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April 2013 HCV Advocate

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In This Issue:

Snapshots: CROI Conference 2013
Lucinda K. Porter, RN

HCV and Tattoos
Alan Franciscus, Editor-in-Chief

HealthWise: - Hepatitis C: How to Talk to Us
Lucinda K. Porter, RN


New Treatments Ahead for HIV/HCV Coinfection
Liz Highleyman


Alcohol Use and Hepatitis C
Alan Franciscus, Editor-in-Chief


HCV Advocate Eblast
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Snapshots: CROI Conference 2013
—Lucinda K. Porter, RN

This month’s Snapshots features news from the March 2013 Conference on Retroviruses and Opportunistic Infections (CROI). There are so many interesting studies, I had trouble choosing which to discuss. To read more studies, visit
www.retroconference.org/2013

Since these Snapshots were gathered from conference posters, presentations and abstracts, these data represent part of the story. Unless and until these studies are published in a peer-reviewed journal, these data and conclusions are considered preliminary.

Research: STARTVerso 4:  High Rates of Early Virologic Response in HCV Genotype 1/HIV-Co-infected Patients Treated with Faldaprevir plus PegIFN and RBV
Authors: Douglas Dieterich, et al.

Summary: These 12-week interim data of HIV/HCV, genotype 1 co-infected patients using faldaprevir with PegIFN/RBV showed an 80% response rate. Patients who relapsed from prior treatment had 91% response rates at week 12. There were 308 subjects in this study; 239 were treatment-naïve and 69 were responder-relapsers.

The most frequent side effects were nausea (37%), fatigue (33%), diarrhea (27%), headache (23%), and weakness (22%). Serious adverse events occurred in 32 patients (10%), including three deaths. To date, 18 patients have discontinued because of side effects. The safety results of this study were comparable to those observed in HCV mono-infected treatment-naïve patients in prior faldaprevir clinical studies.

Editorial Comment: These data are impressive, but the safety profile is disturbing.  IFN-free faldaprevir studies are in progress, and if the efficacy rates hold, coupled with improved safety profiles, we will have something to sing about. 

Research: Telaprevir Combination Treatment in Hard-to-treat African American, Null Responder G1 Chronic Hepatitis C Patients: Early Data from the OUTLOOK Study
Authors: Steven L. Flamm, et al.

Summary: African Americans with genotype 1, hepatitis C virus (HCV) infection have lower response rates to treatment using peginterferon (Peg-IFN) and ribavirin (RBV). The purpose of this phase 3 study is to evaluate the safety and efficacy of telaprevir (TVR), Peg-IFN, and RBV in African Americans with genotype 1, HCV who did not have a previous sustained viral response (SVR) from prior treatment with Peg-IFN and RBV. The data analyzed 34 subjects.

This early data from week 12 showed 59% of those receiving TPR, Peg-IFN and RBV had undetectable virus. Most had a treatment-resistant IL28B CT/TT subtype. Those with cirrhosis were less likely to have a response by week 12.

Editorial Comment: Although these are early and small data, I am cautiously encouraged. These numbers are a significant improvement for this hard-to-treat group. Now we need to get better numbers for those with cirrhosis.

Research: 12 Weeks of ABT-450/Ritonavir, Non-nucleoside Inhibitor and Ribavirin Achieved SVR24 in >90% of Treatment-naïve Hepatitis C Virus GT1 Patients and 47% of Prior Non-responders
Authors: Eric Lawitz, et al.

Summary: This study assigned 61 HCV genotype 1, non-cirrhotic patients into one of four interferon-free groups: ABT-450/r (an NS3 protease inhibitor with low-dose ritonavir) once daily plus ABT-072 once daily or ABT-333 twice daily (non-nucleoside NS5B polymerase inhibitors), plus weight-based ribavirin (RBV) twice daily. Treatment duration was 12 weeks for everyone.

SVR24 rates after 12-weeks of treatment were greater than 90% among treatment-naïve patients and 47% for prior non-responders. One relapse occurred more than 24 weeks after end of treatment. Treatment was well-tolerated, with no deaths or serious adverse events. Side effects were generally mild or moderate.

