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February 2012 HCV Advocate

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In This Issue:

BMS Acquires Inhibitex
Alan Franciscus, Editor-in-Chief

HealthWise: Searching for Supplements—Part 1
Lucinda K. Porter, RN


HCV Snapshots
Lucinda K. Porter, RN

New National HCV Helpline Launched

Disability & Benefits: Getting Health Insurance After Diagnosis
Jacques Chambers, CLU


HCV Advocate Eblast
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BMS Acquires Inhibitex
—Alan Franciscus, Editor-in-Chief

Last year, Roche acquired Anadys for $230 million, but the big news was the acquisition of Pharmasset by Gilead for $11 billion dollars.  The trend continues—it was announced on January 8, 2012 that Bristol-Myers Squibb will purchase Inhibitex for $2.5 billion.  Although Inhibitex’s acquisition was not as pricey as Pharmasset’s, the price tag is undeniably a large sum of cash. 

Inhibitex has various on-going pre-clinical, Phase I and II programs—INX-189 (HCV polymerase inhibitor), FV-100 (shingles pain reducer), and Aurexis (treatment of S. aureus bloodstream infections).  But the real story is the addition of INX-189 to BMS’s already expansive HCV drug development pipeline.  BMS does not, however, have an HCV polymerase inhibitor so the addition of Inhibitex’s IXN-189, an HCV polymerase inhibitor, fills an important gap in their development program.

It was reported in the media that there were 5 other pharmaceuticals with HCV drugs in development or existing HCV medications that were looking at Inhibitex.  There is also the distinct possibility that the BMS HCV drug pipeline has the potential to corner the future HCV commercial drug market.  Another interesting aspect of this acquisition is the increase in the original stock price—on November 19, 2011 Inhibitex reported that they sold their stock for an average price of $10.25 a share, but because of the agreement with BMS the same shares will now be worth $26.00 a share.  This is, however, typical of this type of acquisition.

Inhibitex
Inhibitex’s main HCV drug is INX-189—a nucleotide polymerase currently in early Phase I/II studies that is being studied as a monotherapy, in combination with pegylated interferon, and with and without ribavirin (PEG, RBV).  INX-189 appears to be pan-genotypic (effective against multiple genotypes) and has been shown to have a high barrier to drug resistance which makes it an attractive drug candidate for further development and to combine with other direct acting antivirals (DAAs) to help prevent resistance.  The studies listed below are either on-going or they have been completed:

Clinical trials for HCV treatment-naïve HCV genotype 1 patients include:

  • A 7-day study using INX-189 once-a-day (QD) as a mono-therapy has been completed and it was found that the median HCV RNA (viral load) reduction was -2.53 log10 IU/mL
  • A 7-day study using INX-189 100 mg QD in combination with ribavirin—interim results reported the median HCV RNA reduction was -3.79 log10 IU/mL

Inhibitex also has plans to study INX-189 in higher doses with and without ribavirin, and another clinical trial is being planned that will test a single isomer of INX-189.  A single isomer is basically the same drug but the chemical structure has been altered, which may produce less side effects and/or yield higher efficacy.     

INX-189 has been granted fast track designation by the Food and Drug Administration to help speed along the drug approval process.  

Clinical trials for the treatment of HCV genotype 2 and 3 treatment-naïve patients: 

  • The trial to evaluate INX-189 QD—25 mg, 50 mg, and 100 mg doses in combination with PEG/RBV began enrollment in September 2011.  The study will include 90 patients (INX-189 arms and a control/placebo arm (PEG/RBV without INX-189).  In the groups that receive INX-189 the treatment duration will be 12 weeks for those patients who achieve eRVR (extended HCV RNA undetectable levels at week 4 and 12) or 24 weeks if eRVR is not achieved.  It was recently announced that Inhibitex will submit a protocol amendment to this trial to study 100 mg and 200 mg QD in combination with ribavirin for a 12-week treatment duration. 

Bristol-Myers Squib
Bristol-Myers Squib has a very robust HCV drug pipeline.  The list below includes some, but not all of the studies initiated by BMS. 

