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January 2013 HCV Advocate

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In This Issue:

Top News of 2012
Alan Franciscus, Editor-in-Chief

HCV Snapshots
Lucinda K. Porter, RN

HealthWise: - Fifteen Years of HCV Advocacy
Lucinda K. Porter, RN

Review of "The Partner's Study"
CD Mazoff, PhD

AASLD 2012: Part 2
Alan Franciscus, Editor-in-Chief

Incivek Rash Warning!
Alan Franciscus, Editor-in-Chief

HCV Advocate Eblast
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Top News of 2012
—Alan Franciscus, Editor-in-Chief

It’s that time of year when the staff at the HCV Advocate pulls together our top news stories of the year.  Every year the decision of what to include in the list becomes more difficult—that is a really good thing!  This year, in particular, saw so many important news stories about the advances in HCV that it was difficult to pull together the list.  The first two news items tied for “First Place.”  The remainder of the list is not in any particular order. 

The top news item was a two-way tie between the direct acting antiviral (DAA) combination study results (without interferon), and the CDC ‘Baby Boomer’ testing recommendations. 

This year we saw results from phase II clinical trials of multiple interferon-free studies.   There were many, many reports that came out of this year’s American Association for the Study of Liver Diseases (AASLD) Conference about the new DAA clinical trial results from various DAA combination studies–Abbott, Boehringer Ingelheim, Bristol-Myers Squibb and Gilead, to name a few.  In addition to cure rates approaching 90 to 100%, the lower side effect profile (especially compared to PEG/RBV containing regimes) and shorter treatment duration mean that we are on the way to having an interferon-free HCV therapy that will likely be available in less than 5 years.  (See November 2012 Newsletter).

'Baby Boomer' Testing
In 2012 the Centers for Disease Control and Prevention published their recommendation for a one-time HCV antibody test for everyone born between 1945 and 1965.   If this is implemented it has the potential to identify 800,000 infections and save 120,000 lives. 

The remainder of the list contains important stories which are not in any particular order:

A milestone—GS-7977
The first ever interferon-free Phase 3 trial has been completed and the reported SVR12 rates for HCV genotype 2 was 93% and 61% for HCV genotype 3.  The next step will be compiling the clinical trial data and submitting it to the Food and Drug Administration for approval to treat people with HCV genotype 2 and 3.

Phase III studies (HCV mono-infection and HIV/HCV coinfection):
There are now 9 drugs in Phase 3 clinical trials in people who have HCV and 6 drugs in phase 3 studies to treat HCV in people with HIV.  It’s amazing how fast the new HCV medications are moving through the drug development process.  Many of these combinations hold the promise of higher cure rates and less side effects compared to the currently approved HCV protease inhibitor combinations with PEG/RBV.  (Check out our Drug Pipeline and www.clinicaltrials.gov).  

Deaths in Clinical Trials
The sad news this year was the deaths of 2 people who participated in HCV clinical trials.  This is the other side of the coin about clinical trials and it’s an important reminder that the clinical trials are conducted to find out if drugs are safe and effective.  Still, no one should die just because they are in a clinical trial.  Hopefully more information will be released to help to understand the deaths and why they happened.   

Outbreaks of HCV in Health Care Settings
The biggest outbreak in 2012 and one of the worst that has occurred was the outbreak at Exeter Hospital in New Hampshire.  David Kwiatkowski, a traveling medical technician, was charged with switching syringes—one filled with a pain killer was switched with one filled with saline solution.  Kwiatkowski is believed to have infected more than 30 people with hepatitis C.  In December, he pleaded not guilty to multiple charges that would, if he is convicted, lead to a possible prison sentence up to 98 years.  Mr. Kwiatkowski also worked in other hospitals—Arizona, Georgia, Kansas, Maryland, Michigan, New Hampshire, New York and Pennsylvania—and investigations are on-going in these medical centers.  What is troubling is that Mr. Kwiatkowski was caught switching syringes in another hospital, but he was not charged and there was no record of the crime.  This is because there are few regulations in place governing medical technicians and background checks are not available for potential employers to screen applicants.