Editorial Comment: Although these are small numbers, they are notable ones. The safety profile really stands out, making this regimen one to watch for as more research is published. Although this study used mostly genotype 1a patients, they mostly enrolled white subjects. The majority had the more favorable IL28B CC genetic type. I would like to see data using more African Americans, cirrhotic patients and HIV/HCV co-infected patients.

Research: ELECTRON: 100% SVR Rate for Once-Daily Sofosbuvir Plus Ledipasvir Plus Ribavirin Given for 12 Weeks in Treatment-Naïve and Previously Treated Patients with HCV GT 1
Authors: Edward Gane, et al.

Summary: The goal of this interferon-free study is to evaluate the safety and efficacy of sofosbuvir (formerly GS-7997), ledipasvir (formerly GS-5885), and ribavirin in genotype 1 HCV patients who were either treatment-naïve or null responders to prior treatment. In the group using sofosbuvir and RBV, there were 25 treatment-naïve subjects and 10 null responders.  In the group using sofosbuvir, ledipasvir and RBV, there were 25 treatment-naïve subjects and 9 null responders. 

Week 12 post-treatment results: 100% SVR for both treatment-naive patients and prior non-responders in the sofosbuvir, ledipasvir and RBV group. In the group without ledipasvir, the SVR rate for treatment-naive patients was 84% and 10% for prior non-responders. More than 80% had the more difficult-to-treat HCV subtype 1a and high viral loads. Most had treatment-resistant IL28B genetic make-up.

Editorial Comment: These data are small but encouraging. One thing worth noting, in this study, SVR12 is considered a cure. It seems to me that it is hard enough for us to believe we are cured after 24 weeks, so I will be interested in seeing how we react to 12 week SVRs. Plus, my confidence was somewhat shaken by the fact that there was a post 24 week relapse in the ABT-450/r study mentioned above.


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HCV and Tattoos
—Alan Franciscus, Editor-in-Chief

The risk of acquiring hepatitis C (HCV) from receiving a tattoo has been a controversial topic ever since the hepatitis C virus was discovered in 1989.  The controversy stems from the high prevalence of HCV in people who have tattoos.  The data directly linking tattooing to HCV, however, has not been scientifically rigorous enough to give us a clear answer one way or the other.  The reality is that it would be almost impossible to directly link tattooing to HCV transmission unless there was an outbreak of HCV at a tattoo parlor.  The association between receiving a tattoo and acquiring HCV is a different story because we know that many people with hepatitis C have tattoos.  But even trying to prove the association between HCV and tattoos has yielded mixed results.  Earlier this year, however, a study was released that provides more evidence of the association between tattoos and HCV:  “Association of Tattooing and Hepatitis C Virus Infection:  A Multicenter Case-Control Study,” by K Carney and colleagues.1 

The study analyzed records from 3 New York City primary and gastroenterology clinics.  Three thousand eight hundred and seventy-one patient records were analyzed—1,930 with chronic hepatitis C and 1,941 without HCV.  The study period was April 2004 to May 2006.  After excluding people who had a history of injection drug use or a blood transfusion before 1992, 465 HCV positive patients and 1,421 people without HCV (control) remained to analyze using a self-administered questionnaire.  Two different questionnaires were used—one for HCV positive participants and another questionnaire for HCV negative participants.  The questionnaires were anonymous to encourage the patients to answer truthfully.   

After analyzing the responses to the questionnaires, the authors reported that in the HCV patients who did not have traditional risk factors there was a significant association between HCV and receiving a tattoo.   

It is important to keep this study in context:  There is a significant risk of getting a tattoo in a non-commercial setting where there is no attention to safety, such as in prisons, on the streets, parties, etc.  In a commercial setting that follows blood borne pathogen safety practices—new needles, separate ink pots, autoclaving and other safety practices—the risk of transmitting hepatitis C is virtually non-existent. 