  • Daclatasvir (BMS-790052; NS5A inhibitor) QD in combination with PEG/RBV to treat HCV genotype 1 treatment-naïve patients started enrollment in a Phase III study in September 2011.  This is a response-guided protocol (treatment length will be 24 or 48 weeks) 
  • PEG-Lambda (injected once a week) is in Phase III studies for the treatment of HCV genotype 1 and 4 treatment-naïve patients.  The protocol is for a 48-week treatment duration and will compare PEG-Lambda plus ribavirin to Pegasys plus ribavirin
  • A DAA combination Phase II study of Daclatasvir and asunaprevir (BMS-650032; protease inhibitor) with and without PEG/RBV to treat HCV genotype 1 patients who were null responders to a prior course of therapy
  • A Phase II study of BMS-791325 (protease inhibitor) in combination with PEG/RBV to treat HCV genotype 1 treatment-naïve patients.  Treatment will be guided by on-treatment response
  • Daclatasvir 60 mg QD and PSI-7977 400 QD, a polymerase inhibitor, (without and without ribavirin) to treat HCV genotype 1, 2, and 3 treatment-naïve patients.  The total treatment duration will be 12 weeks.  This study is being conducted in collaboration with Pharmasset–now Gilead

Who’s Next
The news media has been abuzz with speculation that a couple of smaller pharmaceutical companies are being courted by the big guys.  Achillion and Idenix are the likely new targets for acquisition:

  • Achillion has a protease and an NS5A inhibitor in Phase I studies.  Achillion’s main HCV drug candidate is ACH-1625 (protease inhibitor) QD currently in Phase II studies for treatment of HCV genotype 1 treatment-naïve patients  
  • Idenix’s main HCV pipeline drug is IDX184 (polymerase inhibitor) QD which is being evaluated as a treatment for HCV genotype 1 treatment-naïve patients with PEG/RBV.  

The list of companies that are developing HCV medications is shrinking so it will be an interesting year for acquisitions—stay tuned! 


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HEALTHWISE: Searching for Supplements—Part 1
—Lucinda K. Porter, RN

Let me begin with a disclosure:   I am schizophrenic when it comes to herbs and other dietary supplements. On one hand, I have a huge amount respect for the power of herbs and folk remedies. There are centuries of wisdom to draw upon; long before people reached for an aspirin, they used the bark of the white willow. I believe in better living through biology.

On the other hand, I am uncomfortable with how supplements are used. In our fix-it-quick society, some of us would rather pop a pill rather than address a problem. Feeling fatigued? Some reach for ginseng when the real problem is poor sleeping habits. Having memory problems? The remedy may be exercise, stress reduction, or addressing a sleep disorder, but instead, some of us take gingko. 

I view health more like a daily practice rather than a goal, a practice of good sleep, diet, exercise, meditation, and recreation. If I need extra help, I prefer to get ingredients from whole foods or teas, rather than from a pill. Taking a capsule of herbs feels like I am submitting to the pill-popping behavior so prevalent in Western society. For instance, rather than taking cranberry extract, I will eat whole cranberries. I like to get my omega 3’s from food, my antioxidants from green tea. My exception to this is  that I do take a multi-vitamin and calcium with vitamin D.

I have been interested in herbs and supplements for forty years and I stay abreast of the latest research. If reports of a supplement seem really compelling, I will consider it. If I am willing to take a drug to treat chronic hepatitis C virus (HCV) infection, I am equally willing to take a supplement that might fight this virus. However, I apply rigorous critical thinking to any medicine that goes into to my mouth.

Discouraged by the latest research showing that milk thistle and its derivatives do not work any better than placebo on HCV, I reactivated my search to find out what might work. My goal was to see if there was anything worth considering. This 2-part series includes my findings and opinions. In part one, I review supplements that were tested on HCV but didn’t hold up under scientific scrutiny.

Right off the bat, I ruled out St. John’s wort for two reasons. There is no evidence that this herb may improve HCV and St. John’s wort should not be taken with protease inhibitors, such as telaprevir and boceprevir. I also ruled out: astragalus, choline, colloidal silver, cordyceps, European mistletoe, ginseng, lecithin, L-carnitine, licorice root (glycyrrhizin extract), oxymatrin (an extract from the sophora root), picrorhiza, thymus extract, vitamin E and whey protein isolate. These may be perfectly fine to take, but there is no evidence that they improve liver health, improved HCV-related symptoms, or suppress or eliminate HCV.

