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September 2010 HCV Advocate

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In This Issue:

Top Line Results: Boceprevir & Telaprevir
Alan Franciscus, Editor-in-Chief

HCV Outside the Body: How Well Does It Survive on Surfaces, in Syringes, and in the Lab?
Liz Highleyman

HealthWise: Planning for the Future
Lucinda Porter, RN

HCV Snapshots
Lucinda Porter, RN
Alan Franciscus, Editor-in-Chief

HCV Advocate Eblast
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Top Line Results: Boceprevir & Telaprevir
—Alan Franciscus, Editor-in-Chief

Merck/Schering and Vertex released exciting news about their top-line results from phase III studies in August 2010.  Merck’s top-line data included the use of their HCV protease inhibitor, boceprevir, in combination with pegylated interferon and ribavirin in HCV Genotype 1 patients who have never been treated (treatment-naïve) and people who have ‘failed’ a previous course of pegylated interferon plus ribavirin therapy.  Vertex’s data included a study with their HCV protease inhibitor, telaprevir, used in combination with pegylated interferon and ribavirin for treatment of HCV Genotype 1 treatment-naïve patients.  

This is the data that we have all been waiting to hear about – with one exception—we are still waiting to hear the results of the phase III study of telaprevir triple therapy (pegylated interferon plus ribavirin) for people who have not achieved an SVR with a previous course of pegylated interferon and ribavirin combination therapy.

Unfortunately, the three studies only include top-line results so we will have to wait until AASLD to hear more in-depth information.  These results, however, give hope that the new triple combinations of HCV protease inhibitors, pegylated interferon and ribavirin will increase the efficacy for people who have never been treated and for those who have been treated, but didn’t achieve an SVR.     

Boceprevir – Phase III Top Line Results

HCV Sprint 2 
This study included 1,097 HCV genotype 1 treatment-naïve patients.  There was a 4 week lead-in of PegIntron plus ribavirin (without boceprevir), followed by the triple combination of boceprevir, PegIntron and ribavirin.  Duration and continuation of treatment was guided by the type of response to the medications.1

The sustained virological response rates (HCV RNA negative 24 weeks post treatment or SVR) by group are listed below: 

  1. If HCV RNA negative at week 8 through week 24, triple therapy was continued for a total  treatment duration of 28 weeks; sustained virological response (SVR) = 63%
  2. If HCV RNA positive at week 8 but undetectable at week 24, boceprevir was stopped at week 28 and PegIntron/ribavirin combo therapy was continued for a total treatment duration of 48 weeks; SVR = 66%
  3. The control arm was standard of care – PegIntron plus ribavirin with a treatment duration of 48 weeks; SVR = 38%

There were also 159 African American (AA) patients in the study (AA patients comprised 15% of the patient population).  The SVR by response guided treatment duration in the groups listed above included1:

  1. AA – SVR = 42%
  2. AA-  SVR = 53%
  3. AA – SVR = 23%

*If patients were HCV RNA positive at week 24 all treatment was stopped. 

This study included 403 HCV genotype 1 treatment-failure patients and included a 4 week lead-in of PegIntron plus ribavirin, followed by the triple combination of boceprevir, PegIntron and ribavirin with a treatment duration based on type of response.  The SVR rates and treatment duration are listed below.2

  1. If HCV RNA negative at week 8 and at week 12 the total  treatment duration was 36 weeks; SVR = 59%
  2. IF HCV RNA positive at week 8, but undetectable at week 12, boceprevir was stopped at week 36 and the combination of  PegIntron/ribavirin was continued for a total treatment duration of 48 weeks; SVR = 66%
  3. Control arm was standard of care – combination of PegIntron plus ribavirin; SVR = 21%

*If patients were HCV RNA positive at week 12 all treatment was stopped. 