Reference:
1 Hepatology: epub ahead of print. DOI: 10.1002/hep.26245

For more information about HCV and tattoos visit:
www.hepatitistattoos.org
http://hepatitistattoos.blogspot.ca/

 

We recommend only commercial tattoo artists who practice the following:

  • Use only new sterilized needles and separate ink pots

  • Make sure equipment doesn’t come into contact with anything else that could spread an infection

  • Sterilize any equipment that may come into contact with blood

  • Use safety gloves

  • Clean and disinfect surfaces

  • Cover a fresh tattoo with a dressing to prevent infection or disease transmission

  • Safely dispose of any materials that come into contact with blood

  • Check your tattoo regularly to make sure it has not become infected



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HEALTHWISE: Hepatitis C: How to Talk to Us
—Lucinda K. Porter, RN

It's April, the month that has my favorite unrecognized holiday—April Fool's Day. Long-time HCV Advocate readers know that April is when I let loose my hepatic humor and jaundiced jokes. April is when Alan Franciscus rolls his eyes and wonders if Dave Barry might be available to write future columns.

Pondering my April column, I wondered if I had run out of humorous things to say about hepatitis. I might be forced to make gall bladder jokes. However, I got a big break: Stanford informed me that I qualified for an interferon-free hepatitis C clinical trial. I felt like I hit the lottery. Let's face it, nothing is more hilarious than me on hepatitis C treatment.

I told my colleagues at The Advocate and naturally, they were all happy for me. However, I noticed little hints of concern. One person mentioned that she'd be sure to double check my work. Someone else asked me to look at a project before I went "gaga" from the medication. I assume he meant lose my mind, rather than start wearing Lady Gaga outfits. I've never looked good wearing meat.

These are my dear friends and humor is as much a part of our work together as hepatitis C advocacy is. They all have or have had hepatitis C. They know me, this disease, and the rigor of treatment. More importantly, they know what to say and not to say to someone who has hepatitis C. Unfortunately, unless you have hepatitis C, and most especially if you have been through treatment, it is hard to know what to say to someone with this disease.

This month, I present my "Ten Things Not to Say to Someone with Hepatitis C" and "Ten Things to Say to Someone with Hepatitis C" lists. In the spirit of full disclaimer, ribavirin is setting in, so if I sound caustic, it is because I am.

Let's start with ten things not to say to someone with hepatitis C, especially if they are going through treatment:

  1. "That is a really nasty looking rash." Yes, we get nasty looking rashes, but we are hoping it doesn't look as bad to you as it does to us. Pretend you don't notice it.

  2. "Should I call 911?" Sometimes we look and act as if we are on death's door. We may get light-headed or have shortness of breath after walking up a flight of stairs. However, we are more resilient than you think we are. However, if we have chest pain, call 911.

  3. "Your problem is that you aren't a positive thinker. If you change your attitude, you would feel better." Excuse me, but I am positive. I am positive that if you knew what I was feeling, you wouldn't say such a stupid thing.

  4. "Try this herbal drink—Liver Detox—I know people who cured hepatitis C with this stuff." I appreciate your concern, and I wish that there were a miracle cure. However, don't you think that if Liver Detox worked, that venture capitalists would have bought the company by now?

  5. "If you just got some exercise, you would feel better." This is probably true, but I don't want to hear this unless it comes from other patients. 

  6. "You are so lucky that you can take time off from work and stay in bed all day." Would you like to switch places?

  7. "Are you losing your hair?" No, I am simplifying my life by trying to get rid of some excess hair. 

  8. "My (insert relative) had hepatitis C, and he/she was cured by a psychic healer." This may or may not be true, but in either case, it isn't helpful. We all make our own choices about how to manage hepatitis C. My choice is to try antiviral drugs. I am not sure what your intention is when you tell me that a relative chose another path, but it feels like you may be criticizing my choice. 

  9. "You must be feeling better, otherwise you wouldn't be here." Sometimes we push ourselves. We don't feel better, but we are sick and tired of feeling sick and tired, so we force ourselves to show up for work, social events, and other activities. Don't assume that because we do these things we are feeling good.

  10. "You look really good." We feel awful and when you say that, are you suggesting that we are lying about our health? If you want to cheer me up, it is best not to say anything about how I look.

Ten things to say to someone with hepatitis C, especially if they are going through treatment:

  1. "I imagine this is hard. How can I support you?" Many patients may not have a direct answer for this, but we like to be asked this question.

  2. "You look better than I thought you would, but looks can be deceiving. How are you feeling?" Feeling unwell is complicated. We want to look attractive, but not look so good that you can't tell that we are sick. By phrasing the question this way, it allows us to tell you how we are feeling and soothes our need to look attractive.  

