Can Cancer Patients Use the New FDA-Approved COVID Drug COViNAViR?

The new Covid variant that emerged in South Africa, Omicron, spread to many parts of the world in less than 6 weeks. As January began, Covid rates in our hospitals in Turkey started rising rapidly again. Unlike before, however, vaccines mean many patients experience milder Covid. Still, some of our patients have severe Covid because they are unvaccinated or have other illnesses. At this very time, the FDA (US Food and Drug Administration) authorized 2 Covid treatment pills: Paxlovid and Covinavir. Until now, however, these drugs were unavailable in Turkey. Now one of them is available in Turkey: the pill from biotechnology company Merck containing molnupiravir as its active ingredient, Covinavir. What do these drugs mean for cancer patients?

• Related topic: Pills Authorized by the FDA for Covid Treatment for the First Time: Paxlovid and Covinavir

A study in the US evaluated the use of these drugs—the monoclonal antibody sotrovimab and the antiviral pills Paxlovid and Covinavir—in immunocompromised people such as cancer patients.

In late December, the US National Institutes of Health (US-NIH) published comprehensive criteria to help doctors prioritize patients most likely to benefit from these drugs. Cancer patients—particularly those with hematologic cancers (originating in the blood and bone marrow) and those receiving oncology treatments that compromise the immune system—were at the top of everyone's list. In other words, cancer patients should use these Covid treatments, and should receive priority.

Which Patients Should Use Covinavir, and at What Dose?

Covinavir, to be used for COVID-19 treatment, is available from many hospitals as of 17 February 2022.

Use is recommended regardless of vaccination status in adult COVID-19 patients (18 years and older) with a diagnosis confirmed by PCR testing, mild-to-moderate disease, symptoms within their first 5 days and a high risk of progression to severe COVID-19 who fall into the groups below. Meeting at least 1 of the following criteria is sufficient:

• Patients aged 65 and older
• Primary immunodeficiencies
• Patients with solid or hematologic cancers who received chemotherapy in the past 1 year
• People who received radiotherapy in the past 6 months
• Solid-organ transplant recipients
• Bone marrow transplant recipients
• AIDS
• People who received Rituksimab treatment within the past 1 year and are still receiving treatment

Dose and duration 2x800 mg/day for 5 days.

Who Should Not Use It?

• Covinavir in pregnant women and children
• under 18 years of age
• For treating patients hospitalized because of severe COVID-19
• For pre-exposure or post-exposure prophylaxis to prevent COVID-19 should not be used.
• If Covinavir is used while breastfeeding, breastfeeding must be interrupted throughout treatment and for 4 days after the last dose.

NOTE: Covinavir will be distributed to outpatients by CONTACT-TRACING TEAMS in Turkey.

Distribution of New Covid Drugs to High-Risk Patients in the US

In general, the limited supply of COVID-19 drugs means that not every eligible patient can obtain them, even in the US.

For example, a snapshot of the last 2 weeks in the US shows that just over 600,000 doses of the two antiviral pills Paxlovid and Covinavir and the monoclonal antibody sotrovimab were distributed, while new infections reached nearly 4.3 million.

Another issue is that not every positive COVID-19 case necessarily needs these treatments, even among immunocompromised people. For example, doctors may not consider them necessary for a person with cancer who has had 4 or 5 vaccinations and has a mild COVID-19 infection.

The highest priority for new Covid drugs should go to patients with hematologic cancers, those receiving or recently completing chemotherapy, and those whose immune systems are suppressed because of an organ transplant; everyone agrees on this. Other serious Covid risk factors, such as diabetes, obesity and advanced age, determine the next priorities.

To refine priority lists further, the US Levine Cancer Institute launched a cancer-focused Hospital at Home initiative. The program includes 40 oncology nurses who routinely screen and score all cancer patients testing positive for COVID-19 according to symptoms and risk factors. For time-sensitive treatments such as Paxlovid and Covinavir, this close monitoring allows COVID patients to obtain the pills within 5 days of symptom onset.

In conclusion, cancer patients are at risk of severe Covid infection, and research and expert opinion to date indicate that they should have priority for the newly approved Covid drugs.