First National Hepatitis Testing Day (May 18)
Testing initiatives occurred in over 20 cities across the nation and this has the potential to raise the level of awareness and diagnosis of hepatitis in the general population.  This will, hopefully, be expanded in the future to test and identify more people with viral hepatitis.   

First National Helpline
Finally, there is a national helpline for people with hepatitis C.  The national helpline is composed of various regional HCV organizations that can provide local support services to people in need.  The number is 877.help.4.hep—please distribute this number and information. 

Deaths of HCV surpassed HIV
A report was released in 2012 that looked at deaths from hepatitis C and HIV between 1999 and 2007.  It was found that the annual deaths from HCV (15, 106) surpassed deaths from HIV (12, 734).   The report also found that deaths from HBV were 1,815 and many of the HCV and HIV deaths were in people who had coinfections.

Since deaths of HCV have surpassed deaths from HIV—where’s the money to fund HCV? (See the May HCV Advocate)

Canadian Management Guidelines
For our friends up North, the Canadian Government finally issued HCV management guidelines that included recommendations for the use of boceprevir and telaprevir. The guidelines also stated that “Currently in Canada, a relatively small number of physicians treat hepatitis C, leading in some cases to prolonged wait times for patients before being adequately evaluated and treated.”  Their recommendations included increasing training and funding for more medical providers to effectively tackle the burden of hepatitis C.  The same can be said for the United States.   

DAA’s and Transplant Patients
There was really good news this year about treating transplant patients with the new DAA’s plus PEG/RBV.  Treatment for some was successful and now there are new studies with DAA’s to treat hepatitis C pre- and post- transplant.  This is indeed hopeful news for people who are at the highest need for treatment

U.S. Preventive Task Force Recommendations
The USPTF released their draft recommendations for testing at-risk adults for hepatitis—a positive grade B recommendation—but only a lowly grade C for testing HCV among the ‘Baby Boomer’ population.  The good news is that this decision has spurred a great deal of HCV advocacy nationwide.  Hopefully, all the advocacy from the HCV community will translate into a change in the ‘Baby Boomer’ recommendations that could be the tipping point to identifying the thousands of people with hepatitis C who can then seek medical care and  guidance. 

Honorable mention: 
In years past, coffee consumption has been shown to decrease the risk of fibrosis and liver cancer.  In 2012 we continued to see reports on the beneficial effects of caffeine.  It’s very reassuring that some things that taste so good are good for you also!  

The OraQuick Rapid HCV Antibody Test is still pending FDA approval.  Hopefully, it will be approved shortly—it is going to be another game changer. 

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HCV Snapshots:
—Lucinda K. Porter, RN

Article: Accessing Hepatitis C Patients Who Are Difficult to Reach: It Is Time to Overcome Barriers by P. Bruggmann (Note: This is a review article rather than research article, but because it addresses important points, it is included in this month’s HCV Snapshots.) 
  Source: Journal of Viral Hepatitis December 2012; Volume 19, Issue 12, pages 829–835

This article reviewed the existing literature on barriers to care of patients with chronic hepatitis C virus (HCV) infection and summarized measures to overcome these obstacles. The author observed the following:

  • Regarding HCV treatment, only a small proportion of HCV-infected patients are reached.
  • Treatment rates are lowest in groups with the highest risk—people who inject drugs (PWID).
  • There is little literature showing that PWID are screened for HCV.
  • There are multiple barriers to HCV screening and treatment, such as access to health care, no medical insurance, etc.  
  • Fears related to liver biopsy and HCV treatment side effects, coupled with stigma associated with this disease are patient-centered obstacles.
  • Provider-related obstacles include poor training and insight around issues related to managing common HCV patient issues, including treatment.

The Bottom Line: Overcoming barriers to HCV care involves multiple approaches.  Studies have shown ways to improve HCV management among PWID. HCV education needs to be increased among primary medical providers and addiction specialists. National coordination of action is needed, and needed now.

Editorial Comment: I appreciated that this review mentioned stigma as an obstacle to care. Education may help with this. Perhaps our refusal to be stigmatized may also contribute to pushing us past this needless obstacle.