  3. "I'd love to bring lunch over, but only if you feel up to it. If we get together, promise me you won't clean the house. I will only stay 30 minutes." This is concrete. The patient is off the hook, you will provide the food, and you set a short time limit on the commitment.

  4. "When I am at the store, may I pick up some groceries for you?" This tells me that you aren't going out of your way, and makes it easier for me to accept the offer.

  5. "Do you want to talk about how you are doing, or would you rather we talk about something else?" Sometimes we feel ignored when no one asks how we are doing, but sometimes we'd rather be distracted by talking about other things.

  6. "I made some extra soup. I'd like to bring it by later. If you don't want it now, you can always freeze it." It's hard to say "no" when it's put this way.

  7. "Just emailing to let you know that I am thinking about you and I hope your treatment goes well. No need to reply." It feels good to be thought about without having to answer an email.

  8. "I am free on Thursday. How about I come by to help with the laundry or run some errands." We are proud, and often reluctant to accept help. Stated this way, I might accept the offer.

  9. "You are amazing." We feel so bad, that we forget this simple truth. Anyone who has hepatitis C or goes through its treatment is amazing.

  10. "Do you want to hear a great joke?" This won't work for everyone, but it is a surefire way to make me feel better.

This is the third time I've gone through treatment, and I know it is hard on family and friends. They don't know what to say, so I try to be patient. My patience is running thin, so I just might give them these lists.

Lucinda K. Porter, RN, author of Free from Hepatitis C is a long-time contributor to the HCV Advocate. Her blog is
http://lucindaporterrn.com


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New Treatments Ahead for HIV/HCV Coinfection
—Liz Highleyman

Two experimental HCV protease inhibitors added to interferon-based therapy look promising for HIV-positive people coinfected with hepatitis C, according to studies presented at the Retrovirus Conference last month in Atlanta.

Other studies show that the currently approved boceprevir (Victrelis) and telaprevir (Incivek) improve treatment response for HIV/HCV coinfected prior non-responders, while telaprevir doubles the success rate in half the time for HIV-positive men with acute hepatitis C.

First-generation HCV Protease Inhibitors
The Conference on Retroviruses and Opportunistic Infections (CROI) is one of the major annual HIV meetings, and last year it started including research on HCV in HIV-negative people as well, reflecting the ongoing shift of hepatitis C management from hepatologists and gastroenterologists to infectious disease doctors.

Douglas Dieterich from Mt. Sinai School of Medicine presented study findings at two oral sessions on hepatitis C treatment. Approximately 20% to 30% of people with HIV are coinfected with HCV, he said. HIV-positive people experience more rapid liver disease progression, and liver-related complications are a leading cause of death among people with HIV.

HIV/HCV coinfected people also do not respond as well to interferon-based therapy. The 2004 APRICOT study showed a coinfection response rate of 29% for HCV genotype 1 patients using pegylated interferon/ribavirin, compared with just under 50% for people without HIV.

Adding one of the approved direct-acting antiviral agents raises sustained virological response (SVR) rates for previously untreated genotype 1 coinfected people, up to 61% with boceprevir or 74% with telaprevir—very similar to SVR rates for treatment-naive people with HCV alone.

These first-generation HCV protease inhibitors are difficult to take and come with added side effects, but they can have acceptable safety and raise the odds of treatment success even for difficult-to-treat coinfected patients, many of whom have advancing liver disease and cannot afford to wait for new options.

The French National Agency for AIDS Research (ANRS) designed a pair of trials to test the safety and efficacy of triple therapy for this population. While only 16-week on-treatment data are available, results look promising so far.

Isabelle Poizot-Martin presented findings from the BocepreVIH Study (abstract 37), which enrolled 64 genotype 1 HIV/HCV coinfected prior non-responders. Most were white men and the median age was 49 years. More than 75% had hard-to-treat HCV sub-type 1a and 17% had liver cirrhosis (stage F4). There were similar proportions of prior null responders, partial responders, and post-treatment relapsers, though null responders with cirrhosis were excluded.

