Table 4. Generic medicines used, systematic review and meta-analysis of generic direct-acting agents for treating hepatitis C, 2019.
| Study and generic direct-acting agents used | Commercial name | Manufacturer | Quality assessment |
||
|---|---|---|---|---|---|
| WHO prequalification | Listed by the Global Fund’s Expert Review Panel | Other | |||
| Yakoot et al., 201639 | |||||
| SOF (400 mg) | Gratisovir® | Pharco Pharmaceutical (Egypt) | No | No | No |
| SOF (400 mg) | Grateziano® | European Egyptian Pharmaceutical Industries (Egypt) | Yes (reference: HP003) | No | No |
| Hill et al., 201727 | |||||
| SOF (400 mg), DCV (60 mg), LDV (90 mg) | Numerous | Direct-acting agents from 24 different companies; 34% from Cipla Ltd (Egypt) and 30% from Hetero Laboratory Ltd (India) | Yes (SOF from Cipla Ltd and Hetero Laboratory Ltd) | Yes (DCV from Cipla Ltd and Hetero Laboratory Ltd) | No |
| Merat et al., 201733 | |||||
| SOF–DCV combination (400/60 mg) | Sovodak® | Fanavaran Rojan Mohaghegh Darou (Islamic Republic of Iran) | No | No | No |
| Nagral et al., 201734 | |||||
| SOF (400 mg), DCV (60 mg), SOF–LDV combination (400/90 mg) | Not reported | All direct-acting agents manufactured in India | ND | ND | ND |
| Sharafi et al., 201736 | |||||
| SOF–LDV combination (400/90 mg) | Sobopasvir® | Sobhan Medicine Trade Development Co. (Islamic Republic of Iran) | No | No | No |
| Vargas et al., 201738 | |||||
| SOF (400 mg), DCV (60 mg), SOF–LDV combination (400/90 mg) | Not reported | Most direct-acting agents manufactured in India | ND | ND | ND |
| Yakoot et al., 201740 | |||||
| SOF (400 mg) | Gratisovir® | Pharco Pharmaceutical (Egypt) | No | No | No |
| DCV (60 mg) | Daktavira® | European Egyptian Pharmaceutical Industries (Egypt) | No | No | No |
| Zeng et al., 201741 | |||||
| SOF–LDV combination (400/90 mg) | Hepcinat LP® | Natco Pharma (India) | No | No | No |
| Abozeid et al., 201823 | |||||
| SOF (400 mg) | Gratisovir® | Pharco Pharmaceutical (Egypt) | No | No | No |
| DCV (60 mg) | Daktavira® | European Egyptian Pharmaceutical Industries (Egypt) | No | No | No |
| SOF–LDV combination (400/90 mg) | MPI-Viropack-Plus® | Marcyrl Pharmaceutical Industries (Egypt) | No | No | Bioequivalence shown for SOF–LDV combination versus Harvoni®42 |
| El-Nahaas et al., 201824 | |||||
| SOF (400 mg) | Sofolanork® | Mash Premiere (Egypt) | No | No | No |
| DCV (60 mg) | Daklanork® | Mash Premiere (Egypt) | No | No | No |
| Elsharkawy et al., 201825 | |||||
| SOF (400 mg), DCV (60 mg) | Not reported | All direct-acting agent s manufactured in Egypt | ND | ND | ND |
| Gupta et al., 201826 | |||||
| SOF (400 mg) | Hepcvir® | Cipla Ltd (Egypt) | Yes (reference: HP004) | ND | ND |
| DCV (60 mg) | Hepdac® | Cipla Ltd (Egypt)a | Yes (reference: HP008) | ND | ND |
| SOF–LDV combination (400/90 mg) | Not reported | The direct-acting agent combination was manufactured in Indiab | No | No | No |
| Kumar et al., 201828 | |||||
| SOF (400 mg), DCV (60 mg), SOF–LDV combination (400/90 mg) | Not reported | All direct-acting agents manufactured in India | ND | ND | ND |
| Liu et al., 201831 | |||||
| SOF–VEL combination (400/100 mg) | Sofosvel® | Beacon Pharmaceuticals (Bangladesh) | No | No | No |
| Liu et al., 201830 | |||||
| SOF (400 mg) | Hepcinat® | Natco Pharma (India) | No | No | Bioequivalence shown for SOF versus Sovaldi®13 |
| SOF–DCV combination (400/60 mg) | Darvoni® | Beacon Pharmaceuticals (Bangladesh) | No | No | No |
| SOF–LDV combination (400/90 mg) | Hepcinat-LP® | Natco Pharma (India) | No | No | No |
| SOF–LDV combination (400/90 mg) | Ledifos® | Hetero Laboratory Ltd (India) | No | No | No |
| SOF–VEL combination (400/100 mg) | Velpanat® | Natco Pharma (India) | No | No | No |
| SOF–VEL combination (400/100 mg) | Velasof® | Hetero Laboratories Ltd (India) | No | No | No |
| Li et al., 201829 | |||||
| SOF (400 mg), DCV (60 mg), SOF–LDV combination (400/90 mg) | Not reported | All direct-acting agents manufactured in India | ND | ND | ND |
| Marciano et al., 201832,c | |||||
| SOF (400 mg) | Probirase® | Laboratorios Richmond SACIF (Argentina) | No | No | No |
| Omar et al., 201835 | |||||
| SOF (400 mg), DCV (60 mg) | Numerous | AUG Pharma, Magic Pharma, Marcyrl Pharmaceutical Industries and Pharco Pharmaceutical (all Egypt) | No | No | Bioequivalence shown for SOF versus Sovaldi® and for DCV versus Daklinza® (Marcyrl Pharmaceutical Industries)42 |
| Shousha et al., 201837 | |||||
| SOF–LDV combination (400/90 mg) | MPI-Viropack Plus® | Marcyrl Pharmaceutical Industries (Egypt) | No | No | Bioequivalence shown for SOF–LDV combination versus Harvoni®42 |
DCV: daclatasvir; Global Fund: Global fund to Fight AIDS, Tuberculosis and Malaria; LDV: ledipasvir; NA: not applicable; ND: not determined; SOF: sofosbuvir; VEL: velpatasvir.
a The generic drug was produced by Cipla Ltd in collaboration with the Bristol-Myers Squibb Co. through the Medicines Patent Pool.
b The SOF–LDV combination was produced by Indian companies using voluntary manufacturing licences from Gilead Sciences Inc.
c In this study, patients received generic sofosbuvir (Probirase®) and brand-name daclatasvir (Daklinza®) from the Bristol-Myers Squibb Co.