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HCV Advocate Newsletter

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October 2011 HCV Advocate

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In This Issue:

Pharmasset: 98% to 100% Cure Rates
Alan Franciscus, Editor-in-Chief


HealthWise: Reducing the Cost of Hepatitis C Treatment
Lucinda K. Porter, RN


Disability & Benefits: Medicare Enrollment Explained
Jacques Chamber, CLU

HCV Snapshots
Lucinda K. Porter, RN

Clinical Trials
Alan Franciscus, Editor-in-Chief



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Pharmasset: 98% to 100% Cure Rates
—Alan Franciscus, Editor-in-Chief

There are numerous HCV polymerase inhibitors in clinical development to treat chronic hepatitis C.  HCV polymerase inhibitors include three different types—nucleoside, nucleotide and non-nucleotide and they all work by preventing the hepatitis C virus from replicating or making more copies of itself.  Pharmasset has developed three different polymerase inhibitors—PSI-7977, PSI-938 and RG7128 (mericitabine).  In addition, Pharmasset is co-developing their polymerase inhibitors in collaboration with Genentech, Bristol-Myers Squibb and Tibotec. 

PROTON STUDY
Various parts of the PROTON phase II study results were released this year.  In this study HCV treatment-naïve genotype 1, 2, and 3 patients were treated with PSI-7977 (400 mg QD – once-a-day), an HCV polymerase (nucleotide ) inhibitor given in combination with pegylated interferon and ribavirin for a total treatment duration of either 12 weeks for genotype 2 and 3 or 24 weeks for genotype 1.

GENOTYPES 2 & 3
In July the SVR data from the group of HCV genotype 2 and 3 treatment-naïve patients was released.  In this part of the study patients were treated for 12 weeks with the triple combination therapy—PSI-7977 (400 mg QD), pegylated interferon and ribavirin.  Twenty four out of twenty four (100%) of the patients who completed treatment became HCV RNA negative (lower level of detection (<12 IU/mL) 24 weeks after completion of therapy (viral cure).  Note:  one patient who only completed one-week of therapy dropped out and was lost to follow-up.  This patient was omitted from the study results.  

GENOTYPE 1
More results were released in September from another part of the PROTON study that treated HCV treatment-naïve genotype 1 patients.   In this part of the study the patients were treated with PSI-7977 (400 mg QD), pegylated interferon, and ribavirin for 12 weeks followed by an additional 12 weeks of pegylated interferon and ribavirin (without PSI-7977) for a total treatment duration of 24 weeks.  Of the available data 98% (43 out of 44 patients) were HCV RNA negative 12 weeks after the completion of therapy (SVR12). The final SVR results will be released later this year.

QUANTUM
One of the most exciting and promising studies that is being initiated this year is the QUANTUM study.   Please see the clinical trials column of this month’s HCV Advocate newsletter for more information about this interferon free study across all HCV genotypes.


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Healthwise: Reducing the Cost of Hepatitis C Treatment
—Lucinda K. Porter, RN

“You have got to be kidding me!” is what I said, after hearing the estimated cost of a month of hepatitis C treatment drugs. What I wanted to say was, “Holy expletive deleted!” It never occurred to me that treatment for chronic hepatitis C virus infection (HCV) would amount to the price of a used car. This was not an easy choice—a used 4-wheel drive or a shiny new liver?

I am one of the lucky ones, because I have medical insurance. It isn’t a great plan, but having hepatitis C means that I am uninsurable, so better a lousy plan than no plan. I am aware of how fortunate I am to have any insurance, so I haven’t complained, that is, until now. After I recovered from the sticker shock, I set out to find ways to reduce the cost of treatment so I could buy a used 4-wheel drive vehicle to keep my liver safe on those snowy winter drives. This article explores ways to lower the cost of HCV treatment.

Let’s begin with reviewing typical treatment regimens. In the U.S., the majority of HCV patients have genotype 1. These patients will need either 24 or 48 weeks of medication, depending on a number of factors. The recommended regimen for this group is triple therapy using one of the new HCV protease inhibitors, Incivek (telaprevir) or Victrelis (boceprevir), combined with peginterferon and ribavirin.

