Snapshots, by Alan Franciscus, Editor-in-Chief

Article: Prevalence and risk factors for patient-reported joint pain among patients with HIV/Hepatitis C coinfection, Hepatitis C monoinfection, and HIV monoinfection—A Ogdie et al.
   Source:  BMC Musculoskeletal Disorders 2015, 16:93  doi:10.1186/s12891-015-0552-z

A common symptom that people with hepatitis C report is pain—liver pain, muscle and joint pain, fibromyalgia, headaches and the list goes on and on.  The aim of the current study was to determine the prevalence of patient reported joint pain among 3 groups (a total of 202 patients, mostly males): HCV mono-infection (93 patients); HIV-mono-infection (30 patients); and HIV/HCV co-infection (79 patients).  The ages and genders were similar across all three groups.  More than half were Black. 

The Multi-Dimensional Health Assessment Questionnaire was used to determine joint pain and any related symptoms. The patients were also interviewed and their charts were reviewed. 

The Bottom Line:  Joint pain was more commonly reported in HCV-monoinfected patients than in HIV/HCV-coinfected patients—71% vs. 56.  Joint paint was also more commonly reported in HCV mono-infected patients than in HIV-monoinfected patients—71% vs 50%.

The study found that a previous diagnosis of arthritis and current smoking were risk factors for joint pain among people who are infected with hepatitis C. 

Editorial Comment:  This is another reason why everyone with hepatitis C should be treated.  There are so many symptoms and conditions caused by hepatitis C.   

For more information see this month’s HealthWise.

Article: Liver-related death among HIV/hepatitis C virus-co-infected individuals: implications for the era of directly acting antivirals—D Grint et al. 
   Source: AIDS. 2015 Apr 13. [Epub ahead of print]

The new interferon-free therapies provide similar cure rates in people who are co-infected with HIV and hepatitis C as in people who are mono-infected with hepatitis C.  However, access is being restricted due the higher costs of the newer medications.  

In general, people who are co-infected with HIV and hepatitis C have a faster rate of HCV disease progression than someone with hepatitis C mono-infection.  Even so, treatment is being restricted to those with the greatest risk of liver-related death.  The current study sought to provide a degree of guidance on who should be prioritized for receiving the new direct acting antiviral medications (DAAs) or HCV inhibitor combination medications.  The study looked at the liver-related deaths of the people who were co-infected with HIV and hepatitis C.

In the current study 3,941 HCV antibody positive patients who were part of a European study (EuroSIDA) and who were followed-up after 1 January 2000 were included. 

Liver-related deaths accounted for 145 of 670 (21.6%) deaths in the study population. Liver-related death rates peaked in those aged 35-45 years, and occurred almost exclusively in those with at least F2 fibrosis at baseline.  Note: The Metavir scale is F0, no activity, F1 for inflammation, F2 for light scarring, F3 for moderate-severe scarring and F4 for cirrhosis. 

The Bottom Line: The authors reported that the 5- year probability of liver related death (LRD) was low for those with F0-F1, but substantial for those F2, F3 and F4. 

The authors also noted that “treatment with DAAs should be prioritized for those with at least a F2 fibrosis.  Early initiation of cART with the aim of avoiding low CD4 cell counts should be considered essential to decrease the risk of LRD and the need for HCV treatment.” 

Editorial Comment:  I wonder how many people coinfected with HIV/HCV are F0-F1, how quickly people progress from one stage to another, how often do you need to monitor people in stage F0/F1, how much does it cost to monitor, and would it be cheaper in the long run to treat everyone?  

Article: Hepatitis A and B among young persons who inject drugs—Vaccination, past, and present infection. MG Collier et al.
  Source:  Vaccine. 2015 Apr 15. pii: S0264-410X(15)00472-7. doi: 10.1016/j.vaccine.2015.04.019. [Epub ahead of print]

It is recommended that people who inject drugs (PWID) should be vaccinated against hepatitis A (HAV) and hepatitis B (HBV). There is some evidence that some young individuals who were vaccinated as children may have lost their immunity.  The current study sought to understand the current HAV and HBV immunity status among 519 persons who inject drugs.   The study group included 18 to 40 year olds who lived in San Diego—49% were non-Hispanic white, 7% were non-Hispanic Blank, 27% were White Hispanic, 4% were born outside of the U.S. 