The side effects in both studies were similar across all treatment arms except that anemia was 20 to 27% higher in the arms that included boceprevir.  The discontinuation rate from all side effects was similar across arms including the boceprevir containing arms.  The use of erythropoietin (a growth factor used to treat anemia) was allowed, which may explain the low discontinuation rate due to anemia. 

Merck/Schering has indicated that they expect to complete filing for marketing approval in the U.S. and Europe by the end of 2010. 

Source:  Merck & Co., press release.

Telaprevir – Phase III Top Line Results

This study included 540 HCV genotype 1 treatment-naïve patients.  The aim of this study was to find out if there was a benefit in extending the total treatment duration from 24 weeks to 48 weeks.  The study was response guided—patients who were HCV RNA negative at weeks 4 and 12 of treatment were randomized at treatment week 20 to receive either 24 or 48 week total treatment duration.  The overall SVR rate of all patients in the study was 72%.  When treatment was guided by type of response during therapy, the SVR rates were higher—88% (24 weeks) and 92% (48 weeks).  During the period that telaprevir was used 6.9% of the patients discontinued treatment, which is similar to the treatment discontinuation rates usually seen in pegylated interferon plus ribavirin combination therapy.  The study validated that a 24 week treatment duration was as effective as a 48 week treatment duration. 

The use of erythropoietin was not allowed in this study or in the larger Phase III ADVANCE study.   

Source: Vertex Pharmaceutical, INC., press release.

 The results from all three studies are impressive, but the real story will unfold once more data is made available.  It is expected that more information will be released at the 2010 AASLD Conference that will be held in Boston, MA on October 29, 2010 to November 2, 2010.  Another phase III Vertex study is expected to be released soon—this study examined the use of telaprevir, pegylated interferon and ribavirin to treat HCV genotype 1 people who did not achieve an SVR with a prior course of pegylated interferon plus ribavirin

Medical providers and patients will soon be making important decisions about which drug to take based on the complete data set from all of the Phase III studies of telaprevir and boceprevir.  Important issues that will play into the treatment decision process will be the efficacy of the new HCV protease triple therapy, how long someone will need to be treated based on drug and guided by response, frequency and severity of the side effects,  cost of the new medications, additional costs of medicines to manage side effects, additional costs of HCV RNA tests (if response guided), overall insurance coverage and limitations, and the willingness and capacity of the medical provider to tackle the new therapies.  But the most important issue will be the person living with hepatitis C who will ultimately be in charge of the treatment decision process.    

1 Boceprevir (800 mg three times a day), PegIntron (1.5 mcg/kg/week) and ribavirin (600-1,400 mg day)
2 Triple combination (telaprevir, pegylated interferon, ribavirin).  Telaprevir was not given for more than 12 weeks.

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HCV Outside the Body: How Well Does It Survive on Surfaces, in Syringes, and in the Lab?
—Liz Highleyman

The hepatitis C virus (HCV) is relatively hardy compared with some other viruses, which has implications for transmission and prevention. HCV may survive outside the body for days in dried blood on surfaces, or for months in a liquid medium under favorable conditions. Paradoxically, however, HCV has proven difficult to maintain in laboratory cell cultures, which has hampered research on potential treatments.

Survival in the Lab
Due to the difficulty of maintaining viable HCV in the laboratory, researchers have relied on “replicon” models of a specific strain of HCV (JFH-1 genotype 2a) in a liver cancer cell line. But this year researchers from Massachusetts Institute of Technology and Rockefeller University finally found a way to sustain viral replication in healthy liver cells for up to three weeks.

As described in the February 16, 2010 Proceedings of the National Academy of Sciences, Sangeeta Bhatia and colleagues developed a way to maintain healthy hepatocytes, or liver cells, for four to six weeks by precisely arranging them on a specially patterned plate and mixing them with fibroblast cells that support their growth. The liver cells could then be infected with HCV for two to three weeks, giving time to study response to candidate drugs. The HCV strain used for this research came from a Japanese patient with fulminant hepatitis; the researchers hope to modify their system to maintain a genotype 1 HCV strain, the most common type in the U.S. and the hardest to treat.