Patients with other genotypes will be treated with peginterferon and ribavirin without a protease inhibitor. Treatment lengths vary between 24 weeks (for genotype 2 or 3) and 48 weeks for the remaining genotypes.

Since the majority of patients have genotype 1, I set out to find how much triple therapy would cost. Before delving into actual numbers, I need to mention:

  • For this exercise, I used Wholesale Acquisition Costs (WAC). This is the cost that the manufacturer sells the drug to the pharmacy or hospital. The pharmacy will sell the drug at a higher price, so I am using rock bottom prices.
  • Determining retail costs for Incivek and Victrelis is difficult. Some of my figures are estimates, but my explanations are transparent, so you can see how I arrived at these numbers. I am drawing a picture rather than giving firm facts.
  • Do not let the price difference between two drugs influence your treatment choice. Medication choices should be based on evidence, your medical history and sound advice from your healthcare provider.
  • I based my calculations on a patient who needs only 24 weeks of treatment and who is less than 175 lbs. and needs 5 ribavirin pills daily. A heavier patient or one who will need longer treatment will incur higher costs.

According to the Fair Pricing Coalition (FPC), the WAC for Merck’s Victrelis is approximately $1100 a week. There is a four-week lead-in phase of only peginterferon and ribavirin, so you only need 20 weeks of Victrelis for 24 weeks of treatment. Using WAC information from the FPC and website prices from Drugstore.com, here are my calculations:

$22,000

Victrelis for 20 weeks

$15,500

Peginterferon for 24 weeks (avg. of PegIntron and Pegasys prices)

$  3568

Generic ribavirin for 24 weeks 

$41,068

Total for 24 weeks of treatment using Victrelis

But what if the medical provider prescribes Incivek? According to the FPC, the WAC for Vertex’s Incivek is $49,200 for 12 weeks of treatment. These totals do not include medical appointments, labs, medications to help with side effects, or the cost of psychotherapy or a bankruptcy attorney, which I would surely need to get through this if I didn’t have health insurance.

$49,200

Incivek for 12 weeks

$15,500

Peginterferon for 24 weeks (avg. of PegIntron and Pegasys prices)

$  3568

Generic ribavirin for 24 weeks 

$68,268

Total for 24 weeks of treatment using Incivek

Fortunately, I have health insurance. Incivek or Victrelis will be subject to prescription co-pay, unless the insurance company deems it a non-preferred brand, which means I’d have to pay 50% of the cost. Perish that thought. Here is what I would pay for 24 weeks of treatment:

$  250

Pharmacy deductible

$4650

Peginterferon (30% for injectable medications)

$  180

Ribavirin ($30 monthly co-pay for 6 months)

$  150

Victrelis ($30 monthly co-pay for 5 months)

$5230

 

 

$  250

Pharmacy deductible

$4650

Peginterferon (30% for injectable medications)

$  180

Ribavirin ($30 monthly co-pay for 6 months)

$    90

Incivek ($30 monthly co-pay for 3 months)

$5170

 

Vertex, the manufacturer of Incivek, offers multiple ways to help patients. Their Free Medicine Program gives free Incivek to those who do not have insurance and have an annual household income of $100,000 or less. This option doesn’t help me since I have insurance, but I may be eligible for Vertex’s Co-Pay Support plan. If you have no insurance but your income exceeds the Free Medicine Program requirements, or you have insurance but want help with the co-payments, it covers up to $10,000 total of the out-of-pocket costs for Incivek. This would save me $30 a month. If, God forbid, I had to pay 50% of the $49,200 cost for 12 weeks of Incivek, then this would knock $10,000 off the $24,600 out-of-pocket costs, leaving me with $14,600 for just the Incivek. However, if I had that kind of money in the first place, I would not be driving around in a twelve-year-old sedan.