I also eliminated substances that had insufficient evidence to recommend them, but that may be worth considering with more research. These supplements have potential, but until I see the proof, I am saving my money. These include:

• Alpha lipoic acid. An antioxidant made by the body. There have been a few, small HCV-related alpha lipoic acid studies, usually administering alpha lipoic acid intravenously or by other injection. One interesting German study published in 1999 administered alpha lipoic acid, silymarin and selenium to three subjects with advanced liver disease.1 All three were markedly improved. It would be wonderful to see this study reproduced on a larger scale and to have long-term follow-up of the three subjects. It would also be interesting to see research using oral alpha lipoic acid rather than by injection.

• Betaine (betaine anhydrous or trimethylglycine). This substance is made in the body, particularly involved in liver function. One small study combined betaine with SAMe and showed modest improved response to interferon treatment.2 Betaine has not been tested with protease inhibitors.

• Lactoferrin is a protein and important part of the immune system. A number of HCV-related lactoferrin studies show a possible, but slight benefit; none convinced me to add it to my medicine cabinet.3

• N-acetyl-cysteine (NAC) is an amino acid that is critical to the liver. NAC prevents cell death, and is used as the antidote for acetaminophen overdose. There is no doubt that it is a powerful substance, but when it comes to HCV, there just isn’t any proof that it helps.

• Phosphatidylcholine is a phospholipid found in every cell of the body. Egg yolks and soybeans are good sources of phosphatidylcholine. The studies I found were old, few, small, animal or lab-based.4 They were so unconvincing that this was an easy choice for me. I will keep eating eggs and occasional soy, but I will not spend money on phosphatidylcholine supplements.

• Schisandra is an herb that has been used for centuries in Chinese Medicine to treat liver disorders. Although its effect on HCV has not been proven, I am watching this one closely.5

• Selenium is a mineral that acts as an antioxidant, particularly when combined with vitamin E. I have been watching selenium for years, hoping the research would pan out.

And finally, I am still keeping a watchful eye on milk thistle, specifically its constituent, silibinin. Intravenous silibinan has been used along with standard HCV treatment medications in a variety of ways, most recently to prevent organ rejection following liver transplantation.6 The mere fact that silibinin and other constituents of milk thistle are actively being researched, testifies to this herb’s theoretical potential.

I realize that this article seems filled with bad news, showing what hasn’t been proven to work, rather than what might. I am aware that just because there isn’t proof that something works, doesn’t mean that it doesn’t. If the Wright brothers quit trying to fly after the first failed attempt and said, “We proved that it couldn’t be done,” we’d still be limited to travel by land and sea. However, they stuck with it. Stay tuned—next month the second installment of “Searching for Supplements.”

Endnotes
1  Berkson, BM. A Conservative Triple Antioxidant Approach to the Treatment of Hepatitis C - Combination of Alpha Lipoic Acid, Silymarin, and Selenium: Three Case Histories Medizinische Klinik October 1999
2  Filipowicz M, et al. S-Adenosyl-Methionine and Betaine Improve Early Virological Response in Chronic Hepatitis C Patients with Previous Non-response PLoS ONE 5(11)
3  Kaito M, et al. Effect of Lactoferrin in Patients with Chronic Hepatitis C: Combination Therapy with Interferon and Ribavirin. J Gastroenterology and Hepatology 2007, 22: 1894-7; Konishi M. et al. Lactoferrin Inhibits Lipid Peroxidation in Patients with Chronic Hepatitis C Hepatology Research 2006, 36: 27-32; Iwasa M, et al. Lactoferrin Inhibits Hepatitis C Virus Viremia in Chronic Hepatitis C Patients with High Viral Loads and HCV Genotype 1b. Am J Gastroenterology 2002, 97:766-7; Ishii K, et al. Long-Term Follow-Up of Chronic Hepatitis C Patients Treated with Oral Lactoferrin for 12 Months. Hepatology Research 2003, 25:226-233
4  Niederau C,et al. Polyunsaturated Phosphatidyl-Choline and Interferon Alpha for Treatment of Chronic Hepatitis B and C: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial. Leich Study Group. Hepatogastroenterology 1998;45:797-804
5  Azzam HS, et al. Natural Products and Chronic Hepatitis C Virus Liver International Volume 27, Issue 1, pages 17–25, February 2007
6  Rutter K, et al. Intravenous Silibinin as ‘Rescue Treatment’ for On-Treatment Non-Responders to Pegylated Interferon/Ribavirin Combination Therapy. Antiviral Therapy 2011; 16:1327-1333

