DFDA

Sofosbuvir/Ledipasvir

Treatment for Acute Hepatitis C

Typical Dosage: 400 mg sofosbuvir / 90 mg ledipasvir once daily

Effectiveness
97%
Safety Score
70%
Clinical Trials
3
Participants
8K

Comparative Safety Scale(Higher is safer)

Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
70
DangerousModerateSafe
Treatment Details
Dosage Range
400 mg sofosbuvir / 90 mg ledipasvir once daily
Time to Effect
Within 8-12 weeks of treatment completion
Treatment Duration
8-12 weeks
Evidence Quality
HIGH
Number Needed to Treat (NNT)
1(Treat 1 patients to see 1 additional successful outcome)
Number Needed to Harm (NNH)
100(Treat 100 patients to see 1 additional serious adverse event)
Confidence Score
95%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$22,000
Monitoring:$1,000
Side Effect Mgmt:$200
Total Annual:$23,200
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
GOOD
ICER
$60,000/QALY
QALYs Gained
2.8
Outcome-Based Costs
Cost per Responder
$23,918
Cost per Remission
$23,918
Comparison vs Pegylated Interferon + Ribavirin
Cost Difference
$-11,800/year
Less expensive
QALY Difference
+2.30 QALYs
Better outcomes
Dominance
DOMINATESBetter + cheaper
Prescription Access Economics
Annual Societal Loss per Patient
$18,390
Cost of prescription-only barriers (visits, time, admin, price premium)
Physician Visit Cost
$250/year
Time Cost
$120/year
Travel + wait time
Insurance Admin Cost
$20/year
Prior auth, claims
Rx Price
$22,000/year
Potential OTC Price
$4,000/year
Estimated if OTC available
Risk Assessment
Misuse Risk
LOW
Missed Diagnosis Risk
LOW
Sofosbuvir/Ledipasvir Outcomes

for Acute Hepatitis C

Efficacy Outcomes
Overall Effectiveness
+97%
Response Rate
+97%
Remission Rate
+97%
Common Side Effects
Headache
+19%
Fatigue
+15%
Nausea
+8%
Diarrhea
+5%

Sources:

tum.de
nih.gov
nih.gov

WARNING: LIMITED TRIALS AVAILABLE

You can search for trials, but you probably can't join any because the 1% Treaty hasn't passed yet. Most trials are severely limited by lack of funding and bureaucratic barriers. Help change this!

Active Clinical Trials
No active trials currently recruiting for this treatment

No active trials found in ClinicalTrials.gov

Completed Clinical Trials
3 completed trials for Sofosbuvir/Ledipasvir in Acute Hepatitis C

Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute Hepatitis C Virus (HCV) Infection

NCT02128217COMPLETEDPHASE1
View Study
44 participants
INTERVENTIONAL
San Diego, United States +11 more
Started: May 30, 2014

HepNet Acute HCV IV - LDV/SOF FDC in Acute Genotype 1 Hepatitis C Virus Infection

NCT02309918COMPLETEDPHASE2
View Study
20 participants
INTERVENTIONAL
Berlin, Germany +19 more
Started: Nov 1, 2014

Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection

NCT02457611COMPLETEDPHASE2
View Study
26 participants
INTERVENTIONAL
Berlin, Germany +3 more
Started: Jun 1, 2015