Should I start Tab Sovihep (Sofosbuvir) with an HCV viral load less than 35?

Should You Start Sofosbuvir (Sovihep) with HCV Viral Load <35 IU/mL?

Do not start sofosbuvir-based treatment with an HCV viral load below 35 IU/mL, as this level is below the lower limit of quantification for standard HCV RNA assays and may represent a false positive, resolved infection, or laboratory error rather than active chronic hepatitis C requiring treatment.

Understanding Your Viral Load Result

• An HCV viral load <35 IU/mL falls below the detection threshold of most quantitative PCR assays used to measure HCV RNA 1
• This result requires confirmation with repeat testing using a sensitive qualitative HCV RNA assay to determine if you have detectable virus 1
• If HCV RNA is truly undetectable or intermittently detectable at such low levels, you may have spontaneously cleared the infection or have occult hepatitis C, which does not require treatment 1

Essential Pre-Treatment Assessment Required

Before considering any HCV treatment, you must complete the following evaluations:

• Confirm active chronic infection: Repeat HCV RNA testing with both qualitative and quantitative assays to establish that you have persistent viremia above the lower limit of quantification 1
• Determine HCV genotype: This is essential to select the optimal regimen and duration, as different genotypes respond differently to various DAA combinations 2, 1
• Assess liver fibrosis stage: Use non-invasive methods (FibroScan, FIB-4, APRI) or imaging to determine if cirrhosis is present, as this affects treatment duration and monitoring 1
• Test for HIV co-infection: This is mandatory because co-infection affects drug-drug interactions and treatment selection 1

When Treatment Is Indicated

Treatment should only be initiated when you have:

• Confirmed chronic HCV infection with HCV RNA consistently detectable and quantifiable (typically >1000 IU/mL) 1
• Known HCV genotype (1-6) to guide regimen selection 2, 1
• Completed fibrosis staging to determine if you have compensated cirrhosis, which may require longer treatment duration 2, 1

First-Line Treatment Regimens (Once Infection Confirmed)

If you ultimately have confirmed chronic HCV infection, the recommended regimens depend on your genotype:

• Sofosbuvir/velpatasvir 400mg/100mg once daily for 12 weeks is the preferred pan-genotypic regimen for treatment-naïve patients without cirrhosis, achieving 98-99% cure rates across all genotypes 2, 3, 4
• Sofosbuvir/ledipasvir is an alternative for genotypes 1,4,5, or 6, given as one tablet daily for 12 weeks without ribavirin in treatment-naïve patients 2
• Glecaprevir/pibrentasvir for 8 weeks is another pan-genotypic option for treatment-naïve patients without cirrhosis 2, 1

Critical Pitfalls to Avoid

• Never treat based on a single low or undetectable viral load: This may represent laboratory error, spontaneous clearance, or occult infection not requiring therapy 1
• Do not use sofosbuvir monotherapy: It must always be combined with other DAAs (ledipasvir, velpatasvir, daclatasvir) or ribavirin to prevent resistance 2
• Avoid sofosbuvir in severe renal impairment (eGFR <30 mL/min/1.73 m²) due to 20-fold accumulation of the metabolite GS-331007 2
• Never co-administer with amiodarone: This combination is contraindicated due to risk of life-threatening bradycardia and cardiac arrest 2

Next Steps

1. Repeat HCV RNA testing with both qualitative and quantitative assays to confirm active infection
2. If HCV RNA remains undetectable or <35 IU/mL on repeat testing, you likely do not have active chronic hepatitis C and do not need treatment
3. If HCV RNA is confirmed detectable and quantifiable, proceed with genotype testing and fibrosis assessment before initiating appropriate DAA therapy 1