Efficacy of tenofovir disoproxil fumarate at 240 weeks in patients with chronic hepatitis B with high baseline viral load.
Bottom Line: Among HVL patients, time to achieving HBV DNA <400 copies/mL was shorter among those initially receiving TDF, compared to ADV.No patient with baseline HVL had persistent viremia at week 240 or amino acid substitutions associated with TDF resistance.CHB patients with HVL can achieve HBV DNA negativity with long-term TDF treatment, although time to HBV DNA <400 copies/mL may be longer, relative to patients with non-HVL.
Affiliation: Henry Ford Health System, Detroit, MI, USA.Show MeSH
Related in: MedlinePlus
Mentions: A total of 489 patients completed 240 weeks of therapy (304 from GS-US-174-0102 and 185 from GS-US-174-0103) (Table2 and Supporting Table1). On-treatment VR was high for both HVL and non-HVL patients, with 98.3% of HVL and 99.2% of non-HVL patients achieving HBV DNA <400 copies/mL by week 240 (Fig. 1). Also, by week 240, HBV DNA levels were <169 copies/mL for 96.6% of HVL patients and for 99.0% of non-HVL patients on treatment. The time course for achieving HBV DNA <400 copies/mL was longer among HVL patients versus non-HVL patients (Fig. 2), but by week 96, the percentage of patients with HBV DNA <400 copies/mL was similar between the two groups. At week 48, the percentage of HVL patients achieving HBV DNA <400 copies/mL was higher among patients initially randomized to TDF, compared to ADV (Fig. 3); however, after the switch to TDF, the rate of virologic suppression rapidly increased, and by week 96, the proportion of patients with HBV DNA <400 copies/mL was similar in both groups.