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.

Latest findings

These new drugs can be used in well tolerated all oral, interferon-free regimens, such as sofosbuvir/ledipasvir (Harvoni, Gilead) and Viekira Pak (AbbVie). [source, 2016]
Sofosbuvir (GS-7977, Fig. 2A)6, 7 is a nucleotide analog that inhibits HCV NS5B polymerase. [source, 2016]
On December 6, 2013, FDA approved sofosbuvir (brand name: Sovaldi) for use in the treatment of chronic hepatitis C, genotypes 1, 2, 3 and 4, in combination with PEG-IFN and RBV, or with RBV alone (depending on the genotype). [source, 2016]
Harvoni (sofosbuvir+ledipasvir; GS7977+GS-5855) is a fixed-dose combination tablet containing ledipasvir (90 mg) and sofosbusvir (400 mg) for oral administration. [source, 2016]
The efficacy of Harvoni against HCV genotype 1 was demonstrated in three phase III trials in which SVR rates of 93%–99% were achieved after 12 weeks of therapy. [source, 2016]
The US FDA approved Harvoni to treat chronic HCV genotype 1 infection on October 10, 2014. [source, 2016]
The anti-HCV activities of the synthesized hit compounds were then evaluated using the HCV cell culture system, with PSI-7977 [90] and telaprevir [91] as positive control. [source, 2016]
Initially the antiviral potency of a mixture of PSI-7977 diastereomers was evaluated, but it was later discovered that a purified non-racemic single diastereomer produced significantly greater reductions in HCV RNA. [source, 2015]
This compound, PSI-7977, is now known as sofosbuvir and allows for once-daily dosing and the potential for generating high concentrations of the active triphosphate in the liver. [source, 2015]
Gilead Sciences acquired Pharmasset Inc. and PSI-7977 in November of 2011 and conducted additional preclinical and clinical research to evaluate the pharmacology and clinical safety and efficacy (Phase 2b and 3) of sofosbuvir, the results of which are summarized here. [source, 2015]