Hepatitis Till around 2010, PEGylated interferon alfa-2b in combination with
ribavirin, was part of the standard regimen used in management of
hepatitis C. Ribivarin helped in increasing the
Sustained Virologic Response (SVR) even more. Developed by
Schering-Plough, the drug was approved by
Food and Drug Administration (FDA) of the
United States in 2001, and has been on the
World Health Organization's List of Essential Medicines as a therapy for chronic hepatitis C since 2013. A 2012
meta-analysis had found
PEGylated interferon alfa-2a to be the more effective variant for treatment-naive patients. With the advent of Direct-Acting-Antivirals (DAAs — ), interferon-based treatment regimens gradually fell out of fashion due to relatively poor efficacy and high frequency of adverse side-effects. No longer recommended, the use of PEGylated interferon alfa-2b has essentially ceased in all countries, where DAA therapeutics are available. It was first approved for the purpose by FDA on 29 March 2011, based on a single phase III trial. The usage remains controversial — frequency of severe side-effects is high,
overall survival benefits substantially vary across different trials, and there is no consensus on the dosage regimen. Meta-analyses have suggested that the drug might be more helpful for patients with ulcerated primary lesion. No publication (or
preprint) yet exists; the phase II trial was poorly designed and not robust.
Side effects Adverse side effects are common and often require dose reduction or outright discontinuation. Common side effects include
fatigue, headache,
insomnia,
depression,
mood swings,
hair loss,
nausea,
diarrhea,
myalgia and associated skeletal pain,
anorexia, fever etc. Relatively rare effects include
imbalance of thyroid hormones,
xerostomia,
thrombocytopenia,
hepatomegaly,
pharyngitis,
cough,
psychosis,
rashes,
arrhythmia,
anemia etc. Severe side effects may include a range of potentially fatal neuropsychiatric, autoimmune, ischemic, or infectious disorders. ==Mechanism of action==