Treatment of hepatitis C virus (HCV) during pregnancy can cure maternal HCV and prevent perinatal HCV transmission. The primary objective was to compare the pharmacokinetics (PK) of sofosbuvir (SOF)/velpatasvir (VEL) in pregnant versus nonpregnant people.

Treatment of hepatitis C virus (HCV) during pregnancy can cure maternal HCV and prevent perinatal HCV transmission. The primary objective was to compare the pharmacokinetics (PK) of sofosbuvir/velpatasvir (SOF/VEL) in pregnant versus nonpregnant people.

Treatment of hepatitis C virus (HCV) during pregnancy can cure maternal HCV and prevent perinatal HCV transmission. The primary objective was to compare the pharmacokinetics (PK) of sofosbuvir/velpatasvir (SOF/VEL) in pregnant versus nonpregnant people.

Nova formulação do SUS facilita a aceitação por crianças que tenham dificuldade de engolir comprimido

WHO recommends treating hepatitis C infection with one of three antiviral combinations for 8–12 weeks. No randomised trials have compared these regime…

AbstractSofosbuvir/velpatasvir/voxilaprevir is recommended for hepatitis C virus (HCV) retreatment in those who fail initial treatment but is unavailable in resource-limited settings. We describe a government sofosbuvir/velpatasvir + ribavirin (SOF/VEL + RBV) × 24 weeks retreatment program in Rwanda (November 2021–October 2022). Of 231 participants, 174 were cured (75.3% intention-to-treat analysis). SOF/VEL + RBV may be considered for HCV retreatment in resource-limited settings.

Treatment of hepatitis C virus (HCV) during pregnancy can cure maternal HCV and prevent perinatal HCV transmission. The primary objective was to compare the pharmacokinetics (PK) of sofosbuvir (SOF)/velpatasvir (VEL) in pregnant versus nonpregnant people.MethodsPregnant people with chronic HCV infection were enrolled between 23 and 25 weeks’ gestation and were provided SOF/VEL daily for 12 weeks. PK visits were performed at 3, 6, and 9 weeks. VEL, SOF, and GS-331007 (the inactive metabolite of SOF) in plasma and the SOF active metabolite (007-TP) in peripheral blood mononuclear cells (PBMCs) and dried blood spots (DBSs) were measured and compared to historical data in nonpregnant people. Maternal adverse events, delivery outcomes, the sustained virologic response 12 weeks after therapy, infant adverse events, and HCV perinatal transmission were assessed.ResultsFourteen participants were screened, and 11 enrolled. One participant discontinued treatment due to worsening of hyperemesis. VEL area under the curve (AUC) was similar to historic data in nonpregnant people, but the AUCs of SOF and GS-331007 were 38% higher and 38% lower, respectively. Concentrations of 007-TP in PBMCs were comparable or higher, whereas 007-TP in DBSs was approximately 50% lower in pregnant versus nonpregnant people. All 10 participants who completed treatment had undetectable HCV RNA at delivery. Two participants were lost to follow-up after delivery, but 1 had an HCV RNA through clinical care. All participants with data were cured (n = 9) and none of the infants acquired HCV (n = 8).ConclusionsSOF/VEL exposures were not clinically different in pregnancy and support further evaluation of antenatal SOF/VEL treatment.

Sofosbuvir–daclatasvir was non-inferior to sofosbuvir–velpatasvir. High efficacy was seen with novel strategies, which might help to inform approaches to treatment for harder-to-reach populations.

