For patients with mild to moderate COVID-19 infection receiving standard care, the addition of sofosbuvir/ledipasvir or nitazoxanide alone resulted in a higher rate of viral shedding, according to the results of a study published in the Arab Journal of Gastroenterology.
This study included adult patients from multiple centers in Egypt who tested positive for COVID-19 infection via reverse transcriptase-polymerase chain reaction (RT-PCR) testing between July 2020 and October 2021. All patients received standard care and were randomly assigned to receive sofosbuvir/ledipasvir (400/90 mg once daily), nitazoxanide (500 mg 4 times daily), or standard care alone. All patients received treatment for 14 days, and standard care included azithromycin for 3 days plus vitamin C and zinc supplementation throughout the treatment cycle. Included patients were those who met the World Health Organization definition for a non-severe COVID-19 infection and had a creatinine clearance greater than 30 mL/min without malignancy. The primary endpoint was SARS-CoV-2 viral shedding, with viral load assessed by RT-PCR on days 5, 8, 11, and 14 after initiation of treatment.
A total of 190 patients were enrolled, of whom 70 received sofosbuvir/ledipasvir, 77 received nitazoxanide, and 73 received standard care alone. The most common comorbidities included hypertension and diabetes mellitus. With the exception of the sofosbuvir/ledipasvir and nitazoxanide groups comprising populations in which more than half of the patients were women, and the standard care group comprising mostly men, no other significant demographic differences were observed between the groups. 3 groups.
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At each follow-up visit, the SARS-CoV-2 viral shedding rate was significantly increased among patients in the 2 treatment groups compared with those in the standard care group (p < 0.001). Among patients who received sofosbuvir/ledipasvir, 36.9% demonstrated early viral clearance on day 5. The percentage of patients who tested negative for infection on day 14 was 83.1%, 39.7%, and 19. 4% among those receiving sofosbuvir/ledipasvir, nitazoxanide, and standard care groups, respectively.
The only significant factors identified through Cox regression analysis for negative RT-PCR test result were sofosbuvir/ledipasvir treatment (hazard ratio [HR], 11.14; 95% CI, 5.923-20.923) or nitazoxanide (HR, 2.25; 95% CI, 1.13-4.46). Four and 10 patients in the sofosbuvir/ledipasivir and nitazoxanide groups reported minor gastrointestinal events, respectively, and no mortality or serious adverse event outcomes were observed in either group.
Study limitations included the small sample size. The researchers suggested the need for additional multicenter studies to compare the effects of different sofosbuvir-based therapies.
According to the researchers, “these drugs [were] well tolerated for the duration of therapy… [and] they represent a promising, safe and affordable treatment in the management of COVID-19.”
Reference
Medhat MA, El-Kassas M, Karam-Allah H, et al. Sofosbuvir/Ledipasvir in combination or nitazoxanide alone are safe and efficient treatments for COVID-19 infection: a randomized controlled trial for antiviral reuse. Arab J Gastroenterol. Published online May 6, 2022. doi:10.1016/j.ajg.2022.04.005
Source: www.infectiousdiseaseadvisor.com