Latest research on Harvoni

Sofosbuvir is a medication used as part of combination therapy to treat hepatitis C virus (HCV) infection or HCV and HIV co-infection. Sofosbuvir is nucleotide analog inhibitor, which specifically inhibits HCV NS5B polymerase. Sofosbuvir was approved by the FDA in December 2013, and is marketed under the brand name Sovaldi.

Harvoni interactions

Vitamin e (α-, rac-β-, and γ-tocopherols), 4-deoxypyridoxine hydrochloride (DOP), coenzyme Q10, butylated hydroxytoluene, N-ACETYL-L-cysteine, diphenyleneiodonium chloride, oleic acid, and Cyclosporine A were from Sigma-Aldrich. nSMase spiroepoxide and cumene hydroperoxide were from Santa Cruz Biotechnology, D609 was from Enzo Life Sciences, and sofosbuvir (PSI-7977) was from Chemscene. [source, 2014]
Aiming at treatment-naïve subjects with genotypes 2 and 3, the FISSON study compared 12-week treatment with Sovaldi and Ribavirin to a 24-week treatment with peginterferon-alpha plus Ribavirin [17]. [source, 2015]
The FUSION study conducted experiments on patients previously treated with interferon with genotypes 2 or 3 who either relapsed or failed to respond, and a 12- or 16-week treatment with Sovaldi and Ribavirin was performed [16]. [source, 2015]
The VALENCE trial showed that for treatment-naïve genotype 3 patients, Sovaldi plus Ribavirin for 24-week treatment obtained a 93 % SVR with no cirrhosis and a 92 % SVR with cirrhosis [18]. [source, 2015]
With the exception of treatment-experienced patients with cirrhosis, genotype 2 and 3 HCV-infected patients may be treated with sofosbuvir (Sovaldi, Gilead) plus Ribavirin for 12 and 24 weeks, respectively. [source, 2015]
Two, generic products of sofosbuvir, Gratisovir and Grateziano, produced by Pharco and European Egyptian Pharmaceutical Industries (EEPI), Alexandria, Egypt, respectively, that had been proven to be bioequivalent to the brand Sovaldi and already registered in Egypt, were tested for comparative efficacy in the dual sofosbuvir + Ribavirin protocol. [source, 2015]
The year 2013 announced an unprecedented therapeutic victory with several new DAAs having different viral targets, including NS3 protease inhibitors, nucleoside/nucleotide analogues and non-nucleoside inhibitors of the RNA-dependent polymerase and NS5A inhibitors, some already approved by the EMA and/or FDA in 2013 (sofosbuvir and simeprevir) and 2014 (daclatasvir; Abbvie’s Viekira Pak (ombitasvir and Ritonavir boosted paritaprevir plus dasabuvir); Harvoni (ledipasvir + sofosbuvir)), with more to expect in 2015 and in the next two to three years. [source, 2015]
Gilead has just launched on the market its anti-HCV ProTide, Sofosbuvir (PSI-7977),[ ] whereas Nucana Biomed has taken to trial a Gemcitabine ProTide (NUC-1031), for patients with advanced solid tumours. [source, 2015]
The COSMOS (A Study of TMC435 in Combination With PSI-7977 [GS7977] in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-naïve Patients) Phase II, randomized, open-label study evaluated the efficacy and safety of simeprevir 150 mg QD and sofosbuvir 400 mg QD – an HCV NS5B nucleotide polymerase inhibitor – with or without ribavirin for 12 or 24 weeks in HCV genotype 1 patients with METAVIR score F0–F2 who were prior null responders to peginterferon plus ribavirin (cohort 1) or treatment-naïve patients and prior null responders with F3–F4 (cohort 2). [source, 2014]
In HCV genotype 1 infection, SVR results of a once-daily regimen of simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without Ribavirin were 79–96% and 96–100%, in staging fibrosis of the liver of F0–F2 and F3–F4, respectively. [source, 2014]