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12-10-2016 | HBV | News | Article

Monthly monitoring needed during first months of tenofovir discontinuation

medwireNews: The vast majority of hepatitis B e antigen (HBeAg)–negative chronic hepatitis B patients who experience clinical relapse following tenofovir discontinuation do so within the first 6 months, study findings indicate.

This suggests that “monthly monitoring is required during the first 3 to 6 months off-[tenofovir]” to enable timely retreatment when required, say Yun-Fan Liaw (Chang Gung Memorial Hospital, Linkou, Taiwan) and co-researchers.

They add: “Of particular importance is that patients with cirrhosis need more cautious follow-up evaluation and earlier retreatment to prevent hepatic decompensation.”

The study included 85 HBeAg–negative, anti-HBe–positive patients (86% men, mean age 52 years) who discontinued tenofovir therapy following undetectable HBV DNA levels on three occasions at least 6 months apart. The median treatment duration was 157 weeks, which included a median 122 weeks of consolidation therapy.

During a median off-therapy follow-up period of 39 weeks, 38 (44.7%) patients experienced clinical relapse: 57.9% within 3 months and 86.8% within 6 months. The earliest relapse occurred at just 4 weeks, with a median time-to-relapse of 12 weeks.

Writing in Clinical Gastroenterology and Hepatology, the researchers note that alanine aminotransferase (ALT) and serum bilirubin levels were high among the relapsers.

Specifically, 57.9% had an ALT level greater than 10 times the upper limit of normal and 23.7% had a bilirubin level of 2 mg/dL or greater. Two patients, both with cirrhosis, developed hepatic decompensation, at 6 and 14 weeks post-discontinuation of tenofovir.

And compared with patients who did not relapse, those who did had a significantly higher pretherapy baseline hepatitis B surface antigen level (3.31 vs 2.94 log10 IU/mL, p=0.021), were more likely to have had prior anti-HBV therapy (73.7% vs 48.9%, p=0.021), less likely to experience ALT normalisation by 6 months (54.1% vs 79.5%, p=0.014) and less likely to have received at least 144 weeks of treatment (68.4% vs 89.4%, p=0.027).

Using this information, Liaw and team calculated that the optimal duration of treatment and consolidation therapy were 3 and 2 years, respectively. Patients treated with this combination had a significant 61% lower risk of relapse than those treated for shorter periods (p=0.008).

The authors say that their findings were “unexpected and therefore very important”, because clinical relapse after cessation of tenofovir occurred much earlier and tended to be more severe than that observed in a comparable population of patients treated with entecavir therapy at the same hospital.

They conclude that further work is needed to understand the reasons for these differences.

By Laura Cowen

medwireNews is an independent medical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2016

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