Welcome to the New AAHIVM Institute for Hepatitis C ReSource!

This e-newsletter is a product of the AAHIVM Institute for Hepatitis C.  The ReSource provides a synthesis of the most relevant recent clinical studies in co-infection presented and published throughout the world in an attempt to keep our AAHIVM members and credentialed providers current in this rapidly changing arena.  Edited by Dr. Margaret Hoffman-Terry of Lehigh Valley Hospital and Dr. Mark Sulkowski, of John Hopkins University School of Medicine, the ReSource seeks to keep you current on the most crucial clinical and non-clinical information in this important and ever changing field.


 

CLINCAL UPDATES
This section includes syntheses of significant HCV clinical updates occurring over the past two months. Drs. Sulkowski and Hoffman-Terry will select the items and draft the syntheses.


The New World of the Direct Acting Antivirals: Drug-drug interactions in the HIV-infected Patient

Change continues at a lightning fast pace in the world of hepatitis C treatment with multiple all oral combinations of direct acting antivirals (DAAs) now available as the recommended regimens for treatment. Injectable pegylated interferon has finally been fully replaced by safer, more efficacious and much better tolerated all oral combinations with AASLD/IDSA HCV guidance (www.hcvguidelines.org) no longer recommending its use except in alternative regimens for the treatment of certain patients infected with HCV genotype 3.

Attaining sustained virologic response (SVR) equates with virologic cure and is defined as an undetectable viral load 12 weeks after the cessation of therapy. This results in a dramatic decrease in the rate of complications from HCV such as fibrosis and hepatocellular carcinoma, extra-hepatic manifestations like cryoglobulinemia, and debilitating symptoms such as fatigue. Evidence supports treating all patients with HCV, unless their life expectancy is less than 12 months because of a non-liver related condition. As such, current guidelines recommend treatment for all HCV infected persons.  Read More....



NON-CLINCAL ISSUES
This section includes syntheses of non-clinical issues (regulatory, coverage and payment, etc.) over the past two months. The topics and information are selected written by Mr. Jules Levin, Executive Director of NATAP.

Access to HCV DAAs (Direct Acting Antivirals), Price War - New Models for Healthcare Funding Needed

 

2014 was accented by the restricted access to new HCV DAAs. Only patients with advanced disease were provided access, and patients with a history of substance abuse had restricted access. Additional restrictions were also imposed that varied by state including that HIV or ID doctors could not treat in some states, only hepatologists. In December 2014 after Abbvie was granted FDA approval Express Scripts, Abbvie announced a deal that is supposed to allow for unrestricted access to the Abbvie regimen "VIEKERA PAK".  Then January 8 2015 Gilead & CVS announced a similar deal.  Price reductions were provided by Gilead & Abbvie in exchange for exclusivity so CVS will exclusively provide Harvoni & Express Scripts will exclusively provide the Abbvie regimen, and for patients who need Harvoni it will be available, but my understanding is that access to simeprevir is permitted as well although this has not gotten much press attention. In addition on January 8, 2015 Gilead & Anthem, a big provider of health insurance to businesses, struck a deal. Read More....

 

 

CASE STUDIES


Case 1

53 y.o. Caucasian male with HIV, HCV, HTN and hyperlipidemia. Social history of remote IDU with cocaine, no alcohol, 1 ppd tobacco for 35 years. His HCV had been treated with 48 weeks of PEG-interferon alfa-2a with weight based ribavirin in 2010. While his HCV viral load was undetectable after  4 weeks of treatment, he relapsed after the medications were stopped. HIV currently well-controlled on tenofovir/emtricitabine/ rilpivirine single tablet regimen with lisinopril for hypertension and fenofibrate for hyperlipidemia. Physical exam reveals facial lipoatrophy; otherwise WNL.  Read More....

Case 2
54 y.o. Latina female with HIV, HCV which has never been treated, and migraine headaches. Social history of remote IDU with heroin, occasional beer, non-smoker. HIV currently well- controlled on tenofovir/ FTC/ atazanavir/ ritonavir with sumatriptan prn for headaches. Physical exam WNL.

 
CBC with differential WNL/ CMP with AST 99/ ALT 111 and creatinine clearance of 85. CD4 550 with HIV VL <20 copies/ mL. INR 1.2. GT 1b. HCV VL 684,000 IU/mL.  Abdominal ultrasound shows heterogeneous echotexture with mild splenomegaly. Liver biopsy with inflammation grade 3 and fibrosis grade 4. AFP WNL. Drug screen negative. 


Which is the best combination for this patient?  Read More....


THE BASICS


Click here to access the updated chapter (October 15, 2014) on HIV/HCV from the AAHIVM Fundamentals of HIV Medicine 2014 Update by the original author, Dr. Margaret Hoffman-Terry. It will be updated on an annual basis. 
 

Letter to the Editor


Close up of the hand of a man writing with a fountain pen on a sheet of blank white paper or document in a conceptual image. Dear Editor,

In November 2014, the Connecticut Department of Social Services Medicaid program released a two page policy transmittal announcing limitations on the use of sofosbuvir (Sovaldi), prompted by the previous fiscal quarter's  30 million dollar cost overrun for Sovaldi.  Even though most of us treating Hepatitis C (HCV)- infected individuals had begun prescribing the newly available but also very costly co-formulated medication ledipasvir/sofosbuvir (Harvoni) for our HCV Genotype 1 patients,  it was clear that this policy transmittal on Sovaldi could be the  harbinger of more restrictions to come.  As part of the new policy, only physicians board certified in Infectious Diseases and Gastroenterology could prescribe Sovaldi, and even more restrictive, only for those patients with a Metavir Stage F4, i.e. liver cirrhosis.   Several other restrictions in the use of Sovaldi were also put in place, but  as clinicians, we felt we needed to immediately address the most concerning barriers to patient access and treatment: the limitations on who can prescribe and who can be treated.  Read More....

 

 

The HIV/HCV ReSource was made possible through support from
Janssen Pharmaceuticals Inc. and Gilead Sciences.