Daclatasvir for Hepatitis C: Key FAQs on Dosage, Side Effects & Cost

Haig Sandavol Oct 17 1

Key Takeaways

• daclatasvir is an NS5A inhibitor used in combination regimens to cure hepatitis C.
• It works against multiple genotypes, but dosing varies by genotype and co‑medications.
• Common side effects are mild; serious events are rare but require monitoring.
• Cost depends on insurance, country, and treatment length; patient assistance programs exist.
• Always follow a physician’s guidance and get baseline labs before starting.

What Is Daclatasvir?

Daclatasvir is an oral antiviral medication that targets the NS5A protein of hepatitis C virus (HCV), blocking viral replication and helping clear the infection when used with other direct‑acting antivirals. First approved by the FDA in 2015, it quickly became part of several all‑oral regimens that eliminated the need for interferon.

How Does Daclatasvir Fit Into Hepatitis C Treatment?

Hepatitis C is a liver infection caused by the hepatitis C virus, classified into seven genotypes (1‑7) that differ in geographic spread and treatment response. Daclatasvir belongs to the NS5A inhibitor class, alongside drugs like Ledipasvir and Ombitasvir. By binding to NS5A, it disrupts the formation of the viral replication complex, making the virus vulnerable to other agents such as the nucleoside polymerase inhibitor Sofosbuvir.

When Is Daclatasvir Prescribed?

• Genotype 1, 2, 3, 4, or 5 infections when combined with Sofosbuvir (with or without Ribavirin).
• Patients who cannot tolerate interferon‑based regimens.
• Cases where resistance‑associated substitutions (RAS) to other NS5A inhibitors are present.

Its flexibility makes it a go‑to option for patients with chronic kidney disease or advanced liver disease, as the drug is primarily metabolized by the liver and requires no dose adjustment for renal impairment.

Typical Dosage and Treatment Length

1. Standard adult dose: 60mg (one tablet) taken orally once daily.
2. If combined with Sofosbuvir+Ribavirin for genotype 3, the course is usually 12weeks.
3. For genotype 1 or 4 without Ribavirin, 12weeks of Daclatasvir+Sofosbuvir is common.
4. Patients with cirrhosis may require 24weeks depending on prior treatment history.

Always follow the prescribing physician’s schedule; missing doses can lead to viral breakthrough and resistance.

Potential Side Effects

Most users experience mild, transient symptoms. The most frequently reported events (≥10%) include:

• Fatigue
• Headache
• Nausea
• Diarrhea

Serious adverse events are uncommon but may involve:

• Elevated liver enzymes (ALT/AST)
• QT‑interval prolongation (especially when taken with certain anti‑arrhythmics)
• Severe anemia when ribavirin is co‑administered.

Patients should have baseline liver function tests and periodic monitoring during therapy. If ALT rises more than five times the upper limit of normal, the clinician may pause or adjust treatment.

Drug Interactions You Should Know

Daclatasvir is a substrate of CYP3A4 and P‑gp transporters. Significant interactions include:

Key Drug Interactions with Daclatasvir

Interacting Agent	Effect on Daclatasvir	Clinical Action
Strong CYP3A4 inducers (e.g., rifampin, carbamazepine)	Decreases exposure by ~80%	Avoid co‑administration or increase dose under specialist guidance
Strong CYP3A4 inhibitors (e.g., ketoconazole, lopinavir/ritonavir)	Increases exposure by ~1.9‑fold	Reduce Daclatasvir dose to 30mg daily
Antacids (aluminum‑ or magnesium‑based)	May reduce absorption	Separate intake by at least 2hours
Amiodarone or other QT‑prolonging drugs	Potential additive cardiac risk	Electrocardiogram monitoring; consider alternatives

Always provide a complete medication list to the prescribing clinician.

Cost, Insurance, and Patient Assistance

In the United States, a 12‑week course of Daclatasvir+Sofosbuvir (brand name Harvoni‑like regimens) averages $30,000‑$45,000 before insurance. Prices vary by pharmacy and whether generic versions are available. Many insurers cover the drug under specialty pharmacy benefits, but prior authorization is typical.

The WHO recommends that treatment be made affordable worldwide; several global programs provide the medication at reduced cost in low‑income countries.

Patients can apply for manufacturer‑sponsored assistance programs, which may cover up to 100% of the out‑of‑pocket expense for eligible individuals.

Monitoring and Follow‑Up

Effective therapy is measured by sustained virologic response (SVR) 12 weeks after treatment ends (SVR12). The steps are:

1. Baseline HCV RNA quantitative PCR.
2. Mid‑treatment HCV RNA check at week 4 (optional, but useful for high‑risk patients).
3. End‑of‑treatment HCV RNA test.
4. SVR12 test to confirm cure.

If SVR12 is achieved, the virus is considered cleared in >95% of cases. Relapse is rare but may occur in patients with advanced cirrhosis or poor adherence.

Frequently Asked Questions

Bottom Line

Daclatasvir remains a cornerstone of modern hepatitis C therapy thanks to its high barrier to resistance, once‑daily dosing, and compatibility with multiple genotype regimens. Proper patient selection, awareness of drug interactions, and diligent monitoring are the keys to achieving cure while minimizing side effects and cost burdens.