Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tenofovir DF · 8 trials · 4 indications
This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 48 weeks of exposure to randomized study drug.
DAVG24 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 24 minus the baseline value. DAVG24 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value. Data for participants who discontinued the randomized (double-blind) phase of the study early were included up until the point of study discontinuation (missing data not imputed).
The percentage of participants with HBV DNA \< 400 copies/mL at Week 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation.
DAVG2 was defined as the time-weighted average between baseline value through the last available value up to week 2 minus the baseline value.
| Arm | Type | Description |
|---|---|---|
| Tenofovir DF (Blinded Randomized Treatment) | EXPERIMENTAL | Participants will receive tenofovir disoproxil fumarate (tenofovir DF; TDF) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3). |
| Placebo to match TDF (Blinded Randomized Treatment) | PLACEBO_COMPARATOR | Participants will receive TDF placebo for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3). |
| Tenofovir DF (Open-label Treatment) | EXPERIMENTAL | Following 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) of blinded randomized treatment, participants will switch to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3). |
| Tenofovir DF (Open-label Extension Phase) | EXPERIMENTAL | Following the completion of study at Week 192, participants may have the option to receive open-label TDF until it is commercially available in that country for treatment of chronic HBV in participants of their age and weight. |
| Tenofovir DF | EXPERIMENTAL | - |
| stavudine or zidovudine | ACTIVE_COMPARATOR | - |
| OBR + Tenofovir DF | EXPERIMENTAL | Tenofovir DF administered orally, one tablet daily without regard to meals |
| OBR + Tenofovir DF Placebo | PLACEBO_COMPARATOR | Placebo to match tenofovir DF administered orally, one tablet daily without regard to meals |
| FTC+Tenofovir DF | EXPERIMENTAL | Participants were randomized to receive FTC plus tenofovir DF once daily. |
| 1 | EXPERIMENTAL | TDF |
| 2 | EXPERIMENTAL | FTC/TDF |
| A | EXPERIMENTAL | Stop zidovudine (ZDV) or stavudine (d4T) and start tenofovir DF 300mg once daily along with the other antiviral drugs that are used as part of their HAART regimen |
| B | ACTIVE_COMPARATOR | Stop zidovudine (ZDV) or stavudine (d4T) and start abacavir 300mg twice daily along with the other antiviral drugs that are used as part of their HAART regimen |
| Tenofovir alafenamide 50 mg | EXPERIMENTAL | Participants received tenofovir alafenamide 50 mg for 14 days |
| Tenofovir alafenamide 150 mg | EXPERIMENTAL | Participants received tenofovir alafenamide 150 mg for 14 days |
| Name | Type | Description |
|---|---|---|
| Tenofovir DF | DRUG | * Participants weighing ≥ 17 kg will receive TDF one tablet administered orally once daily (150, 200, 250 or 300 mg tablets based on body weight). * Participants weighing \< 17 kg or ≥ 17 kg who are unable to swallow a tablet will receive TDF oral powder in a dose of 8 mg/kg once daily up to a maximum dose of 300 mg. |
| TDF Placebo | DRUG | * Participants weighing ≥ 17 kg will receive TDF placebo tablet administered orally once daily. * Participants weighing \< 17 kg or ≥ 17 kg who are unable to swallow a tablet will receive TDF placebo oral powder once daily. |
| Zidovudine | DRUG | Zidovudine as prescribed by the investigator prior to study entry (pediatric participants \< 30 kg: 1 mg/kg/dose given every 12 hours; pediatric participants ≥ 30 kg: 30 mg twice daily). |
| Stavudine | DRUG | Stavudine as prescribed by the investigator prior to study entry (pediatric participants 6 weeks to 12 years of age: 160 mg/m\^2 every 8 hours; pediatric participants \> 12 years of age: 300 mg twice daily). |
| Placebo | DRUG | Tenofovir DF Placebo administered orally, daily + OBR |
| FTC | DRUG | Emtricitabine (FTC) 200 mg capsule taken orally once daily |
| emtricitabine /tenofovir DF | DRUG | emtricitabine 200 mg/tenofovir DF 300 mg once daily (combination tablet) |
| abacavir 300mg twice daily | DRUG | abacavir 300mg twice daily along with the other antiviral drugs |
| Tenofovir alafenamide | DRUG | Tenofovir alafenamide tablet(s) administered orally once daily |
Key Inclusion Criteria: * Male or Female, 2 to \< 12 years of age * Weight ≥ 10 kg * Chronic HBV infection ≥ 6 months * Hepatitis B e antigen (HBeAg)-positive or HBeAg-negative * HBV Viral Load ≥ 100,000 copies/mL * Alanine aminotransferase (ALT) ≥ 1.5 x the upper limit of the normal range (ULN) at...
Tenofovir DF is a small molecule drug being developed for the treatment of chronic Hepatitis B, HIV infections, and lipodystrophy. It is currently in Phase 3 clinical development for these indications, with studies conducted in various countries including the United States, Brazil, Panama, and Taiwan.
Tenofovir DF is a nucleotide reverse transcriptase inhibitor that works by blocking the activity of reverse transcriptase, an enzyme essential for viral replication. This mechanism makes it effective against both HIV and Hepatitis B virus, as it interferes with the viruses' ability to multiply within the body.
Tenofovir DF is developed by Gilead Sciences, Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol GILD. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating HIV infections and Hepatitis B.
Tenofovir DF is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trials are completed and focus on HIV-1 infected adolescents and children, evaluating the drug's safety and efficacy in these populations.
Tenofovir DF has been studied in several clinical trials, including NCT00352053 and NCT00528957, both Phase 3 trials in HIV-1 infected adolescents and children. Additionally, NCT01334567 is a Phase 2 rollover study in Hepatitis B patients in Taiwan. These trials have been completed.
Tenofovir DF is not the same as Tenofovir Alafenamide. While both are antiviral drugs, Tenofovir DF refers to tenofovir disoproxil fumarate, a prodrug of tenofovir. Tenofovir Alafenamide is a different prodrug with distinct pharmacokinetic properties, and it was studied in a separate dose escalation trial.