Sofosbuvir/Velpatasvir for Hepatitis C in Pregnancy
(STORC Trial)
Recruiting in Palo Alto (17 mi)
+9 other locations
Overseen byCatherine Chappell, MD, MSc
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Catherine Chappell
Must not be taking: Acid-suppressants, others
Disqualifiers: Cirrhosis, Cardiovascular, Renal, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests a combination pill called Sofosbuvir/Velpatasvir (SOF/VEL) for treating hepatitis C in pregnant people. The treatment aims to stop the virus from multiplying and clear the infection. The study will check if this treatment is effective and safe during pregnancy. Sofosbuvir/Velpatasvir (SOF/VEL) has been demonstrated to be safe and effective in treating almost all types of hepatitis C infected individuals.
Will I have to stop taking my current medications?
The trial requires that if you are taking acid-suppressant medications, you must either stop them during the 12-week treatment or follow specific dosing instructions. Additionally, you cannot take any medications that are contraindicated with velpatasvir or sofosbuvir.
What data supports the effectiveness of the drug Sofosbuvir/Velpatasvir for treating Hepatitis C in pregnancy?
Sofosbuvir/Velpatasvir (Epclusa) has been shown to be effective in treating chronic Hepatitis C in adults, achieving high cure rates in various genotypes of the virus. A case study also reported successful treatment of Hepatitis C in a pregnant woman using Sofosbuvir, followed by Sofosbuvir/Velpatasvir postpartum, resulting in a healthy baby without HCV.
12345Is Sofosbuvir/Velpatasvir safe for humans?
Sofosbuvir/Velpatasvir, also known as Epclusa, has been shown to be generally safe in humans for treating chronic hepatitis C, with common side effects including headache, fatigue, and nausea. Serious side effects were rare and not considered related to the treatment.
13678How is the drug Sofosbuvir/Velpatasvir unique for treating Hepatitis C in pregnancy?
Sofosbuvir/Velpatasvir is unique because it combines two antiviral medications that target different stages of the Hepatitis C virus's life cycle, making it a potent option for treating the infection. This combination is particularly novel for use in pregnancy, as there are limited standard treatments available for Hepatitis C in pregnant women.
910111213Eligibility Criteria
This trial is for pregnant individuals aged 18-45 with chronic hepatitis C, between 20-30 weeks of gestation, and no major pregnancy complications. They must not have plans to relocate and should agree not to join other drug/device trials during the study. Exclusions include certain medication use, severe liver abnormalities, low blood counts, or uncontrolled health conditions.Inclusion Criteria
I have HIV, am on antiretroviral therapy, and my latest viral load was under 50 copies/mL.
I have hepatitis C with a detectable virus level.
Singleton pregnancy at 20 + 0 to 30 + 0 weeks' gestation at enrollment with gestational dating confirmed by ultrasound
+8 more
Exclusion Criteria
Any other condition that, in the opinion of the site PI/designee, would preclude appropriate informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.
I don't have any major uncontrolled health issues apart from HCV or HIV.
I was treated for hepatitis C but don't have proof of being virus-free after 12 weeks.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants receive Sofosbuvir/Velpatasvir treatment for chronic hepatitis C during pregnancy
12 weeks
6 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including maternal and infant health assessments
12 weeks postpartum
3 visits (in-person)
Infant Follow-up
Infants are monitored for health and development from birth until one year of age
12 months
3 visits (in-person)
Participant Groups
The trial tests Sofosbuvir/Velpatasvir (SOF/VEL) in treating chronic hepatitis C during pregnancy. About 100 participants will take one tablet daily for 12 weeks starting in their second or third trimester. The main goals are to see if the virus stays undetectable after treatment and how it affects delivery timing.