They had well-controlled HIV with a median CD4 T-cell count of 728 cells/mm3 and mostly undetectable HIV viral load. Based on information—or lack thereof—about drug-drug interactions with antiretrovirals, participants had to be taking specific nucleoside/nucleotide analogs with ritonavir-boosted atazanavir (Reyataz) or raltegravir (Insentress).

Participants received three-times-daily boceprevir plus pegylated interferon alfa-2b (PegIntron) and weight-based ribavirin for 48 weeks, with pegylated interferon/ribavirin alone—extended for an additional 24 weeks for slow responders.

After four weeks on treatment, 44% of participants had rapid virological response (RVR), and at 16 weeks, 63% overall had undetectable HCV RNA. This rose to 90% for prior relapsers, but fell to 38% for null responders. About one-third experienced serious adverse events and four people stopped treatment early for this reason. About 40% experienced anemia, but this was managed proactively with erythropoietin (EPO) and led to only one discontinuation. No HIV breakthrough occurred, despite a previously reported drug interaction with boceprevir that reduces HIV protease inhibitor levels.

Laurent Cotte reported parallel findings from the TelapreVIH Study (abstract 36), which looked at a demographically similar population of 69 coinfected non-responders with mostly HCV subtype 1a. Here, 16% had advanced fibrosis and 23% had cirrhosis; previous relapsers, partial responders, and null responders were well represented, but again null responders with cirrhosis were excluded. The median CD4 count was 630 cells/mm3, almost all had undetectable HIV viral load, and patients could take the same antiretrovirals with the additional option of efavirenz (Sustiva).

Participants received three-times-daily telaprevir plus pegylated interferon alfa-2a (Pegasys) and weight-based ribavirin for 12 weeks, then continued on pegylated interferon/ribavirin alone for 24 or 48 additional weeks, depending on early response.

Only 1.5% of participants had rapid virological response at four weeks, but by week 16 the response rate reached 88%. Type of prior non-response had a smaller effect than seen in the boceprevir study: 85% for relapsers, 100% for partial responders, and 86% for null responders. Most participants experienced some adverse events, including 70% with skin rash and 30% with anemia, and eight people discontinued treatment early for this reason.

Both studies are still at an early stage and follow-up will continue to determine whether HCV remains suppressed after finishing treatment, indicating a cure.

Acute Hepatitis C
Another telaprevir study by Daniel Fierer, also from Mt. Sinai, looked at treatment of HIV-positive men with apparently sexually transmitted acute HCV infection (abstract 156LB). Acute hepatitis C often has few or no symptoms, so most people do not seek treatment when they first become infected. But HIV-positive people on antiretroviral therapy receive regular liver function tests to monitor for drug toxicity, and unexplained liver enzymes may trigger hepatitis testing that reveals recent infection.

Treating hepatitis C during acute infection (within six months) leads to high SVR rates—up to 98% in one study of HCV monoinfected people treated with interferon monotherapy for 24 weeks. The decision to treat is not straightforward, as treatment comes with costs and side effects while approximately ~25% spontaneously clear the virus without therapy. But HIV-positive people are less likely to naturally clear HCV.

In an open-label pilot study, Fierer assessed whether adding telaprevir to pegylated interferon/ribavirin for 12 weeks could shorten treatment duration and improve response for HIV-positive gay and bisexual men with recent HCV coinfection. Most were white men with a median age in the mid-40s.

Half of the 40 participants initially enrolled were never treated, including several with HCV genotypes other than 1, no insurance that would cover telaprevir, or spontaneous HCV clearance. Most of the remaining 20 had HCV subtype 1a and an unusually high 65% had the favorable IL28B CC gene pattern.

An interim analysis showed that 85% had undetectable HCV RNA both at the end of treatment and at four weeks post-treatment (SVR4). This is too soon to say whether people are actually cured, but among participants with longer follow-up, 82% achieved SVR12 and 79% reached SVR24, with no relapses so far.

Fierer concluded that starting pegylated interferon/ribavirin treatment during acute rather than chronic HCV infection doubles the sustained response rate in half the time, and adding telaprevir is twice as good and cuts treatment time in half again. He suggested triple therapy should be the new standard of care for acute hepatitis C in HIV-positive gay men because “treatment is prevention.”