Merck offers a $200 monthly discount card that may be used for up to twelve months towards the purchase of Victrelis and PegIntron. The card must be used with a co-pay or cash payment. Some restrictions apply, such as it cannot be used by Massachusetts residents or Medicare or Medicaid patients. In my case, this would knock $1200 off 24 weeks of treatment if I used PegIntron. If I also used Victrelis, I’d save the $30 co-pay (5 months of Victrelis for $150 total). If my insurance required me to pay 50% of $22,000, then I’d save $1000 off the $11,000 price tag.

For those needing help with Pegasys, Genentech’s Access Solutions provides assistance for HCV patients. I was told that Genentech intends to offer a co-pay assistance card, but the program was not operational at the time this article went to press. For details, call Genentech or see their website.

Patients who purchase Ribasphere (ribavirin) manufactured by Kadmon may qualify for financial assistance, if they meet the eligibility requirements. Kadmon offers various programs, including help with insurance co-pay—the patient pays the first $10.00 for each monthly prescription and the company pays the rest. This would save me $20 a month for a total of $120.

Let’s assume I qualify for these programs and apply these savings:

With
Savings

Without Savings

 

$ 250

$ 250

Pharmacy deductible

$3450

$4650

Pegylated

$    60

$ 180

Ribasphere

$      0

$ 150

Victrelis

$3760

$5230

Savings = $1470

 

With Savings

Without Savings

 

$ 250

$ 250

Pharmacy deductible

$3450

$4650

Pegylated

$    60

$  180

Ribasphere

$      0

$    90

Incivek

$3760

$5170

Savings = $1410

There is help for those with no medical insurance. You may qualify for financial assistance, and possibly free medication if your total household income is less than that set by each pharmaceutical company. In some cases, these income limits are as high as $100,000. For those who have insurance but fall 400% below the federal poverty line, there are grants from the Patients Access Network Foundation (PANF). This non-profit organization provides financial assistance for HCV patients up to $7000 a year. Partnership for Prescription Assistance and Needy Meds are two other programs dedicated to offering financial assistance for prescriptions drugs.

Clinical trials are another option for those without medical insurance. However, before agreeing to participate in a clinical trial, make sure you know what you are getting into. Find out what your chances are of receiving a placebo and what is expected of you.

Wading through this process to see what you qualify for may be overwhelming at times. Pharmaceutical companies have set up access programs to help you. Although it is in their best interest to provide this assistance, it can be a huge help to work with someone who knows how to navigate the system. These programs begin after your medical provider has prescribed a drug regimen for you. 

As I said, I am fortunate to have health insurance, even though I pay a huge premium for this protection. It’s a good thing that my old car has good tires, because it snowed a lot here last year and I won’t be buying a 4-wheel drive vehicle anytime soon.

HCSP Fact Sheets

Clinical Trials

Prescription Assistance
Programs


Addendum:

After reading this article, a reader wrote, “I was wondering if you could do a follow up web post or article on cost for people who are on, or about to go on, Medicare. I'm trying to choose a Medicare supplemental policy…Literally dozens of choices, and almost all have the "donut hole" coverage gap in their drug plans, and even after that it’s 5% of drug cost. Total cost could still be very high, and most help programs may not apply with Medicare.”

We asked regular contributor and Benefits Consultant, Jacques Chambers, CLU to answer this question and he replied, “Medicare supplement policies (Medigap) plans do not cover medications other than those few medications that are covered under Part B Medicare. If you plan to go with original Medicare Parts A & B with a supplement, you will also need a Medicare Part D - Prescription plan. To find the best plan for you, go to www.medicare.gov and search for a stand-alone drug plan. There you can enter your medications, along with the dosage and quantity, and it will show you the costs including your out-of-pocket costs for all the plans you are eligible for. 

Drug plans are by state, and California plans stopped providing coverage in the donut hole some years back. Remember now under the Affordable Care Act, all plans cover 50% of brand name drugs while in the donut hole. Also, if your income is low, you may want to apply for Extra Help, which can subsidize your Part D plan. You can see if you are eligible and apply at www.ssa.gov.