1Treatment groups
Experimental Treatment
Group I: Sofosbuvir/VelpatasvirExperimental Treatment1 Intervention
Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet, one tablet taken once daily for 84 days
Sofosbuvir/Velpatasvir is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Epclusa for:
- Chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6 infection (including with or without cirrhosis)
🇪🇺 Approved in European Union as Epclusa for:
- Chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6 infection (including with or without cirrhosis)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Victoria Hospital, London Health Sciences CenterLondon, Canada
University Health Toronto, St Michaels HospitalToronto, Canada
Denver HealthDenver, CO
Mount Sinai Health SystemNew York, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Catherine ChappellLead Sponsor
Catherine Anne ChappellLead Sponsor
Gilead SciencesIndustry Sponsor
References
Safety and efficacy of sofosbuvir-velpatasvir: A meta-analysis. [2022]The sofosbuvir-velpatasvir single-tablet regimen (Epclusa) is a newly FDA-approved inhibitor of hepatitis C virus (HCV). This meta-analysis aimed to investigate the safety and efficacy of velpatasvir-sofosbuvir in the treatment of chronic HCV infection.
Ledipasvir plus sofosbuvir in pregnant women with hepatitis C virus infection: a phase 1 pharmacokinetic study. [2022]Hepatitis C virus (HCV) infection is increasing among pregnant women because of the opioid epidemic, yet there are no interventions to reduce perinatal HCV transmission or to treat HCV during pregnancy. Physiological changes in pregnancy alter the pharmacokinetics of some medications; thus, our aim was to compare the pharmacokinetic parameters of ledipasvir 90 mg plus sofosbuvir 400 mg during pregnancy with non-pregnant women.
Sofosbuvir/Velpatasvir: A Review in Chronic Hepatitis C. [2022]A once-daily, single-tablet, pangenotypic regimen comprising the hepatitis C virus (HCV) NS5B polymerase inhibitor sofosbuvir and the HCV NS5A inhibitor velpatasvir (sofosbuvir/velpatasvir; Epclusa®) was recently approved for the treatment of adults with chronic HCV genotype 1, 2, 3, 4, 5 or 6 infection in the USA, EU and Canada. In the phase III ASTRAL trials, once-daily oral sofosbuvir/velpatasvir for 12 weeks provided very high rates of sustained virological response at 12 weeks post treatment (SVR12) in treatment-naive and -experienced patients with chronic HCV genotype 1-6 infection, including those with compensated cirrhosis or HIV-1 co-infection. High SVR12 rates were also observed with sofosbuvir/velpatasvir plus ribavirin for 12 weeks in patients with chronic HCV genotype 1-6 infection and decompensated cirrhosis. Sofosbuvir/velpatasvir was generally well tolerated, with low rates of adverse events. Thus, sofosbuvir/velpatasvir represents a valuable treatment option in adults with chronic HCV genotype 1-6 infection, including those with compensated or decompensated cirrhosis, previous treatment experience or HIV-1 co-infection.
Successful sofosbuvir lead-in monotherapy for the treatment of hepatitis C virus (HCV) infection in a pregnant woman living with HIV. [2023]A 30-year-old woman living with HIV was diagnosed with genotype 2b hepatitis C virus (HCV) infection during the second trimester of her pregnancy. She had achieved virologic suppression on an HIV protease inhibitor-based regimen and had recurrent genital herpes simplex virus infection managed with antivirals. Given the risk of perinatal transmission of HCV and to avoid performing a caesarean section, after multidisciplinary consultations and consideration of the limited data on safety on HCV direct-acting antivirals (DAAs) in pregnancy, she consented to and was successfully treated with a 6-week lead-in course of sofosbuvir (SOF) alone followed by a 6-week course of SOF and velpatasvir postpartum. This resulted in cure of her HCV infection. The neonate tested negative for HCV at birth and was healthy without birth defects 2 years postdelivery. Our case highlights a successful HCV treatment approach in a pregnant woman with newer DAAs.
Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis. [2022]The combination of sofosbuvir and velpatasvir is used to treat patients with hepatitis C virus (HCV) infection of different genotypes. We compared the effects of this treatment regimen, with and without ribavirin, on outcomes reported by patients (patient-reported outcomes [PROs]) with HCV infection, with or without cirrhosis.
Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection. [2020]Sofosbuvir-velpatasvir is approved for the treatment of chronic hepatitis C virus (HCV) infection. In this single-arm, open-label, phase 3, deferred treatment study, we investigated the efficacy and safety of sofosbuvir-velpatasvir among patients randomized to the placebo group in the ASTRAL-1 study. Patients received sofosbuvir-velpatasvir (400/100 mg) once daily for 12 weeks. The primary efficacy endpoint was the proportion of patients with sustained virologic response 12 weeks after the end of therapy (SVR12). The primary safety endpoint was any adverse events (AEs) leading to the permanent discontinuation of study drug. Overall, 108/111 (97%, 95% confidence interval [CI], 92%-99%) achieved SVR12, and only one patient had virological failure. SVR12 was achieved by 61/63 (97%, 95%CI, 89%-100%) genotype 1 patients, 20/20 (100%; 95%CI, 83%-100%) with genotype 2, 19/19 (100%; 95%CI, 82%-100%) with genotype 4 and 8/9 (89%; 95% CI, 52%-100%) with genotype 6. All (19/19; 95%CI, 82-100) patients with cirrhosis and all (31/31, 95%CI, 89-100) with prior treatment experience achieved SVR12. The safety profile during treatment was similar to that observed in patients receiving placebo treatment. The most common AEs were headache, fatigue and nausea. One patient (1%) discontinued treatment due to an AE of gallbladder carcinoma, which was not considered related to treatment. Of five reported serious AEs, none were considered related to study drug. Sofosbuvir-velpatasvir for 12 weeks was effective and well tolerated among untreated and previously treated patients with HCV genotype 1, 2, 4 or 6 infection, including those with compensated cirrhosis (ClinicalTrials.gov NCT02346721).
Efficacy and Safety of Sofosbuvir and Velpatasvir Combination for the Treatment of Chronic Hepatitis C in Patients With or Without Cirrhosis. [2021]Background and aim For years, interferon-based treatment has been offered to patients with chronic hepatitis C virus (HCV) infection; however, the complexity of the treatment, efficacy, and adverse effects were the primary concerns. All these concerns were addressed with the introduction of directly acting antivirals (DAAs) to treat chronic HCV. Sofosbuvir and velpatasvir are second-generation DAAs used in combination for the treatment of chronic HCV infection. The aim of our study was to determine and compare the efficacy and safety profile of the sofosbuvir and velpatasvir combination in treating patients with chronic hepatitis C with or without cirrhosis. Materials and methods This descriptive study was conducted at the Department of Medicine, Khyber Teaching Hospital, Peshawar, from March 15th to September 15th, 2021 after approval from the Institution Research and Ethical Review Board (IREB). Diagnosis of HCV was based on the detection of hepatitis C ribonucleic acid (RNA) fragments by reverse transcription-polymerase chain reaction (RT-PCR). Liver status was assessed with liver function tests and imaging. Sofosbuvir (400 mg) and velpatasvir (100 mg) were administered once daily for 12 weeks, followed by polymerase chain reaction (PCR) for HCV RNA after 12 weeks of completion of treatment for determination of sustained virologic response at 12 weeks (SVR12). Patients with cirrhosis also received weight-based ribavirin. Adverse events experienced by the study participants during the course of treatment were recorded. Data were collected regarding patients' demographics, laboratory parameters, SVR12, and adverse events, and were then analyzed using SPSS, version 22 (IBM SPSS Statistics, Armonk, NY). Results A total of 58 patients with cirrhosis and 58 patients without cirrhosis with chronic HCV were enrolled. The rate of SVR12 in patients with cirrhosis was 89.7% (52 patients achieved SVR12), compared to 98.3% in patients without cirrhosis (57 patients achieved SVR12). Subgroup analysis of patients with cirrhosis revealed that patients who have failed to achieve SVR12 were mostly males, had prolonged disease duration, and low hemoglobin at baseline; however, the association of these factors with SVR12 was not significant. The incidence of adverse events among all study participants was 46.5%. Among the cirrhotic cohort, 37 (63.8%) patients experienced adverse events, while only 17 (29.3%) patients among the non-cirrhotic cohort had adverse events. A total of 24 patients with cirrhosis (41.37%) reported mild complaints. The most commonly reported adverse event was gastrointestinal (GI) upsets (46.2%), followed by fatigue (33.9%), while 19.9% developed miscellaneous adverse events such as headaches, rash, and insomnia. Conclusion The combination of sofosbuvir and velpatasvir is highly effective and safe in patients with HCV with or without cirrhosis. However, this combination's efficacy was slightly higher in non-cirrhotic patients (98.3%) than in cirrhotic patients (89.7%).
