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April 11, 2011

City Council Committee Oversight Hearing on HIV/AIDS - Hepatitis C Co-Infection


Good afternoon Chairperson Arroyo and members of the Health Committee, I am Dr. Joseph Masci, Director of Medicine at Elmhurst Hospital Center, which is part of the New York City Health and Hospitals Corporation (HHC). I am also a Professor of Medicine - and also Preventive Medicine - at the Mount Sinai School of Medicine. On behalf of HHC, thank you for the opportunity to discuss HIV/AIDS - Hepatitis C co-infection. I will begin with an overview of HIV/AIDS services, and then discuss Hepatitis C and current treatment protocols.

All eleven HHC acute care hospitals are state-designated AIDS Centers that provide comprehensive HIV/AIDS (both inpatient and outpatient care) services to their patients to help them achieve the best possible outcomes. The centers work with pediatric and obstetrical departments to deliver the specialized HIV care that infants, children and pregnant women need. Coler-Goldwater, one of HHC’s long-term care facilities, also provides specialized care to individuals with HIV who require ongoing medical care in a skilled nursing setting. Through HHC’s health plan, MetroPlus, we operate a Special Needs Plan (SNP) for people living with HIV/AIDS. Lastly, any New Yorker can come to any HHC hospital or diagnostic and treatment center and quickly obtain confidential HIV testing, as well as expert treatment and counseling, regardless of his or her ability to pay or immigration status.

HHC is committed to improving patient outcomes by delivering comprehensive high quality HIV related medical care and supportive services, and by increasing access to HIV testing so that people are able to learn of their HIV infection earlier in the course of the disease and can be linked to life-prolonging treatment. HHC has been very fortunate in this endeavor over the last several years to receive considerable resources from the City Council to support an expanded routine HIV testing program. In Fiscal Year 2010, more than 188,000 individuals were tested and more than 1,750 individuals tested positive. Since the program began in 2006, more than 840,000 individuals have been tested for HIV and more than 8,400 individuals were diagnosed with HIV. Through the efforts of HHC staff more than 60% of them were linked to HIV primary care within the month they were diagnosed, and more than 90% were linked to care within 90 days. HHC is the largest provider of HIV primary care in New York City.

It is estimated that between 15% and 30% of people who have HIV also are co-infected with Hepatitis C. The estimates vary since some people who are infected do not show symptoms of the disease and testing for Hepatitis C may not be consistent among populations.

As you know, Hepatitis C is a disease that inhibits the proper functioning of the liver and is a leading cause of death due to liver disease in the HIV infected population. Hepatitis C is one of the three most common forms of Hepatitis – the other two are Hepatitis A and Hepatitis B. HIV and Hepatitis C share some common routes of transmission. People who are at a very high risk of becoming infected with Hepatitis C are injection drug users. This is also a main source of HIV infection. It is important to recognize that it is the needle sharing behavior that transmits Hepatitis C, so high risk behaviors may also include the use of “street” hormones, getting a tattoo or body piercing from an unlicensed establishment and other behaviors; not just the use of injection drugs. Others at high risk of infection include men who have sex with men without protection and through heterosexual transmission, especially for those with multiple partners engaging in anal intercourse.

We estimate that of the 19,000 HHC patients who are HIV positive, approximately 25% are also co-infected with Hepatitis C. For these individuals, the effects of Hepatitis C are more serious, treatment is complex and some options may not be available due to contra-indications or other complicating factors such as alcohol or drug abuse. However, Hepatitis C is a treatable disease and treatment options are steadily improving. There are new classes of prescription drugs currently in the Food and Drug Administration trial phase with the possibility that one of these will be available later this year.

At Elmhurst Hospital Center we provided care in our Immunology Clinic for approximately 1,180 individuals with HIV infection in 2010. Of this group, 97 are co-infected and are under treatment or monitoring by our joint Infectious Disease-Liver Clinic 62 have infection with Type 1 Hepatitis C virus, the type least likely to respond to current therapies. In total, 70 co-infected patients have either declined therapy, have a contraindication for treatment or are among those for whom hepatitis is not causing significant liver damage.

All persons with known HIV infection should be screened for Hepatitis C infection regardless of whether they self report the common risk factors for acquiring Hepatitis C. Hepatitis C is diagnosed by having a positive antibody (a protein response the body makes against the virus) test. For some people with HIV, this Hepatitis C test may be negative because their immune systems are weakened. Therefore, if persons with HIV do have risk factors for Hepatitis C or they have abnormal liver tests, we order a more specific test that can detect if any Hepatitis C is in their blood.

Guidelines from the New York State Department of Health (SDOH) recommend a baseline test for Hepatitis C for newly diagnosed HIV infected patients and yearly testing of patients thereafter. The next step that we at HHC take, is to conduct an assessment for signs of liver disease, drug or alcohol abuse, depression or other mental health diagnoses that have major affects on patients’ health outcomes and eligibility for treatment of their Hepatitis C disease. Persons with Hepatitis C infection should be offered vaccination for Hepatitis A and B to prevent other harmful liver diseases. We also provide education as a guide to maintaining a healthy liver. Many commonly used medications and supplements can harm the liver such as acetaminophen (Tylenol) or cold medicines. While some supplements like milk thistle can improve liver health, others like St John’s Wort may interfere with patients’ HIV therapies and cause harm. All persons with HIV and Hepatitis C co-infection should have an ultrasound of their liver yearly to screen for hepatocellular carcinoma, a type of liver cancer associated with Hepatitis C that is much more common when one also has HIV infection.

Based on SDOH clinical guidelines, the decision whether or not to treat a HIV-Hepatitis C co-infected individual must be made in consideration of several factors which include:

  • Contraindications and relative contraindications to therapy. For example, persons with severe anemia (low blood counts), kidney disease or significant depression are not able to tolerate the medications. The major medication used, Interferon, can induce thoughts of suicide and severe depression even among persons without such history;
  • Whether or not the patient has acute Hepatitis C;
  • Likelihood of response to treatment;
  • Likelihood of progression of scar tissue (fibrosis) of the liver in the absence of treatment;
  • Immune system status;
  • Extent of liver damage;
  • Status of HIV disease. Treating the HIV will slow the progression of Hepatitis C virus, but liver disease may affect a person’s ability to take the HIV medications;
  • Risk for adverse effects of treatment (those that I mentioned before including severe depression or thoughts of suicide), as well as lowering of the person’s white blood count, which places the person at risk for infection; lowering the red blood count causing anemia; and lowering of platelets (those cells needed for clotting) which places the person at risk for bleeding. This risk assessment becomes quite complex as persons with HIV and Hepatitis C frequently have these conditions already;
  • Motivation for treatment and barriers to adherence to therapy; and
  • CD4 count (T cells) to measure the immunity system. Persons with low CD4 counts are already at too high of a risk for infection and the Interferon medicine for Hepatitis C cannot be given to them since it would further lower their CD4 counts.

After this review, if it is determined that treatment may prove to be beneficial, the patient’s physician should discuss the benefits and subsequent risks of various treatments. Currently, there is only one option for treatment, a special formulation of Interferon called Pegylated Interferon that requires weekly injection and Ribavirin, pills that are taken daily in combination for at least one year.

The outcomes of those with HIV-Hepatitis C co-infection are considerably worse than those with Hepatitis C mono-infection. First, the HIV infection speeds the progression of liver damage from the Hepatitis C. Second, there are significantly more barriers to care and more contraindications to the medications affecting patients’ eligibility to even be offered treatment for Hepatitis C. Third, there is a lack of qualified HIV-Hepatitis C experts trained to treat this population. Finally, the response rate to these medications is much poorer among patients with HIV infection compared to those with Hepatitis C mono-infection.

Investigational drug trials are currently underway to evaluate new forms of drug treatment. This is very exciting news and offers much promise. Two new protease inhibitors that work by inhibiting the replication of the Hepatitis C Virus are expected to be approved by the FDA later this year. In addition, there are several new classes of drugs being developed that are or will be in study at centers in New York City.

There are strategies now being employed that may improve outcomes. For instance, HIV infected persons may have more fatty liver disease so by reducing the fat, a person may respond better to the Interferon and Ribavirin. Also, a new genetic marker was discovered last year which showed that among persons who had this marker, their overall response rate to medications would be higher. Employing such strategies could help identify those individuals who would have better response rates rather than providing medications where the risk outweighs the benefit.

For those who are unlikely to benefit or cannot take the current medications to treat Hepatitis C, it is essential that we have the resources to monitor their HIV-Hepatitis C co-infection and provide education on ways to improve liver health. Examples include, imaging the liver on an annual basis and if any suspicious cancerous mass is identified, making a referral to a liver surgeon for biopsy and possible removal. Another example, is provision of medications to prevent end stage liver disease. Complications of end stage liver disease include enlargement of blood vessels in the esophagus (feeding tube) resulting in bleeding or building up of body fluids in the abdomen and the person turning yellow from jaundice (by-products of a failing liver).

For those who do develop end stage liver disease, there are considerable measures that can be taken including for some, liver transplants which is much riskier for persons with HIV infection. Nationwide, 30% of all liver transplants are done because of Hepatitis C disease; however, very few transplant candidates have HIV co-infection.

Now I would like to discuss what can be done to prevent and/or reduce the spread of both HIV and Hepatitis C. The current SDOH recommendations for prevention (and thereby reduction) of the spread of these viruses includes:

  • Avoiding practices that transmit both HIV and Hepatitis C. Chief among these are high risk sexual practices including unprotected sex and needle sharing among injection drug users.
  • Providing counseling and treatment for active drug users to reduce or eliminate drug use.
  • For those who continue to be active drug users, counseling them to use new sterile equipment at all times and to properly dispose of their syringes after one use.
  • Advising those who have contact (household) with persons infected with Hepatitis to avoid sharing items that may be contaminated (such as toothbrushes and razors).
  • Encouraging uninfected long term sexual partners of persons co-infected to continue to follow safe-sex guidelines to prevent transmission.
  • Encouraging those seeking tattoos and body piercing to use only licensed establishments

Of course, education and awareness are large components of any prevention strategy, whether it is for HIV or Hepatitis C. By holding this hearing, the Council is contributing to the public discourse on the growing problem of HIV Hepatitis C co-infection. I ask the City Council to help us spread the word of the importance to be tested for both HIV and Hepatitis C infection. The spread of hepatitis C is a large and underreported problem worldwide that is further compounded by HIV co-infection. I believe this topic is one that needs to be discussed in the public forum more often. I appreciate the opportunity to come before the Council to have this discussion. I conclude my written testimony with some thoughts about the impact that earlier diagnosis and therapy can have on an individual.

A healthy 25 year old man can expect to live another 53.1 years and that same man with HIV infection who is promptly diagnosed and takes HIV therapy according to SDOH guidelines can expect to live another 52.7 years. But, if he has Hepatitis C co-infection, his lifespan will be markedly reduced to only 10-30 years beyond diagnosis unless the Hepatitis C is controlled or cured. We will have the opportunity to change this outcome as we did for those with HIV infection alone, as the new diagnostic technologies and medications increasingly becoming available.

I would now be happy to answer any questions you have.



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