February 3, 2014

Provided by NATAP

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Gilead is conducting coinfection studies with their fixed dose regimen of Sofosbuvir+Ledepisvir, although a small study in mono infected 12 weeks of Sofosbuvir+Ledipasvir+rbv yielded 100% SVR rates in treatment-naives & prior null responders [http://www.natap.org/2013/CROI/croi_07.htm]. It is expected that generally coinfected patients will respond similarly to the new oral HCV DAA drugs but studies are ongoing. In mono and coinfected the hardest to treat patients are those with cirrhosis & have failed prior therapy with Peg/Rbv or telaprevir or boceprevir+Peg/Rbv. As mentioned below the Daclatasvir+Sofosbuvir coinfection study has just opened, although this is the 1st study in coinfected patients, in mono infected patients with genotype 1 this combination yielded essentially a 100% SVR rate in treatment-naives & telaprevir or boceprevir failures, link below. And these recently published results:http://www.natap.org/2014/HCV/011714_04.htm

Of note ongoing are studies by BMS, Merck & Janssen looking at interferon-free therapies, with BMS in phase 3 & Janssen & Merck in phase 2, with the results so far showing the same as the regimens mentioned in this article, 95-100% SVR rates. Coinfection studies are planned.

Recruiting

A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 (HIV-1) Coinfection (TURQUOISE-I) Subject must be treatment naive or previous pegylated interferon/ribavirin treatment experienced

Phase III HIV/HCV Co-Infection Daclatasvir (DCV)+ Sofosbuvir (SOF).......in Treatment-naïve and Treatment-experienced Chronic Hepatitis C (Genotype 1, 2, 3, 4, 5, or 6)

The New HCV Guidelines on HIV/HCV coinfection:
http://www.hcvguidelines.org/full-report/unique-patient-populations

Patients with HIV/HCV Coinfection-

Immediately below is the link to their coinfection Guidelines & the text is imbedded here too below.

Again, these Guidelines do not mention Daclatasvir+Sofosbuvir in coinfected patients, there has not been a study of this regimen yet, but above is the link to the recently announced study just last week. It is considered that generally HIV/HCV coinfected will respond as well as mono infected to the new oral DAAs. In previous studies of daclatasvir+sofosbuvir in treatment-naives & treatment experienced with a HCV protease+Peg/RBv SVR rates were essentially 100% [http://www.natap.org/2013/IDSA/IDSA_39.htm] for genotype 1 patients. Below you can see Sofosbuvir+Peg/Rbv for 12 weeks is recommended, in a small study of this regimen for 12 weeks the result was a 91% SVR rate [http://www.natap.org/2013/IDSA/IDSA_24.htm] so FDA approval is based on this. The phase 3 PHOTON Study is the basis for the 2nd recommendation of Sofosbuvir+Rbv [http://www.natap.org/2013/AASLD/AASLD_34.htm] where the overall SVR rate was 76% with 24 weeks treatment, but the SVR rate was higher in patients without cirrhosis & in sub-genotype 1a patients. Simeprevir+Sofosbuvir has not been studied in coinfection but the data from the COSMOS Study yielded such good results with 12 weeks therapy, 96-100% [http://www.natap.org/2013/AASLD/AASLD_24.htm], this regimen too is in the prioritized list below of recommendations for treating coinfected patients. Discussed below in the Guidelines as an alternate regimen is Simeprevir+Peg/Rbv [http://www.natap.org/2013/CROI/croi_35.htm]. I don't see mentioned Faldaprevir+Peg/Rbv but here is the study data [http://www.natap.org/2013/CROI/croi_138.htm] and the drug interaction data [http://www.natap.org/2013/CROI/croi_03.htm]. The issue of drug interactions with HIV ARTs are always to be kept in mind but the interactions appear to be not clinically significant with Sofosbuvir and are significant so they must be considered when using a HCV protease - simeprevir, faldaprevir, or with a NS5A - daclatasvir.

The summary of recommendations for HIV-coinfected patients is in the Unique Patient Populations: HIV/HCV Coinfection Box.

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