The Bottom Line:  After being tested it was found that 47% were susceptible to HBV infection and 63% were susceptible to hepatitis A infection.  Additionally, 26% tested positive for HCV antibodies.  The authors reported that even though the participants believed that they had been vaccinated, many had not.  The authors commented that "Programs serving this population should vaccinate PWIDs against HAV and HBV and not rely on self-report of vaccination."

 
Editorial Comment:  This recommendation makes perfect sense. People forget about what vaccines they received as children or if they were vaccinated at all.  If you have hepatitis C it is even more important to be protected.  Becoming co-infected with another hepatitis virus such as HAV or HBV can lead to serious health consequences, even death.   The HAV vaccine can be given without serologic testing since it will do no actual harm.   It is important, however, to give the HBV serologic test to make sure that people are not already infected with the hepatitis B virus before giving the HBV vaccine.  The HBV vaccine doesn’t provide any benefit to people who have acute or chronic HBV and might just might give people a false sense of security and prevent much needed follow-up medical care.

http://hcvadvocate.org/news/newsLetter/2015/advocate0615.html#3

Southern Illinois sees shocking rise of Hepatitis C

Cases of Hepatitis C -- a blood borne virus that attacks the liver and is spread via shared drug needles, unsterile tattoos and other means -- are on the rise. It's a "silent epidemic" waiting to strike many unsuspecting Baby Boomers and young adults, health officials warn, because the liver has a long memory. Even if you have forgotten what you did this past weekend, or in the freewheeling 1970s, your liver did not.  

Hoping to stem the tide of premature deaths from liver-related complications, lawmakers narrowly passed a bill in recent days that would require doctors to offer screening tests for patients considered high-risk for Hepatitis C.

It is curable in most cases, but left undetected can lead to cirrhosis of the liver and death.

Read more... 

Note: You may need to answer a quiz to gain access to this article

Public Health Hepatitis C map by county: Illinois

This map from the Illinois Department of Public Health shows Hepatitis C case numbers, confirmed and suspected, by county as of May 19, 2015.

http://thesouthern.com/public-health-hepatitis-c-map-by-county/pdf_12d9703a-d9d7-56ba-9c8b-223e1c269cf6.html 

Note: You may need to answer a quiz to gain access to this article 

FDA addresses concerns on approval of drugs to treat chronic hepatitis C

Public Release:1-Jun-2015 

Wiley 

Treatment options for chronic hepatitis C, a serious and life-threatening infection, have improved substantially and several new regimens with shorter durations and improved efficacy and safety profiles are now available.

Groups have raised concerns about the evidence used to support the approval of some newer drugs, however, and the issue has been used to cast doubt on their efficacy and even to question treatment or deny reimbursement.

To address these concerns, the US Food and Drug Administration's Division of Antiviral Products in the Center for Drug Evaluation and Research (CDER) has published a paper that highlights the agency's scientific approaches and regulatory processes that support the development and approval of promising drugs to treat hepatitis C.

"FDA's approach to evaluation of recent hepatitis C drugs underscores the Agency's flexibility in considering innovative or alternative trial designs for drugs that have demonstrated highly promising outcomes in early phase development," said Dr. Poonam Mishra, deputy director for Safety, Division of Antiviral Products/Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research and lead author of the Hepatology paper. "Expedited approaches can be used without compromising efficacy standards for drugs that demonstrate breakthrough therapy potential."

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Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

Source: http://www.eurekalert.org/pub_releases/2015-06/w-fac060115.php

Hep C drug tourism has begun as patients seek Harvoni, Sovaldi overseas

When Gilead Sciences ($GILD) struck its hepatitis C supply deal with Indian generics makers, the terms were tight, with provisions designed to keep the knockoff pills in countries where Gilead allows cut-rate pricing. Some state health systems overseas require patients to show IDs to get their meds and present empty pill bottles for refills.

And this is why.

As Bloomberg reports, everyone from individual patients on up to pharmacy benefits managers has been scheming about how to get Gilead's Harvoni and Sovaldi at the lower prices available in other countries--as low as 1% of the U.S. sticker price, the news service notes.

Read more..

