Research ArticleOriginal Article
Open Access

Effectiveness of generic sofosbuvir in the treatment of chronic hepatitis C virus infection in Saudi patients

Hamdan S. AlGhamdi, Ali A. AlHabobi, Rakan S. AlQahtani, Firas A. Ghomraoui, Khalefa M. AlThiab, Abdulrahman A. AlOun, Abduljaleel M. AlAlwan, Mutaz B. Abdelmahmoud, Ibrahim H. AlTraif and Abdulrahman A. Aljumah
Saudi Medical Journal December 2023, 44 (12) 1240-1247; DOI: https://doi.org/10.15537/smj.2023.44.12.20230481

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  • Table 1

    - Baseline demographic and laboratory characteristics of 140 patients.

    ParameterPatients (n=140)SOF-DCV with ribavirin (n=42)SOF-DCV without ribavirin (n=98)P-value
    Age (y), mean (SD)61.5±13.663.8±12.560.6±14.00.221
    Female, n (%)87 (62.1)28 (66.7)59 (60.2)0.470
    Weight (kg), mean±SD71.7±15.968.6±13.473.0±16.80.136
    Diabetes mellitus, n (%)45 (32.1)10 (23.8)35 (35.7)0.167
    Treatment naive, n (%)120 (85.7)29 (69.0)91 (92.9)0.001
    Organ transplant, n (%)9 (6.4)4 (9.5)5 (5.1)0.452
    Hepatocellular carcinoma, n (%)8 (5.7)2 (4.8)6 (6.1)0.751
    HCV genotypes, n (%)   0.951
    G1a14 (10.0)5 (11.9)9 (9.2) 
    G1b16 (11.4)4 (9.5)12 (12.2)
    G28 (5.7)2 (4.8)6 (6.1)
    G39 (6.4)3 (7.1)6 (6.1)
    G481 (57.9)23 (54.8)58 (59.2)
    Mixed genotype4 (2.9)2 (4.8)2 (2.0)
    Indeterminant genotype8 (5.7)3 (7.1)5 (5.1) 
    Fibrosis stage, n (%)   0.019
    F034 (24.3)7 (16.7)27 (27.6) 
    F122 (15.7)6 (14.3)16 (16.3)
    F213 (9.3)1 (2.4)12 (12.2)
    F316 (11.4)3 (7.1)13 (13.3)
    F455 (39.3)25 (59.5)30 (30.6)
    MELD, mean±SD9.3±2.79.0±2.89.5±2.70.458
    Bilirubin total (µmol/l), mean±SD21.49±20.719.0±16.222.5±22.40.359
    ALT (IU/L) mean±SD59.7±48.868.1±62.256.1±41.70.182
    AST (IU/L), mean±SD57.0±41.666.4±57.152.9±32.30.079
    Albumin (g/L), mean±SD36.16±5.636.1±4.636.2±6.00.899
    WBC (103/mm3), mean±SD6.3±2.45.8±2.26.5±2.40.101
    Hemoglobin (g/L), mean±SD133.3±19.6130.4±21.5134.5±18.70.260
    Platelets (103/mm3), mean±SD203.3±96.3182.0±90.7212.5±97.60.086
    eGFR (ml/min), mean±D86.3±27.782.7±32.487.8±25.50.329
    HCV RNA (IU/ml), mean±SD1253598±2765121801326.7±4209481018857.0±18113290.125
    HbA1 C (%), mean±SD7.9±1.87.8±1.58.0±1.80.806

    SOF-DCV: Sofosbuvir-Daclatasvir, SD: standard deviation, MELD: model of end-stage liver diseases, ALT: alanine aminotransferase, AST: aspartate aminotransferase, WBC: white blood cells, GFR: glomerular filtration rate, HCV: hepatitis C virus, G1a, b,2,3,4: Genotype 1a, b,3,4, HCV: Hepatitis C virus, RNA: ribonucleic acid

    • Table 2

      - Assessment of treatment effectiveness in patients with SVR 12.

      Treatment responseOverall N=140SOF-DCV with ribavirin (n=42)SOF-DCV without ribavirin (n=98)P-value
      Intention to treat (ITT) analysis (n=140)
      Undetectable HCV RNA at EOT*130 (92.9)37 (88.1)93 (94.9)0.1520
      Detectable HCV RNA at EOT10 (7.1)5 (11.9)5 (5.1)
      SVR12131 (93.6)38 (91.0)93 (94.9)0.666
      Failed9 (6.4)3 (7.2)6 (6.1)
      Per protocol (PP) analysis (n=136)
      Undetectable HCV RNA at EOT*129 (95.6)36 (94.7)93 (95.9)0.937
      Detectable HCV RNA at EOT5 (3.7)2 (5.3)3 (3.1)
      SVR12131 (96.3)35 (92.1)96 (98.0)0.133
      Failed5 (3.7)3 (7.9)2 (2.0)

      Values are presented as number and precentages (%).

      EOT: end of treatment, SVR: sustained virologic response, HCV: hepatitis C virus, SOF-DCV: sofosbuvir-daclatasvir

      • ↵* Two patients had no HCV RNA performed at EOT.

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