The following snapshot was written before the FDA and Vertex issued a safety alert that Incivek (telaprevir) can cause serious skin rashes that could be fatal.  See our article on this on page 9 of this issue and follow the link at the end to read the press release from Vertex.

Article: Telaprevir-Related Dermatitis by Roujeau JC, Mockenhaupt M, Tahan, S, et al.
  Source: Archives of Dermatology Published online November 2012

This study evaluated the incidence, type, and severity of telaprevir-associated skin reactions among subjects enrolled in Phase 1 to 3 studies using telaprevir triple-therapy for treatment of HCV.

More than half (56%) of patients who received telaprevir as part of hepatitis C treatment experienced rashes compared with patients receiving peginterferon and ribavirin alone (34%). Rash severity was ten times greater among patients taking telaprevir. More than 90% of cases were diagnosed as a treatment-related rash (itchy eczematous dermatitis). However, the remaining 10% were potentially life-threatening: three cases of Stevens-Johnson Syndrome (SJS), and 11 cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS); 2 likely cases of SJS and 3 of DRESS.

The Bottom Line: This study affirms earlier ones describing the high incidence of telaprevir-related skin problems along with the potential for serious, potentially life-threatening risk of DRESS or SJS which signal the need for constant surveillance of patients taking telaprevir.

Editorial Comment: HCV treatment-related rashes that aren’t life-threatening will still affect quality of life.  Rashes respond better to early, pro-active management. For more information, see HCV Treatment Side Effect Management: Rashes or A Guide to Help You Assess and Manage Rash

Article:  FDA Approves New Indication for PROMACTA (eltrombopag) (Note: This next HCV Snapshot is from a press release rather than scholarly journal. Normally I don’t summarize press releases, but this is worth mentioning.)
  Source: GlaxoSmithKline press release Nov. 19, 2012

A side effect of interferon used for HCV treatment is low platelet counts (thrombocytopenia).   Up to 3.5% of HCV patients have platelet counts <75,000/µL, which could make them ineligible to start or maintain their interferon-based treatment. Although medical providers have used eltrombopag off-label, this medication is now approved for patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon therapy or limits the ability to maintain optimal interferon-based therapy.

CAUTION: Safety and efficacy have not been established in combination with direct-acting antiviral agents approved for treatment of chronic hepatitis C genotype 1 infection. Since eltrombopag may cause serious liver damage, patients need close medical supervision.

The most common side effects are: anemia, fever, fatigue, headache, nausea, diarrhea, decreased appetite, flu-like illness, weakness, insomnia, cough, itching, chills , muscle aches, hair loss, and peripheral edema.

The Bottom Line: Eltrombopag may help certain people, but it ‘s use is not to be entered into lightly, particularly because of the risk of liver damage. If your medical provider prescribes eltrombopag, familiarize yourself with the prescribing information.

Editorial Comment: Do these side effects sound familiar? Interferon and eltrombopag together sounds intense. Be aware that there is insufficient research on the use of eltrombopag with boceprevir or telaprevir.

Article: The Natural History of Compensated HCV-Related Cirrhosis: A Prospective Long-Term Study by Vilar Gomez E, Sanchez Rodriguez Y, Calzadilla Bertot L, et al.
  Source: Journal of Hepatology published online Oct 16, 2012

This was a six-year prospective study designed to identify major clinical outcomes in a large Cuban study group with HCV-related cirrhosis.

Among 402 subjects, 294 were categorized as stage 1 (absence of esophageal varices)  and 108 as stage 2 (presence of esophageal varices).  There were 42 deaths (10%); 30 were considered liver-related (7%); 8 individuals (2%) underwent liver transplantation; 30 patients (7%) developed liver cancer. Among those in stage 1, varices occurred in 67 subjects (22%) and decompensation occurred in 80 patients (20%). The overall mortality or liver transplantation was 15% for stage 1 and 45% for stage 2. The rate of liver cancer was higher among patients with varices (29%) than those without varices (9%). Liver-related complication was higher in patients with stage 2 (66%) than those with stage 1 (26%). 