Next-generation Protease Inhibitors
While first generation HCV protease inhibitors can shorten treatment and improve efficacy relative to pegylated interferon/ribavirin alone, more tolerable, effective, and convenient options are in sight. Dieterich presented results from trials of two next-generation HCV protease inhibitors tested in combination with pegylated interferon and weight-based ribavirin.

The first Phase 3 trial looked at Janssen/Medivir’s simeprevir, formerly TMC435 (abstract 154LB). The study enrolled 106 HIV/HCV coinfected people, both hepatitis C treatment-naive and prior non-responders. Most were white men, the median age was 48 years, and about one-quarter were IL28B CC. About 80% had HCV subtype 1a, 12% had advanced fibrosis, and 9% had cirrhosis. Their median CD4 count was 629 and most had undetectable HIV viral load on an antiretroviral regimen containing raltegravir, but 12% had not yet started HIV treatment.

Everyone received once-daily simeprevir with pegylated interferon alfa-2a and weight-based ribavirin for 12 weeks, then continued on pegylated interferon/ribavirin alone through week 24. Using response-guide therapy (RGT), HCV treatment-naive people and prior relapsers with good early response stopped all study drugs, while slower responders, prior partial or null responders, and everyone with cirrhosis continued through week 48.

An interim analysis revealed an RVR rate of 66%. The preliminary SVR12 rate for RGT-eligible patients who finished treatment at week 24 was 77% overall (75% for treatment-naives, 80% for prior relapsers). A large majority of eligible participants (88%) met the RGT criteria and finished therapy at week 24, with an SVR12 rate of 75%.

Overall, 15% of patients experienced virological failure while on treatment and stopped early, with rates ranging from 0% for prior relapsers to 36% for prior null responders. Another 13% relapsed during post-treatment follow-up (10% of treatment-naives, 18% of prior relapsers); all relapses occurring in people with subtype 1a. Prior null responders were still being followed, but two-thirds had not yet experienced treatment failure at the time of the interim analysis.

Triple therapy with simeprevir was generally safe and well tolerated, with 5% of participants reporting serious adverse events and 4% discontinuing treatment for this reason; 21% developed anemia, 17% reported rash, and elevated bilirubin was common. None of the participants on antiretroviral therapy saw an increase in HIV RNA.

Dieterich also reported earlier findings, after 12 weeks of treatment, from the STARTVerso 4 trial, looking at Boehringer Ingelheim’s faldaprevir, formerly BI 201335 (abstract 40LB).

This Phase 3 trial enrolled 308 HIV/HCV coinfected people who were either not previously treated for hepatitis C (78%) or relapsed (22%). The study population was similar to that of the simeprevir study. Nearly 80% had HCV subtype 1a, 17% had compensated cirrhosis, and they had well-controlled HIV with a mean CD4 count of approximately 540.

About half were taking antiretroviral regimens containing raltegravir, with the rest split between efavirenz and boosted atazanavir or darunavir (Prezista); 4% were not on any HIV treatment. Drug-drug interaction studies (also reported at CROI, (abstract 527) showed that faldaprevir did not lower antiretroviral drug levels, but some antiretrovirals did raise or lower faldaprevir levels.

Participants received 120 or 240 mg once-daily faldaprevir (with doses varying according to antiretroviral regimen), plus pegylated interferon alfa-2a and weight-based ribavirin for 12 or 24 weeks. Using RGT, people with early treatment success were then re-randomized to either stop treatment or continue pegylated interferon/ribavirin alone through week 48, while the rest got the longer course.

After four weeks on treatment, 60% of previously untreated participants and 74% of prior relapsers had undetectable HCV RNA, rising to 82% and 91%, respectively, at 12 weeks. The relapsers’ 12-week response rate was similar to the 93% previously seen in the SILEN-C1 study of HCV monoinfected patients. Most people—77% of treatment-naives and 88% of relapsers—had early viral clearance and were eligible for shorter treatment.

Here, too, triple therapy was generally safe and well tolerated, with 10% experiencing serious adverse events and 18 participants withdrawing early due to adverse events; 18% developed anemia and 18% reported rash. Again, no one experienced an increase in HIV viral load.

