Successful treatment of vertically acquired Hepatitis C in a child using direct‐acting antiviral therapy administered via gastrojejunal tube: A case report

Abstract

Hepatitis C virus (HCV) remains a significant global health burden, with vertical transmission being the primary route of infection in children. Direct‐acting antivirals (DAAs) have transformed HCV treatment in pediatrics, but limited data exist on their administration in medically complex children who are dependent on enteral tubes. We report the case of a medically complex child with vertically acquired HCV who achieved sustained virologic response at 12 weeks (SVR12) following treatment with crushed sofosbuvir/velpatasvir (SOF/VEL) administered to a patient with a gastrojejunal tube. She was ineligible for oral therapy due to feeding difficulties but was granted insurance approval for off‐label enteral administration. The patient completed a 12‐week SOF/VEL regimen and achieved SVR12. This case supports the feasibility and effectiveness of enteral DAA administration using crushed SOF/VEL in children with complex medical needs. Further research and formal guidance are needed to optimize treatment strategies for pediatric patients with similar challenges.

1. INTRODUCTION

Hepatitis C virus (HCV) infection remains a significant global health concern, with an estimated 50 million people living with chronic infection worldwide, ¹ of whom 3.26 million are estimated to be children. ² Vertical transmission from mother to child is the primary cause of pediatric HCV, affecting about 5% of infants born to viremic mothers. ³ In children, the disease course is typically milder than in adults, though spontaneous clearance occurs in only a subset. Left untreated, chronic infection can lead to long‐term hepatic complications. The World Health Organization has targeted elimination of viral hepatitis by 2030, underscoring the importance of pediatric identification and treatment. ¹

Historically, interferon‐based regimens were limited by toxicity and poor efficacy. The advent of direct‐acting antivirals (DAAs) has revolutionized management, offering short, well‐tolerated, and highly effective courses. ⁴ DAAs are now approved for children as young as 3 years but are only approved in pill form, with guidelines recommending early identification and treatment of infected children. ⁵ This case describes successful administration of crushed sofosbuvir/velpatasvir (SOF/VEL) via gastrojejunal (GJ) tube in a medically complex child, highlighting the feasibility of this approach.

2. CASE REPORT

The patient, a female child with vertically acquired HCV, was born at term to a 22‐year‐old mother with a history of substance use disorder. Her postnatal course was prolonged and complicated by cerebral ischemia, seizures, neonatal abstinence syndrome, and feeding difficulties requiring gastrostomy placement. Parental rights were relinquished upon hospital discharge, and the child entered state custody.

Throughout infancy, she experienced recurrent hospitalizations for respiratory decompensation, infections, and seizures, requiring multiple antiepileptics. Additional diagnoses included dysautonomia, spasticity, cortical visual impairment, and adrenal insufficiency. Serial labs demonstrated persistent elevations in serum aminotransferases (alanine aminotransferase [ALT] 63–144 IU/L; aspartate aminotransferase [AST] 44–170 IU/L) and gamma‐glutamyl transferase (70–100 IU/L). At 12 months, her gastrostomy tube (G‐tube) was converted to a gastrojejunal, or gastrojejunostomy (GJ) tube due to aspiration concerns.

At 19 months, she was confirmed to have HCV infection with viral load of 6.90 log₁₀ IU/mL. Liver elastography at age 3 years was normal with a median shear wave speed of 1.46 m/s. She remained persistently viremic over serial testing through age 4.5 years, with Genotype 1a identified. Despite stable hepatobiliary status, ongoing viremia and enzyme elevations prompted consideration of antiviral therapy.

Given reports of successful treatment with crushed DAAs administered via enteral tube in adult patients, ⁶ her team pursued approval for SOF/VEL. Insurance authorization was secured following submission of supporting case reports. Instructions were given to crush tablets, mix with water, and administer via her gastric port; precautions were given to avoid co‐administration with proton pump inhibitors. Treatment began at age 5 years and 10 months.