Now is the time to find or change a Part D Medications Plan. Open enrollment is from October 15 to December 7 with an effective date change of 01-01-2012.



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Disability & Benefits: Medicare Enrollment Explained
—Jacques Chambers, CLU

A person becomes eligible for Medicare generally when they turn age 65. Medicare also becomes available to persons collecting Social Security Disability benefits before they turn 65. This is a good time to review the enrollment rules in Medicare since the annual Open Enrollment period—when Medicare beneficiaries are able to make changes in their Medicare coverage—starts soon.

In reviewing when a person may enroll or make changes to his or her Medicare coverage, one needs to understand the various parts of Medicare as eligibility periods and rules can vary:

  • Part A – Hospital Coverage: This part covers stays in hospitals, convalescent care facilities, and hospices. Persons who have paid into the Medicare program in their working career through payroll taxes generally pay nothing for this coverage. Persons who have not may purchase Part A and pay for it themselves upon turning 65.
  • Part B – Medical Coverage: This part generally covers the professional charges of physicians and other health care workers; doctors in or out of the hospital; X-rays, laboratory tests, durable medical equipment, etc. This part is considered “voluntary” and a premium is charged to everyone enrolled in it.
  • Part C – Medicare Advantage Plans: These are the alternate plans to “original” Medicare. Offered by insurance companies, they include Medicare HMOs, PPOs, and other plans. If elected, the beneficiary must seek medical care only through the plan; their Part A and B coverages are suspended while they are covered under a Part C plan.
  • Part D – Prescription Drug Charges: These are plans that cover only prescription drugs. Authorized by Medicare, they are sold only through private insurance companies and must be purchased separately. Medicare Advantage Plans (Part C) often include prescription drug coverage within their plans so separate coverage does not have to be purchased.
  • Medigap (Medicare Supplement) Plans: These plans fill in the “gaps” in the original Medicare Parts A & B due to the deductibles and co-insurance of Medicare. Although Medicare designs these plans, they are sold exclusively by private insurance companies. It should be noted that one may enroll in these plans anytime they have Medicare Parts A & B, but if they do not enroll during special open enrollment periods, they will be subject to medical underwriting which allows the carrier to decide whether or not to offer coverage based on an applicant’s medical condition and health history.

Annual Open Enrollment Period
A Medicare beneficiary has the opportunity to make changes to their coverage during the Annual Open Enrollment Period. While the changes are not effective until the following January 1, they must be made between October 15 and December 7. During this period a person may:

  • Change from Original Medicare to a Part C Medicare Advantage Plan;
  • Change from a Part C Medicare Advantage Plan to Original Medicare;
  • Change from one Part C Medicare Advantage Plan to another Part C Medicare Advantage Plan;
  • Purchase a Part D Prescription Drug Plan; Late Enrollment Penalty—it should be noted that if you purchase a Part D Prescription Drug Plan some time after first becoming eligible to purchase one, with few exceptions, your premium will be surcharged 1% for each month you could have been in a drug plan and didn’t purchase one; or

Switch from one Part D Prescription Drug Plan to another Part D Prescription Drug plan. NOTE: Even if your current Drug Plan has been serving you well, it is advisable to re-run the program at www.medicare.gov in case your medications have changed or your drug plan is revising its formulary or premiums for the coming year. The plans for 2012 are already up on the website at www.medicare.gov.

Annual Disenrollment Period
Beginning in 2012, Medicare is offering another annual opportunity for persons who are dissatisfied with their Part C Medicare Advantage Plan. Between January 1 through February 14, a Medicare beneficiary may:

  • Leave a Part C Medicare Advantage Plan and switch to Original Medicare Parts A & B. NOTE: This will trigger an opportunity to add a Part D Prescription Drug Plan without penalty.
  • That is all that can be done during this period. There is no longer an opportunity to switch from one Part C plan to another or switch drug plans as in former years. That must now be done in the October 15 – December 7 Open Enrollment.

