AI Article Synopsis
- A study was conducted to assess the safety and effectiveness of sofosbuvir plus ribavirin in elderly patients (≥ 75 years old) with genotype 2 hepatitis C, who were previously excluded from clinical trials.
- The study involved 265 patients and found that the overall sustained virological response rate was 97%, with similar rates among different age groups, including the elderly (98% for those ≥ 75 years old).
- While some elderly patients experienced anemia requiring dosage adjustments, the treatment was deemed highly effective and tolerable for older patients.
Article Abstract
Background: Although clinical use of sofosbuvir plus ribavirin has been approved for patients infected with genotype 2 hepatitis C virus, patients ≥ 75-years-old have not been included in previous clinical trials.
Aim: To evaluate the real-world safety and efficacy of sofosbuvir plus ribavirin for elderly patients (≥ 75-years-old) compared to nonelderly patients, we conducted a post-marketing prospective cohort study.
Methods: We treated 265 patients with genotype 2 hepatitis C virus using standard approved doses of sofosbuvir (400 mg/d) plus ribavirin adjusted by body weight, administered orally for 12 wk.
Results: Sustained virological response rates for the overall cohort, patients < 65-years-old, ≥ 65-years-old but < 75-years-old, and ≥ 75-years-old were 97% (258/265), 98% (93/95), 97% (84/87), and 98% (81/83), respectively ( = 0.842). Logistic regression analyses identified history of hepatocellular carcinoma treatment and alpha-fetoprotein as factors significantly associated with sustained virological response. Alpha-fetoprotein was the only independent factor identified. Sustained virological response rate was significantly lower for patients with hepatocellular carcinoma treatment (91%) than for patients without history of hepatocellular carcinoma treatment (98%, = 0.004). One patient (0.4%) discontinued treatment due to drug-induced pneumonia. Dose reduction or interruption of ribavirin was required for 12.1% (32/265) of patients because of anemia, including 7.7% (14/182) of patients < 75-years-old and 21.7% (18/83) of patients ≥ 75-years-old ( = 0.002).
Conclusion: Although ribavirin dose reduction or interruption was required with advanced age, sofosbuvir plus ribavirin appears tolerable and highly effective even in patients ≥ 75-years-old.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7522558 | PMC |
| http://dx.doi.org/10.4254/wjh.v12.i9.672 | DOI Listing |
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