Almost three quarters of HIV/HCV group may have DDA-ARV interactions

Among 125 HIV/HCV-coinfected people taking antiretrovirals in a Denver group, 70% could have moderate or severe interactions with one of four common direct-acting antiviral (DAA) regimens for HCV [1]. Researchers calculated that 20% of patients who needed to switch antiretrovirals because of certain DAA interactions could not switch because of antiretroviral resistance.
 
This retrospective study involved 125 HIV/HCV-coinfected adults with antiretrovirals prescribed within the last year. All participants were in care at an academic medical center in Denver. Researchers assessed potential interactions between each person's antiretroviral regimen and four possible DAA combinations: simeprevir and sofosbuvir (SIM/SOF), sofosbuvir and ledipasvir (SOF/LDV), sofosbuvir and daclatasvir (SOF/DCV), and ritonavir-boosted paritaprevir plus dasabuvir and ombitasvir (3D). The analysis did not explore potential interactions between non-HIV drugs and DAAs.

Read  more...

HealthWise: Hepatitis C and Pain—Part 1, by Lucinda K. Porter, RN

Hepatitis C or no hepatitis C, everyone experiences pain from time to time. However, if you have chronic hepatitis C virus (HCV) infection, you are likely to have pain. The Institute of Medicine (IOM) estimates that around 100 million Americans have pain. Compare this to the 3 million Americans living with HCV, how do you know if HCV or something else is causing your pain? This two-part series will explore hepatitis C and pain.

Hepatitis C is called the “silent killer,” because the liver is a non-complaining organ. Liver cells don’t have nerves, so there can be serious tissue damage, but no pain. However, lack of nerve cells doesn’t mean there can’t be liver pain (hepatalgia or hepatodynia). Located in the right upper part of the abdomen, hepatalgia is usually caused by stretching of the capsule surrounding the liver, as well as by complaints from nearby organs. Liver pain does not mean that hepatitis C is worsening. The discomfort may be dull, sharp, mild, severe, constant or intermittent. For me it felt like my liver was fluttering. The only way I can describe it was it felt like when I was pregnant and the baby moved.

Even if there isn’t discomfort in the area of the liver, HCV may cause pain in other parts of the body. These are known as extrahepatic manifestations, and the complaints most associated with pain other than hepatalgia are:

• Musculoskeletal (myalgia)
• Joint pain (arthralgia)
• Stomach pain 

Since pain is a common symptom of many medical conditions, the first order of business is to get a medical diagnosis to determine the cause of your discomfort. Is HCV the cause, or is there something else? It doesn’t have to be either/or, as some people have more than one cause of pain. If HCV is the cause, the next order of business is to find out if the pain is a direct result of the virus, or has HCV caused a secondary problem, such as cryoglobulinemia or an autoimmune disorder.

In the case of cryoglobulinemia, hepatitis C causes the body to produce proteins called cryoglobulins. Cryoglobulins clump together in the blood when they are cold; this causes joint pain. Various studies have shown that successful HCV treatment also improves cryoglobulinemia. The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) HCV Guidelines highly recommend HCV treatment for people with cryoglobulinemia.

Treatment may also help HCV-positive people with autoimmune disorders such as lupus and rheumatoid arthritis. If the pain is primarily from HCV, then eradicating the virus usually eliminates the aches and pains that are caused by the virus.

Pain Medication
Acute pain, meaning that it is short-lived, is the easiest to manage. There is a wide selection of pain medications or analgesics, ranging from over-the-counter (OTC) aspirin to prescription narcotics. These drugs generally work well for acute pain because patients don’t take them for long periods of time, since the problem that caused the pain usually heals. 

That is not to say that there aren’t risks and downsides to taking painkillers—there are, especially from a liver standpoint. This risk increases if the liver is severely damaged by HCV. However, if someone with hepatitis C has a well-functioning liver, most physicians are comfortable prescribing a short-course of narcotics for conditions that warrant it, such as injuries or surgery. The risk to the liver is low, and it’s inhumane and medically unwise to withhold pain relief.

A much bigger problem is chronic pain, or pain that lasts for more than three months (some experts say six months). Chronic pain affects body, mind, and spirit, and it can change your life. The more severe the pain, the greater the transformation. Not the good transformation, like from a caterpillar to a butterfly; more like from a butterfly to an ogre.  

People with hepatitis C who are in pain, are confronted with the issue of finding pain relief that doesn’t further damage the liver. Fortunately, there is a wide selection of medications and pain management tools. Let’s explore pain medication this month; next month I’ll delve into medication-free pain management.

Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

Acetaminophen (Tylenol) is one of the most commonly used non-prescription analgesics. Known as paracetamol in Europe, acetaminophen is great for headaches, fever and mild pain. Technically, acetaminophen is an NSAID, but it’s anti-inflammatory effects are not as good as drugs such as ibuprofen.

cetaminophen is one of the safest drugs there is, even if you have liver disease. It is harmless at low doses. However, acetaminophen can cause acute liver injury and death from acute liver failure at amounts just twice the maximum recommended dose of acetaminophen. The big problem with acetaminophen is that it is added to many medications. Remedies for colds, headaches, pain, sleep, sinus problems, cough and PMS often contain acetaminophen. Lose track of this fact, and you may take toxic amounts. For more information, read Acetaminophen: Safe or Harmless?(HCV Advocate,February 2014)

In the U.S., approximately 50 million people take acetaminophen every week, and more than 25 billion doses are sold yearly. Slightly more than 300 people die annually from it. Nearly all of these are from overdose; half are from intentional overdose (suicide attempts). Acetaminophen hepatotoxicity most commonly arises after a suicide attempt using more than 7.5 grams, but more often at more than 15 grams as a single overdose.

Aspirin is perhaps the most commonly used analgesic and fever-reducing medication in the world. At low daily doses (81 mg), aspirin is used to decrease the risk of stroke, and may prevent a second heart attack. Daily aspirin is no longer recommended to prevent heart disease unless there is a pre-existing condition.

At high doses, aspirin can injure the liver. However, this damage is not from toxicity, such as what may occur with high doses of acetaminophen. The biggest risk with aspirin is a gastrointestinal (GI) bleed. Far more people are injured every year from aspirin use than from acetaminophen. Mortality and morbidity studies are scant, but it appears that there are 10 times more deaths and hospitalizations from NSAID use than from acetaminophen. Complications may occur even at low doses, and the risk increases with age.

Rounding out OTC NSAIDs are drugs such as ibuprofen (Advil, Motrin) and naproxen (Alleve). These drugs are used for mild-to-moderate pain and inflammation. Around 30 million Americans take NSAIDs every year. These drugs rarely cause liver problems, but have other risks, such as injury to the kidneys and GI tract. In addition to OTC NSAIDs, there are many prescription NSAIDs.

Opioids
Opioids are medications related in structure to the natural plant alkaloids found in opium. There are natural and synthetic opioids, and many medications in this category. The most commonly prescribed opioids for pain are codeine, hydrocodone (Vicodin), and oxycodone (Oxycontin). Unlike NSAIDs, opioids have a high potential for dependency and abuse.

According to the CDC, more than 16,000 people in the United States die every year from overdose of prescription painkillers. This is approximately 44 people every day. On their own, opioids rarely injury the liver. However, opioids are sometimes formulated with acetaminophen, and excessive amounts can injure the liver. The FDA has recommended that physicians not use opioid combinations in which the dose of acetaminophen is greater than 325 mg per dose.

Opioid use is making the news these days. Hepatitis C infections rates are increasing at alarming rates in young people, most notably in Kentucky, Tennessee, Virginia and West Virginia. Sharing needles through opioid abuse is fueling this rise.

Another reason that opioids are making the news has to do with how it is prescribed. In some cases, opioids are over-prescribed. Just as bad, is that in some cases opioids are under-prescribed, leaving patients in misery. I am not going to dive in to this debate, but for those looking for well-written information on this, I highly recommend Judy Foreman’s book, “A Nation in Pain.”

What’s Ahead
When it comes to managing pain, there are more choices than just prescription and OTC medications. Next month, I will present information on effective alternatives, such as medical marijuana and drug-free pain management techniques including an effective technique that may surprise you. 

Lucinda K. Porter, RN, is a long-time contributor to the HCV Advocate and author of Free from Hepatitis C and Hepatitis C One Step at a Time. Her blog is www.LucindaPorterRN.com

Resources

• LiverTox: Clinical and Research Information on Drug-Induced Liver Injury
• U.S. Veterans Administration’s: Viral Hepatitis and Managing Pain

http://hcvadvocate.org/news/newsLetter/2015/advocate0615.html#2