Survival on Surfaces
According to the U.S. Centers for Disease Control and Prevention (CDC), HCV can survive on environmental surfaces at room temperature for at least 16 hours but no longer than four days. The more fragile HIV virus, in contrast, only lives on surfaces for a few hours, while influenza viruses may survive for several hours up to about a day.

The CDC estimate is based on a study by Kris Krawczynski and colleagues, presented at the 2003 American Society for the Study of Liver Diseases (AASLD) meeting and published in the May 2007 issue of Infection Control and Hospital Epidemiology. The researchers examined the stability of genotype 1a HCV in dried blood plasma from an infected chimpanzee.

Plasma samples were dried in test tubes overnight (for about 16 hours) then either rehydrated immediately using sterile water and stored at -70ºC (about -160ºF, the temperature of biomedical research freezers), or put in a controlled environment chamber with 42% humidity at 25ºC (77ºF, room temperature) for four or seven days before rehydration. The rehydrated virus was then injected into a different chimp to see whether it remained infectious.

HCV RNA (genetic material) was detectable in plasma dried overnight and stored for seven days, though viral load decreased by 1 log, or ten-fold, compared with the original plasma sample. The test chimpanzee injected with virus dried overnight developed detectable HCV RNA and elevated alanine aminotransferase (ALT), became HCV antibody positive, and had detectable HCV antigen in liver cells. Injection of rehydrated virus stored for four or seven days, however, did not lead to infection. The researchers therefore concluded that HCV could remain infectious on surfaces outside the body somewhere between 16 hours and four days.

Viability outside the body, however, can vary widely depending on conditions. Viruses survive longer on hard surfaces such as stainless steel and less time on soft surfaces like fabric. HCV can live longer at cooler temperatures and prefers humidity to dry conditions.

Survival in Liquid
HCV survives longer in liquids than it does when dried on surfaces. In one recent study, described in the June 15, 2010 Journal of Infectious Diseases, Sandra Ciesek from Hannover Medical School in Germany and colleagues looked at the environmental stability and infectivity of HCV grown in a laboratory cell culture, as well as its susceptibility to chemical disinfectants. The researchers measured changes in viral load and introduced recovered HCV RNA into cultured Huh7.5 liver cancer cells to test for infectiousness.

In a liquid environment, HCV was detectable for up to five months at lower temperatures. However, the researchers noted that the risk of HCV infection may not accurately be reflected by measuring HCV RNA levels, because viral infectivity and viral load were not directly correlated. Further, they found that various alcohols and commercially available antiseptics reduced HCV to undetectable levels, though diluting hand disinfectants reduced their virucidal activity.

In another study published in the February 2010 Virology Journal, Hongshuo Song from Peking University and colleges found that JFH-1 cell culture-derived HCV could survive in liquid culture medium for two days at 37ºC (98ºF, body temperature) and 16 days at 25ºC, but was relatively stable at 4ºC (about 40º, average refrigerator temperature) without major loss of infectivity for at least six weeks.

This cell culture-derived HCV was vulnerable to heat; infectious virus could be inactivated in four minutes at 65ºC (about 150ºF) or eight minutes at 60ºC (140ºF), but this took 40 minutes at 56ºC (about 130ºF). Ultraviolet light efficiently inactivated HCV within two minutes. Exposures to formaldehyde and various detergents destroyed infectious HCV effectively in both culture medium and human serum.

HCV’s ability to live for a prolonged period in liquid blood underlies its transmission via nasal drug use (HCV RNA was detected on 5% of straws from hepatitis C patients who “snorted air”—simulating drug use—in one recent study), tattooing, sharing personal care equipment such as razors, childbirth, certain sexual activities, and re-use of medical equipment in healthcare settings.

