Effectiveness, safety and cost per sustained virological response in Hepatitis C patients treated with Sofosbuvir based therapies in clinical practice in Germany

Introduction: Real-world (RW) clinical outcomes of sofosbuvir (SOF)-based treatment from Germany have recently been presented but no study to date has evaluated these economic outcomes. The aim of this study was to estimate the total costs, RW effectiveness, safety and cost per sustained viral response (SVR) of chronic hepatitis C (CHC) patients treated with SOF-based therapies in Germany.

Materials and Methods: A retrospective single centre cohort study was conducted. The first 159 sequential CHC adult patients treated with SOF-based therapies were included. SVR rates (ITT), overall and per subgroup including treatment experience and fibrosis stage, along with incidence of adverse events (AE) requiring intervention, were analysed. Total cost incurred from therapy initiation to 12 weeks after treatment was estimated by adding expenses for drugs, lab costs, patient care including AE and follow-up. Drug costs include VAT as well as wholesale and pharmacy surcharges. Cost per SVR was calculated as median cost divided by the SVR rate.

Results: 159 patients initiated treatment between 22/01/2014 to 05/11/2014. Patients received SOF+ pegIFN plus ribavirin (PR) (21%), SOF+R (20%), SOF+ simeprevir (SMV) (24%) and SOF+ daclatasvir (DCV) (35%). 58% of patients were G1, 15% G4, 12% G2 and 14% G3. Mean age was 56 years and 62% were male. At baseline, 55% of patients were cirrhotic and 50% had received at least one prior therapy (73% PR, 21% PI+PR, 6% other/unknown). Results are based on 144/159 for whom SVR is currently available. Complete results will be available at time of presentation. SVR12 rate was 91%, 98% of patients completed treatment, no AE led to discontinuation. Total median cost per SVR was estimated to be 113,967 € with information by patient subgroup presented in the table.

Conclusion: This study suggests as a result of a good tolerability profile, monitoring and AE related costs are minimal in SOF-based regimens. This study also suggests that the cost per SVR is significantly higher in experienced and in cirrhotic patients when compared to naïve and non-cirrhotic patients, indicating an economic benefit of early treatment selecting short, well tolerated highly effective first line therapies.

Patient groups	SVR12	Median cost of Therapy (€)	Other costs (€)	Cost per SVR	SVR12	Median cost of Therapy (€)	Other costs (€)	Cost per SVR
				(Median/SVR) (€)				(Median/SVR) (€)
	Naïve patients				Experienced patients
Genotype 1
Overall	94.9%	103,522	295	109,407	86.7%	115,701	339	133,754
SOF+(PR or R)	88.9%	62,443	244	70,478	57.1%	65,779	308	115,589
SOF+(SMV or DCV)	96.7%	115,262	321	122,466	92.1%	185,97	340	202,311
SOF+DCV	100.0%	187,083	387	187,47	95.8%	188,197	392	196,745
SOF+SMV	93.3%	103,522	274	111,347	85.7%	103,522	233	121,038
No cirrhosis	93.3%	65,584	253	70,53	91.7%	94,655	302	103,583
Cirrhosis	95.8%	110,357	355	115,431	84.8%	185,97	365	219,673
Genotypes 2 – 4
Overall	96.9%	58,665	339	60,942	85.2%	75,51	338	89,127
SOF+(PR or R)	96.3%	57,074	300	59,554	80.0%	59,598	303	75
SOF+(SMV or DCV)	100.0%	187,083	409	187,492	91.7%	104,421	382	114,401
SOF+DCV	100.0%	187,083	409	187,492	100.0%	181,197	358	188,508
SOF+SMV	-	-	-	-	85.7%	99,869	386	116,956
No cirrhosis	95.2%	56,811	299	59,841	92.9%	59,484	331	64,331
Cirrhosis	100.0%	109,66	413	110,008	76.9%	104,74	379	136,664