The Bottom Line:  The rate of morbidity, mortality, liver transplantation and other clinical outcomes is higher for compensated cirrhotic patients who have varices.

Editorial Comment: I assume that this study applies to non-Cubans, but further studies will have to address these assumptions. It would also be interesting to see what the effect of HCV treatment would be on these  clinical outcomes, although this is a difficult group to treat.

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HEALTHWISE: Fifteen Years of HCV Advocacy
—Lucinda K. Porter, RN

The first issue of the HCV Advocate was published in January 1998. It is the newsletter of the Hepatitis Support Project, founded in 1997 by Alan Franciscus. It was three double-sided pages of print, distributed by postal mail—there was no website at this point. Copies of the first year’s HCV Advocate are collectors’ items, as they are not available on the HCV Advocate website. 

Articles in the inaugural issue include information about liver enzymes, a story from a person living with hepatitis C virus (HCV), and listings of local support groups and clinical trials. There was a note from Ron Duffy, the founder of the long-disbanded HCV Global Foundation. As someone who knew Ron, his words are sobering for me; Ron died from hepatitis C in January 2000, at the age of 47. He would be one of many HCV advocates and friends for whom we would grieve.

My first contribution did not appear until March 1998. I thought I was writing a one-time article. However, my involvement stuck, and in August Alan suggested the title Healthwise. My first article was “Moving from Cause to Cure,” an expression of my dismay about the stigma attached to HCV.

We have made a great deal of progress in fifteen years, particularly in the realm of treatment. When the first HCV Advocate went to press, HCV treatment consisted of interferon, administered by injection three times weekly. The response rates were dismally low. However, many were undaunted by the odds, and tried treatment, including Alan and me. Initially neither of us cleared HCV, but with time and multiple treatments Alan had a sustained response, and is what I call cured.

Although I am still HCV-positive, I know it is just a matter of time before I am cured. Current treatments are yielding response rates in the 75-80% range, particularly for those who have minimal liver damage. There are so many promising drugs in development, that it can be difficult to keep up with them. Cure is really around the corner.

However, cure is not possible without access to healthcare. A year from now, the Affordable Care Act (ACA) will begin. Although this will help many people, including me, it is not a magic bullet. The ACA will not feed or house people, supply them with jobs, or fix all their medical problems, particularly those that are lifestyle-related. In short, obstacles to HCV treatment will remain.

Another obstacle to overcome is reaching those who do not know that have HCV—which is the majority of those infected.  HCV awareness campaigns are improving every year. The Centers for Disease Control and Prevention (CDC) declared May 2012 as Viral Hepatitis month, instituting the first National Hepatitis Testing Day on May 19, 2012.  On July 28th, the World Hepatitis Alliance set a new Guinness World Record after organizing 12,588 people to participate in the  “See No Evil, Hear No Evil, Speak No Evil” campaign.

Also in 2012, the CDC recommended a one-time HCV screening for all people in the U.S. who were born from 1945 through 1965 (Baby Boomers). Since approximately 75% of all HCV cases occur among Baby Boomers, routine screening may identify around 800,000 people who otherwise might fall through the cracks. Currently HCV tests are not included in routine physicals, and there is no HCV vaccine. When this article went to press, the CDC screening recommendations were under consideration by the U.S. Preventive Services Task Force.  HCV advocates are working for a stronger recommendation.

Diagnostic tools for HCV screening have made giant leaps. Rapid testing, including a fingerpick test are now available. An oral HCV test is in development, and when it is available screening will be even easier.

An area that progress has left behind is the one that I addressed in my first article in 1998—stigma.  This year as I travelled across the country, I heard stories that tore at my liver. People live in isolation in their communities and homes, afraid of what might happen if neighbors find out that have HCV. Even in my the liberal state of California, people whisper to me, “I have hepatitis C but I haven’t come out of the closet.”

Hepatitis C disclosure is a deeply personal decision, one that cannot be undone. I gave up my privacy long ago, figuring that if Magic Johnson could be public about  HIV, then I could follow suit with HCV. Disclosure has worked for me, and it feels good not to live in the shadows of a secret. However, I do understand that others may need to keep quiet in order to function in their communities.