 

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HCV Snapshots
Lucinda K. Porter, RN

Article: Novel Adenovirus-Based Vaccines Induce Broad and Sustained T Cell Responses to HCV in Man – E Barnes, et al.
  Source: Science Translational Medicine January 2012; Volume 4, Issue 115

There is no vaccine against hepatitis C virus (HCV). In this study, 41 healthy volunteers (subjects without HCV) were enrolled in one of four groups. Subjects received varying doses and structures of the vaccine, with the goal of stimulating an HCV-specific T cell response (an important indication of an immune response). By using a “recombinant adenoviral vector strategy,” researchers targeted the more stable internal mechanism of the virus. This study focused primarily on safety.

The Bottom Line: Subjects tolerated the vaccine with no major adverse events. The tested vaccine produced a strong and functional T cell response, lasting at least one year. Further clinical trials are planned to test efficacy and safety.

Editorial Comment: This is very early and small research, but nonetheless encouraging. Do we dare hope to live to see an effective HCV vaccine within a generation of having discovered HCV?

Article: Influence of Interferon-Based Therapy on Liver Fibrosis Progression in HIV/HCV Coinfected Patients: A Retrospective Repeated Liver Biopsy Analysis – P Ingiliz, et al.
  Source: Journal of HepatologyJanuary 2012; Volume 56, Issue 1, Pages 49-54

This retrospective study investigated one of the leading causes of death for HIV patients—HCV. Researchers looked at serial liver biopsies of 126 subjects, 68 who had received HCV treatment and 58 who had not. The average time between first and last biopsy was 4 years with a range of 0.5–15 years. About 79% were male and the age range at first biopsy was 33±7years.

Untreated patients with worsening fibrosis was 60%; 44% of the nonresponder/relapser group had worsening fibrosis; 28% of those who were treated and had a sustained virologic response (SVR) had worsening fibrosis.

The Bottom Line: Liver fibrosis was significantly better in HIV/HCV coinfected patients achieving an SVR than in those who were untreated or who did not respond to treatment. 

Editorial Comment: These results are consistent with findings among mono-infected HCV patients. The next step would be to see this study conducted prospectively, followed by research testing even more effective treatment options to offer HIV/HCV coinfection patients. 

Article: Efficacy of the Protease Inhibitor BI 201335, Polymerase Inhibitor BI 207127, and Ribavirin in Patients with Chronic HCV Infection – S Zeuzem, et al.
  Source: Gastroenterology December 2011; Volume 141, Number 6, Pages 2047-2055

This study examined the antiviral effect and safety of BI 201335 (an inhibitor of the NS3/4A protease) and BI 207127 (an inhibitor of the NS5B non-nucleoside polymerase) with ribavirin.

There were 32 treatment-naïve subjects with chronic HCV genotype 1 infection, randomly assigned to receive either 400 mg or 600 mg BI 207127 3 times daily plus 120 mg BI 201335 once daily and 1000 to 1200 mg/day ribavirin for 4 weeks. The primary end-point was complete (but not sustained) virologic response.

The best response rates were in the group given 600 mg 3 times daily of BI 207127. The rates of virologic response were 100% at weeks 3 and 4, and did not differ among genotypes. The treatment was well-tolerated; mild gastrointestinal disorders, rash, and photosensitivity were the most common reported adverse events. There were no severe or serious adverse events, and no patients discontinued therapy prematurely. One patient on the lower dose had virologic breakthrough and was switched to peginterferon and ribavirin per protocol.

The Bottom Line: These study results strengthen the notion that in the future, HCV patients may have interferon-free treatment options.

Editorial Comment: A virologic response is not the same as an SVR, and these numbers are small. However, the 100% response rate coupled with the high tolerability of this regimen, put BI 201335 and BI 207127 high on the list of drugs to watch. It will be interesting to see the results of Phase 2b clinical trials.