Epidemiologic studies show that hepatitis C prevalence is higher among people who have undergone various medical procedures including kidney dialysis, indicating that HCV can spread from one patient to another via contaminated equipment if proper infection control practices are not followed. In 2008, for example, several patients at a Las Vegas endoscopy clinic contracted hepatitis C when clinicians gave multiple people injections from the same vials of anesthesia medication.

Survival in Syringes
HCV survival in blood in syringes is a key concern, given that sharing needles for drug injection is the most common route of hepatitis C transmission. In a presentation at the 17th Conference on Retroviruses and Opportunistic Infections in February, Elijah Paintsil from Yale University School of Medicine reported findings from a laboratory study looking at how long HCV can live in syringes.

The researchers first filled syringes with HCV-infected blood and depressed the plunger, simulating what happens when a user “boots,” or draws blood up into a syringe to mix with drugs and then reinjects it. Either immediately or after storing for up to two months at various temperatures, the team flushed out the syringes and attempted to grow recovered virus in genotype 2 HCV in cell cultures. They analyzed both low-volume (2 microliter) insulin syringes with permanently attached needles and high-volume (32 microliter) tuberculin syringes with detachable needles.

In the low-volume syringes, the likelihood of finding infectious HCV declined rapidly, with no viable virus recovered after one day of storage at 37ºC or three days at 22ºC (72ºF). At 4ºC, viable virus could be detected in two-thirds of syringes after one day of storage, about 25% after three days, and about 5% after seven days.

But in high-volume syringes, infectious HCV could still be recovered from nearly all syringes stored at 4ºC for seven days, from about half of those stored for 35 days, and from about 10% even after 63 days. At higher temperatures of 22ºC or 37ºC, viable HCV could still be recovered from a small percentage of syringes after two months.

The longer survival of HCV in syringes helps explain why HCV transmission occurs ten times more often than HIV transmission from accidental needle sticks, and why harm reduction measures such as needle exchange have reduced HIV incidence more than new HCV incidence.

At an accompanying press conference Paintsil said that while it might be advisable for needle exchange programs to offer smaller insulin syringes, some individuals (for example, transgender people who inject hormones) want larger syringes, and the most important thing is to provide enough so that people never have to share.

Understanding how long HCV can survive outside the body can inform practices to reduce the risk of viral transmission. According to Krawczynski and colleagues, “The potential for HCV to survive in the environment re-emphasizes the importance of cleaning and disinfection procedures, safe therapeutic injection practices, and harm reduction counseling and services for injection drug users.”

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Healthwise: Planning for the Future
—Lucinda K. Porter, RN

It is always sad when I hear that someone I know has died from chronic hepatitis C virus infection (HCV).  Recently, I learned of the death of an acquaintance.  This death was particularly tragic to witness as this person held a low opinion of Western medicine and elected to stick with herbs.  In January, she sought my opinion, and I told her that although I respected the well-researched use of alternative medicine, her symptoms were extreme; I urged her to seek immediate medical help.  She did see a physician, but in the end she chose alternative methods.  

Those close to this woman are having difficulty with her decision to favor alternative over Western medicine.  My opinion is simple: her choices are none of my business.  She lived a consistent life, choosing herbs over chemicals.  She may have died young, but she lived and died by her rules. 

I have witnessed the opposite when people demand expensive, painful interventions with little or no evidence supporting a favorable outcome.  When my mother was dying, she chose procedures that I don’t think I would have undergone.  As her advocate, I supported her wishes. 

It is not the choices that people make that bothers me.  Rather, I am rattled when people don’t make plans about end-of-life care.  This is such an important event; why let others make the decisions?  Thinking about death is uncomfortable, but leaving it to others to decide our fate may actually be worse.  To me, it is like the dead tree I have in my yard.  Last year it looked sick, but I hoped it would rally.  This year it is clearly dying.  I can ignore it, but it could fall down on the structures around it, leaving me with a bigger mess and expense.  Alternatively, I can have it removed, controlling the amount of damage and expense I incur.  The tree service comes tomorrow.

