PEG-Intron and
PEG-Intron + Ribavirin

This information was taken from the Product Information Insert that comes with PEG-Intron. Don't forget, Interferon and Ribavirin effect everyone differently. These numbers are just to give you an idea of what you may expect and in NO WAY mean you will have ALL of these sides. The package insert does NOT give sustained response rates.

Side Effects **

 
Adverse-Events
PEG
Intron
PEG-Intron
Rebetrol
Adverse-Events
PEG
Intron
PEG-Intron  Rebetrol
Injection Site Inflammation
47
75
Myalgia
54
56
Dry Mouth
6
12
Arthralgia
23
34
Increased Sweating
6
11
Musculoskeletal Pain
28
21
Flushing
6
4
Insomnia
23
40
Fatigue/Asthenia
52
66
Depression
29
31
Headache
56
62
Anxiety, Emotional Lability,
Irritability
28
47
Rigors
23
48
Concentration Impared
10
17
Fever
22
46
Agitation
2
8
Weight Loss
11
29
Nervousness
4
6
RUQ Pain
8
12
Menstrual Disorder
4
7
Chest Pain
6
8
Viral Infection
11
12
Malaise
7
4
Fungal Infection
<1
6
Nausea
26
43
Dyspnea
4
26
Anorexia
20
32
Coughing
8
23
Diarrhea
18
22
Pharyngitis
10
12
Vomiting
7
14
Rhinitis
2
8
Abdominal Pain
15
13
Sinusitis
7
6
Dyspepsia
6
9
Alopecia
22
36
Constipation
1
5
Pruritus
12
29
Neutropenia
6
26
Rash
6
24
Anemia
0
12
Dry Skin
11
24
Leukopenia
<1
6
Taste Perversion
<1
9
Thrombocytopenia
7
5
Vision Blurred
2
5
Hepatomegaly
6
4
Conjunctivitis
4
4

**Number (%) of patients
 

Response Rates

Study #1

 
PEG-Intron 0.5 ug/kg
PEG-Intron 1.0 ug/kg
TreatmentResponse: 
(Combined Virologic Response/ALT Normalization
17%
24%
Virologic Response
18%
25%
ALT Normalization
24%
29%

Patients with both viral genotype 1 and high serum levels of HCV RNA at baseline were less likely to respond to treatment with PEG-Intron. Among patients with the two unfavorable prognostic vairables, 8% (12/157) responded to PEG-Intron treatment. Patients with viral genotype 1 had a response rate of 14% (28/199) while patients with other viral genotypes had a 45% (43/96) response rate.
 

Study #2

 
PEG-Intron 1.5 ug/kg QW 
REBETROL 800mg QD
Overall Response
52% (264/511)
Genotype 1
41% (141/348)
Genotype 2-6
75% (123/163)

Patients with viral genotype 1, regardless of viral load had a lower response rate to PEG-Intron (1.5 ug/kg)/REBETROL compared to patients with other viral genotypes. Patients with poor prognostic factors (genotype 1 and high viral load) had a response rate of 30% (78/256) compared to a response rate of 29% (71/247) with Intron A/REBETROL (combo therapy).
 
 

PLEASE note that genotype 1 does NOT respond much better with the PEG-Intron either with or without Ribavirin.


 



SOURCE:
Schering Plough
Drug Insert
 

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