How I got HCV is the one disclosure I wish I could take back—not because I am  embarrassed by how I got HCV—but because I want people to get past their curiosity about it. Now when someone meets me, I deliberately withhold information about how I contracted HCV because their inquisitiveness is a teaching opportunity. I believe we want to know how someone got HCV not because we are curious, but because we are longing for reassurance.  The moment I tell them how I was infected, they can sit back, relieved by the fact that they weren’t at risk, and that they don’t have to worry about HCV.

However, everyone needs to be concerned about HCV. It affects us all, whether in healthcare costs, job loss, Medicare dollars, or by our shared humanity. We need to get past the stigma that HCV is an injection drug users problem, and embrace the notion that HCV is everyone’s problem.

With millions of Americans who have HCV, likely we all know someone who suffers or will die from it. HCV does not recognize boundaries, and likely we will witness many public figures confront their own HCV diagnosis, such as U.S. Congressman Hank Johnson from Georgia. While serving in the House of Representatives, Johnson announced he had HCV, went through treatment, launched his reelection campaign while on treatment, and won.

People like Congressman Johnson are challenging the stigma.  We need strong voices and action to lead us through the years ahead. We need to put hepatitis C out of business. I am hoping that in the next fifteen years, hepatitis C will become a distant nuisance rather than a present threat. Wouldn’t it be wonderful if progress was so significant that the HCV Advocate would be unnecessary?

Please join me and other activists who are working to increase the public’s awareness about viral hepatitis. Together we can change the world. Let’s put hepatitis C out of business.
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

Additional Resources
Caring Ambassadors Program-Hepatitis C

Centers for Disease Control and Prevention

Know More Hepatitis Campaign

Hepatitis C Support Project

National Alliance of States and Territorial AIDS Directors (NASTAD)
—Be sure to check out the Viral Hepatitis Advocacy Toolkit

National Viral Hepatitis Roundtable

Preparing for Hepatitis Day

Project Inform

World Hepatitis Alliance
www.worldhepatitisalliance.org  (Look for future World Hepatitis Day events)

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Review of "The Partner's Study"
—CD Mazoff, PhD

In my experience as an HCV advocate the 2 most frequent questions I get concerning HCV are: “Will I die?” and “Can I give it to someone else sexually?”  The answer to the first one has always been easy: Probably not.  The answer to the second one has not been so easy, for me at least, because I take my advocacy seriously, and I do not want to give out false information that will hurt people.

So, when I saw that this most recent and excellently designed and executed study was available I jumped at the chance to review and share it with our readers—who I know will, hopefully,  be just as interested in the answer as I am!

This study investigated the most intimate details of 500 couples in which one partner (the “index person”) was known to be HCV-positive.  The couples had to be together for at least 3 years, and be monogamous, and not have HIV, HBV, a transplant, or if both partners had a history of IDU.  These were the criteria for participation.  As it turns out some of the partners of the “index person” turned out to be HCV-positive or to have a history of IDU, which to my mind was a good thing because all of these things needed to be taken into account.

Other interesting things investigated in the study were the number of lifetime sexual partners, frequency of sex, type of sex (vaginal, anal), whether sex occurred during menses (a woman’s period), and whether condoms or barriers were used.  As it turns out in the beginning of the relationships more protection was used, but eventually this became much more infrequent as did the sex.  Many couples reported sex during menses or unprotected anal sex.

After all of the above was taken into account, including people dropping out because they wouldn’t answer all of the questions—and by-the-way, if there were conflicting answers in a couple (like did you ever have an affair?) then the researchers went with the answer that was the most damaging, i.e., they assumed someone was lying—20 partners tested positive for HCV antibodies, and 13 of these were HCV RNA positive.  Yikes!!!

Unlike previous studies, which would basically stop at this point, and which of course produced rather high rates of sexual transmission, this study decided to put everything under the microscope, which in this case was not only the minute details of a couple’s sexual behavior but the actual virus itself.

