| Eligibility |
Inclusion Criteria:
1. Immunocompromised (due to conditions including but not limited to HIV infection,
hematopoietic-cell or solid organ transplantation, and chronic use of immunosupressive
treatment) men and women of any ethnic group aged =16 years.
2. ACV-resistant and foscarnet-resistant/intolerant mucocutaneous HSV infection based on
clinical failure (no improvement after oral or iv doses for at least 7 days at doses
equivalent to or greater than the local agency approved high doses of valacyclovir or
famciclovir and/or foscarnet iv therapy or intolerance to foscarnet requiring
cessation of foscarnet treatment) or result from genotypic/phenotypic testing.
Patients previously treated in PRIOH-1 or the EAP with proven ACV-R mucocutaneous
lesions and foscarnet resistance or intolerance, which have a recurrence in the
location of previous HSV outbreaks, do not need a new genotypic/phenotypic analysis of
HSV or clinical proof of ACV-R or foscarnet resistance/intolerance. Manifestations of
foscarnet intolerance may include: renal function impairment, seizures, genital
irritation and/or ulcerations, extremity paraesthesia, nausea, granulocytopenia,
anemia, leukopenia, thrombocytopenia, hypokalemia, hypocalcemia, hypomagnesemia,
diabetes insipidus, injection site reactions, psychotic disorders, including but not
limited to anxiety and aggression.
3. The current lesion(s) should be confirmed to be positive for HSV before the start of
treatment. If not tested beforehand, a lesion swab should be taken for PCR or cell
culture before starting treatment, but treatment may be started before obtaining
results.
Patients previously treated in PRIOH-1 or the EAP with proven ACV-R mucocutaneous
lesions and foscarnet resistance or intolerance, which have a recurrence in the
location of previous HSV outbreaks, do not need a new genotypic/phenotypic analysis of
HSV or clinical proof of ACV-R or foscarnet resistance/intolerance.
4. Visual confirmation of lesion at start of treatment (including by endoscopy).
5. Willing to use highly effective method of contraception:
Male subjects must be surgically sterile (e.g., vasectomy at least for the last 26
weeks) or must agree to use an adequate method of contraception (see definition below)
during sexual intercourse with women of childbearing potential to make sure the
fathering of a child will be ruled out during treatment and for at least 6 complete
months after the final dose of pritelivir. Female subjects of non-childbearing
potential must be either surgically sterile (hysterectomy, bilateral tubal ligation,
salpingectomy, and/or bilateral oophorectomy at least 26 weeks before starting
treatment) or post-menopausal (defined as spontaneous amenorrhea for at least 2 years,
with follicle-stimulating hormone (FSH) in the postmenopausal range at start of
treatment based on the laboratory's ranges).
Female subjects of childbearing potential must use an adequate method of contraception
(see definition below). An adequate method of contraception is defined as a highly
effective method of contraception plus use of a condom during participation in this
expanded access program and for at least 6.5 complete months after the final dose of
pritelivir. A highly effective method of contraception is defined as:
- copper intrauterine device
- the levonorgestrel-releasing intrauterine system
- the progestogen implant
- combined (estrogen and progestogen containing) hormonal contraception (oral,
intravaginal, transdermal) associated with inhibition of ovulation
- progestogen-only hormonal contraception (oral, injectable, implantable)
associated with inhibition of ovulation.
6. Negative pregnancy test for females of childbearing potential at Day 1 and every 4
weeks thereafter.
7. Patient must be willing and able (in the opinion of the physician) to understand the
informed consent form.
8. Patient must give written informed consent.
Exclusion Criteria:
1. Eligibility and feasibility for a patient to participate in a currently ongoing
clinical trial with pritelivir.
2. Known intolerance to pritelivir or any of the excipients (microcrystalline cellulose,
croscarmellose sodium, mannitol, colloidal anhydrous silica, magnesium stearate,
hydroxy propyl methyl cellulose, polyethylene glycol, calcium diphosphate).
3. Need to use the following medications at any dose: esomeprazole, rabeprazole. Need to
use the medications with the following daily dose levels: omeprazole > 20 mg/d,
lansoprazole > 20 mg/d or pantoprazole > 80 mg/d.
4. Baseline safety laboratory abnormalities:
1. ANC < 1000 cells/mm3
2. Platelet count < 25,000 cells/mm3
3. Hemoglobin < 8.0 g/dL
4. AST or ALT > 5 x ULN
5. Bilirubin > 2.5 x ULN
5. History or current evidence of gastrointestinal malabsorption which, in the opinion of
the physician, may affect the extent of absorption of pritelivir.
6. Hemodialysis for any indication and ESRD (eGFR <15 mL/min; stage 5 CKD).
7. History or current evidence of significant cardiovascular, pulmonary, hepatic, renal,
gastrointestinal, hematological, endocrinological, metabolic, neurological,
psychiatric, or other diseases, which, in the opinion of the physician, may affect the
patient's safety.
8. Abnormalities in hematological, clinical chemical or any other laboratory variables
regarded as clinically relevant by the physician unless they are due to underlying
disease or condition.
9. Not able to communicate meaningfully with the physician and site staff.
10. Any other condition which in the opinion of the physician would interfere with
successful completion of the treatment.
11. Pregnant and/or breastfeeding women.
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