Medicare Enrollment Opportunities
Turning Age 65 – A person turning 65 has 7 months to enroll in Medicare without penalty, the three months prior to the month he or she turns 65, the month he or she turns 65, and the three months after the month he or she turns 65. It is strongly recommended that you enroll in Medicare in the three months before turning 65; if so, Medicare will be effective on the first of the month that you turn 65. Enrolling in the later four months will delay the Medicare effective date.

Bureaucratic humor: If your birth date is on the first of a month, Medicare coverage will start on the first of the month PRIOR to the month of your birthday. The government apparently has decided the first day of a month really should be considered as part of the earlier month.

At the same time, you should find and enroll in a Part D drug plan as well as Parts A & B of Medicare without penalty. You will also have a guaranteed right (without medical underwriting) to purchase a Medigap policy from a private insurance company.

Once enrolled in Parts A & B of Medicare you will have the opportunity during that seven month period to trade Parts A & B of Medicare for a Part C Medicare Advantage Plan.

Under age 65 and Receiving Social Security Disability Benefits – Medicare benefits start on the 25th month of collecting SSDI benefits. No enrollment is necessary; the Medicare card will arrive in the mail about two months prior to the effective date of coverage. You will be automatically enrolled in both Parts A & B.

While you may return the card and not enroll in Part B coverage, be sure you don’t or won’t need it as there are penalties for enrolling “late” in Part B. You will also have an open opportunity to add a Part D Prescription Drug Plan and also have the right to switch your coverage to a Part C Medicare Advantage Plan.

Federal law does not require insurance companies to accept Medicare beneficiaries under age 65 (disabled beneficiaries) for Medigap coverage on an open enrollment basis as they do for persons turning age 65. Many states, however, have filled that gap with a state statute requiring persons under 65 to be accepted without medical underwriting when first getting Medicare. In states without such legislation, a person under age 65 getting Medicare must go through medical underwriting before getting Medigap coverage.

Exception: Persons receiving Social Security Disability benefits due to End Stage Renal Disease (permanent kidney failure requiring dialysis or a kidney transplant) or from Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s disease) do not have the 24 month waiting period to get Medicare. They are eligible for Medicare upon being approved for Social Security Disability benefits.

A Word about Late Enrollment Penalties
Any insurance plan that will let someone join whenever they want without any repercussions won’t last long as most people will simply wait to enroll until they know they will be using the plan benefits. This is the principal behind requiring medical underwriting of persons applying for individual health insurance as well as the Coverage Mandate in the new Affordable Care Act.

Medicare resolves this by imposing substantial financial penalties for someone delaying enrollment into Medicare coverages. For example, if you don’t enroll in Medicare Part A when first eligible, you will pay a 10% surcharge on monthly premium once you do enroll for as long as you are on Part A. Medicare Part B is the same except the premium is surcharged 10% for each twelve month period you didn’t enroll. Similar penalties apply to Part D Prescription Drug coverage.

There are Special Enrollment periods during which, due to special circumstances, you will be allowed to enroll late without penalty. However, those rules can be difficult to understand, and very expensive for you if you misread them.
For example, there will be no late enrollment penalties for enrolling late in Medicare Parts A, B, and D IF you were covered under a group health plan through an employer due to the ACTIVE employment of you, your spouse, or other family member AND you enroll in Medicare within the 8 month period beginning the month AFTER the employer-based health insurance is lost. Coverage continued under COBRA Continuation is NOT considered to be active employment.

Before declining or delaying enrollment in any part of Medicare, make sure that the coverage will not later be subject to late enrollment penalties. You can ask Medicare at 800-MEDICARE (800-633-4227). Medicare also has a 12 page publication titled Understanding Medicare Enrollment Periods. This can be found by typing the title above in the search box at www.medicare.gov.

Finally, when you are ready to apply for Medicare, in addition to going into a Social Security office, you can apply on line at www.ssa.gov.