Article: Transmission of Hepatitis C Virus through Transplanted Organs and Tissue — Kentucky and Massachusetts, 2011 Reported by M Marvin, et al.
  Source: Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report (MMWR); December 23, 2011, Volume 60, Number 50, Pages 1697-1700

A September 2011 report filed by the United Network for Organ Sharing (UNOS) stated that organs and tissue from a deceased donor were transplanted and later found to be positive for HCV. An investigation identified that the liver recipient and two kidney recipients became HCV-positive because of receiving infected organs. The 15 tissue recipients tested negative for HCV and will have further follow-up. The cause of this mistake was human error—a misread lab test.

The Bottom Line: There is only one way to say this: three people now have HCV because of human error. The CDC issued recommendations to prevent further infections.

Editorial Comment: Human error occurs for various reasons: insufficient checks and balances, stress, inadequate sleep, and simply, because we are human. As patients, we are already vulnerable from our disease and navigation through the medical system, so thinking about human error may increase our sense of powerlessness. However, the chances of this happening are very, very low. It helps me to realize that this sort of mistake is rare.


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New National HCV Helpline Launched

On February 1, 2012 a new HCV helpline will be launched that promises “One Call – Lots of Help.” 

The helpline will include an up-to-date national database of 25,000 referral resources and a secure shared caller database for counseling continuity.  The volunteers who staff the helpline are specially trained peer counselors using a structured approach to help callers navigate through screening, diagnosis, medical evaluation, and treatment.  Additionally, the counselors will follow-up with the callers to help them make and follow through with their hepatitis C-related decisions. 

The new national helpline is a collaboration between five national nonprofits.  For more information visit
www.help4hep.org/

Need help and support?
Call 877-HELP-4-HEP (877-435-7443)



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Disability & benefits: Getting Health Insurance After Diagnosis
—Jacques Chambers, CLU

Insurance companies, being profit-making entities, are not particularly interested in providing health insurance to someone who has known health problems, especially chronic conditions. While they protect their profits by medically screening new applicants, that required review of health history becomes a barrier to coverage for someone, such as a person with HCV, who desperately needs health insurance to help with their ongoing medical bills, but is not currently insured. 

As discussed in prior articles, thanks to state and federal legislation over the past years, some methods have been established for a person to obtain health insurance regardless of their medical condition or health history.

Now, of course, there is the federal Affordable Care Act, signed into law in 2010. Once fully in place it should end the need for articles such as this; however, the major part of it does not take effect until January 1, 2014. That is when insurance companies will be required to cover anyone who applies for health insurance regardless of their health history or medical condition.

But that is still two years away. Then there’s the Supreme Court; which is scheduled to review the act’s “mandate,” the provision that requires everyone to purchase health insurance or face financial penalties which is a vital issue if carriers must cover anyone who applies. Additionally, in the midst of this year’s presidential campaign, many candidates are threatening—or promising depending on your point of view—to get rid of the law completely. Therefore, it seems appropriate to review the current status of health insurance and its availability for persons with ongoing medical conditions such as HCV.

Employer Provided Health Insurance
Most people now get their health insurance through their employer; but it was not always available to all employees. Since 1996, under a federal law called HIPAA, if you work for an employer who provides group health insurance to its employees, you cannot be refused the insurance because of your medical condition or health history. If the employer offers it, they must let you enroll in the plan regardless of your health.

There are advantages and disadvantages to getting health insurance through your employer. The primary advantage is that the employer pays most or all of the costs of the health insurance, and what they pay for you and your dependents’ coverage is not considered taxable income to you. Also, many employers offer a choice of plans so that each employee can choose the plan that best fits his or her needs.

The primary disadvantage is that your health insurance is tied to your employment and you have no say in what plan you get. Also, if the employer changes plans, you have no choice but to change plans too, even if it means less coverage.

However, thanks to COBRA and the 1996 HIPAA law, once you have acquired health insurance through an employer, you have the right to keep either that insurance or a private plan of similar quality, even if you terminate employment, provided you extend your health coverage as long as possible under the COBRA extension. That means that once you acquire health insurance through an employer you will be able to maintain some form of health insurance regardless of any change in your employment status.

Eligible Spouse or Domestic Partner of an Employee with Health Insurance
If you are the spouse of an employee who gets health insurance through an employer, you too are eligible for health insurance just as the employee is. Also, more and more employers and health insurance plans allow “domestic partners” the same rights to health insurance as a married spouse.

Because there is no standard definition of a “domestic partner,” each health plan will have its own requirements as to who can be covered as a “domestic partner.” It usually includes the partner in a committed relationship regardless of sexual orientation. Some plans require that they live together; others don’t. A few plans will permit any other person to whom the employee has close ties, including a parent or sibling, to be included in the plan.

Union or Guild Health Plans
Most union employees are covered through employer provided health plans that are part of a bargaining agreement with the union. However, some unions and trade guilds provide health insurance directly to their members. This is most common in trades or occupations where the union member either works freelance or moves frequently from employer to employer. Examples would include: musicians, actors, writers, editors, decorators, truck drivers, service employees, and some professional occupations such as attorneys, architects, or dentists. The requirements for joining the union health plan can be fairly strict. Most will require a minimum number of hours worked or dollars earned in that profession to be eligible for the health insurance plan.

Association Plans
At one time, many associations made health insurance available to their members without requiring medical underwriting. However, as health insurance became more difficult to find and more expensive to maintain, insurance companies largely stopped writing association plans on such a simplified basis. Of those association plans that still exist, virtually all require medical underwriting, evidence of good health to join – just as if it were being purchased directly from an insurance company.

Veterans Administration Medical Benefits
If you are a veteran of the military service you may be eligible for medical benefits from the Veteran’s Administration. For more information on getting benefits through the VA, go to http://www.va.gov/ and click on “Health – Benefits & Services.” While this may not affect many readers, for those that are affected, VA benefits can be very helpful especially for persons dealing with HCV.

If a disability is “service-connected,” you may be eligible for monthly disability benefits in addition to completely free medical care. Because of the methods of transmission for HCV and because of its relative newness as an identifiable diagnosis, the VA may interpret HCV infection as “service connected.”

Medicare/Medicaid
These federal health insurance plans can provide medical care to a person with HCV as well, assuming that you are eligible for the coverage.

Medicare is available to all legal residents age 65 or older. It is also available to persons under age 65 who have collected Social Security Disability Insurance benefits (often called SSD, SSDI, or Disability Insurance Benefits) for 24 months.

Medicaid is a federally mandated health plan that is based on need. In addition to being either age 65 or older or disabled, you must also show that your income and resources (assets) are low enough to qualify. Medicaid is administered by each state so the eligibility rules will vary slightly from state to state.

State High Risk Plans
Many states offer a health insurance plan for persons who, due to their medical history, are unable to purchase it on the open market. The plans vary from state to state. Most charge a premium that is higher than regular health plans, and some offer benefits that are not as broad as many private plans.

To learn more about your state’s High Risk Health Insurance Plan, called by different names in each state, contact your state’s Department of Insurance.

Contact numbers and addresses for all 50 states’ Departments of Insurance can be found at http://www.ican2000.com/state.html.

Open Enrollment Periods
A few states require their Blue Cross – Blue Shield plan to open their enrollment at least once a year to anyone who applies for health insurance, regardless of their health history.  Call your local Blue Cross – Blue Shield insurance carrier in your state and ask for information on their “open enrollment for individual health plans,” if there is any.

Guarantee Issue by State Mandate
Finally, there are a few states that require all insurance companies to offer at least a few health insurance plans, if not all, to persons without any medical underwriting at all. Each state has its own requirements as to when these plans are offered and what plans must be offered. For more information contact your state’s Department of Insurance to see if your state offers either an open enrollment period or guarantee issue health insurance.

Pre-Existing Conditions Health Plan
As part of the Affordable Care Act, each state has set up health insurance plans for persons who are not able to purchase individual health insurance due to their medical condition. These plans are available to all such persons who have been without health insurance for at least six months. Plans and costs vary by state. More details on these plans can be found at https://www.pcip.gov/ . You can usually find the PCIP plan in your state with a browser search for “PCIP in Oklahoma,” using your state.


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