Plans we make about end-of-life care are called advance directives.  These are legal documents that state our wishes in advance.  By declaring our preferences ahead of time, we don’t have to think about it when we are ill.  Advance directives communicate our desires to our family, friends, and medical team. 

The main components of advance directives may include any or all of the following:

  • Do not resuscitate orders
  • Power of attorney for healthcare (has multiple labels, such as proxy, agent or durable power of attorney for health)
  • A living will (aka health care directives or declarations)

A do not resuscitate order (DNR) means that if I stop breathing or my heart stops, cardio-pulmonary resuscitation (CPR) would not be started.  A DNR is appropriate for those who do not want to be revived under certain circumstances.  A DNR is often not part of a person’s advance directives.  For instance, if I had a heart attack right now, I would want to be resuscitated.  I don’t have a DNR order.  However, when my mother was dying, she wanted to pass away at home and in peace, not wanting handsome paramedics pounding on her chest.  She had a DNR.  If anyone had tried to resuscitate her, she would come back from the dead and haunt them forever. 

A medical power of attorney (POA) appoints someone to carry out your wishes for you in the event that you are unable to.  If I had a heart attack and did not regain consciousness, then my POA would advocate for my wishes.  If it was determined that I had severe brain damage and the only way to keep me alive would be by resuscitation, then my POA would speak out according to my desires.  I have already conveyed to my POA that I don’t want to be kept alive under those circumstances, so CPR would not occur.  The POA does not decide for me; the POA is merely advocating for what I want.

A living will expresses what you want or do not want at the end of life.  Living wills can be simple or extensive.  You may state your preferences about resuscitation, artificial respiration, tube feeding, dialysis, pain control, and the like.  Wishes about organ and tissue donation may be included.  Since it is difficult to cover every possible circumstance, it is advisable to also appoint a medical power of attorney.

Here are some suggestions to get you started:

  • Research the various options.  A list of resources is provided at the end of this article. 
  • Talk to your loved ones about your wishes.  If you tell others about your preferences, some states will honor these in case you don’t complete the paperwork.
  • Ask someone to be your POA.  This may be your spouse, another family member, or a friend.  Your medical provider may not fill this roll.
  • Do the paperwork. 
  • Make copies of your advance directives; give copies to your POA, physician (s), and loved ones who may be most affected.  Keep a copy for yourself. 

Do not keep your advance directives in a bank safe deposit box.  Easy and quick access will help if there is a medical emergency.  My mother kept a copy in a sealed bag in the refrigerator with a huge red DNR magnet on the door.  That’s not happening on my refrigerator for a long time—it does not go with the décor.  However, I do have a copy on my computer and in my file cabinet.  Really organized people have copies on their handheld mobile devices. 

A few more things to keep in mind regarding advance directives:

  • You may revoke your advance directives at any time simply by telling your physician. 
  • Make sure you use forms that are legal for your state.  For instance, the Five Wishes form listed under Resources at the end of this column is fabulous, but not legal in 8 states.  You can still use the document to help you fill out your advance directives, but you need to complete the paperwork on the proper form for your state. 
  • Follow your state’s legal requirements regarding signature witnessing.  Some states require a signature witness who is not a family member; some require notarization of advance directives.  This means going to a notary public.  Notaries are listed in the phone book. 
  • Review the document on a regular basis and modify if necessary.  I review my advance directives after completing my income taxes, reminded by the saying “you can’t avoid death or taxes.”

Although only a small percentage of those with HCV will die from this virus, all of us will die from something.   Although you can’t control your death, you may be able to control some of the terms.  Don’t get caught unprepared for this event of a lifetime.



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HCV Snapshots
—Lucinda K. Porter, RN
—Alan Franciscus, Editor-in-Chief

This Month’s “HCV Snapshots” includes studies on shortening HCV treatment duration for people with HCV genotypes 2 and 3, the incidence and clearance of HCV in the blood donor population, treatment of NASH with vitamin E and a type-2 diabetes medication and using  lactic acid levels for dosing ribavirin in people who are being treated for hepatitis C who are coinfected with HIV and hepatitis C. 