Using serotyping and phylogenetic analysis (precisely identifying the genetic variations in the sample and running algorithms to map the divergence over time of a mutating virus), the researchers found that of the 20 partners who were HCV-antibody positive, 9 had the same genotype as the index person and 6 couples had active HCV.  Of these 6 couples, “3 had strong evidence that the partners were infected with the same HCV isolate and 3 were consistent with infection by different HCV strains.”  

For the partners with the same “strain,” the “estimated minimum divergence” times were 6.5 years (relationship of 18 years), 14.6 years (relationship of 28 years), and 6.2 years (relationship of 10 years) and in this last couple both reported sharing drug snorting equipment. This means that if in these cases the virus was transmitted in the relationship, it would have been 6.5, 14.6, or 6.2 years ago.

The researchers noted that the “concordantly-infected couples (3) were no more likely to share blood-contaminated objects, such as nail clippers, razors, and toothbrushes, than couples in which one partner remained uninfected…but were more likely to have vaginal intercourse during menses and anal intercourse and less likely to use condoms.”  They concluded that “these differences, however, were not statistically significant.”

So, where does this leave us?  In the “Discussion” of the paper the researchers summarize their findings:

“Sexual transmission of HCV among monogamous heterosexual couples is an extremely infrequent event.  The maximum prevalence of HCV infection among sexual partners of persons with chronic HCV infection was only 1.2%, and the maximum incidence of HCV transmission by sex was 0.07% per year or ~1 per 190,000 sexual contacts.  Condom use was infrequent among the study participants and decreased over the duration of the sexual relationship, indicating that the very low rate of sexual transmission in our study population was not due to use of barrier methods during sexual activity….The minimum estimate of prevalence of HCV infection among viremic couples was 0.6% (95% CI: 0.0%, 1.3%) and the incidence was 0.04% per year.” 

But even this is inconclusive, because the “incidence of HCV transmission by sex” was never conclusively shown, but rather only extrapolated—i.e., after taking everything into account, and excluding all other possibilities, it really looks like it could be sex but we have no definite proof that it was sex.

The researchers hypothesized that a low viral load in genital secretions “may be one reason that HCV is transmitted less efficiently than hepatitis B virus or HIV.... [T]ransmission of infection by sex may require a specific genital tract environment such as disrupted mucosal integrity or the presence of viral or bacterial coinfections. These factors may explain the recent reports of HCV transmission by sex in HIV-infected men who have sex with men.”

One question seemed to nag at the researchers.  What if the virus had been transmitted sexually in the beginning, but the partners had developed immunity and spontaneously cleared the virus?  This would account for the fact that of the “12 couples that had concordant (or indeterminant) HCV genotypes or serotypes, 50% were HCV RNA negative.”  The authors note that,

“This rate of spontaneous clearance is similar to that observed among persons infected at younger (<30 years) ages (by transfusion of whole blood, receipt of contaminated Rh immune globulin, IDU, or accidental needlestick injuries), and prospectively followed for 20 years.  Although a younger age at infection might explain the high proportion of anti-HCV-positive, HCV RNA-negative partners in our study, one might speculate that repeated exposures to small “doses” of HCV resulted in an immunization-like effect or facilitated viral clearance once infection occurred.”

Of course the only way they could prove this would be to enroll people into a study that monitored them from “Day 1” of a sexual relationship, but this would really be difficult to set up for obvious reasons.

So, in the end, what can we say?  It would appear that people who live together for a long time and have sex with each other can maybe pass the infection to their partners.  Whether this happens sexually or not is difficult to say.  What can be said is that it appears that HCV can be transmitted to a life partner, but it is extremely rare.   How rare?  Well, I asked our friend Lucinda K. Porter, RN and her scientist husband to do some statistical analysis for me (hey… I can’t do everything) and find out exactly how the stats stack up. Here’s what they found:

  • If HCV risk is ~1 per 190,000 sexual contacts, then you would have to have sex 6.5 times a day for 80 years, and assuming that you were an early-starter at age 10, you would be having sex until age 90. I think this is way more than Magic Johnson had sex. 
  • Your odds are 10x greater of getting murdered in the U.S. (18,000 to 1)
  • Odds are greater that you would die in an explosion: 1 in 107,787 
  • 100 x greater of dying from any kind of injury during the next year: 1 in 1,820

(PS: don’t blame me; remember this is from the Queen of Hepatic Hilarity!)