A Significant Advance
At an accompanying press conference Dieterich said the combined findings were “very encouraging,” showing that HIV/HCV coinfected people have outcomes about equal to those of HCV monoinfected individuals, with similar SVR rates and tolerability. Next-generation HCV protease inhibitors “represent a significant advance” over boceprevir and telaprevir, he added, with reduced side effects and higher success rates.

Regardless of treatment type, curing hepatitis C not only reduces the risk of liver disease dramatically, but decreases HIV-related complications as well, Dieterich noted, emphasizing that while we wait for interferon-free regimens, “in the meantime we’re still seeing patients every day, and some are really sick and need to be treated now.”

Looking forward, press conference moderator David Thomas from Johns Hopkins compared the hepatitis C drug development timeline to HIV, stating, “It’s as if we’re going from Crixivan to Atripla in a year and a half.”


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Alcohol Use and Hepatitis C
—Alan Franciscus, Editor-in-Chief

It is a well-known fact that heavy alcohol use is detrimental to the health of people with chronic hepatitis C.  But what hasn’t been well documented is whether light or moderate alcohol use is harmful for people with hepatitis C (HCV). 

A recent study “Moderate, excessive or heavy alcohol consumption:  each is significantly associated with increased mortality in patients with chronic hepatitis C,” by Z.M. Younossi and colleagues1 confirms that heavy alcohol use is harmful to the liver of anyone infected with HCV, and it is also providing important information about the effect of moderate alcohol use on the liver of someone with hepatitis C (HCV). But in my opinion it comes with some caveats.

In the study, records of patients with and without hepatitis C were obtained from the Third National Health and Nutrition Examination Survey (NHANES III)—8,767 people who were HCV negative (comparator group) and 218 people who were HCV positive were included in the study.  The initial survey and mortality results were based on NHANES III records from 1988 to 1994. 

Alcohol consumption was assessed for the prior 12 month period.  The participants were asked if they consumed 12 drinks of alcohol in the previous 12 months and assessed for their lifetime drinking patterns.  The drinking patterns were defined as follows:

  • “Historical drinkers” as people who reported at least 12 drinks of alcohol in their entire lifetime, but no alcohol use in the past 12 months. 

  • People who never drank alcohol were considered as “never drinkers.” 

  • People who reported at least 12 drinks of alcohol in the past 12 months were classified as “current drinkers.”

The participants were then quizzed on the number of days and average number of drinks they consumed in the past 12 months.  The number of average days that alcohol was consumed and number of alcoholic drinks that were consumed was estimated and broken into grams based on the definition by NHANES—one drink was equal to 10 grams ethanol (alcohol):

  • 12-oz beer,

  • 4-oz wine or,

  • 1 oz liquor

 

Then the number of drinks/days were averaged for the past 12 months. 

The amount of alcohol consumed was then categorized as an average of alcohol consumed per day:

  • Moderate: 1 to 19 grams (g) of  alcohol

  • Excessive: 20 g or greater of alcohol

    • Subcategory – heavy alcohol consumption = 30 g or more

The follow-up time period was 162.95 months for the HCV group and 178.27 months for the comparator group.  The long-term health outcomes (all-cause deaths, cardiovascular and liver disease) between the two groups were compared.

The study authors reported that people with HCV had a “significantly higher risk for all-cause mortality.” Those who consumed excessive amounts of alcohol had a higher risk for overall death and liver-related deaths—two-fold to seven-fold increase depending on the amount consumed within the excessive category.

The damage caused by excessive consumption of alcohol in the study for people with hepatitis C is well-known and expected.  But for the first time it was found that people with HCV who consumed moderate amounts of alcohol were also at increased risk of death (two-fold increase). 

The study authors acknowledged that a weakness of the study was the small number of people with HCV in this study.

Comments:  Another weakness of the study is that the quantity of alcohol consumed was self-reported. It would also be interesting to know (but, of course, not possible) if the self-reporting was under reported—many people are likely to underreport the amount of alcohol they drank since alcohol use and abuse is perceived as a negative behavior.  Under reporting could be further compounded in the HCV group since most people with HCV know that they should not drink alcohol.   

At any rate, this is an important study that everyone with HCV should take note of and hopefully reduce or abstain from drinking alcohol.

Reference:
1 Aliment Pharmacol Ther, online edition. DOI: 10.1111/apt.12265, 2013.  


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