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HCV Snapshots
—Lucinda K. Porter, RN

Article: Cerebral Magnetic Resonance Imaging Reveals Marked Abnormalities of Brain Tissue Density in Patients with Cirrhosis without Overt Hepatic Encephalopathy – Guevara M, Baccaro ME, Gómez-Ansón B, Frisoni G, Testa C, et al.
Source: Journal of Hepatology September 2011; Volume 55, Issue 3, Pages 564-573

Patients with cirrhosis are at risk for hepatic encephalopathy, a brain disorder caused by liver dysfunction. Hepatic encephalopathy may begin with subtle changes in behavior, mental state, and thinking ability, and may progress to coma and death.

In this study, researchers used imaging studies to look at the brains of forty-eight subjects with cirrhosis but no obvious signs of hepatic encephalopathy. Also enrolled were 51 healthy subjects of similar age and sex. Twelve additional subjects were enrolled who underwent liver transplantation. Slightly more than half of the cirrhotic patients had a history of or minimal hepatic encephalopathy at enrollment. Subjects did not have active alcoholism or neuropsychiatric diseases. The causes of the cirrhosis were hepatitis B, hepatitis C, and alcoholic liver disease.

The Bottom Line: Compared to healthy subjects, those with cirrhosis showed decreased brain density in many areas of the brain. The greater the degree of liver failure, the greater the brain abnormality. The images were similar to those found in patients with Alzheimer’s disease. Patients with alcohol-related cirrhosis lost more brain density and had more cerebral dysfunction than patients with hepatitis B or C. Patients who received a liver transplant continued to have reduced brain density. This research introduces the idea of a new type of cerebral lesion, comparable to Alzheimer’s disease.

Editorial Comment: It is hard not to be distressed by the information in this article. However, keep in mind the following:

  • This is a relatively small study.
  • It appears that alcohol-related cirrhosis is more likely to be associated with brain abnormalities than with hepatitis B or C; however, this was not adequately explained in the final paper.
  • No matter what disease you have, good habits are good for the brain. Regular exercise, avoid alcohol and other substances that are hard on the brain, get sufficient sleep, etc.

Article: Systematic Review: Epidemiology of Hepatitis C Genotype 6 and Its Management – Chao DT, Abe K, Nguyen MH
Source: Alimentary Pharmacology and Therapeutics August 2011; Volume 34, Issue 3, Pages 286–296 

Hepatitis C virus (HCV) is classified by six genotypes. In this paper, the author did a major review of the literature to gather data on various aspects of genotype 6, including epidemiology and treatment. Genotype 6 is most prevalent in Southeast Asia. The prevalence of HCV in some Southeast Asian countries is as high as 6 to 7%, compared to 1.8% in the U.S.

The Bottom Line: When treated with peginterferon and ribavirin, HCV patients with genotype 6 had response rates similar to those of patients with genotypes 2 or 3, however treatment lengths were more like those with genotype 1 (48 weeks rather than 24 weeks). The researchers recommended further studies to see if 24 weeks is a viable treatment length for patients with genotype 6.

Editorial Comment: Most of the treatment data about genotype 6 comes from Asia and Australia. In the U.S., clinical trials tend to focus on the most common genotype, which is 1, followed by 2 and 3. Genotypes 4, 5, and 6 are often the last of which we gain good data. It would be very interesting to see research testing HCV genotype 6 patients using one of the new protease inhibitors along with peginterferon and ribavirin.

Article: A New Model of Interactive Effects of Alcohol and High-Fat Diet on Hepatic Fibrosis – Gabele E, Dostert K, Dorn C, Patsenker E, Stickel F, Hellerbrand C
Source: Alcoholism: Clinical and Experimental Research July 2011; Volume 35, Number 7, Pages 1361-1367

The most common cause of elevated liver enzymes is nonalcoholic fatty liver disease (NAFLD). This condition can result in fibrosis and cirrhosis. Another common cause of liver damage is alcoholic liver disease (ALD). NAFLD and ALD are characterized by the accumulation of fat in and around the liver—a condition also known as steatohepatitis. A fatty liver can progress to cirrhosis and death. In this study, mice were given either 1) a standard mouse chow diet, 2) a high fat diet, 3) water laced with alcohol, or 4) a high fat diet and water with alcohol.