Article: Identifying Hepatitis C Virus Genotype 2/3 Patients Who Can Receive a 16-Week Abbreviated Course of Peginterferon Alfa-2a (40KD) plus Ribavirin by Moises Diago , Mitchell L. Shiffman, Jean-Pierre Bronowicki, Stefan Zeuzem , Maribel Rodriguez-Torres , Stephen C. Pappas , Andreas Tietz , David R. Nelson

Source: Hepatology June 2010; Vol. 51 Issue 6  

The standard length of treatment for chronic hepatitis C virus (HCV) infection is determined by genotype. Genotype 1 patients are generally treated for 48 weeks, although some may receive longer courses; genotype 2 and 3 patients are usually treated for 24 weeks.

In this study, 1309 genotype 2/3 patients had viral load tests done 4 weeks after starting peginterferon alfa-2a and ribavirin. Those who had a rapid virological response (RVR), meaning no detectable virus at week 4, were assigned to one of two groups. There were 863 subjects who had an RVR, and they were assigned to either: A) 24 weeks of treatment (405 subjects), or B) 16 weeks of treatment (458 subjects).

The goal was to compare the sustained virological response (SVR) between both groups. SVR occurs when no viral load is detected 6 months after HCV treatment is completed.  Patients with no detectable HCV are considered to have an SVR.

The results overall were that those who were treated for 24 weeks were more likely to achieve SVR (91% versus 82%; P = 0.0006). This was particularly true for those with genotype 2 (92% versus 81%; P = 0.0010), and less so for those with genotype 3 (90% versus 84%; P = 0.1308).

What was interesting was information gathered about some of the subsets. Those with a viral load of 400,000 IU/mL or less had similar SVR rates in both the 24 and 16 week groups (95% and 91%; P = 0.2012). Overall, those who were more likely to have an SVR after 24 weeks of treatment had absence of advanced fibrosis on liver biopsy (P = 0.0032), lower viral loads (P = 0.0017), and lower body weight (P < 0.0001).

The Bottom Line: For genotype 2/3 patients, the 24-week standard of care is better than 16 weeks. However, 16 weeks of treatment may be worth future consideration for patients with a low baseline viral load who achieve an RVR.

Article: Hepatitis C Virus Prevalence and Clearance among US Blood Donors, 2006–2007: Associations with Birth Cohort, Multiple Pregnancies, and Body Mass Index by Edward L. Murphy, Junyong Fang, Yongling Tu, Ritchard Cable, Christopher D. Hillyer, Ronald Sacher, Darrell Triulzi, Jerome L. Gottschall, Michael P. Busch

Source: The Journal of Infectious Diseases August 15, 2010; Vol. 202, No. 4

HCV is the most common blood-borne disease in the United States. Anyone who received one or more blood transfusions prior to 1992 is at risk for HCV. Since that time, the presence of HCV in the blood supply in the U.S. has been extremely low, although current data are lacking. 

The incidence of HCV antibodies (anti-HCV) among U.S. blood donors was 0.36% in 1992–1993. Using this as a point of comparison, this study looked at a cross-section of blood donors from 6 U.S. centers during 2006-2007. Researchers measured HCV antibody (anti-HCV) and viral load (HCV RNA).

Of 959,281 donors, anti-HCV was detected in 695 donors (0.072%). Of those, 516 (74%) had positive viral loads. Compared to the 1992–1993 period, the prevalence during 2006–2007 was lower. Additionally, the researchers found that anti-HCV was associated with a body mass index (BMI) >30. Also, women with higher pregnancy rates were more likely to test positive for anti-HCV.  A negative HCV viral load was associated with black race and completion of high school.

