Table 2 Clinical trials and their outcome for pegaspargase conjugate. 6.1.3. Mircera (Continuous Erythropoiesis Receptor Activator or Methoxy Polyethylene Glycol-Epoetin Beta) Mircera is a PEGylated continuous erythropoietin (EPO) receptor activator (CERA) introduced by Hoffmann-La Roche. It got approved by FDA in 2007 and is currently used
to treat renal anemia in patients with chronic kidney disease (CKD). PEGylation of erythropoietin helps to prolong the half-life to approximately 130h [69]. Darbepoetin alfa (Aranesp, Amgen), a second-generation EPO, due to the inclusion of an amino acid mutation has a higher glycosylation Inhibitors,research,lifescience,medical rate, and hence requires only weekly or biweekly injections. On the other hand, third-generation Inhibitors,research,lifescience,medical EPO (CERA) requires only monthly administration and thus helps in significantly improving the quality of life. However, it has been reported to have
negligible effects on click here morbidity or mortality like other ESAs [70]. 6.1.4. Pegasys (Peginterferon Alfa-2a) Inhibitors,research,lifescience,medical Pegasys (peginterferon alfa-2a) (Hoffmann-La Roche) drug is used to treat chronic hepatitis C (HCV) either alone or in combination with antimicrobial ribavirin. Pegasys was approved by FDA in 2002. It consists of a PEGylated interferon alfa-2a intended to mediate antiviral immune response. PEGylated interferon demonstrated higher efficacy by increasing the clearance time of the protein, thus maintaining interferon concentration levels in the blood to control HCV. The clinical study of peginterferon revealed that 180μg of peginterferon alfa-2a, administered once a week in patients with hepatitis C-related cirrhosis or bridging Inhibitors,research,lifescience,medical fibrosis
was significantly more effective than 3 million units of standard interferon alfa-2a [71–73]. Inhibitors,research,lifescience,medical 6.1.5. PEG-Intron (Peginterferon Alfa-2b) PEG-Intron [74] marketed by Schering-Plough is used to eradicate hepatic and extrahepatic hepatitis C virus infection. PEG conjugated with α-interferon (IFN) was approved by FDA for use in 2001. Monomethoxy-PEG-linked interferon has a sustained serum for 48–72h compared to the native protein half-life of 7–9h. The recommended over dosage for standalone PEG-Intron therapy is 1mgkg−1 per week for 52 weeks on the same day of the week subcutaneously [74, 75]. Interestingly, peginterferon α-2a has a higher market share because peginterferon α-2b is dosed on a body weight basis, whereas peginterferon α-2a is not. As a result, peginterferon α-2a is more frequently utilized to treat hepatitis C [68]. Nevertheless, some reports have suggested that peginterferon α-ribavirin combination therapy has higher risks of neutropenia and thrombocytopenia than interferon α-ribavirin combination therapy [87, 88], although both therapies have been reported to have similar side effect profiles. 6.1.6.