@article{fdi:010081518,
  title = {{E}fficacy and safety of ravidasvir plus sofosbuvir in patients with chronic hepatitis {C} infection without cirrhosis or with compensated cirrhosis ({STORM}-{C}-1) : interim analysis of a two-stage, open-label, multicentre, single arm, phase 2/3 trial},
  author = {{A}ndrieux-{M}eyer, {I}. and {T}an, {S}. {S}. and {T}hanprasertsuk, {S}. and {S}alvadori, {N}. and {M}enetrey, {C}. and {S}imon, {F}. and {C}ressey, {T}. {R}. and {S}aid, {H}. {R}. {H}. {M}. and {A}bu {H}assan, {M}. {R}. and {O}mar, {H}. and {T}ee, {H}. {P}. and {C}han, {W}. {K}. and {K}umar, {S}. and {T}hongsawat, {S}. and {T}hetket, {K}. and {A}vihingsanon, {A}. and {K}hemnark, {S}. and {Y}erly, {S}. and {N}go-{G}iang-{H}uong, {N}icole and {S}iva, {S}. and {S}wanson, {A}. and {G}oyal, {V}. and {B}ompart, {F}. and {P}ecoul, {B}. and {M}urad, {S}.},
  editor = {},
  language = {{ENG}},
  abstract = {{B}ackground {I}n low-income and middle-income countries, affordable direct-acting antivirals are urgently needed to treat hepatitis {C} virus ({HCV}) infection. {T}he combination of ravidasvir, a pangenotypic non-structural protein 5{A} ({NS}5{A}) inhibitor, and sofosbuvir has shown efficacy and safety in patients with chronic {HCV} genotype 4 infection. {STORM}-{C}-1 trial aimed to assess the efficacy and safety of ravidasvir plus sofosbuvir in a diverse population of adults chronically infected with {HCV}. {M}ethods {STORM}-{C}-1 is a two-stage, open-label, phase 2/3 single-arm clinical trial in six public academic and nonacademic centres in {M}alaysia and four public academic and non-academic centres in {T}hailand. {P}atients with {HCV} with compensated cirrhosis ({M}etavir {F}4 and {C}hild-{T}urcotte-{P}ugh class {A}) or without cirrhosis ({M}etavir {F}0-3) aged 18-69 years were eligible to participate, regardless of {HCV} genotype, {HIV} infection status, previous interferon-based {HCV} treatment, or source of {HCV} infection. {O}nce daily ravidasvir (200 mg) and sofosbuvir (400 mg) were prescribed for 12 weeks for patients without cirrhosis and for 24 weeks for those with cirrhosis. {T}he primary endpoint was sustained virological response at 12 weeks after treatment ({SVR}12; defined as {HCV} {RNA} <12 {IU}/m{L} in {T}hailand and {HCV} {RNA} <15 {IU}/m{L} in {M}alaysia at 12 weeks after the end of treatment). {F}indings {B}etween {S}ept 14, 2016, and {J}une 5, 2017, 301 patients were enrolled in stage one of {STORM}-{C}-1. 98 (33%) patients had genotype 1a infection, 27 (9%) had genotype 1b infection, two (1%) had genotype 2 infection, 158 (52%) had genotype 3 infection, and 16 (5%) had genotype 6 infection. 81 (27%) patients had compensated cirrhosis, 90 (30%) had {HIV} co-infection, and 99 (33%) had received previous interferon-based treatment. {T}he most common treatmentemergent adverse events were pyrexia (35 [12%]), cough (26 [9%]), upper respiratory tract infection (23 [8%]), and headache (20 [7%]). {T}here were no deaths or treatment discontinuations due to serious adverse events related to study drugs. {O}f the 300 patients included in the full analysis set, 291 (97%; 95% {CI} 94-99) had {SVR}12. {O}f note, {SVR}12 was reported in 78 (96%) of 81 patients with cirrhosis and 153 (97%) of 158 patients with genotype 3 infection, including 51 (96%) of 53 patients with cirrhosis. {T}here was no difference in {SVR}12 rates by {HIV} co-infection or previous interferon treatment. {I}nterpretation {I}n this first stage, ravidasvir plus sofosbuvir was effective and well tolerated in this diverse adult population of patients with chronic {HCV} infection. {R}avidasvir plus sofosbuvir has the potential to provide an additional affordable, simple, and efficacious public health tool for large-scale implementation to eliminate {HCV} as a cause of morbidity and mortality.},
  keywords = {{MALAISIE}, {THAILANDE}},
  booktitle = {},
  journal = {{L}ancet {G}astroenterology {AND} {H}epatology},
  volume = {6},
  numero = {6},
  pages = {448--458},
  year = {2021},
  DOI = {10.1016/s2468-1253(21)00031-5},
  URL = {https://www.documentation.ird.fr/hor/fdi:010081518},
}