Table 7.4.
Antiviral therapeutics (small molecules, antibodies, and protein) that have been evaluated in humans.
| IND | Clinical trial phase | Results/Status | Other clinical data | References |
|---|---|---|---|---|
| EBOV | ||||
| BCX4430 | Phase I (NCT02319772) | Phase I complete; results not available yet | N/A | |
| Brincidofovir | Phase II (NCT02271347) | Terminated due to low enrollment; not currently under further development as EBOV therapeutic | Administered to 5 patients during the outbreak, often in combination with other therapies | [101], [121], [122] |
| GS-5734 | Phase II (NCT02818582) | Phase I complete; Phase II for efficacy in survivors with viral persistence in semen | Administered to a newborn in combination with ZMapp and buffy coat transfusion; patient survived | [123] |
| TKM-100802 | Phase I (NCT02041715) | Terminated | 100802: Administered to two patients in combination with convalescent plasma; both survived | [124], [125] |
| TKM-130803 | Phase II (PACTR201501000997429) | Terminated early; did not demonstrate efficacy; development has been suspended | ||
| Favipiravir (T-705) | Phase II (NCT02329054: JIKI; NCT02662855: Sierra Leone) | Efficacy in patients with low-to-moderate levels of virus (Ct values >20) | Administered with ZMab to a patient who recovered; administered to a patient with convalescent plasma who recovered; retrospective study indicated increased survival and lower viral loads | [126], [127], [128], [129] |
| ZMapp | Phase II (NCT02363322) | Inconclusive efficacy due to insufficient statistical power | Administered to patients during 2014 outbreak, often in combination with other therapies | [130] |
| AVI-6002, AVI-7537 | Phase I (AVI-6002: NCT01353027; AVI-7537: NCT01593072) | 6002: Favorable safety and tolerability 7537: Terminated prior to enrollment; further development has been suspended |
N/A | |
| IFN-β | Phase I/II (ISRCTN17414946) | Results not yet released | N/A | |
| LASV | ||||
| Ribavirin | Phase II | Evidence of efficacy in patients with ASTs > 150 IU/L: iv treatment (16 mg/kg q6h for 4 days, then 8 mg/kg q8h for 6 days; serum levels 12–100 μM) starting within 6 days of fever onset, 1/20 fatality (11/43 if >7 days after fever onset); p.o. treatment had 1/5 fatality (<6 days) and 1/9 (>7 days); placebo had 11/18 fatality (<6 days) and 22/43 (>7 days) | FDA approved for RSV and HCV with black box warnings for birth defects and breakdown of red blood cells. Used off label to treat Lassa fever. Need for higher powered randomized trials, inclusion of comparator and patients at a later stage of disease | [131] |
AST, Aspartate Aminotransferase; EBOV, Ebola virus; FDA, Food and Drug Administration; HCV, Hepatitis C virus; IND, investigational new drug; LASV, Lassa virus; RSV, Respiratory syncytial virus.