In conclusion then, I am comfortable with the study, and agree with most of its conclusions.  But I am not happy with the reality that HCV can be transmitted to a loved one.  This makes me very sad—although thanks to Lucinda and her husband, this has been mitigated somewhat.  The only glimmer of hope, then, lies in the promise of a cure for everyone, and that is quickly coming.

In this light, I still do not know how to counsel those who wish to begin a relationship, wherein one partner is positive and the other not.  It is a tough decision, and requires some very big hearts.

Sexual Transmission of HCV Among Monogamous Heterosexual Couples: The HCV Partners Study. Norah A. Terrault, Jennifer L. Dodge, Edward L. Murphy, John E. Tavis, Alexi Kiss, T.R. Levin, Robert Gish, Michael Busch, Arthur L. Reingold, Miriam J. Alter. Hepatology. ‘Accepted Article’, doi: 10.1002/hep.26164

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AASLD 2012: Part 2
—Alan Franciscus, Editor-in-Chief

In the December 2012 HCV Advocate newsletter I wrote about the various Phase 2 interferon-free study results.  This article will focus on HCV antiviral medications that include direct-acting antivirals (DAAs) in combination ribavirin and with and without interferon.  

BMS has many different types of drugs in development to treat hepatitis C.  Last month I wrote about a small study of an interferon and ribavirin-free combination of daclatasvir, asunaprevir, and BMS-791325 to treat HCV genotype 1 treatment-naïve patients for 12 weeks that produced SVR12 rate of 94% (15 out of 16 patients).  Every HCV pharmaceutical company is studying interferon-free, but it is thought that a minority of patients will still need interferon to cure hepatitis C.  

To fill this possible gap BMS is also developing a newer type of interferon called Peginterferon Lambda 1-a (PEG-Lambda) that has been shown (so far) to have fewer side effects compared to Peginterferon alpha.  Interim results from a small Phase 2b study called D-LITE were released at AASLD.  In the study, treatment-naïve HCV genotype 1 patients were treated for 24 weeks with PEG- Lambda (SQ, once-a-week injection), daclatasvir (QD) and ribavirin (BID) and achieved 76% SVR12 (28 of 37 patients).  The highest SVR12 rates were seen in people with HCV genotype 1b (93%—3 of 14 patients).  The company also noted that in their Japanese study SVR4 results were 100% in HCV genotype 1b patients. 

BMS is also conducting a study with PEG-Lambda plus ribavirin vs. PEG-interferon alpha 2a plus ribavirin. The results of a phase II study found that the SVR24 rates were similar to the SVR24 rates of PEG-interferon alpha 2a plus ribavirin, but that there were less overall side effects especially blood deficiencies (anemia, neutropenia, and thrombocytopenia) in the group that received the PEG-Lambda compared to the group that received PEG-interferon alpha 2a.

Preliminary results from a study evaluating danoprevir boosted with ritonavir (DNV/r), mericitabine (MCB) and ribavirin with and without interferon to treat HCV genotype 1 prior partial and null responders to PEG/RBV were presented—the MATTERHORN study.  Danoprevir is an HCV protease inhibitor and mericitabine is an HCV polymerase inhibitor—both are dosed twice a day.  The treatment duration was 24 weeks except one group that was treated with quad therapy for 24 weeks followed by an additional 24 weeks of PEG/RBV.  The Quad treatment groups achieved SVR12 results of 84 to 86%.  Breaking it down by subtype—genotype 1b had the highest response rates with 91% SVR12 (96% in partial responders, 100% in null responders) compared to SVR12 rates of 75% in genotype 1 partial responders and 73% in null responders.  In the interferon-free group the SVR12 results for HCV genotype 1b were 39% (partial responders) and 55% (null responders). 

