Support for Tenofovir Disoproxil Fumarate Monotherapy for Multidrug-Resistant Chronic HBV Infection
Atif Zaman, MD, MPH reviewing Lee HW et al. Clin Gastroenterol Hepatol 2018 Oct 26
Long-term efficacy data show that TDF monotherapy is equally as safe and effective as combination therapy.
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SUMMARY AND COMMENT | GASTROENTEROLOGY, INFECTIOUS DISEASES
November 13, 2018
Support for Tenofovir Disoproxil Fumarate Monotherapy for Multidrug-Resistant Chronic HBV Infection
Atif Zaman, MD, MPH reviewing Lee HW et al. Clin Gastroenterol Hepatol 2018 Oct 26
Long-term efficacy data show that TDF monotherapy is equally as safe and effective as combination therapy.
Early monotherapy regimens for chronic hepatitis B virus (HBV) infection, such as lamivudine, led to high rates of multidrug resistance (MDR). More-potent regimens such as tenofovir disoproxil fumarate (TDF) alone or in combination with another agent have been recommended for MDR, but a lack of long-term efficacy data hampers clear, consistent guidelines.
In an industry-funded, prospective, multicenter cohort study, researchers in Korea evaluated the long-term efficacy of TDF alone or in a combination regimen among 423 patients receiving rescue therapy for MDR HBV infection. The primary endpoint was virologic response, defined as serum HBV DNA <20 IU/mL.
Forty-one percent of patients received TDF monotherapy and the rest combination therapy. Those with adefovir resistance were more likely to receive combination therapy, while those without adefovir resistance were more likely to receive TDF alone. During a median follow-up of 180 weeks (16,615 person-years total), the overall virologic response was 70% at 48 weeks, 86% at 96 weeks, 92% at 144 weeks, 95% at 192 weeks, and 96% at 240 weeks. Response rates were similar in monotherapy and combination therapy groups. Low baseline HBV DNA levels and absence of adefovir resistance were associated with virologic response.
Comment
These data from a real-world setting demonstrate that TDF monotherapy is as effective as TDF combination therapy in achieving and maintaining virologic response in HBV patients who develop multidrug resistance. Most guidelines suggest add-on therapy, but switching to TDF monotherapy would reduce cost, improve compliance, and minimize adverse side effects compared with combination therapy. Therefore, clinicians should first consider TDF monotherapy for these patients.
Editor Disclosures at Time of Publication
Disclosures for Atif Zaman, MD, MPH at time of publication
Grant/Research support:
Merck
Citation(s):
Lee HW et al. Long-term efficacy of tenofovir disoproxil fumarate monotherapy for multidrug-resistant chronic HBV infection. Clin Gastroenterol Hepatol 2018 Oct 26; [e-pub]. (https://doi.org/10.1016/j.cgh.2018.10.037)作者: StephenW 时间: 2018-12-6 10:13