The Bottom Line: The mice fed the high fat diet had significantly more liver damage than the mice that were fed mouse chow or alcohol. However, the mice that ate the high fat diet and alcohol had substantially more damage than the high fat diet alone. The researchers speculated about the ability of alcohol and high fat to act synergistically to cause liver damage.

Editorial Comment: Animal studies help us gain information, but until we have good human data, we can’t draw firm conclusions – only preliminary ones. Still, it is natural to want to find meaning from this information. One conclusion that cannot be drawn from this study is that alcohol without a high fat diet is safe for the liver. We know that is not true, especially for those with hepatitis C. It does look like a high fat diet, particularly with alcohol, can increase the risk of fatty liver disease. More research is needed. Until then, I am sticking to mouse chow.

Article: Sexual Transmission of Hepatitis C Virus among HIV-Infected Men Who Have Sex with Men: New York City, 2005–2010 – Centers for Disease Control and Prevention
Source: Morbidity and Mortality Weekly Report (MMWR) July 22, 2011; Volume 60, Number 28, Pages 945-950

There are questions about sexual transmission of HCV. We know that HCV transmission is very low between partners in long-term monogamous relationships. Evidence of a higher risk of HCV among human immunodeficiency virus (HIV)–infected men who have sex with men (MSM) raises questions about sexual transmission of HCV. In this study conducted at Mount Sinai Medical Center in New York City, 74 HIV-infected MSM with no reported history of injection-drug use were studied from 2005 to 2010. The subjects had newly elevated ALT levels, positive HCV antibody tests and all but one had documented HCV viral loads. Participants answered surveys about sexual behavior and drug and alcohol use. Blood samples were analyzed for multiple factors.

The Bottom Line: Test samples revealed five clusters of closely related HCV variants. Researchers concluded that high-risk sexual behavior was associated with HCV transmission among HIV-infected MSM in New York City. Unprotected receptive anal intercourse with ejaculation and use of methamphetamine during sex were predictors of HCV infection. Sexual transmission of HCV does not occur efficiently or commonly, but concurrent HIV infection seems to increase HCV viral loads, which may increase HCV infectiousness. Those who are coinfected with HIV/HCV have a higher risk of liver damage since HIV accelerates HCV disease progression.

 Editorial Comment: We need to bolster our public health departments and offer more testing, education, and a stronger prevention strategy. Acute HCV is curable, so early testing followed with treatment should be considered.

New Tattoo After Care Fact Sheet

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Clinical Trials
—Alan Franciscus, Editor-in-Chief

The QUANTUM clinical study is a phase II interferon free study that will evaluate the safety and efficacy of Pharmasset’s polymerase (nucleotide) inhibitors—PSI-7977, PSI-938 and ribavirin. The study will enroll 450 chronic HCV patients that will include all HCV genotypes.

Information from www.clinicaltrials.gov (identifier:  NCT01435044) includes:

  • This is a randomized (a computer randomly assigns patients to various arms of the study), double-blinded (neither the patient nor the medical provider is told who receives what drugs), placebo (sugar pills) controlled study
  • Treatment duration is 12 or 24 weeks
  • People with and without cirrhosis will be enrolled
  • PSI-938 (300 mg) & PSI-7977 (400 mg) are pills taken once a day (QD)
  • Ribavirin (standard doses) is a pill that is taken twice-a-day (BID)
  • The various combination of study drugs in the study include: 
    • PSI-938 (monotherapy)
    • PSI-938 & PSI-7977 (combination therapy)
    • PSI-938 & PSI-7977 (combination therapy with and without ribavirin)
    • PSI-7977 (combination therapy with and without ribavirin)
    • Placebo, PSI-938 and or PSI-7977 (monotherapy, combination therapy with and without an/or ribavirin)
  • The clinical trial will begin in September 2011 with a July 2013 completion date
  • Study participants will be tested for IL28B variation (CC,CT or TT genotype)



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