At AASLD, Gilead also reported high viral cure rates with an interferon-free regime.  In the study, sofosbuvir (polymerase inhibitor) QD plus PEG/RBV was given for 12 or 24 weeks to treat HCV genotype 1.  The SVR12 results were 91% and the SVR12 results were similar between the groups that received 12 or 24 weeks of treatment.  Importantly, no patients relapsed during the follow-up.  There was also SVR12 data on a small number of HCV genotype 4 (82% of 11 pts) and genotype 6 (100% of 5 patients).  The drugs were generally safe and well-tolerated. 

Tibotec/ Janssen/J & J
Simeprevir (TMC435), an HCV protease inhibitor, in combination with PEG/RBV to treat HCV genotype 1 has completed some Phase 3 clinical trials. Janssen (the parent company of Tibotec) has indicated that data will be available in the first quarter of 2013.  The combination of simeprevir plus PEG/RBV, if approved by the Food and Drug Administration (FDA), will likely be in part of the next wave of HCV protease inhibitor combination therapies to treat HCV genotype 1.    

Simeprevir is also in Phase 2 studies with other compounds—their polymerase inhibitor, TMC647055, and a different study of simeprevir plus Gilead’s GS-7977, a HCV polymerase inhibitor. 

Two combined retrospective analyses from the PILLAR and ASPIRE studies were presented—both of these studies evaluated simeprevir plus PEG/RBV to treat HCV genotype 1.   The first presentation was an analysis from the studies that included 156 treatment-naïve and 199 treatment-experienced HCV genotype 1 patients.  The overall SVR24 rates were 81 to 86% in the treatment-naïve patients.  Those people who qualified for a shorter treatment duration (based on response-guided therapy) achieved SVR24 rates of 93 to 96%.  Treatment-experienced patients achieved an overall SVR 24 of 67 to 80% and in those with an F4 metavir score the SVR was 62%. 

The second presentation was a retrospective sub-analysis of the PILLAR and ASPIRE Phase 2 studies.  The sub-analysis  included treatment-naïve and experienced patients who had F3/F4 (fibrosis/cirrhosis) liver disease.  The overall SVR24 rates and the rates by type of prior response are listed below. 

Treatment naïve:

  • Overall SVR—79%
    • Relapsers—65%
    • Partial responders—67%
    • Null responders—33%

Eighty-four percent of the participants in the studies met response-guided treatment criteria for 24 weeks of therapy and achieved an overall SVR24 of 94%.  The medications were generally safe and well-tolerated.  

A 5-arm study of MK-5172 (protease inhibitor) in combination with PEG/RBV to treat HCV genotype 1 treatment-naïve non-cirrhotic patients was presented:  Four arms with MK-5172 plus PEG/RBV, and 1 control arm (boceprevir plus PEG/RBV).  The SVR12 results were 82% to 96% in the groups that received MK-5172 plus PEG/RBV compared to 54% in the boceprevir plus PEG/RBV.  The drugs were well-tolerated. 

Merck announced an all oral phase II study of MK-5172, MK-8742 (NS5A inhibitor) plus ribavirin to treat HCV genotype 1 treatment-naïve non-cirrhotic patients.

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Incivek: Rash Warning!
—Alan Franciscus, Editor-in-Chief

On December 19, 2012 the Food and Drug Administration issued a safety alert that Incivek (telaprevir) can cause serious skin rashes that could be fatal.  In clinical trials, the severe rashes were seen in only 1% of the trial participants, but now that Incivek (plus pegylated interferon and ribavirin) are in wide use there have been more cases of people who develop the rash—the fatal cases occurred in people who continued to take Incivek combination therapy.  Note the following:

Any sign of rash—report it immediately to your medical provider.  Don’t second guess what kind of rash it is or the severity of the rash.  Your medical provider will tell you if you need to stop taking all of the medications.

If there is any reason to suspect that the rash is severe and your medical provider can’t be contacted immediately—go to an emergency room—describe the problem and ask to be seen immediately.  

Never stop taking the combination therapy unless directed to do so by your medical provider.

Source: http://investors.vrtx.com


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