During the 12‐week course, she was hospitalized three times for unrelated illnesses, during which two doses were missed, eight doses were delivered through the jejunal tube, and 31 doses were given simultaneously with lansoprazole. Nevertheless, she completed therapy. At 12 weeks post‐treatment, HCV RNA was undetectable, confirming sustained virologic response (SVR12). Unfortunately, the patient later passed away from unrelated medical complications. The trend of her serum aminotransferases throughout her course is depicted in Figure 1. The overall timeline of her care is summarized in Figure 2.

Figure 1.

Serum aminotransferase levels over time. The yellow bar denotes the SOF/VEL treatment period. ALT, alanine aminotransferase; AST, aspartate aminotransferase; SOF/VEL, sofosbuvir/velpatasvir.

Figure 2.

Timeline of care given by chronological age of patient. GJ, gastrojejunostomy; HCV, Hepatitis C virus; M, months; SOF/VEL, sofosbuvir/velpatasvir; Y, years.

3. DISCUSSION

Despite the recent advancements in the treatment of HCV, challenges remain in ensuring equitable access to treatment for all pediatric patients, particularly those with complex medical needs. ⁷ Children with enteral feeding tubes, such as G‐tubes and GJ‐tubes, represent a unique population in which oral administration of DAAs may not be feasible. Given the increasing prevalence of children with medical complexity, including those requiring enteral nutrition, strategies for administering DAAs via alternative routes are necessary. Although case reports have documented successful use of DAAs via nasogastric or G‐tubes, this approach remains underreported and lacks standardized guidelines. ⁶ Manufacturer labeling and pharmacokinetic data on enteral administration are limited, necessitating further exploration of this treatment modality. ⁶ This case highlights the feasibility and success of treating pediatric HCV in medically complex patients requiring enteral feeding. The administration of crushed SOF/VEL to a child with a GJ‐tube led to an SVR12 post‐treatment, demonstrating that this method of drug delivery can be an effective alternative for children unable to take oral medications. Given the increasing prevalence of children with complex medical needs, providers must keep in mind the importance of adapting antiviral treatment strategies to accommodate these patients.

The choice of SOF/VEL was guided by existing reports of successful enteral administration and by manufacturer recommendations. ⁸ While data on the pharmacokinetics of crushed DAA formulations remain limited, case reports suggest that efficacy is maintained. Despite interruptions to her medication schedule, this patient still achieved SVR12. This underscores the need for further research and formalized guidelines for enteral DAA administration in pediatric patients. Additionally, the involvement of a multidisciplinary team, including hepatologists, pharmacists, and long‐term care providers, is crucial in ensuring appropriate medication delivery and monitoring.

One of the major challenges in treating pediatric HCV is access to antiviral therapy, particularly for children with medical complexity. Insurance approval for DAAs remains a barrier, often requiring additional documentation and justification. In this case, advocacy efforts and literature support were crucial in securing approval for crushed SOF/VEL therapy. Ensuring streamlined access to these life‐saving treatments will be essential for achieving HCV elimination in the pediatric population.

Despite the patient's untimely passing secondary to unrelated medical concerns, her circumstances nevertheless demonstrate the importance of expanding therapeutic options for medically complex children. This case contributes to the growing body of evidence supporting enteral DAA administration and emphasizes the need for ongoing research and guideline development to optimize HCV treatment for all pediatric patients, regardless of their medical challenges.

4. CONCLUSION

The successful treatment of chronic Hepatitis C in a medically complex child with crushed DAA therapy administered via GJ tube demonstrates the potential feasibility of adapting this antiviral therapy to meet the needs of patients with significant feeding limitations. This report emphasizes the importance of flexible, patient‐centered approaches in achieving HCV cure in all children, regardless of medical complexity. Further research and formalized guidance are warranted to support broader implementation of this treatment modality.

CONFLICT OF INTEREST STATEMENT

The authors declare no conflict of interest.

ETHICS STATEMENT

Verbal informed consent was provided by the patient's legal guardian.