Efficacy of the Combination of Sofosbuvir, Velpatasvir, and the NS3/4A Protease Inhibitor GS-9857 in Treatment-Naïve or Previously Treated Patients With Hepatitis C Virus Genotype 1 or 3 Infections. [2021]We performed a phase 2 trial of the efficacy and safety of 4, 6, and 8 weeks of sofosbuvir, given in combination with the NS5A inhibitor velpatasvir and the NS3/4A protease inhibitor GS-9857, in patients with hepatitis C virus (HCV) infection.
[Tocolysis in prevention of spontaneous abortion]. [2013]In the course of 1975 and 1976 the authors applied Partusisten (Th 1156 a) in 34 pregnant women at the risk of spontaneous abortion in the 16th to the 28th week of pregnancy. The therapy started with intravenous infusions by means of an automatic electromechanic infusion pump; peroral application of the drug followed, both in hospital and for a certain period in outpatient treatment under the gynecologist's supervision. Out of 34 women, 27 remained pregnant for more than 37 week of gestation and gave birth to a live at-term baby; in 5 cases the success was relative, and only in 2 cases was there no success at all. According to the tocolysis index, at index 2 or less, the success was achieved in 87% of cases and at index exceeding 2, the success was achieved in 63% of cases. The side-effect observed was invariably tachicardia in the mother, while all other untoward effects (tremor, sweating, slight restlessness, etc) were tolerated very well. An extremely good effect of Partusisten is obvious, because in doses of 4 micrograms/min, it promptly reduces the frequency and intensity of contractions.
Second- and third-trimester termination of pregnancy in women with uterine scar - a retrospective analysis of 111 gemeprost-induced terminations of pregnancy after previous cesarean delivery. [2014]This study was conducted to evaluate and analyze the efficacy and safety of using gemeprost for second- and third-trimester termination of pregnancy (TOP) in women with uterine scar due to previous cesarean section.
Second- and Third-Trimester Medical Abortion Providers and Services in 2019: Results From the Canadian Abortion Provider Survey. [2022]Mifepristone became available in Canada in 2017. Updated national guidelines recommend its off-label use for second/third-trimester medical abortion (STMA/TTMA) by labour induction. The objective of this study was to explore STMA/TTMA provision in Canada and the role of mifepristone.
Mifepristone combined with ethacridine lactate for the second-trimester pregnancy termination in women with placenta previa and/or prior cesarean deliveries. [2022]This study was aimed to evaluate the safety and efficacy of the second-trimester medical abortions using mifepristone and ethacridine lactate in women with placenta previa and/or prior cesarean deliveries.
Acceptability and feasibility of 400 μg buccal misoprostol after 200 mg mifepristone for early medical abortion in Georgia. [2022]The aim of the study was to examine the acceptability and feasibility of early medical abortion using 200 mg mifepristone and 400 μg buccal misoprostol in Georgia, outside the capital city of Tbilisi.