What side effects are associated with this type of intervention?

Common treatments for Herpes include Pritelivir, a helicase-primase inhibitor, and Foscarnet, a pyrophosphate analog. Pritelivir is generally well-tolerated, but potential side effects include headache, nausea, and elevated liver enzymes. Foscarnet, on the other hand, is associated with more severe side effects such as nephrotoxicity, electrolyte imbalances (including hypocalcemia and hypomagnesemia), and gastrointestinal disturbances. Both treatments are used particularly in cases where resistance to standard antiviral therapies like acyclovir is observed.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Herpes infections. Acyclovir, a nucleoside analog, was one of the first antiviral drugs approved for Herpes Simplex Virus (HSV) infections. Valacyclovir and Famciclovir, both prodrugs of acyclovir and penciclovir respectively, have also been approved for HSV treatment. Foscarnet, a pyrophosphate analog, is approved for acyclovir-resistant HSV infections, particularly in immunocompromised patients. Pritelivir, a helicase-primase inhibitor, is currently under investigation and represents a novel class of antiviral agents targeting HSV. These treatments highlight the evolving landscape of antiviral therapy for Herpes infections.

What other types of research exist?

Promising novel alternatives for Herpes treatment in 2024 include: 1) Maribavir, a benzimidazole riboside with activity against cytomegalovirus, showing potential for broader herpesvirus applications. 2) Letermovir, another antiviral initially approved for CMV, which may offer benefits for herpesvirus infections. 3) Newer formulations of existing drugs, such as valacyclovir and famciclovir, with enhanced bioavailability and efficacy. These alternatives are under investigation and may provide effective options for patients resistant to current treatments.

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Antiviral

Pritelivir vs Foscarnet for Resistant Herpes (PRIOH-1 Trial)

Phase 3

Recruiting

Research Sponsored by AiCuris Anti-infective Cures GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Immunocompromised men and women of any ethnic group aged ≥16 years.

Immunocompromised (due to conditions including HIV infection, hematopoietic cell or solid organ transplantation, and chronic glucocorticoid use) men and women of any ethnic group aged >18 years.

Timeline

Screening 1 day

Treatment Varies

Follow Up 4 days

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares two treatments for herpes infections in patients with weakened immune systems who do not respond to standard treatment. One treatment is a pill called pritelivir, and the other is a drug called foscarnet. Both aim to stop the virus from replicating and help heal sores. Foscarnet has been used to treat herpes viruses, including drug-resistant cytomegalovirus (CMV) and herpes simplex viruses types 1 and 2 (HSV-1 and HSV-2).

Who is the study for?

This trial is for immunocompromised adults over 18 years old with mucocutaneous HSV infections resistant to acyclovir. Participants must be willing to use effective birth control and have lesions that can be visually inspected. Pregnant women, individuals unable to consent, or those not following specific treatment protocols are excluded.

What is being tested?

The study compares the effectiveness of Pritelivir tablets (with an initial high dose) against Foscarnet injections in treating herpes infections in people with weakened immune systems. It's a randomized and open-label trial, meaning both researchers and participants know which treatment is given.

What are the potential side effects?

Potential side effects may include nausea, headache, fatigue, kidney issues from Foscarnet; while Pritelivir might cause gastrointestinal symptoms or changes in blood tests monitoring liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 16 or older and have a weakened immune system.

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I am over 18 and have a weakened immune system due to certain conditions.

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My HSV infection didn't improve after 7 days of standard treatment, requiring a switch to foscarnet.

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My lesions can be seen and checked by doctors using special tools.

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You must agree to use very effective birth control methods.

Timeline

Screening ~ 1 day1 visit

Treatment ~ Varies

Follow Up ~ 4 days2 visits

Screening ~ 1 day

Treatment ~ Varies

Follow Up ~4 days

This trial's timeline: 1 day for screening, Varies for treatment, and 4 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Efficacy measured by average pain score

Efficacy measured by clinical shedding rate

Efficacy measured by cure rate

+21 more

Side effects data

From 2020 Phase 1 trial • 16 Patients • NCT05513625

Ankle fracture

Skin abrasion

Tooth impacted

100%

80%

60%

40%

20%

Study treatment Arm

100 mg Pritelivir

40 mg qd ESO and 100 mg Pritelivir

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Part F, PritelivirExperimental Treatment1 Intervention

Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days

Group II: Part E, PritelivirExperimental Treatment1 Intervention

Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days

Group III: Part D, PritelivirExperimental Treatment1 Intervention

Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days

Group IV: Part C, PritelivirExperimental Treatment1 Intervention

Oral tablets, 100mg/day (400mg loading dose on day 1) for up to 28 days and potential prolongation for up to additional 14 days

Group V: Part C,Active Control1 Intervention

Investigator's Choice: Foscarnet iv, 40 mg/kg tid or 60mg/kg bid or Cidofovir iv, 5 mg/kg body weight given once weekly or Cidofovir 1% or 3%, topically applied 2 to 4 times daily or Imiquimod 5%, topically applied 3 times per week, for up to 28 days and potential prolongation for up to additional 14 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pritelivir

2020

Completed Phase 1

~20

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pritelivir, a helicase-primase inhibitor, blocks the enzyme complex necessary for viral DNA replication, preventing the herpes virus from spreading. Foscarnet, a pyrophosphate analog, inhibits viral DNA polymerase by binding to its pyrophosphate binding site, stopping DNA chain elongation and viral replication. These mechanisms are vital for herpes patients, especially those with drug-resistant infections, as they offer alternative treatment options that target the virus at a molecular level.