Hepatitis C virus (HCV) infects nearly one-fourth of people with human immunodeficiency virus (HIV). The role of direct-acting antivirals (DAAs) on immune activation in people with HIV (PWH) and HCV is poorly understood.MethodsWe quantified plasma HCV RNA and CXCL10 in persons with HCV monoinfection versus HIV/HCV coinfection receiving sofosbuvir-velpatasvir. Single-cell laser capture microdissection was applied to liver biopsies obtained before and within 4–7 days of DAA initiation to estimate HCV clearance and changes in interferon-stimulated genes (ISGs).ResultsWe enrolled 10 people with chronic genotype 1a HCV: 5 were PWH with ART-suppressed viremia and CD4+ T cell counts >200 cells/µL. First- and second-phase plasma HCV RNA kinetics were not different between groups. Median (min–max) proportions of infected hepatocytes at biopsy 1 were 0.06 (0.01–0.59) in HCV monoinfection and 0.21 (0.04–0.87) in HIV/HCV coinfection and did not differ. Participants had lower intracellular HCV RNA levels at biopsy 2. CXCL10 levels declined in both groups but were higher in coinfection than in monoinfection even at the end of treatment. The proportion of cells expressing ISGs diminished in monoinfection but increased in coinfection.ConclusionsWhereas DAAs rapidly cleared intrahepatic HCV in both groups, immune activation was slower to diminish in PWH. Residual immune activation in PWH warrants further exploration.Clinical Trials Registration. NCT02938013.

Atea Pharmaceuticals (Nasdaq: AVIR) reported second quarter 2026 results and key viral hepatitis pipeline progress. The Phase 3 C-BEYOND trial of bemnifosbuvir/ruzasvir (BEM/RZR) for HCV met its primary and secondary non-inferiority endpoints versus sofosbuvir/velpatasvir, with sustained virologic response (SVR) of 93.9% vs. 94.8% in the mITT population (n=905). Non‑cirrhotic patients achieved a 93.5% SVR with 8 weeks of BEM/RZR vs. 94.6% with 12 weeks of SOF/VEL; cirrhotic patients had 95.4% SVR in both arms. BEM/RZR was generally safe and well tolerated with no drug‑related serious adverse events.Atea completed enrollment of its second Phase 3 trial, C-FORWARD, with over 880 patients across 17 countries and expects topline data in early Q1 2027, targeting an NDA submission in Q2 2027. A first‑in‑human Phase 1 trial of AT‑587 for chronic HEV started in July. At June 30, 2026, cash, cash equivalents and marketable securities were $219.5 million (vs. $301.8 million at December 31, 2025). Q2 2026 research and development expense was $28.2 million (down from $32.3 million), general and administrative expense was $6.9 million (down from $9.1 million), and net loss was $32.9 million, or $0.41 per share, compared to $37.2 million, or $0.44 per share, a year earlier.

AbbVie's recent approval for Gracaprevir/Velpatasvir offers a vital new treatment option for acute Hepatitis C patients in Europe, reducing disease progression risk.

Atea Pharmaceuticals’ hepatitis C prospect has

Atea Pharmaceuticals (Nasdaq: AVIR) reported positive topline Phase 3 C-BEYOND results in North America for its once-daily fixed-dose combination bemnifosbuvir/ruzasvir (BEM/RZR) in chronic hepatitis C virus (HCV). In the modified intent-to-treat population (n=905), BEM/RZR achieved a 93.9% sustained virologic response (SVR) at Week 24 versus 94.8% for standard-of-care sofosbuvir/velpatasvir (SOF/VEL; Epclusa), meeting the primary endpoint of statistical non-inferiority within a prespecified 5% margin.In patients without cirrhosis (n=721), 8 weeks of BEM/RZR achieved a 93.5% SVR versus 12 weeks of SOF/VEL with 94.6% SVR. In patients with cirrhosis (n=184), 12 weeks of each regimen yielded 95.4% SVR in both arms. Secondary endpoints, including per-protocol analysis, also met statistical non-inferiority. BEM/RZR was generally safe and well tolerated, with no drug-related serious adverse events or drug-related early discontinuations and safety comparable between arms. C-FORWARD, the companion Phase 3 trial outside North America with more than 880 patients enrolled, remains on track to report topline results in early 2027.

AbbVie has submitted a request for approval of gracaprevir/velpatasvir for treating acute hepatitis C in Japan, potentially expanding treatment options in the country.