Table 5.

Randomized- controlled trials on Lonafarnib-based therapy.

RCT, Phase	Authors, year, references	Sample size	Age, cirrhosis	Intervention type	Treatment time	Follow up time	Primary outcome	Number (%) of patients who reached primary outcome	Secondary outcome	Number (%) of patients who reached secondary outcome	% severe adverse reactions - or discontinuations
LOWR 1, II ( Degasperi et al., 2023b )	(Yurdaydin et al., 2018)	3	59 - mean	LNF* 200 mg BID**	12 weeks	/	Decrease in viral load				0% - 0%
		3	40 - mean	LNF 300 mg BID	12 weeks	/					0% - 0%
		3	46 - mean	LNF 100 mg thrice‐daily	5 weeks	/					0% - 33.3%
		3	41 - mean	LNF 100 mg BID + pegIFNα*** 180 μg weekly	8 weeks	/					0% - 0%
		3	46 - mean	LNF 100 mg BID + RTV£ 100 mg day	8 weeks	/					0% - 0%
LOWR 2, II (https://www.natap.org/2023/AASLD/AASLD_59.htm)	(Yurdaydin et al., 2022)	55	23 to 66	At least 75 mg LNF BID + RTV	12 weeks	/	Virologic: HDV RNA ≥2 log decline or undetectability	6 (46%) – in all oral regimens			18.7% -
			27 to 70	25 or 50 mg LNF BID + RTV	24 weeks	/					10.5% -
			29 to 59	25 or 50 mg LNF BID + RTV + pegINFa weekly	24 weeks	/		8 (89%) – with IFN addition			15.7% -
D-LIVR, III ( Hollnberger et al., 2023 )	Etzion et al., 2023 (https://www.natap.org/2023/AASLD/AASLD_59.htm)	405	42.9 (10.8) – 26%	LNF 50mg BID + RTV 100mg BID	48 weeks	24 weeks	Combined: HDV RNA ≥2 log decline and ALT normalization	18/178 (10.1%)	HDV RNA ≥2 log decline and ALT normalization taken singularly	26/178 (14.6%) – 44/178 (24.7%)	8% - 19%
			41.4 (11.5) – 26%	LNF 50mg BID + RTV 100mg BID + PegIFNa				24/125 (19.2%)		40/125 (32%) – 43/125 (34.4%)	14% - 18%
			42.3 (11.0) – 27%	PegIFNa				5/52 (9.6%)		19/52 (36.5%) – 6/52 (11.5%)	10% - 21%
			45.7 (10.9) – 29%	Placebo				1/52 (1.9%)		2/52 (3.8%) – 4/52 (7.7%)	4% - 19%

*Lonafarnib; **Bis in day (twice daily); ***Pegylated Interferon alpha; £ Ritonavir