Regenerative
FDA approves pritelivir for drug-resistant herpes lesions in immunocompromised patients
By Life and Health Today Staff, . Life and Health Today.
The US Food and Drug Administration has approved pritelivir, sold under the brand name Hovilpri, to treat mucocutaneous lesions caused by herpes simplex virus infections in immunocompromised patients who have not responded to existing therapies, according to MedPage Today.
Mucocutaneous lesions are sores affecting the skin and mucous membranes, including the lips, nostrils, eyes and genitals. Herpes simplex virus infections are incurable, and in people with weakened immune systems, whether from cancer, organ transplantation, HIV infection, autoimmune disease or other conditions, the virus can cause persistent, treatment-resistant lesions that are difficult to manage.
Pritelivir belongs to a class called helicase-primase inhibitors, which work differently from the drugs currently used against herpes simplex virus. The existing standard treatments are nucleoside analogues, such as acyclovir, valacyclovir and famciclovir, and a drug called foscarnet. Pritelivir is designed to work against strains of the virus that have become resistant to both of those approaches, the report said.
The FDA's approval was based on results from the PRIOH-1 trial, an open-label phase III study, meaning participants and investigators knew which treatment was being given. The trial enrolled 101 immunocompromised patients whose herpes simplex virus infections had not responded to acyclovir, valacyclovir or famciclovir. Participants were assigned either once-daily pritelivir or one of three alternatives chosen by their treating physician: foscarnet, cidofovir or imiquimod.
By 28 days, 63% of patients taking 100-milligram pritelivir once daily had all lesions healed, the trial's primary measure of effectiveness. Among those receiving the physician-chosen alternatives, 34% reached the same endpoint, according to the report. The most common side effect reported among pritelivir patients was headache.
The trial's participants had a wide range of underlying conditions, including blood cancers and disorders, stem-cell transplantation, HIV infection, autoimmune and inflammatory diseases, non-blood cancers and solid-organ transplantation.
Cynthia Wat, chief medical officer for the drugmaker Aicuris, said in a statement quoted in the report that for these patients, "achieving rapid lesion healing while maintaining tolerability is essential."
Several things the trial does not establish are worth stating plainly. PRIOH-1 was open-label, which means neither patients nor physicians were blinded to treatment, a design that can influence how outcomes are assessed. The trial enrolled 101 people, a small number, and the comparison group received whichever of three different drugs the physician chose rather than a single standardised alternative, making the comparison less clean than a blinded, placebo-controlled design would be. The approval covers immunocompromised patients with treatment-refractory infections specifically; the evidence does not extend to people with intact immune systems or to first-line treatment of herpes simplex virus.
Pritelivir is an FDA-approved prescription drug for a defined patient population. It is not a consumer supplement and is not available without a prescription. Whether it is appropriate for any individual depends on their specific diagnosis, immune status and treatment history, and that is a question for the clinician managing their care.
Source: https://www.medpagetoday.com/infectiousdisease/generalinfectiousdisease/123352
Life & Health Today provides information for educational purposes only, not medical advice, diagnosis, or treatment. Always consult a qualified healthcare professional.