FROM THE TEXAS MEDICAL ASSOCIATION:
As COVID-19 cases surge across the country, five regional infusion centers in Texas have exhausted their supply of sotrovimab, the only monoclonal antibody treatment effective against the omicron variant, the Texas Department of State Health Services (DSHS) announced Monday. But three recently authorized therapeutics are now available throughout the state and may be effective for certain COVID-19 patients.
The federal government has allocated DSHS limited quantities of two oral medications – paxlovid and molnupiravir – for treatment of high-risk patients with mild to moderate COVID-19 infections who are at high risk of progression to severe COVID-19, including hospitalization and death. DSHS also has a limited supply of the monoclonal antibody treatment evusheld, which is a pre-exposure prophylaxis for COVID-19 in people who are immunocompromised and who are not expected to mount an adequate immune response to theCOVID-19 vaccine.
The U.S. Food and Drug Administration (FDA) has issued emergency use authorizations for all three medications, under which physicians must meet certain prescribing criteria. Due to the limited quantity of the medications, the National Institutions of Health (NIH) have also created guidelines for patient prioritization.
DSHS has compiled maps of the Texas pharmacies with on-site supplies of paxlovid, molnupiravir, and evusheld for the week of Dec. 27, which can be found below. Physicians should contact individual pharmacies for the latest product availability.
Paxlovid treatment is authorized for children age 12 and older (weighing at least 40 kilograms or approximately 88 pounds) and adults, according to DSHS. It must start within five days of symptom onset and consists of three pills taken twice daily for five days. More information can be found in the FDA’s fact sheet and FAQ document.
Summary of Conditions with Evidence
1. Comorbidities that are supported by at least one meta-analysis or systematic review or by review method defined in Scientific Evidence brief.
- Cerebrovascular disease
- Chronic kidney disease*
- Chronic lung diseases limited to:
- Interstitial lung disease
- Pulmonary embolism
- Pulmonary hypertension
- Bronchopulmonary dysplasia
- COPD (chronic obstructive pulmonary disease)
- Chronic liver diseases limited to:
- Non-alcoholic fatty liver disease
- Alcoholic liver disease
- Autoimmune hepatitis
- Diabetes mellitus, type 1 and type 2*
- Heart conditions (such as heart failure, coronary artery disease, or cardiomyopathies)
- Mental health disorders limited to:
- Mood disorders, including depression
- Schizophrenia spectrum disorders
- Obesity (BMI ≥30 kg/m2)*
- Pregnancy and recent pregnancy
- Smoking, current and former
2. Comorbidities that are supported by at least one observational study (e.g., cohort, case-control, or cross-sectional):
These studies might include systematic review or meta-analysis that represents one condition in a larger group of conditions (for example, kidney transplant under the category of solid organ or blood stem cell transplantation).
- Children with certain underlying conditions
- Down syndrome
- HIV (human immunodeficiency virus)
- Neurologic conditions, including dementia
- Overweight (BMI ≥25 kg/m2, but <30 kg/m2)
- Sickle cell disease
- Solid organ or blood stem cell transplantation
- Substance use disorders
- Use of corticosteroids or other immunosuppressive medications
3. Comorbidities that are supported by mostly case series, case reports, or, if other study design, the sample size is small (and no systematic review or meta-analysis available was available to review):
Defined as having an association in one or more case series studies. If there are cohort or case-control studies, the sample size was small. Conditions included might be less common.
- Cystic fibrosis
4. Comorbidities that are supported by mixed evidence:
Defined as having an association in at least one meta-analysis or systematic review and additional studies or reviews that reached different conclusions about risk associated with a medical condition.
- Hypertension, possibly*
- Immune deficiencies (except people with moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments)