September 30, 2013

Characterizing and improving HIV and hepatitis knowledge among primary prescription opioid abusers

Drug and Alcohol Dependence

Article in Press

Kelly E. Dunn, Kathryn A. Saulsgiver, Mollie E. Patrick, Sarah H. Heil, Stephen T. Higgins, Stacey C. Sigmon,

Received 27 June 2013; received in revised form 8 August 2013; accepted 9 August 2013. published online 19 September 2013.
Corrected Proof



The high rates of HIV and Hepatitis C (HCV) infection among opioid abusers is a serious public health problem, and efforts to enhance knowledge regarding risks for HIV/hepatitis infection in this population are important. Abuse of prescription opioids (POs), in particular, has increased substantially in the past decade and is associated with increasing rates of injection drug use and HCV infection.


This study describes the effects of a brief HIV/HCV educational intervention delivered in the context of a larger randomized, double-blind clinical trial evaluating the relative efficacy of 1-, 2-, and 4-week outpatient buprenorphine tapers and subsequent oral naltrexone maintenance for treating PO dependence. HIV- and HCV-related knowledge and risk behaviors were characterized pre- and post-intervention in 54 primary PO abusers.


The educational intervention was associated with significant improvements in HIV (p<.001) and HCV (p<.001) knowledge. Significant improvements (p<.001) were observed on all three domains of the HIV questionnaire (i.e., general knowledge, sexual risk behaviors, drug risk behaviors) and on 21 and 11 individual items on the HIV and HCV questionnaires, respectively. Self-reported likelihood of using a condom also increased significantly (p<.05) from pre- to post-intervention. No additional changes in self-reported risk behaviors were observed.


These results suggest that a brief, easy-to-administer intervention is associated with substantial gains in HIV and HCV knowledge among PO abusers and represents the necessary first step toward the dissemination of a structured prevention HIV and HCV intervention for PO abusers.

Keywords: HIV, Hepatitis C, Noninjection, Education, Intervention, Prescription opioids

PII: S0376-8716(13)00323-2


© 2013 Elsevier Ireland Ltd. All rights reserved.


Warnings for Hepatitis B Reactivation in Cancer Patients Welcomed by the American Association for the Study of Liver Diseases


ALEXANDRIA, Va., Sept. 30, 2013 /PRNewswire/ -- Food and Drug Administration (FDA) announced the requirement of a Boxed Warning for the anti-cancer immunosuppressive drugs Arzerra (ofatumumab) and Rituxan (rituximab). The Boxed Warning is specific to the risk of reactivating hepatitis B virus (HBV) in patients who were previously infected with the virus. Use of these drugs in patients with prior HBV infection can result in severe liver damage if the virus is reactivated.

The American Association for the Study of Liver Diseases represents the hepatology community, which has recognized for more than a decade that treatment of cancer with chemotherapy sometimes results in reactivation of HBV. The risk of HBV reactivation is already described in the Warnings and Precautions section of the labels for both drugs; however, the FDA's monitoring system had continued to detect cases of HBV reactivation with these agents and independently came to appreciate the problem's persistence.

AASLD convened a conference on the subject of HBV reactivation during chemotherapy in March 2013, and representatives of the FDA were present at the meeting and engaged in discussions. Those discussions between AASLD and the FDA were continued through the summer. According to AASLD President-Elect Adrian Di Bisceglie, MD, "AASLD members were recognized as experts and our persistence as an organization in this area helped FDA make up its mind to notify prescribing physicians of this problem."

The FDA also released new recommendations to decrease the risk of HBV reactivation when these drugs are used. Addressing this risk of hepatitis B reactivation, the full FDA communication states: "The revised labels will include additional recommendations for screening, monitoring, and managing these patients on these drugs to decrease this risk."

The Warnings and Precautions section is being revised for each drug to express new recommendations for health care professionals. Dr. Di Bisceglie added, "We still believe there are other agents and treatment regimens that pose similar risks of HBV reactivation, and AASLD will call for further study and awareness of this and other agents may perhaps need similar box warnings."

Please follow this link for the FDA press release and additional information on HBV reactivation:

AASLD is the leading organization of scientists and healthcare professionals committed to preventing and curing liver disease. AASLD was founded in 1950 by a small group of leading liver specialists and has grown to an international society responsible for all aspects of hepatology.

Press releases and additional information about AASLD are available online at

Media Contact: Gregory Bologna

This release was issued through The Xpress Press News Service, merging e-mail and satellite distribution technologies to reach business analysts and media outlets worldwide. For more information, visit

SOURCE American Association for the Study of Liver Diseases (AASLD)



Why a Backup Plan Is No Plan at All

Provided by The Motley Fool

By Brian Orelli
September 30, 2013

Achillion Pharmaceuticals  (NASDAQ: ACHN )  fell 58% today after giving a pipeline update on its hepatitis-C treatments.

I'm not sure which is worse: that sovaprevir is still on clinical hold or that if it ever gets off of clinical hold, the phase 2 data was nothing special.

They're both pretty bad.

You'll recall the Food and Drug Administration put sovaprevir on clinical hold back in July after the biotech saw elevated liver enzymes in a trial combining sovaprevir with atazanavir. Achillion provided the necessary data that the FDA wanted, but the agency wasn't willing to lift the hold.

Hepatitis-C drugs have hit a rough patch lately. Two of Idenix Pharmaceuticals' (NASDAQ: IDIX ) compounds were put on clinical hold, and the biotech eventually had to scrap them because of their similarity with Bristol-Myers Squibb's BMS-986094, which had side-effect issues.

Vertex Pharmaceuticals' (NASDAQ: VRTX ) VX-135 also had issues with elevated liver enzymes. The drug was only put on a partial hold because the problem was seen solely at the higher dose.

Elevated liver enzymes are never a good sign because they suggest the drug might be damaging the liver. And that goes double for hepatitis-C drugs that are treating a viral infection that primarily attacks the liver.

Good isn't good enough
Achillion managed to get some data from a phase 2 trial combining sovaprevir, one of its other drug candidates called ACH-3102, and a generic drug ribavirin before the clinical hold went into effect. The drug combo removed traces of the virus in 79% of patients when measured four weeks into the 12-week trial.

A cure -- called a sustained viral response -- is typically determined four to 12 weeks after the treatment ends. Some patients with a rapid viral response that Achillion is measuring with this interim data will rebound, so the 79% is the best the cure rate could be. It'll likely be lower.

A 79% cure rate isn't bad compared to the current standard of care. Vertex's Incivek produces comparable cure rates, but must be taken with peg interferon, which has to be injected. Unfortunately, meeting the current standard of care with an all-oral combination isn't good enough anymore because a new standard is on its way. Gilead Sciences (NASDAQ: GILD ) and AbbVie (NYSE: ABBV ) have all-oral combinations that are approaching 100% cure rates.

Backup plan
Achillion's new plan is to combine ACH-3102 with another drug candidate, ACH-2684. Data from that combination will be available next year. But that's only going to be a proof-of-concept trial. The biotech would still have to run a couple phase 3 trials to get the combination on the market.

Being years behind Gilead and AbbVie will end up being very costly. Remember, these drugs cure patients. Any patient who is treated successfully by Gilead's or AbbVie's combinations won't need drugs from Achillion.

The hepatitis-C market is only going to get smaller. A backup plan might end up being no plan at all.

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Extrahepatic Manifestations of Hepatitis C Virus (HCV)

Frontline Gastroenterology

David G Samuel, Ian W Rees

Frontline Gastroenterol. 2013;4(4):249-254. 

Abstract and Introduction


Hepatitis C virus (HCV) is an infectious disease that often remains asymptotic and unrecognised until complications of the virus arise. These often include extrahepatic manifestations of the virus, which first bring patients into contact with the medical profession. First recognised in the 1990s several syndromes and conditions have now been linked to hepatitis C, while others are still emerging. In some patients, extrahepatic manifestations can be the dominant feature, while hepatic disease is mild. Some conditions have an established association with the virus with a proven pathophysiological and epidemiology, such as cryoglobulinaemia. Others have consistently been found to be seen in patients with HCV, but the underlying cause of these conditions is not clearly understood. These include porphyria cutanea tarda. Many other autoimmune conditions are commonly seen in the patients with HCV as well as nephropathies, but the exact interplay between virus and resulting clinical condition is not clear. Clinicians have to have a high index of suspicion and a knowledge of the extrahepatic manifestations of HCV in order to not only treat the manifestation but also in initiated timely therapies for the underlying HCV.


Hepatitis C virus (HCV) is an infectious disease that often remains asymptotic and unrecognised until complications of the virus arise. These often include extrahepatic manifestations (EHM) of the virus, which first bring patients into contact with the medical profession.[1] Up to 75% of patients will develop an EHM during their illness. First recognised in the 1990s several syndromes and conditions have now been linked to hepatitis C, while others are still emerging. In some patients, EHM can be the dominant feature, while hepatic disease is mild.[2]

Some conditions have an established association with the virus with a proven pathophysiological and epidemiology such as cryoglobulinaemia.

Others have consistently been found to be seen in patients with HCV, but the underlying cause of these conditions is not clearly understood. These include porphyria cutanea tarda. Many other autoimmune conditions are commonly seen in patients with HCV as well as nephropathies, but the exact interplay between virus and resulting clinical condition is not clear. Among these, glomerulonephritis is an important condition to consider (Table 1).

Table 1.  The extrahepatic conditions related to hepatitis C1 2

Haematological Systemic Rheumatology Dermatology Organ dysfunction
Cryoglulinaemia Arthralgia Bechet's disease Canities Diabetes
Membranoproliferative glomerulonephritis Arthritis Vasculitis Lichen myxoedematosus Cardiomyopathy
Multiple myeloma Fatigue Raynaud's syndrome Porphyria cutanea tarda Idiopathic lung fibrosis
Neutropenia/thrombocytopenia Fibromyalgia Sialadenitis Pruritis Peripheral neuropathy
Non-Hodgkin's lymophoma Corneal ulceration Systemic lupus erythematous Spider naevi Hypothyroidism
Waldenstrom Macroglobulinaemia   Vitiligo Renal failure  

This review aims to provide an overview of the conditions with the greatest level of evidence supporting a direct link with HCV, as well as looking at the potentially most life-threatening manifestations, with a focus on investigations and management. I have selected conditions, which have the greatest amount of pathophysiological evidence for a causal effect by the HCV, as looking at multiple conditions would be beyond the scope of a single paper, but the principles of investigations and management apply to many of the other conditions listed above. The paper provides a helpful overview for the hepatology clinic as well as encounters on general medical takes.

Before looking at the individual conditions focused on in this article, I will provide a brief overview of the current evidence suggesting the pathophysiology of extrahepatic tissue invasion and pathogenesis of the HCV.

The Pathophysiology of EHM of HCV

It is thought that extrahepatic tissues serve as a reservoir for the hepatitis virus, but especially tropism for the lymphoid tissues.[2] Like other viruses, the HCV has developed an ability to evade detection by the immune system, which in turn leads to chronic inflammation, tissue damage and immune-complex aggregation, activating autoimmune phenomena.[2, 3] In cryoglubulinaemia, which will be discussed in detail below, B-cell lymphoproliferation is the initial immune-cascade trigger. The HCV tropism allows the lymphocytes to serve as host and reservoir, with the virus thought to bind to the CD81 ligand of the B lymphocyte using an E2 protein.[4] Flint was the first to show that this engagement with the HCV envelope activates lymphocytes and subsequently leads to immunoglobulin production.


Cryoglobulinaemia is among the most common and closely linked extrahepatic HCV manifestations and is most often a mixed cryoglobulinaemia of type 2 or 3.[2, 5] Considered a lymphoproliferative disorder, it is thought to result from chronic stimulation and over production of B cells[6] producing immunoglobulin. The disorder is characterised by these abnormal blood-borne protein, which precipitate and aggregate into gel-like substances at reduced temperatures, normally aggregate below 37°C.[2, 4] When the cryoglobulins aggregate and form gel-like substances cause clinical signs and complications through occluding vessels and inflicting target organ damage.[7] Symptoms relate to the organ affected and can range from joint pain, muscle pain, acute kidney injury and glomerulonephritis, or more commonly manifesting as a vasculitic syndrome. Critical ischaemia can result with loss of limbs, particularly digits.[1, 7] Other non-specific symptoms including lethargy are common, with the most common symptoms including arthralgia and pruritus in up to 18% of patients. Up to 50% of patients remain relatively asymptomatic until a critical assault on an organ occurs[1, 6] (Table 2).

Table 2.  The immunological profile and classification of cryoglobulinaemia6

Cryoglobulinaemia class Clonal precipitates
Type I (lymphoproliferative) Isolated monoclonal IgG or IgM
Type II—mixed Polyclonal immunoglobulins (IgG and monoclonal IgA, IgM, IgG
Type III—mixed Polyclonal IgM and IgG

At first presentation of cryoglobulinaemia investigating for the cause would include a hepatitis screen. Other investigations include urinalysis, which sometimes shows haematuria, a complement assay, which is low, cryoglobulin levels if available within local hospitals and a full blood count. Rheumatoid factor is often positive in types 2 and 3 and can sometimes point to coexisting disease[4, 6] ().

Table 3.  The initial investigations to consider in a patient presenting with the symptoms and clinical signs of cryoglobulinaemia 4

Cryoglobulin levels HCV antibody±PCR and virology
Immunoglobulin and protein levels Urine analysis
Complement levels Biopsy of lesion (within 48 h)
Gammopathy assessment Biochemistry

Adapted from Khattab et al.4 HCV, hepatitis C virus

Biopsies typically show a leukoclastic vasculitis, which usually involves the medium-sized vessels.[7, 8]

Another important manifestation of cryoglobulinaemia is a peripheral neuropathy, which has been reported in up to 90% of patents depending on the case series.[9] Most cases involve a sensory impairment similar to the diabetic neuropathy, and also in a similar glove stocking distribution, but not exclusively.[9] The condition can be made worse by interferon therapy, which is an important issue to consider in managing the underling HCV.[10] A biopsy typically shows axonal damage and an epineural vasculitic infiltrate.[7, 10]

Therapy is targeted at

  1. treating the underlying HCV and reducing or eradicating viral load

  2. immune-targeted therapy.

The most widely studied and used regimes include cyclophosphamide along with steroid therapy with the aim of suppressing antibody production and cryoglobulin production, but with mixed results.[2, 8, 11] A major concern and drawback of this therapy is the risk of allowing HCV viral replication and the most recent review of therapy does not endorse cyclophosphamide therapy.[12] More targeted therapies such as rituximab have shown greater promise and has been shown to rapidly reduce antibody and cryoglobulin levels.[13, 14] Severe cases, or those involving major organs, warrant early corticosteroid therapy and immunosuppression therapy.[12] Patients are often treated with plasmapheresis[14] (see next section). Treating the underlying HCV remains the cornerstone of preventing both hepatic and extrahepatic complications (figure 1).


Figure 1. An algorithm for investigating and managing patients with cryoglobulinaemia.1,2,4,10,13,14


Glomerulonephritis is defined as an inflammatory process which, in the case of hepatitis C, is due to immune dysregulation and an ineffective response by the body to deal with the HCV.[5, 15] The most common glomerulonephritis associated with HCV-related cryoglobulinaemia is membranoproliferative glomerulonephritis.[11] The pathophysiology of HCV-related glomerulonephritis is believed to involve deposition of immune complexes, anti-HCV immunoglobulin and an IgM subtype rheumatoid factor.[13]

Presentation ranges from hypertension, which is present in 80% of patients with an associated moderate renal insufficiency.[13] 20%–35% of patients may present as a nephrotic syndrome and up to a quarter of patients will be nephritic.[4, 15] However, 10% of patients will present with rapidly deteriorating renal function and warrant urgent referral to specialist nephrology services (Table 4).

Table 4.  The typical findings and differential features of mesangiocapillary and rapidly progressive glomerulonephritis (RPGN)15

Glomerulonephritis Proteinuria Nephrotic Nephritic Haematuria ARF CRF
Mesangiocapillary ++ ++ + + ++ +
Rapidly Progressive + ± +++ ++ ++ +

Very common=+++; quite common=++; common=+; rare or never seen=−.15
ARF, acute renal failure; CRF, chronic renal failure.

Treatment is underpinned by aggressive hypertensive therapy with associated renin-angiotensin system blockade.[15] This is achieved using ACE inhibitors, angiotensin receptor blockers and diuretics. Patients tend to have high lipid and triglyceride levels and managing coronary risk factors have been proven to be beneficial.[15, 16] Treating the underlying HCV infection has not only been shown to clear the virus successfully but also in preventing or limiting renal damage.[15] Dual therapy with interferon and ribavirin has been shown to reduce viral load, as well as reduce proteinuria but has mixed success in improving glomerular filtration and creatinine levels, but studies have consistently shown that commencing antiviral therapy stabilises renal function.[17] Data also support prolonged therapy for at least 48–52 weeks, irrespective of early reductions in HCV loads at 12 weeks, but therapy can be considered for as long as 72 weeks in patients with non-responding viral load, but with biochemical and clinical improvements.[14] Caution has to be taken in using ribavirin at full dose as clearance is related to renal function.[14, 17]

In patients who present with rapidly progressive glomerulonephritis and nephritic syndrome, early aggressive therapy is crucial.[12] Plasma exchange is used in order to remove circulating cryoglobulins and hence reducing the insult on organs and tissues.[13] This is normally carried out by exchanging 3 litres, three times a week over 2–3 weeks. Pulsed steroid therapy in conjunction with plasma exchange has also been shown to be beneficial in correcting glomerular filtration dysfunction.[7, 16] Cyclophosphamide has been used to suppress B cell function during the acute phase of the illness by reducing cryoglobulin production.[10, 18] However, as discussed previously, more recent studies have not provided evidence to support its recommendation and is not currently recommended as first-line therapy.[14] More recent studies have looked at the potential role of rituximab in treating nephritic syndrome and glomerulonephritis. The rationale behind this research is the impact that the CD20 targeted antibody has on selectively targeting B cells, the driving force in cryoglobulinaemias.[18] Small studies have shown mixed benefits in reducing proteinuria and stabilising renal function, but no large randomised control studies have yet shown clear benefit and concerns remain over the potential to predispose patients to overwhelming sepsis.[13, 17, 18] There also remains concern that suppressing immune function leads, while improving renal disease, paradoxically increases circulating viral load, which has been shown in cyclophosphamide,[14] but not yet shown in rituximab.

Unlike the HCV, prognosis with glomerulonephritis is relatively poor and up to 50% of patients will progress to end stage renal disease[15] (figure 2).


Figure 2. The treatment algorithm for patients presenting with glomerulonephritis.13,15,17,18

Porphyria Cutanea Tarda

Porphyria cutanea tarda (commonly referred to as PCT) is recognised as the most prevalent subtype of porphyritic diseases. The disease is characterised by onycholysis and blistering of the skin in areas that receive higher levels of exposure to sunlight.[19, 20] The primary cause of this disorder is a deficiency of uroporphyrinogen decarboxylase (UROD), a cytosolic enzyme that is a step in the enzymatic pathway that leads to the synthesis of haem.[19] The disorder results from low levels of the enzyme responsible for the fifth step in haem production.[20] Haem is a vital molecule for all of the body's organs. It is a component of haemoglobin, the molecule that carries oxygen in the blood. Excess circulating iron has been shown to enhance toxic metabolite formation, which include oxidation products which inhibit UROD.[19]

Typically, patients who are ultimately diagnosed with PCT first seek treatment following the development photosensitivities in the form of blisters and erosions on commonly exposed areas of the skin.[19, 21] This is usually observed in the face, hands, forearms and lower legs. It heals slowly and with scarring.[20] Though blisters are the most common skin manifestations of PCT, other skin manifestations like hyperpigmentation (as if they are getting a tan) and hypertrichosis (mainly on top of the cheeks) also occur.[19] PCT is a chronic condition, with external symptoms often subsiding and recurring as a result of a number of factors. In addition to the symptomatic manifestation of the disease in the skin, chronic liver problems are extremely common in patients with the sporadic form of PCT.[20]


While the most common symptom of PCT is the appearance of skin lesions and blistering, their appearance in isolation cannot lead to a conclusive diagnosis.[19, 22] Laboratory testing will commonly reveal high levels of uroporphyrinogen in the urine, clinically referred to as uroporphyrinogenuria.[19, 21]

Treatment options include avoidance of sunlight, which precipitates the typical rash associated with PCT. In addition, smoking cessation and avoidance from alcohol is advised, especially in patients with hepatitis C,[19] although evidence to strongly support these measures specifically to PCT is limited.[23] More targeted treatments include regular venosection, with the aim of reducing iron stores to the lower limit of normal.[20] This in turn improves haem synthesis disturbed by ferro-mediated inhibition of UROD.[23] Clinicians must be careful not to cause anaemia in patients; therefore, interval phlebotomy must be tailored to the individual. Reducing the iron stores, and therefore, the potential detrimental effect on hepatocytes has been shown to improve the efficacy of HCV therapy.[21] A unit of blood is normally removed between twice weekly and once 3 weekly intervals with regular blood counts taken to avoid inducing anaemia, particularly pertinent if being treated with ribavirin.[20, 23] This is also the preferred therapy of choice in patients with a significant iron load.

If phlebotomy is not convenient or is contraindicated or for patients with relatively mild iron overload, oral chloroquine phosphate (125–250 mg per oral (PO) twice weekly) or hydroxychloroquine sulfate (100–200 mg PO 2–3 times/week), doses much lower than those used for antimalarial or photoprotective indications, can be effective, although significant caution has to be applied in patients with hepatitis C, where hepatoxicity can occur even at low doses of these medications.[22, 23] In obese patients, doses should be adjusted to ideal weight in order to avoid toxicity. Remission is often seen within 6–12 months.[23] All patients should receive regular ocular examination both before and during therapy, as recommended by the Royal College of Ophthalmologists. The following steps should be taken when initiating and monitoring hydroxychloroquine therapy (Table 5).

Table 5.  The monitoring protocol required for patients receiving hydroxychloroquinine therapy (taken from BNF 62 September 2012)

Before initiating therapy During therapy monitoring
Baseline renal and hepatic function Review vision and note changes
Visual check and optometry review Reading chart comparison
Visual acuity assessed using standard chart Slit lamp examination if indicated to assess for uveitis
Initiate dose at max 6.5 mg/kg Long-term therapy—ophthalmology assessment on a yearly basis

Summary and Conclusions

While hepatitis C is typically associated with liver dysfunction and progression to cirrhosis, its clinical presentation remains diverse and sometimes unexpected. Clinicians have to have a high index of suspicion and a knowledge of the EHM of HCV in order to not only treat the manifestation, but in initiated timely therapies for the underlying HCV.


  1. Cacoub P, Renou C, Rosenthal E, et al. Extrahepatic manifestations associated with hepatitis C virus infection. A prospective multicenter study of 321 patients. Medicine 2000;79:47–56.

  2. Agnello V, De Rosa FG. Extrahepatic manifestations of HCD infection: some current issues. J Hepatol 2004;40:341–52.

  3. Flint M, McKeating JA. The role of the Hepatic C virus glycoproteins in infection. Rev Med Virol 2000;10:101–17.

  4. Khattab MA, Elsam M, Alavian SM. Hepatitis C virus as a multifaceted disease: a simple and updated approach for extrahepatic manifestations of hepatitis C virus infection. Review article. Hepatol Mon 2010;10:258–69.

  5. Pascual M, Perrin L, Giostra E, et al. Hepatitis C virus in patients with cryoglobulinemia type II [letter]. J Infect Dis 1990;162:569–70.

  6. Zignego AL, Giannini C, Ferri C. Hepatitis C virus-related lymphoproliferative disorders: an overview. World J Gastroenterol 2007;13:2467–78.

  7. Lunel F, Cacoub P. Treatment of autoimmune and extrahepatic manifestations of hepatitis C virus infection. J Hepatol 1999;31 (Suppl 1):210–16.

  8. Pubmed Health. Cryogobulinaemia. Created January 24 2011 (last accessed 24 Oct 2012)

  9. Tarantino A, Campise M, Banfi G, et al. Long term predictors of survival in essential mixed cryoglobulinemic glomerulonephritis. Kidney Int 1995;47:618–23.

  10. Lidove O, Cacoub P, Maisonobe T, et al. Cryoglobulinaemia and hepatitis C: worsening of peripheral neuropathy after interferon treatment. Gastroenterol Clin Biol 1999;23:403–6.

  11. Ferri C, Zignego AL, Pileri SA. Cryoglobulins. J clin Pathol 2002;55:4–13.

  12. Iannuzzella F, Vaglio A, Garini G. Management of hepatitis C virus-related mixed cryoglobulinemia. Am J Med 2010; 123:400–8.

  13. Zaja F, De Vita S, Mazzaro C, et al. Efficacy and safety of rituximab in type II mixed cryoglobulinaemi vasculitis. Curr Opin Rheumatol 2008;20:23–8

  14. ietrogarandeM, De Vita S, Zignego AL, et al. Recommendations for the management of mixed cryoglobulinaemia syndrome in hepatitis C virus-infected patients. Autoimmun Rev 2011;10:444–54.

  15. Kamar N, Rostaig L, Alric L. Treatment of hepatitis C-virus-related glomerulonephritis. Mini Review. Kidney Int 2006;69:436–9.

  16. Chadban SJ, Atkins RC. Glomerulonephritis. Lancet 2005;365:1797–806.

  17. Sabry AA, Sobh MA, SheaashaaMA, et al. Effect of combination therapy (ribivarin and interferon) in HCV-related glomuerulonephropathy. Nephrol Dial Transplant 2002;17:1924–30.

  18. Sansonno D, De Re V, Lauletta G, et al. Monocloonal antibody treatment of mixed cryoglobulinaema resistant to interferon alpha with an anti CD-20 Blood 2003;101:3818–26.

  19. Phillips JD, Bergonia HA, Reilly CA, et al. A porphomethene inhibitor of uroporphyrinogen decarboxylase causes porphyria cutanea tarda. Proc Natl Acad Sci USA 2007;104:5079–84.

  20. Gisbert JP, Garcia-Buey L, Pajares JM, et al. Prevalence of hepatitis C virus infection in porphyria cutanea tarda: systematic review and meta-analysis. J Hepatol 2003;39:620–7. 21 Fernandez I, Castellano G, de Salamanca RE, et al. Porphyria cutanea tarda as a predictor of poor response to interferon alfa therapy in chronic hepatitis C. Scand J Gastroenterol 2003;38:314–19.

  21. Ryan Caballes Sendi H, Bonkovsky HL, et al. Hepatitis C, porphyria cutanea tarda and liver iron: an update. Liver Int 2012;32:880–93.

  22. Frank J, Poblete-Gutierrez P. Porphyria cutanea tarda–when skin meets liver. Best Pract Res Clin Gastroenterol 2010;24:735–45.


OraQuick(R) In-Home HIV Test Launches New Targeted Campaign Strategy -- "Life. As we know it.(TM)" Encourages HIV Testing Among High Risk Groups

PRESS RELEASE  September 30, 2013, 10:12 a.m. ET

OraQuick(R) In-Home HIV Test Launches New Targeted Campaign Strategy -- "Life. As we know it.(TM)" Encourages HIV Testing Among High Risk Groups

Ross Mathews, Dr. Rachael Ross and Other Leading Community Voices Join OraSure to Promote Sexual Health and HIV Testing

BETHLEHEM, Pa., Sept. 30, 2013 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR), makers of the OraQuick(R) In-Home HIV Test, announced today the launch of its newly revamped targeted nationwide awareness campaign to encourage open and honest dialogue about sexual health and the importance of learning your HIV status.

The "Life. As we know it." campaign takes a bold new strategic approach to reaching consumers most at risk for HIV through the creation and sharing of relevant content designed to engage consumers in a discussion about topics related to love, sex, relationships and sexual health.

Initially, the campaign will reach out to two groups among those at highest risk for HIV -- gay men and African American women. OraSure has teamed up with powerful and influential voices to reach consumers in these communities through testimonials, interactive panel discussions, sharable discussion guides and informative videos. The campaign will also use leading media properties to communicate with these communities, including LOGO TV and its online properties for the gay community -- a network that reaches into over 52 million homes -- and Essence, the top-rated media brand for African American women.

"HIV testing is a challenging subject to address head on with consumers. After a careful analysis of available channels to gain mindshare of our target markets, we've determined that the most effective way to approach the topic is through a broader conversation on relationships, dating and sex, and through the engagement of passionate, trusted community influencers to help us introduce product," said Kathleen Weber, Senior Vice President and General Manager, Consumer Products at OraSure Technologies.

The campaign will also feature engagement in high profile consumer events, as well as targeted broadcast, outdoor, digital and print advertising through the first half of 2014.

Television host and best-selling author Ross Mathews has teamed with OraSure to kick off the campaign to the gay community which launched on September 27(th) , in conjunction with National Gay Men's HIV/AIDS Awareness Day.

Mathews debuted on television as a correspondent for "The Tonight Show with Jay Leno" in 2001. Mathews then became a regular panelist and occasional guest host on E!'s talk show "Chelsea Lately," and remains a xture on E! News and E! Network's live red carpet awards show coverage. Mathews recently added best-selling author to his resume with his rst book, Man Up: Tales of My Delusional Self-Con dence, released in May. He currently stars in and produces his own weekly talk show, "Hello Ross!" for E!. "Hello Ross!" is the new weekly fan destination where the intersections of celebrity gossip and pop culture collide, hosted by the world's biggest super fan himself, Mathews.

He will be joined throughout the campaign by influential members of the gay community to talk about topics such as sex, love, health and the importance of testing for HIV. OraSure is also proud to be a sponsor of RuPaul's Drag Race -- the most watched series on LOGO TV. Working with LOGO, the Company is also developing custom co-branded content that will air on the network. The campaign will also have a very active and visible presence on the ground at Gay Pride events being held in eight major U.S. cities over the next year. Additionally, the campaign will reach gay men in the top 15 markets via out of home advertising (billboards, bus shelters and posters) placed in key neighborhoods such as West Hollywood, South Beach, Miami and the Castro in San Francisco and print advertising in over 40 gay-targeted publications.

To engage the African American community, the "Life. As we know it." campaign will feature a dynamic, timely, new web series that will entertain, inform and engage today's modern African American woman with candid, real talk about life, love and sex. The inviting and uplifting interactive panel conversations will be structured like a talk show and will be hosted by an esteemed trio of celebrity panelists from the community including physician, sex expert and co-host of nationally-syndicated television show The Doctors Dr. Rachael Ross, author, life coach and relationship expert Demetria L. Lucas and national television/radio personality and veteran journalist Jacque Reid.

   -- Dr. Rachael Ross, a family doctor and sexologist, is a forerunner of 
groundbreaking discussions surrounding relationships, sex, health,
abstinence & comprehensive sex education for teenagers, and most
importantly HIV/AIDS prevention. Dr. Rachael tours college campuses to
speak, is frequently quoted in Cosmopolitan and Self Magazine,
contributes to several medical publications, is often a featured guest on
the nationally syndicated Tom Joyner Morning Show, and just became a
co-host on the nationally syndicated television show, The Doctors.

-- Demetria L. Lucas, the author of "A Belle in Brooklyn: The Go-to Girl for
Advice on Living Your Best Single Life (Atria)", is the creator of the
award-winning personal blog and the founder of
Coached By Belle, a boutique life-coaching service. Lucas, chosen as one
of's "40 Fierce & Fab Under 40", is also a contributing
editor for The Root, and is a contributing writer for the websites of The
Grio, XO Jane, Essence, Clutch, Vibe Vixen and Uptown.

-- Jacque Reid, a veteran journalist with a background in entertainment and
news, has interviewed some of the world's most influential and
interesting people. Currently, Jacque serves as a daily co-host on NBC's
celebrity and lifestyle show, New York Live and is a regular part of the
nationally syndicated radio program, The Tom Joyner Morning Show. Reid
reports on women and women's issues on her Inside Her Story segments.
The conversations, which will be hosted in conjunction with major events throughout the country, will focus on life, relationships, sexual health and the importance of testing for HIV. Video captured from these conversations, will be featured as a web series on and also be housed on a dedicated campaign website.
The web series will kick off with a panel events taking place in October -- October 4(th) at the Blogalicious conference in Atlanta, October 20(th) at the Circle of Sisters Expo in New York City, and October 22(nd) at the 2013 Spelman College and Morehouse College Homecoming in Atlanta. More information will be posted on October 4(th) to the campaign website at
The fall schedule of activity will culminate with a panel event and media day, featuring Magic "Earvin" Johnson on November 19(th) in New York City in recognition of World AIDS Day which is held annually on December 1(st) .
"Through the use of our OraQuick(R) In-Home HIV Test, we believe more than 200,000 individuals now know their HIV status," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "The more we can find ways to start conversations about HIV testing, especially among the communities most impacted by HIV, the better the chance there is to stop the spread of HIV."
The OraQuick(R) In-Home HIV Test is the first ever in-home rapid HIV test made available directly to consumers. It detects antibodies to both HIV-1 and HIV-2 with an oral swab, providing a safe, effective and confidential in-home testing option with results in as little as 20 minutes. It is available in most national drugstore and mass merchandiser retail outlets nationwide and online at CVS/, Rite Aid/, Walgreens/, Walmart/, and on and The OraQuick(R) In-Home HIV Test is an over-the-counter version of OraQuick ADVANCE(R), an oral swab rapid test with more than 25 million units sold in the professional market, and the same test that doctors and healthcare professionals have relied on and used for 10 years.
To ensure optimal support for individuals using the OraQuick(R) In-Home HIV Test, OraSure offers live support and comprehensive referral services 24 hours a day, seven days a week, every day of the year, through a toll-free support center and consumer website at The OraQuick(R) Support Center is staffed with bi-lingual (English/Spanish) representatives who are available by telephone at 866-436-6527 to answer questions about HIV/AIDS and using and interpreting the test. They also provide referrals to follow-up and care, and can take orders for the OraQuick In-Home HIV Test. Additionally, the product website provides access to resources and referral to follow-up counseling, confirmatory testing and medical care.
For more information on OraQuick visit
About OraSure Technologies
OraSure Technologies is a leader in the development, manufacture and distribution of oral fluid diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its innovative products include rapid tests for the detection of antibodies to HIV and HCV at the point of care and testing solutions for detecting various drugs of abuse. In July 2012, the Company received approval from the U.S. Food and Drug Administration for the Company's OraQuick(R) In-Home HIV Test for sale directly to consumers in the over-the-counter (OTC) market - making it the first and only rapid OTC HIV test approved in the U.S. In addition, the Company is a leading provider of oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications. OraSure's portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians' offices, and commercial and industrial entities. The Company's products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health.
For more information on OraSure Technologies, please visit

Cocaine use may increase HIV vulnerability

Public release date: 30-Sep-2013

Contact: Cody Mooneyhan
Federation of American Societies for Experimental Biology

New research published in the Journal of Leukocyte Biology suggests that cocaine makes quiescent CD4 T cells susceptible to HIV resulting in significant infection and new virus production

Bethesda, MD -- Cocaine use may increase one's vulnerability to HIV infection, according to a new research report published in the Journal of Leukocyte Biology. In the report, scientists show that cocaine alters immune cells, called "quiescent CD4 T cells," to render them more susceptible to the virus, and at the same time, to allow for increased proliferation of the virus.

"We ultimately hope that our studies will provide a better understanding of how drugs of abuse impact how our body defends itself against disease," said Dimitrios N. Vatakis, Ph.D., the study's senior author and a scientist with UCLA's Department of Medicine, Division of Hematology-Oncology and the UCLA AIDS Institute. "Such discovery can significantly improve the quality of life of drug users."

To make this discovery, scientists collected blood from healthy human donors and isolated quiescent CD4 T cells, and exposed them to cocaine and subsequently infected them with HIV. Following infection, researchers monitored the progression of HIV's life cycle and compared this progression against that of untreated cells. They found that cocaine rendered this subset of CD4 T cells susceptible to HIV, resulting in significant infection and new virus production.

"The co-epidemics of elicit drug use and infectious disease are well documented, though typically this connection is thought to occur through lifestyle choices and increased exposure," said John Wherry, Ph.D., Deputy Editor of the Journal of Leukocyte Biology. "What often does not come to mind is that drugs such as cocaine may be helping to fuel infections in this high-risk population by altering the immune system. These new studies are an important advance documenting how cocaine use may increase a person's vulnerability to HIV and further highlighting the need for improved education for both HIV prevention and drug abstinence."


The Journal of Leukocyte Biology publishes peer-reviewed manuscripts on original investigations focusing on the cellular and molecular biology of leukocytes and on the origins, the developmental biology, biochemistry and functions of granulocytes, lymphocytes, mononuclear phagocytes and other cells involved in host defense and inflammation. The Journal of Leukocyte Biology is published by the Society for Leukocyte Biology.

Details: Sohn G. Kim, James B. Jung, Dhaval Dixit, Robert Rovner, Jr., Jerome A. Zack, Gayle C. Baldwin, and Dimitrios N. Vatakis. Cocaine exposure enhances permissiveness of quiescent T cells to HIV infection. J Leukoc Biol, October 2013 94:835-843; doi:10.1189/jlb.1112566 ;


National screening strategy for hepatitis C urged for Canada

Public release date: 30-Sep-2013

Contact: Alexandra Radkewycz
416-603-5800 x5294
University Health Network

(TORONTO, Canada; Sept. 30, 2013) – Canada should begin screening 'Baby Boomers' for the hepatitis C virus infection, since this age group is likely the largest group to have the illness, and most don't know they have it, say a group of liver specialists in the Toronto Western Hospital Francis Family Liver Clinic. Unlike many other chronic viral infections, early treatment makes hepatitis C curable.

In an article entitled, A Canadian Screening Program for hepatitis C – is Now the Time? published in the Canadian Medical Association Journal (CMAJ) Sept. 30, 2013, by Drs. Hemant Shah, Jenny Heathcote and Jordan Feld, the authors present arguments and data in favour of developing and implementing a national screening program for hepatitis C in Canada.

"Baby boomers are much more likely to be infected with hepatitis C than other age groups. Most people who have the infection have no or very few symptoms even if they've been infected for decades. Without symptoms, many infected people have no idea they have the disease until it's too late," says Dr. Jordan Feld, Toronto Western Hospital liver specialist and one of the authors of the article.

"Hepatitis C has the greatest impact of all infectious disease in Ontario, even more so than HIV, influenza virus or human papillomavirus," says Dr. Hemant Shah, Clinic and Education Director of the Francis Family Liver Clinic, Toronto Western Hospital. "It's a life-changing diagnosis, yet there is a huge gap in public and healthcare provider awareness about the disease, it's implications and the treatment options for patients."

Hepatitis C causes more years of life lost than any other infectious disease in Ontario, and likely in Canada, and is the leading indication for liver transplantation. The virus slowly destroys the liver over many years of infection eventually leading to cirrhosis and ultimately liver failure or liver cancer.

However, if hepatitis C is diagnosed early, it is curable. Once liver disease is very advanced, treatment is much less effective and may not be possible, so the goal is to find people with hepatitis C before the virus has caused liver damage. Screening for hepatitis C involves a simple blood test which is covered by all provincial health care plans.

Currently, the recommended Canadian approach is to test based on risk factors. These include: injection drug use (even once), receiving blood transfusions or blood products before 1992, piercings or tattoos done in an unclean environment with unsterile equipment, exposure to infected blood through sharing personal care items such as razors, toothbrushes, or even being immunized or receiving a medical procedure in countries where hepatitis C is common.

In contrast, the Centers for Disease Control and Prevention (CDC) in the U.S. has recently recommended screening all individuals born between 1945 and 1965 for hepatitis C virus (HCV). Even though most Baby Boomers do not have the infection, the CDC adopted the policy because they have shown that identifying infected people and treating them early will save lives and money by avoiding the costs associated with complications of liver disease.

The Canadian Liver Foundation has recently advocated that all those born between 1945 and 1975 get a test for HCV, basing their recommendations on the prevalence of the illness in Canada, and on the immigration into Canada from areas where hepatitis C is very common, such as Africa (particularly Egypt), southern Italy, Eastern Europe, and Central and Southeast Asia.

The authors state that HCV meets all the criteria for a condition where wider screening, particularly among Baby Boomers, would be useful, namely:

  1. HCV is a major cause of morbidity and mortality
  2. Prevalence is increased in Baby Boomers
  3. Many individuals are unaware they are infected with HCV
  4. HCV is curable with early treatment.

Additionally, they also point out that risk-factor based screening has not been successful in other countries including the U.S. and Europe. Primary care physicians and those infected are often unaware of risk-factors, individuals may be uncomfortable talking about high-risk behaviours, and up to 30 per cent of infected individuals have no identifiable risk factors and would therefore be missed. Most studies show that risk-factor based screening does not work for HCV and most other chronic infections.

Dr. Feld points out that along with widespread screening, awareness about the illness should be improved among healthcare professionals so that they can identify HCV infection and ensure people have access to the care they need. Moreover, he notes that treatment for HCV is improving rapidly. Current therapy is successful in up to 75% of people but is difficult to tolerate. He estimates that within three to five years, there will be treatment with few or no side effects, with over 90% cure rates.

"Now is the time to consider a national screening strategy," emphasizes Dr. Feld, who is also Assistant Professor of Medicine at the University of Toronto. "This silent epidemic can be prevented and many more lives could be saved with Baby Boomer screening, follow-up treatment and a major education campaign."

"There is a great deal of misinformation about the illness in the public domain, causing patients to feel fear, shame and stigmatized," says Dr. Shah, who is also an Assistant Professor in Medicine, University of Toronto. "An education campaign can help these patients feel more hopeful, and impress on everyone that early diagnosis and intervention can prevent much of the damage of the illness."


Two of the authors report receiving consulting or speaking fees from: Achillon, Abbott, Boehringer Ingeliheim, Gilead Sciences, Janssen, Merck. Hoffman, La-Roche, Vertex.

About Toronto Western Hospital:

Toronto Western Hospital is a member of the University Health Network, along with Toronto General and Princess Margaret Hospitals and the Toronto Rehabilitation Institute. It is a teaching and research hospital affiliated with the University of Toronto. Toronto Western Hospital is a world leader in neuroscience, advanced liver disease, musculoskeletal health and arthritis, orthopaedics, the hand program, rheumatology and complex care.

For media interviews, please contact:

Alexandra Radkewycz
Senior Public Affairs Advisor,
Toronto Western Hospital, University Health Network
416. 603. 5800 x5294

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Key Facts about hepatitis C:

Burden of hepatitis C is high

  • HCV is a major public health problem in Canada and world-wide; infection rates and diagnosis rates are often underestimated
  • HCV infection causes more years of life lost and illness than any other infectious disease in Ontario, and likely Canada
  • HCV is the leading indication for liver transplantation and the leading cause of liver cancer
  • The prevalence in Canada is estimated at about 250,000, but the authors state that this number is likely too low; they suggest that the number is closer to 400,000
  • Because it may take decades for any symptoms to appear, most people who have HCV are unaware that they have it
  • CDC in the U.S. estimates that Baby Boomers account for three fourths of all HCV infections and that anywhere from 45 % - 85 % of those living with HCV infection are unaware that they have it
  • Liver cancer rates are on the rise because the major causes of primary liver cancer – hepatitis B and C – are not being identified and treated early enough
  • An estimated 20% of infected persons will progress to cirrhosis 20 years after infection, which can then lead to liver failure and/or liver cancer,
  • By 2022, the number of hepatitis C-related deaths will increase by one third How is it spread?
  • Hepatitis C virus is spread by blood-to-blood contact meaning that blood infected with the virus must get into a person's blood stream
  • Once infected with the virus, nearly 8 in 10 people remain infected for life
  • Chronic hepatitis C is often called a "silent" disease because no symptoms appear until the liver has been severely damaged; people can live from 20-30 years without feeling ill


  • There is no vaccine for Hepatitis C
  • Treatment with a combination of antiviral medications can cure the body of the virus with prevention of liver-related complications and death
  • Many direct–acting, anti-viral agents are being tested so that within the next five years, there will be improved and better-tolerated treatments with over 90% cure rates


NY-Presbyterian/Columbia reports laparoscopic living donor liver retrieval for adults

Provided by Medical News Today

Article Date: 30 Sep 2013 - 2:00 PDT 

A team of surgeons at NewYork-Presbyterian/Columbia University Medical Center is the first in the country to report a fully laparoscopic hepatectomy - the removal of a portion of the liver - from a living adult donor for adult and teenage recipients. The procedure advances transplant surgery and offers hope for addressing the significant shortage of liver donors.

In the September issue of the American Journal of Transplantation, the team, led by Dr. Benjamin Samstein, surgical director of the Living Donor Liver Transplant Program at NewYork-Presbyterian/Columbia and assistant professor of surgery at Columbia University Medical Center, reports on two of the center's five successful fully laparoscopic hepatectomies from living adult donors for adult and teenage recipients. The group is one of three teams in the world, and the only in the United States, reporting the successful procedure.

"This is a small step, but I think a useful one," says Dr. Samstein. "We're at the forefront of perhaps a new era for living-donor liver transplants."

Despite public awareness campaigns and other efforts aimed at raising the availability of donor organs, there is a nationwide shortage of deceased organ donations. Thus, living donors are an important source of organs to aid patients living with end-stage organ disease, particularly of the liver and kidneys.

The first successful living-donor liver transplant was performed in children in 1989 and subsequently extended to adults. Yet only about four percent of liver transplants are done with a living donor, compared with nearly 50 percent of kidney transplants, Dr. Samstein says. "Even though there is a tremendous need, we're not seeing the same use of living-donor livers as we are of living-donor kidneys," he says.

More than 90 percent of living-donor kidney transplants are done laparoscopically, explains Dr. Samstein, which results in reduced morbidity, scarring, and pain, as well as a quicker return to normal activities. Laparoscopic living-donor kidney removal has replaced the open approach in many centers around the world. Most liver donor surgeries, however, are still done through complex open surgery, leaving the donor with a greater risk of postoperative mortality, morbidity, and pain, as well as a recovery period that lasts, on average, eight to 12 weeks - two to three times longer than the recovery period for a laparoscopic kidney donor. Dr. Samstein says these factors may contribute to potential donors' hesitation or ineligibility.

While open hepatectomy remains the standard procedure for adult living-donor liver transplantation at most centers, a few strategies over the past several years have made the surgery less invasive. Researchers have succeeded in reducing the incision needed to remove a portion of the liver; they have also developed a hybrid technique that uses both open surgery and laparoscopy. This model has reduced postoperative pain for the donor.

In 2009, NewYork-Presbyterian/Columbia surgeons began doing fully laparoscopic hepatectomies on adult donors for transplantation into children. Pediatric recipients require only about 15 to 20 percent of a healthy adult liver for transplant. The liver has the unique ability to regenerate in both the donor and the recipient, growing and remodeling to form a complete, functioning organ. But adult recipients require a much larger portion of liver for successful transplant - about 30 to 35 percent - necessitating a more central cut through the donor liver. With three years of experience with hybrid and full laparoscopic techniques with more than 50 minimally invasive donor hepatectomies, the team was ready to expand laparoscopy to full left hepatectomies for adult recipients.

The current publication presents the details of two living adult donors who donated, through laparoscopic surgery, portions of their livers to others - the first, a 47-year-old man who donated to his young teenage daughter and the second a 28-year-old woman who donated to her mother-in-law.

While the recipient operation still requires an open procedure, the surgeons found the donor recovery in these cases to be half that of traditional open-surgery donation - from eight to four weeks - and substantially reduced even from the hybrid technique, with no additional postoperative donor complications. The donors also appeared to have less pain and lower risk of postsurgical hernia.

The authors caution that this procedure should be performed only in select cases and only by teams with significant experience in both living-donor procedures and laparoscopic liver surgery, as laparoscopic hepatectomies require specific training. "While donor comfort and recovery are extremely important issues, donor safety continues to be paramount and the adoption of new surgical techniques ultimately needs to demonstrate that it meets the standard of safety of old techniques before adopted," they write.

NewYork-Presbyterian/Columbia remains the only center in the country currently performing fully laparoscopic living-donor hepatectomies for transplant into both pediatric and adult recipients.

"Clinical innovation and scientific progress constitute the core of the Center for Liver Disease and Transplantation's mission," says Dr. Jean C. Emond, chief of transplantation at NewYork-Presbyterian/Columbia and the Thomas S. Zimmer Professor of Reconstructive Surgery (in Pediatrics) at Columbia University Medical Center. "While this fully laparoscopic approach is still new and in its infancy, this is an important step in furthering the goal of successful liver transplantation from generous living donors." Dr. Emond was a member of the team that pioneered living donor liver transplantation, which is now considered one of the most important advances in the treatment of severe liver disease.

About the Living Donor Liver Transplant Program at the Center for Liver Disease and Transplantation

The Living Donor Liver Transplant Program at NewYork-Presbyterian/Columbia University Medical Center is one of the largest living-donor liver programs in North America. The program has performed more than 220 living-donor liver transplants since its inception. The team has also performed more left lobe donations than any other living-donor liver program in North America and introduced fully laparoscopic donation for all pediatric living-donor liver transplants in 2009.


Totally Laparoscopic Full Left Hepatectomy for Living Donor Liver Transplantation in Adolescents and Adults

American Journal of Transplantation - Volume 13, Issue 9, pages 2462–2466, September 2013 - DOI: 10.1111/ajt.12360

Authors: B. Samstein, D. Cherqui, F. Rotellar, A. Griesemer, K. J. Halazun, T. Kato, J. Guarrera, J. C. Emond

NewYork-Presbyterian Hospital/Columbia University Medical Center


Prevalence and predictors of hepatitis B virus coinfection in a United States cohort of hepatitis C virus-infected patients

Hepatology. 2013 Aug;58(2):538-45. doi: 10.1002/hep.26400. Epub 2013 Jul 1.

Tyson GL, Kramer JR, Duan Z, Davila JA, Richardson PA, El-Serag HB.

Houston VA Health Services Research and Development Center of Excellence, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA.


There are sparse epidemiologic data on coinfection of hepatitis B (HBV) and hepatitis C (HCV) in the United States. Therefore, the aim of this study was to determine the prevalence and predictors of HBV coinfection in a large U.S. population of HCV patients. We used the National Veterans Affairs HCV Clinical Case Registry to identify patients tested for HCV during 1997-2005. Patients were categorized based on HCV exposure (any two +HCV tests or one test with a diagnostic code), HCV infection (+RNA or genotype), HBV exposure (any +HBV test, excluding +HBsAb only), and HBV infection (+HBsAg, HBV DNA, or HBeAg). The prevalence of HBV exposure among patients with HCV exposure and that of HBV infection among patients with HCV infection were determined. Multivariate logistic regression evaluated potential demographic and clinical predictors of HBV coinfection. Among 168,239 patients with HCV exposure, 58,415 patients had HBV exposure for a prevalence of 34.7% (95% confidence interval [CI] 34.5-35.0). Among 102,971 patients with HCV infection, 1,431 patients had HBV coinfection for a prevalence of 1.4% (95% CI 1.3-1.5). Independent associations with HBV coinfection compared with HCV monoinfection were age ≤ 50 years, male sex, positive HIV status, history of hemophilia, sickle cell anemia or thalassemia, history of blood transfusion, cocaine and other drug use; there was decreased risk in patients of Hispanic ethnicity. Conclusion: This is the largest cohort study in the U.S. on the prevalence of HBV coinfection in HCV patients. Among veterans with HCV, exposure to HBV is common (~35%), but HBV coinfection is relatively low (1.4%). Several possible risk factors were identified.

Copyright © 2013 by the American Association for the Study of Liver Diseases.

PMID: 23505059 [PubMed - in process] PMCID: PMC3729715 [Available on 2014/8/1]


Dr. Davis Describes Why the 2013 Annual Meeting is Particularly Strong



September 29, 2013

FDA approval far away from Achillion’s hepatitis C drug as clinical hold remains

September 28, 2013 10:00 am by Staff


(Reuters) - Achillion Pharmaceuticals Inc said the U.S. Food and Drug Administration decided not to lift a clinical hold it had placed on the firm's hepatitis C drug, sovaprevir, leaving an uncertain fate for the company's most promising drug.

The news caused Achillion's shares to plunge 45 percent in after-market trade on Friday.

The FDA asked the company to halt development of sovaprevir in June, after detecting elevated liver enzymes, an indication of liver damage, in multiple patients who were given the drug in a clinical study.

The regulator asked for some clinical data on the drug, and while Achillion submitted that, the agency concluded that removal of the clinical hold was not warranted, Achillion said in a statement on Friday.

"While we are disappointed that we were not able to resolve the clinical hold at this time despite having addressed all the issues, we believe the breadth of our portfolio allows us to quickly advance other all-oral combination regimens for the treatment of HCV," Achillion's Chief Executive Milind Deshpande stated.

Achillion is among a number of drugmakers developing a new class of drugs to treat the liver-hampering virus by using a drug regimen that does not include the conventional hepatitis C drug constituent, interferon, which causes flu-like symptoms.

However, multiple drugmakers have suffered regulatory and development setbacks over the past year.

Most recently in July, Vertex Pharmaceuticals Inc, which already sells the market-leading hepatitis C treatment Incivek, said U.S. health regulators placed a partial clinical hold on a mid-stage study of its experimental oral hepatitis C treatment, VX-135, because of potential liver problems.

Vertex said it is working with the agency to resolve issues.

Achillion on Friday also reported interim results from an ongoing mid-stage clinical trial testing a combination of its experimental drugs, including sovaprevir.

Initial data from this mid-stage study showed that 79 percent of patients with the most common and difficult to treat genotype 1 form of hepatitis C achieved rapid virologic response, or undetectable virus levels after four weeks of treatment.

Trading in Achillion's shares was halted at 1643 ET on Friday, pending release of the news. After resumption, Achillion's shares hit a low of $3.95 in extended trade.

(Reporting by Zeba Siddiqui in Bangalore; Editing by Ken Wills)


Also See: Achillion Provides Pipeline Update

Non-governmental groups launch program against hepatitis   2013-09-29 16:55:18

BEIJING, Sept. 29 (Xinhua) -- A number of non-governmental organizations on Sunday launched a joint project for the prevention and cure of hepatitis in China.

China Viral Hepatitis Prevention and Control Center Project will publicize information and provide training to improve both public awareness of the disease and capabilities of grassroots doctors.

The Chinese Foundation for Hepatitis Prevention and Control is in charge of the five-year project. Yang Xizhong, deputy head of the foundation, said at the launch ceremony that the project will train 400 doctors in the oil city of Karamay in northwest China's Xinjiang Uygur Autonomous Region.

It will also open a facility for chronic hepatitis patients in Shanghai, and train grassroots doctors in Tibet, said Yang.

U.S.-based Bristol-Myers Squibb Foundation will input more than 1.13 million U.S. dollars into the project in the next three years. Other groups joining the project include Shanghai Charity Foundation and Wu Jieping Medical Foundation among others.

China has almost 100 million hepatitis virus carriers, and 30 million hepatitis B and hepatitis C patients. The public know little about the disease, especially hepatitis C.


New Medical Device Extremely Effective at Preventing HIV in Women

Provided by Science Daily


Previous studies have demonstrated that antiviral drugs can prevent HIV infection, but existing methods for delivering the drug fall short. Pills must be taken daily and require high doses; vaginal gels that must be applied prior to each sex act are inconvenient, yielding poor usage rates. The new ring is easily inserted and stays in place for 30 days. (Credit: Northwestern University)

Sep. 27, 2013 — It's often said that the HIV/AIDS epidemic has a woman's face. The proportion of women infected with HIV has been on the rise for a decade; in sub-Saharan Africa, women constitute 60 percent of people living with disease. While preventative drugs exist, they have often proven ineffective, especially in light of financial and cultural barriers in developing nations.

A new intravaginal ring filled with an anti-retroviral drug could help. Developed with support from the National Institute of Allergy and Infectious Diseases by Northwestern University visiting associate professor Patrick Kiser, the ring is easy to use, long lasting, and recently has demonstrated a 100 percent success rate protecting primates from the simian immunodeficiency virus (SHIV). The device will soon undergo its first test in humans.

"After 10 years of work, we have created an intravaginal ring that can prevent against multiple HIV exposures over an extended period of time, with consistent prevention levels throughout the menstrual cycle," said Kiser, an expert in intravaginal drug delivery who joined Northwestern from the University of Utah, where the research was conducted.

Kiser is a new faculty member in Northwestern's McCormick School of Engineering's Department of Biomedical Engineering and visiting associate professor of obstetrics and gynecology in the Feinberg School of Medicine.

The research was published September 16 in the Proceedings of the National Academy of Sciences (PNAS).

Previous studies have demonstrated that antiviral drugs can prevent HIV infection, but existing methods for delivering the drug fall short. Pills must be taken daily and require high doses; vaginal gels that must be applied prior to each sex act are inconvenient, yielding poor usage rates.

The new ring is easily inserted and stays in place for 30 days. And because it is delivered at the site of transmission, the ring -- known as a TDF-IVR (tenofovir disoproxil fumarate intravaginal ring) -- utilizes a smaller dose than pills.

The device contains powdered tenofovir, an anti-retroviral drug that is taken orally by 3.5 million HIV-infected people worldwide, but that has not previously been studied topically. But the ring's strength stems from its unique polymer construction: its elastomer swells in the presence of fluid, delivering up to 1,000 times more of the drug than current intravaginal ring technology, such as NuvaRing, which are made of silicon and have release rates that decline over time.

The upcoming clinical trial, to be conducted in November at Albert Einstein College of Medicine in New York, will evaluate the ring in 60 women over 14 days. The trial will assess the ring's safety and measure how much of the drug is released and the properties of the ring after use.

Other drugs could potentially be integrated into the ring, such as contraceptives or antiviral drugs to prevent other sexually transmitted infections -- a feature that could increase user rates, Kiser said.

"The flexibility to engineer this system to deliver multiple drugs and change release rates is extraordinary and could have a significant impact on women's health," he said.

Story Source:

The above story is based on materials provided by Northwestern University.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.

Journal Reference:

  1. J. M. Smith, R. Rastogi, R. S. Teller, P. Srinivasan, P. M. M. Mesquita, U. Nagaraja, J. M. McNicholl, R. M. Hendry, C. T. Dinh, A. Martin, B. C. Herold, P. F. Kiser. Intravaginal ring eluting tenofovir disoproxil fumarate completely protects macaques from multiple vaginal simian-HIV challenges. Proceedings of the National Academy of Sciences, 2013; DOI: 10.1073/pnas.1311355110


Drug Found to Eradicate HIV Permanently from Infected Cells

Provided by Science Daily

Sep. 23, 2013 — The topical anti-fungal drug Ciclopirox causes HIV-infected cells to commit suicide by jamming up the cells' powerhouse, the mitochondria -- according to a study by researchers at Rutgers New Jersey Medical School. And unlike current anti-HIV drugs, Ciclopirox completely eradicates infectious HIV from cell cultures, with no rebound of virus when the drug is stopped. The study has been published in the journal PLOS ONE.

of patients with HIV has been revolutionized by the advent of combination anti-retroviral drugs. But although these drugs are highly effective at keeping HIV at bay, they must be taken for the life of the patient and never eliminate the infection completely. This is illustrated by the often rapid resurgence of virus in patients who stop taking these medications. The persistence of HIV is partially due to the ability of the virus to disable the cell's altruistic suicide pathway, which is normally activated when a cell becomes infected or damaged.

A team of researchers from three departments at New Jersey Medical School, led by Michael Mathews and Hartmut Hanauske-Abel, previously showed that Ciclopirox, commonly used by dermatologists and gynecologists to treat fungal infections, inhibits the expression of HIV genes in culture. The group now shows that the drug works against HIV in two ways: It inhibits the expression of HIV genes and also blocks the essential function of the mitochondria, thereby reactivating the cell's suicide pathway. Healthy, uninfected cells examined during this study were spared. And remarkably, the virus did not bounce back when Ciclopirox was removed.

The utility of Ciclopirox in patients with HIV, for instance after topical application to reduce sexual transmission of the virus, awaits verification in future clinical trials. However the fact that Ciclopirox is already approved for treatment of patients by the FDA and by its European counterpart, the EMA, and therefore considered safe for human use, may eliminate much of the time and expense ordinarily involved in the drug development process.

Indeed, the authors note the speed with which a second FDA-approved drug believed to have promise in subduing HIV, Deferiprone, has moved directly from tests in culture to a phase I human trial conducted in South Africa, thanks to previously published results now reinforced by additional research in culture described in the current paper. Studies in animals were safely skipped, creating a model for rapid transition from drug effect in a plastic dish to drug effect in patients. In contrast to Ciclopirox, approved for topical use, Deferiprone is FDA- and EMA-approved for systemic use (in certain thalassemia patients with iron overload). The discovery that two drugs, each well-tolerated by patients when used as indicated, are deadly to HIV-infected cells, may open a new chapter in the fight against HIV/AIDS that moves the world closer to the eradication of HIV-1 infection.

Story Source:

The above story is based on materials provided by Rutgers Biomedical and Health Sciences.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.

Journal Reference:

  1. Hartmut M. Hanauske-Abel, Deepti Saxena, Paul E. Palumbo, Axel-Rainer Hanauske, Augusto D. Luchessi, Tavane D. Cambiaghi, Mainul Hoque, Michael Spino, Darlene D'Alliessi Gandolfi, Debra S. Heller, Sukhwinder Singh, Myung Hee Park, Bernadette M. Cracchiolo, Fernando Tricta, John Connelly, Anthony M. Popowicz, Richard A. Cone, Bart Holland, Tsafi Pe’ery, Michael B. Mathews. Drug-Induced Reactivation of Apoptosis Abrogates HIV-1 Infection. PLoS ONE, 2013; 8 (9): e74414 DOI: 10.1371/journal.pone.0074414


10 Cases Of Liver Failure Linked To Dietary Supplements In Hawaii

Posted: 09/27/2013 7:20 pm EDT  |  Updated: 09/27/2013 7:20 pm EDT

Follow: Center For Disease Control, Food And Drug Administration, Banned Diet Pills, Banned Steroids, Bodybuilding, Centers For Disease Control And Prevention, Diet Pill Deaths, Diet Pills, Dietary Supplements, Epidemiology, Hawaii Department Of Health, Hydroxycut, Liver Failure, Liver Failure Hawaii, Liver Transplants, Steroids, Steroids Bodybuilding, Healthy Living News

Ten young, seemingly-healthy people have been admitted into Hawaii hospitals in the last five months for varying degrees of liver inflammation and failure, and they only have one thing in common: They all took a certain dietary supplement for weight loss and/or muscle growth.

Yesterday, the Hawaii State Department of Health (DOH) announced an investigation into what could be causing the hospitalizations, some of which are “extremely severe” and even require liver transplants, according to State Epidemiologist Dr. Sarah Park.

The only common finding among all cases ... is the use of a dietary or nutritional supplement for the purpose of weight loss and/or muscle gain in the past six months,” the DOH stated in a press release yesterday.

Representatives from the Department of Health are not releasing information as to what supplement the patients were taking or what ingredient could be at fault. According to KHON, the DOH cautions that a number of factors could be at fault: a bad batch of the supplement, a particular toxic ingredient, or the supplement as a whole.

The U.S. Centers for Disease Control and Prevention and the Food and Drug Administration are participating in the investigation.

In 2009, the FDA recalled 14 products made by the diet supplement manufacturer Hydroxycut after the product was linked to at least 23 cases of severe liver damage and the death of a teenage boy.