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I Have Been Diagnosed With HIV
I Am Taking COMBIVIR
I Am A Healthcare Professional
Complete Prescribing Information for COMBIVIR Tablets
How COMBIVIR Works
Possible Side Effects
Work With Your Doctor
Stick To Your Regimen
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How COMBIVIR Works
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COMBIVIR May Help Perserve Future Treatment Options
Risks of Switching
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Safety & Tolerability Profile
You can prescribe COMBIVIR because of its demonstrated safety profile with nearly a decade of patient treatment. COMBIVIR has been studied in over 50 controlled clinical trials enrolling over 18,000 patients. Studies have provided a well-documented understanding of side effects.
Most Common Adverse Events with COMBIVIR (Treatment Emergent, All Grades)1
| |
ZDV+3TC |
| Adverse event |
n=251 |
| -------------- |
--------- |
| Headache |
35% |
| Nausea |
33% |
| Malaise/fatigue |
27% |
| Nasal signs and symptoms |
20% |
| Diarrhea |
18% |
| Cough |
18% |
| Nausea and vomiting |
13% |
| Neuropathy |
12% |
| Musculoskeletal pain |
12% |
| Insomnia and other sleep disorders |
11% |
| Fever or chills |
10% |
| Anorexia and/or decreased appetite |
10% |
| Dizziness |
10% |
Selected Laboratory Abnormalities Associated with COMBIVIR
- Neutropenia (ANC <750/mm3) 7.2% (17 of 237)
- Anemia (Hgb <8.0 g/dL) 2.9% (7 of 241)
In a retrospective analysis of 54 GSK-sponsored trials of at least 24 weeks duration, Grades 2-4 anemia developed in 1.6% of patients treated with a ZDV-containing regimen and in 0.8% of patients treated without ZDV (P = 0.0002).
| Hemoglobin |
ART with ZDV |
ART with COM/TZV |
ART without ZDV |
Total |
| ART-naive |
N=1649 |
N=1987 |
N=3161 |
N=6797 |
| Grade ≥ 2(%) |
1.8 |
1.2 |
1.1 |
1.3 |
| Grade ≥ 3(%) |
1.3 |
0.7 |
0.6 |
0.8 |
| Experienced |
N=955 |
N=949 |
N=3910 |
N=5814 |
| Grade ≥ 2(%) |
2.3 |
1.3 |
0.6 |
1.0 |
| Grade ≥ 3(%) |
1.3 |
0.6 |
0.3 |
0.5 |
COMBIVIR can be used with all NNRTIs and PIs without significant drug-to-drug interactions.
| References |
| | 1. | COMBIVIR [package insert]. Research Triangle Park, NC: GlaxoSmithKline; November 2005. |
| | 2. | Edwards MT, Burkle W, Cutrell A, et al. Characterization of anemia in HIV-infected (HIV+) subjects treated with antiretroviral therapy (ART) with and without zidovudine (+/- ZDV) in 54 clinical trials. 3rd IAS Conf. on HIV Pathogenesis and Treatment. 2005: Poster TuFo0106. |
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