colleagues in their letter. The crux of their concerns relate to the 20.4 percent of patients who were excluded from the original study and a risk ratio from the inhibitors that was less than 2, which they conclude “leave the association weak and questionable.”

Naturally, the issue of inhibitor development is hugely concerning for families with hemophilia and their healthcare providers. This is an important issue to examine, but there is simply not enough data yet to drawn clinically relevant conclusions. In the meantime, recombinant clotting factor remains the best treatment option for those with severe hemophilia.

Stephen C Vogt, PharmD
President and CEO BioPlus SP

www.bioplusrx.com

Overburdened Americans rely on two less-than-healthy methods to stretch their health care dollar and lower their prescription medication costs, according to data gathered from a National Health Interview Survey and released earlier this month by the Centers for Disease Control and Prevention (CDC):

• Skipping medication doses
• Delaying filling their prescriptions 

Both of these cost-saving improvisations by patients could bring dire health consequences. Safer methods, according to this same data set, are the approximately 20 percent of patients who ask their prescribers if there’s a lower cost alternative for their prescription. Even so, 12.6 percent of adults (ages 18-64) admit to “stretching their prescriptions” in order to save money. Only 5.8 percent of adults age 65+ reduce prescription drug costs in this way.

Deviating from a plan of care by not taking prescriptions as prescribed negatively affects health outcomes, burdens ERs, and increases the risk of hospitalizations.

BioPlus Specialty Pharmacy partners with our patients so they understand the importance of sticking with their plan of care. By engaging each patient as an active participant in the treatment process, providing counseling about drug therapy management, discussing side effects, and connecting patients in need of financial support with patient foundations, we succeed in extremely high patient compliance.

In fact, in a recent one-month analysis of 3,124 BioPlus patients (including oncology, hepatitis C, multiple sclerosis, and those treated with Ig therapy), medication compliance reached 97.3 percent. A number we are proud of and one that greatly exceeds the average compliance shown in the CDC data.

Stephen C Vogt, PharmD
President and CEO
BioPlus SP

www.bioplusrx.com

Credit: Immune Deficiency Foundation

Now is the perfect time to think about the immune system: not only is April National Primary Immunodeficiency Awareness Month but this week (April 22-29) is also World PI Week, both of which have the goal of earlier diagnoses and optimal treatment for these immune conditions.

Primary immunodeficiency disorders (PIDD) affect as many as 250,000 people in the United States, while thousands more go undiagnosed (but suffering nonetheless) with this uncommon genetic condition. With PIDD, part of the body’s immune system doesn’t function properly or is missing altogether. This results in severe, persistent, unusual, or recurrent infections. Severe combined immunodeficiency (SCID) and ataxia-telangectasia both fall under the umbrella of PIDD.

Diagnosis of PIDD includes a thorough patient history, as well as a physical exam and blood and immunoglobulin level tests. PIDD should be suspected in a patient who experiences two or more of the following:

• 4+ ear infections within one year
• 2+ serious sinus infections within one year
• 2+ months on antibiotics without resolving an infection
• 2+ pneumonias within one year
• Recurrent abscesses
• Persistent thrush
• Family history of genetic immune dysfunction
• Failure to thrive in an infant 

The most common treatment for PIDD is IgG therapy. IgG (immunoglobulin G) provides antibodies that are missing in those with PIDD. IgG therapy is needed on an on-going basis for patients to decrease the number and severity of infections.

3 PIDD Profiles

Diagnosis of PIDD occurs in childhood 60 percent of the time, leaving the remaining 40 percent diagnosed in adults. Earlier diagnosis improves survival rates. Consider these three composite patient stories of PIDD:

1. A 13-month old girl with a history of recurrent thrush and failure to thrive who has also been hospitalized several times with pneumonia. After arriving to the emergency department with a high fever and rash, a blood test reveals a complete absence of several immune system cells (CD4, CD8, CD19, and CD56). Severe combined immunodeficiency disease (SCID) is diagnosed.
2. A teen girl with a history of recurrent sinusitis, diarrhea, and sinus surgeries is tested by her family doctor for an immune disorder. Her IgA levels are low and she is diagnosed with selective IgA deficiency.
3. A woman in her 50s goes to an allergist after experiencing recurrent sinus infections and multiple courses of antibiotics. Skin testing reveals no sensitivities; however, the lab work shows that her IgG is far below normal range. She is diagnosed with common variable immunodeficiency (CVID).

Primary Immunodeficiency Disorders

250,000: Americans diagnosed with PIDD

185: Different conditions under the umbrella of PIDD

20: Conditions accounting for the majority of PIDD cases

70: Percentage of PIDD patients treated with IgG therapy

60: Percentage diagnosed in childhood

Over the past three decades, a steady rise in AML has been noted in adult patients treated with chemotherapy for non-Hodgkin’s lymphoma. Longer post-treatment survival for patients may account for some of this rising risk for AML. When an individual patient is considered, chemotherapy remains an effective treatment choice and the chance of developing leukemia in that particular patient is low. However, aggregate data in larger numbers does show a pattern of elevated risk for treatment-related AML.

The National Cancer Institute researchers gathered data for this study from the Surveillance Epidemiology and End Results (SEER) cancer registries, which included approximately 426,000 adults diagnosed with cancer between 1975 and 2008. All of these patients were treated with chemotherapy. Of this group, 801 patients were later diagnosed with AML. This incidence of AML is 4.7 times higher than would be expected in the general population.

Surveillance Epidemiology and End Results (SEER)

Over time, according to this data, the risk of AML decreased in certain cancer patients, namely those with ovarian cancer, myeloma, and (possibly) lung cancer. This could be related to changes in chemotherapy for these cancers, such as the decreased reliance on the alkylating agent melphalan in favor of platinum-based chemotherapy for ovarian cancer.

Since 2000, the risk of treatment-related AML increased among esophageal, prostate, and cervical cancer patients. In addition, since the 1990s, the risk went up in bone/joint and endometrial cancer patients.

The information gleaned from the study of this cancer registry is useful in determining which cancer patient groups have increased leukemia risks after chemotherapy, so that the patients and their physicians can be alert for signs of AML. The treatment-related risk of AML should also be weighed against the benefit of chemotherapy treatment for the initial cancer. Patients treated with chemotherapy should also be urged to avoid cigarette smoke and environmental toxins (such as benzene), which are both associated with AML risk.

Stephen C Vogt, PharmD
President and CEO
BioPlus SP

www.bioplusrx.com