Table 2.

Treatment discontinuation and main adverse events.

	BLV monotherapy (n = 27)	BLV + pegIFNɑ (n = 11)	p value
Discontinuation before Week 48, n (%)	4 (14.8)	4 (36.4)	0.1950
Duration of treatment before discontinuation (weeks), mean ± SD	31.1 ± 6.4	14.1 ± 8.5	0.0304
Causes of discontinuation before Week 48, n (%)
Severe adverse events∗	0 (0)	2 (50)
Lost to follow-up	1 (25)	1 (25)
Poor response or compliance	3 (75)	1 (25)
All grade 3 and 4 adverse events∗, n (%)	9 (42.9)	6 (100)	0.0200
Serious adverse events	9 (42.9)	4 (66.7)	0.3845
Increased bile acids (>15 N)	1 (4.8)	0
Thrombocytopenia	1 (4.8)	2 (33.3)
Neutropenia	1 (4.8)	5 (83.3)
Gamma-glutamyl transferase increase	1 (4.8)	2 (33.3)
Pruritus	3 (14.3)	1 (16.7)

Qualitative variables are reported as n (%), and quantitative variables are reported as mean ± SD or median (IQR). The Mann–Whitney U-test was used to compare the quantitative variables, and the Chi-square test or Fisher’s exact test, as appropriate, was used to compare the qualitative variables between groups. Levels of significance: p = 0.05.

BLV, bulevirtide; pegIFNɑ pegylated interferon-ɑ.

^∗Number of patients who presented at least one event (available only in the ANRS HD EP01 BuleDelta cohort).