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Hepatitis C drugs now effective for most genotypes There are two or three options for the treatment of genotypes one and four. Currently, one treatment is preferred for genotype 3 (sofosbuvir and daclatasvir are used — with or without ribavirin depending on whether the patient has cirrhosis). Newer agents held out the prospect of further options, said Dr Feeney.
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@Sukhera sb, You are right. Sovaldi (Sofosbuvir) is cheaper in India compared to Pakistan, due to generics and local manufacturing.
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The recommended treatment duration of Olysio with sofosbuvir is 12 weeks for patients without cirrhosis or 24 weeks for patients with cirrhosis.
Concern about rising costs of specialty drugs has been gaining increased attention since the 2013 launch of Sovaldi, a highly successful hepatitis C medication manufactured by Gilead that costs an eye-popping $84,000 for a 12-week regimen. Hepatitis C, which is a liver disease, affects more than 3 million Americans.
This strategy has worked beautifully for the company in the short term. In the first three months of 2014, Sovaldi broke all records by earning Gilead $2.3 billion.
What is Sovaldi used for
The extensive investigation by the staffs of the Senator Ron Wyden and Senator Charles Grassley confirmed that the pricing of Sovaldi and Harvoni was based on pure greed, ignoring completely the human consequences.
AUG PHARMA has introduced the new product on Egyptian pharmaceutical market - Augispov (Sofosbuvir) one more generic of Sovaldi made in Egypt.
percent of the country's pharmaceutical market. Cipla Launches Hepcvir-L For HepC Genotype 1 Patients. Hepcvir-L will be provided to patients in India at the fraction of the cost of branded Ledipasvir-Sofosbuvir under a licensing agreement with
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Considerata la disponibilità della Gilead Sciences (la ditta produttrice del farmaco), e sentito il parere degli esperti clinici delle società scientifiche, la Commissione Tecnico-Scientifica di Aifa ha espresso parere favorevole in merito all’allargamento dell’uso compassionevole, ai sensi del D.M. 08/05/2003, del farmaco Sovaldi ai pazienti HCV-infetti iscritti in lista per trapianto epatico affetti da epatocarcinoma su cirrosi compensata (MELD<15) con le seguenti caratteristiche cliniche:
The most common adverse events in all groups were fatigue (29%), nausea (23%), and headache (22%), although anemia, diarrhea, and insomnia were also common among the patients who received sofosbuvir–velpatasvir plus ribavirin. Overall, 81% of patients in the groups who received sofosbuvir–velpatasvir alone had at least one adverse event, as compared with 91% of patients receiving sofosbuvir–velpatasvir plus ribavirin (Table 3 ).
Harvoni (sofosbuvir/ledipasvir); GileadOnce daily
The effects of coadministered drugs on the exposure of sofosbuvir and GS-331007 are shown in Table 6. The effects of sofosbuvir on the exposure of coadministered drugs are shown in Table 7 [See Drug Interactions (7.3) ].
55 Rajyaguru S et al . Sofosbuvir selects the NS5B S282T mutation in vitro in genotype 1–6 replicons and is not cross-resistant to resistance associated variants selected by other classes of antiviral inhibitors. Hepatology 2013 ; 58 ( S1 ): 739A .
Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG). Sofosbuvir– Nutzenbewertung gemäß § 35a SGB V. Dossierbewertung A14-05. Köln: IQWiG.02.05.2014.
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T wo new drugs for the treatment of chronic hepatitis C virus (HCV) infection have received FDA approval: simeprevir (Olysio—Janssen) and sofosbuvir (Sovaldi—Gilead).
Sovaldi offers 90 percent cure rate.
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I think it is important to remember that this approval is for sofosbuvir alone with ribaviran and NOT for the combination pill of sofosbuvir and ledipasvir together.
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L'efficacité d'Harvoni (lédipasvir [LDV]/sofosbuvir [SOF]) a été évaluée dans trois études en ouvert de phase 3, avec des données disponibles pour un total de 1 950 patients atteints d'HCC de génotype 1. Les trois études de phase 3 comprenaient une étude menée chez des patients naïfs de tout traitement non cirrhotiques (ION-3), une étude menée chez des patients naïfs de tout traitement cirrhotiques et non cirrhotiques (ION-1) et une étude menée chez des patients cirrhotiques et non cirrhotiques dont le traitement précédent à base d'interféron, y compris un traitement contenant un inhibiteur de protéase du VHC, avait échoué (ION-2). Dans ces études, les patients avaient une maladie hépatique compensée. Ces trois études de phase 3 ont toutes évalué l'efficacité de l'association lédipasvir/sofosbuvir avec ou sans ribavirine.
Ledipasvir + sofosbuvir è un nuovo trattamento antivirale per curare l’infezione cronica da virus dell’epatite C in pazienti adulti ( Fig. 1)
It has been reported that the hepatitis C combination medication ledipasvir/sofosbuvir (LDV/SOF, Harvoni), and in particular the ledipasvir component, may increase tenofovir levels in the body. It also is known from previous investigations that ritonavir-boosted protease inhibitors (PIs) increase serum tenofovir concentrations. Thus, there has been a concern that coadministration of tenofovir with both ledipasvir and a boosted PI may increase the risk of renal toxicity.
2. Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. The New England journal of medicine. 2014;370(16):1483–93. doi: 10.1056/NEJMoa1316366. pmid:24725238
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Zepatier beats Harvoni, Sovaldi in hep C clinical-data safety showdown: Advera Health Analytics
Das Management von Gilead Sciences dürfte die Entwicklung mit Sorge betrachten: Der Umsatz für die beiden hoch wirksamen Hepatitis-C-Arzneimittel Sovaldi und Harvoni ist im dritten Quartal 2016 erneut eingebrochen, nachdem Preise und Erlöse bereits in den vorangegangenen Monaten kräftig unter Druck geraten waren.
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Based on a side-by-side review if disparate studies, Sovald appears ti be more versatile than Olysio as it is approved for treatment of genotypes 1, 2, 3 and 4. Also, for genotype 2 and 3, Sovaldi can be taken with ribavirin alone, excluding the need for interferon altogether. (Interferon, perhaps the most dreaded component of HCV therapy, is administered by injection and many side effects. On the other hand, Olysio must always be used in combination with interferon and ribavirin for the duration of either 24 weeks (for treatment-naive patients) or 48 weeks (for patients previously exposed to HCV therapy). However,iti cannot be used with many retroviral drugs. These drugs are less toxic. Currently, one in seven patients on Incivek or Victrelis abandon therapy prematurely due to high levels of toxic side effects — including severe anemia and serious decreases in blood platelets or neutrophil levels. Additionally, the FDA has warned that Incivek can cause potentially life-threatening skin rash, particularly in patients with cirrhosis (scarring of the liver). Using the two together is beginning to be explored, with early results showing efficacy in even hard-to-treat HCV.patients.
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