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TDF effective, safe in LAM-R chronic hepatitis B patients up to 5 years

Tenofovir disoproxil fumarate monotherapy was effective and well-tolerated in patients with lamivudine-resistant chronic hepatitis B up to 5 years, according to recent findings published in Journal of Hepatology.

However, there was no evidence for additional benefit of combination therapy with emtricitabine (FTC).

“Over 5 years, one of the longest follow-up periods compared with previous trials of [lamivudine-resistant (LAM-R)] patients, [tenofovir disoproxil fumarate (TDF)] treatment was well-tolerated; renal events observed were generally mild and decreases in bone mineral density were seen,” Scott Fung, MD, clinical researcher at Toronto General Research Institute, and colleagues wrote. “Our findings are in accordance with those in published literature that have shown that TDF monotherapy is an appropriate treatment option for LAM-R patients in terms of virological response and prevention of developing additional resistance.”

Fung and colleagues previously reported that 2-year treatment with TDF alone or TDF–FTC was associated with sustained viral suppression in patients with LAM-R chronic hepatitis B. After 240 weeks of treatment, they followed up with their patients to determine if these associations persisted.

The researchers had randomly assigned 280 patients to receive either 300 mg TDF alone (n =141) or a combination of 200 mg FTC and 300 mg TDF (n = 139) once per day. They measured the proportion of patients with plasma hepatitis virus DNA less than 400 copies or 69 international units per mL.

Eighty-three percent of patients who received TDF and 82.7% of patients who received combination therapy had a hepatitis B virus DNA level less than 400 copies per mL. The rates of normal alanine aminotransferase and normalized alanine aminotransferase were similar between the two groups. Hepatitis B e antigen loss and seroconversion were also similar. Six patients achieved hepatitis B surface antigen loss and one patient achieved seroconversion. The researchers did not observe any TDF resistance. Renal events were mild and occurred in 8.6% of patients. Further, there was a 0.98% decrease in bone mineral density of the spine and a 2.54% decrease in the hip.

The researchers concluded that TDF monotherapy was effective and well-tolerated in patients with LAM-R chronic hepatitis B up to 5 years.

“Importantly, 240 weeks of continuous therapy with TDF alone, or in combination with FTC, was not associated with resistance development,” the researchers wrote. “TDF is, therefore, an effective and well-tolerated treatment option for [chronic hepatitis B] patients with resistance to lamivudine.” – by Will Offit

Disclosure: Fung reports receiving research grants and being a speaker and advisor for AbbVie, Bristol-Myers Squibb, Gilead Sciences and Merck. He also is a consultant for GlaxoSmithKline. Please see the full study for a list of all other researchers’ relevant financial disclosures.