The Bottom Line:  Overall, HCV prevalence among U.S. blood donors is decreasing. There is a higher prevalence of HCV antibodies among the obese and women with multiple births. Researchers speculate that there may be genetic factors that explain the differences in viral load clearance among black donors.

Article: Pioglitazone, Vitamin E, or Placebo for Nonalcoholic Steatohepatitis by Arun J. Sanyal, Naga Chalasani, Kris V. Kowdley, Arthur McCullough, Anna Mae Diehl, Nathan M. Bass, Brent A. Neuschwander-Tetri, Joel E. Lavine, James Tonascia, Aynur Unalp, Mark Van Natta, Jeanne Clark, Elizabeth M. Brunt, David E. Kleiner, Jay H. Hoofnagle, Patricia R. Robuck

Source: New England Journal of Medicine May 6, 2010; Vol. 362 No. 18

Nonalcoholic steatohepatitis (NASH) is a common liver disease caused by an accumulation of fat in the liver cells. It may progress to cirrhosis. Weight loss and diet changes are recommended for NASH patients, but otherwise there is no established treatment for it.

In this study, 247 non-diabetic adults with NASH were randomly assigned to three groups. Every day for 96 weeks, subjects in each group received either A) pioglitazone—a type-2 diabetes drug (30 mg)— B) vitamin E (800 IU), or C) placebo. The objective was to look at the condition of the liver tissue before and after the study period.

The results showed significant improvement for the group taking vitamin E compared to those taking placebo (43% vs. 19%; P=0.001). The group taking pioglitazone compared to placebo did not have a significant improvement (34% vs. 19%; P=0.04).

The Bottom Line: Vitamin E may be useful for the treatment of fatty liver disease.

Article: Mitochondrial Toxicity Is Associated with Virological Response in Patients with HIV and Hepatitis C Virus Coinfection Treated with Ribavirin and Highly Active Antiretroviral Therapy by Thomas Reiberger, Lana Kosi, Judith Maresch, Florian Breitenecker, Berit Anna Payer, Fritz Wrba, Armin Rieger, Alfred Gangl, and Markus Peck-Radosavljevic

Sources: The Journal of Infectious Diseases July 2010; Vol. 202, Issue 1
Reuters Health Information by Will Boggs, MD June 24, 2010

Patients who are coinfected with HIV and HCV face multiple medical issues, particularly when it comes to HCV treatment along with the use of antiretroviral medications. This study looks at one of the potential adverse events, mitochondrial toxicity (MT), the damaging of the cell’s mitochondria—the power plant of the cell. If mitochondria are damaged, lactic acid levels increase.  MT is a serious, potentially fatal condition, and the signs are muscle weakness, nausea, vomiting, severe fatigue, rapid, deep breathing, cramps, muscle aches and numbness or tingling. The use of ribavirin along with highly active antiretroviral therapy (HAART) may cause MT.

This study followed 64 subjects all coinfected with HIV/HCV, who were treated with HCV medications, peginterferon and ribavirin , and assessed for MT. Those who were on HAART regimens (48 subjects) had higher levels of lactic acid than those not receiving HAART (16 subjects); the higher the ribavirin dose, the greater the lactic acid levels.

Interestingly, patients who experience MT during HCV treatment had significantly better response rates at week 4 compared to patients without MT (51% vs. 21%; p = 0.015). Also, patients who had MT were more likely to have an SVR than those who did not have MT (73% vs. 44%; p = 0.031).

The Bottom Line: One of the study’s investigators, Dr. Peck-Radosavljevic, noted the potential of this study as a possible tool for customizing ribavirin doses. “Adjusting the ribavirin-dose according to plasma levels has already been shown to be an effective means of getting optimal response, but this is technically demanding and not widely available,” Dr. Peck-Radosavljevic said. “Instead, ribavirin dose could be titrated according to lactate levels, which are much easier to obtain. Do not be afraid of treating HIV-HCV coinfected patients under HAART with full-dose PEG-IFN/ribavirin just like you would treat any HCV-monoinfected patient.

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