Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Valacyclovir · 3 trials · 4 indications
Measure change in HCV RNA viral load in treatment group as compared with placebo
Measure the change in serum HCV viral load at baseline and 12 weeks in patients who have chronic hepatitis C and HSV-2 infection who receive the 3 grams daily valacyclovir versus placebo
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Valacyclovir | EXPERIMENTAL | Valacyclovir 500 mg po bid |
| Placebo | PLACEBO_COMPARATOR | Matching placebo twice daily |
| Arm 1: valacyclovir | EXPERIMENTAL | Assigned patients will take 1.5 mg po valacyclovir twice daily |
| Arm 2: placebo | PLACEBO_COMPARATOR | Assigned patients will receiving matching placebo twice daily |
| Name | Type | Description |
|---|---|---|
| valacyclovir | DRUG | 500 mg twice-daily oral |
| matching placebo | DRUG | twice daily as per experimental drug |
| Placebo | DRUG | Placebo tablet twice daily |
Inclusion Criteria: * Greater than 18 years old, * Documented HIV-1 seropositive, * CD4 count greater than 200, * Not on HIV antiretroviral therapy, * HSV-2 seropositive as determined by Focus EIA (IN \>3.5) * Not intending to move out of the area for the duration of study participation. * Willing ...
Top 19 of 30 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
Valacyclovir has been studied in clinical trials for chronic hepatitis C infection and HIV infection, including research into herpes simplex virus suppression in patients with these conditions. It is a small molecule antiviral developed by GSK plc. Its studied uses in these programs focus on infectious disease, specifically viral co-infections involving hepatitis C and HIV.
Valacyclovir is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical trials evaluating valacyclovir in chronic hepatitis C infection and HIV infection.
Valacyclovir has been investigated in Phase 1, Phase 2, and Phase 3 clinical trials for chronic hepatitis C infection and HIV infection. These trials are completed, and no active trials are currently listed. The development stage varies by indication, with the most advanced completed study being Phase 3.
Valacyclovir has been evaluated in completed trials including NCT01580995, a Phase 2 study of herpes simplex type 1 suppression in hepatitis C; NCT01453075, a Phase 1 trial of three grams daily valacyclovir in chronic hepatitis C and HSV-2 infection; and NCT00378976, a Phase 3 study of HSV-2 suppression to reduce HIV-1 levels in co-infected men.
Valacyclovir is an investigational treatment in the clinical development programs for chronic hepatitis C infection and HIV infection described here. The trials for these indications are completed, and no active trials are ongoing. Approval status for these specific infectious disease indications is not established by the completed research.