Olysio and Sovaldi: Two new drugs for Hepatitis C

Hepatitis C is a major public health problem, especially in Southeast Asia. Interferon and ribavirin have been the standard of care in various combinations. The literature supports intereferon with the two recently FDA  approved oral medications that can be used in combination with the current antiviral regimen or to replace the injectable component of the regimen, peginterferon alfa.

The two new drugs are Olysio (simeprevir) capsules and Sovaldi (sofosbuvir) tablets. Both work by stopping the replication of the Hepatitis C virus.

Olysio 150 mg capsules are a once-daily treatment that must be used in combination with pegylated interferon (peginterferon alfas like Pegasys or Pegintron) and ribavirin. It cannot currently be used as monotherapy, which means it can’t be used alone. Sovaldi 400 mg tablets are a once-daily treatment that can be used without the injectable peginterferon alfa. This is novel and helpful in hepatitis therapy because the peginterferon alfa injectable often contributes to patients not finishing their course of Hep C therapy due to the unfavorable side effects.

Based on a side-by-side review if disparate studies, Sovald appears to 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 ,it cannot be used with many retroviral drugs.

Using the two together is beginning to be explored, with early results showing efficacy in even hard-to-treat cases. In early January, the New England Journal published a study of the combination of these two drugs. he New England Journal of Medicine, investigators designed a Phase II open-label study of Gilead Sciences’ recently approved nucleotide analogue NS5B polymerase inhibitor Sovaldi and Bristol-Myers Squibb’s NS5A replication complex inhibitor daclatasvir.

Sulkowski MS, et al “Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection” N Engl J Med 2014; 370: 211-221.

Sovaldi, Prescribing Information 2014

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