TOPLINE
The World Health Organization has recommended Pfizer’s antiviral pill Paxlovid to treat high-risk Covid patients, the agency announced Friday, which it said is safer, easier to administer and better at preventing hospitalizations than other available treatments.
KEY FACTS
The WHO’s expert panel endorsed Paxlovid—a combination of nirmatrelvir, which inhibits coronavirus replication, and ritonavir, an HIV inhibitor which also slows the liver’s breakdown of nirmatrelvir—for Covid patients without severe disease who are at high risk of hospitalization.
High risk groups include older patients, those with compromised immune systems or chronic illnesses and the unvaccinated, according to the guidelines.
The panel cited new data from two clinical trials involving 3,100 patients, which found Paxlovid led to 84 fewer hospital admissions per 1,000 patients treated with little or no risk of severe side effects when given within five days of the onset of symptoms.
Paxlovid should not be used in lower risk patients as the benefits are “trivial,” though the group said this is a weak recommendation as there are likely an “appreciable number” of people who will place a “high value on very small reductions” in risk.
The panel also issued a weak recommendation for using the antiviral drug remdesivir for patients with non-severe Covid-19 at high risk of hospitalization, replacing earlier guidance against its use in any Covid patients based on new data from five clinical trials.
WHAT TO WATCH FOR
New recommendations. The WHO guidelines are intended to be a “living” document that is updated as new information comes in. The panel said it is evaluating several other medicines, including a cheap and widely available antidepressant, fluvoxamine, that has shown promise as a potential Covid treatment. The panel is also considering colchicine, an anti-inflammatory, and anticoagulation therapy, as well as evaluating whether GlaxoSmithKline and Vir’s antibody treatment sotrovimab is effective against BA.1 and BA.2 omicron variants.
KEY BACKGROUND
Paxlovid is one of the only oral antiviral drugs approved for Covid-19 and has been widely hailed as a game-changer in efforts to control the virus. To be taken at home before or shortly after symptoms developed, the pill plugged a large gap in the treatment of Covid-19, which previously relied on prevention (such as vaccination), treating the most severe cases in hospital or tricky-to-administer on-site treatments for those not in hospital. It is the second—and now preferred—oral antiviral endorsed by the WHO after it recommended Merck and Ridgeback Biotherapeutics’ molnupiravir for high-risk patients in early March. While initially scarce, supply of the antivirals now vastly outstrips demand. Despite this, they are underutilized and not prescribed to many who would benefit from them in Europe, the U.S. and other wealthy countries, which secured the majority of early production.
TANGENT
In a statement, the WHO expressed its concern that low- and middle-income countries will “be pushed to the end of the queue when it comes to accessing this treatment,” as happened with Covid-19 vaccines. Though Pfizer has inked deals with pharmaceutical companies around the world to produce generic forms of the drug, the WHO said these products are “not yet available from quality-assured sources.” The agency said Pfizer’s “lack of transparency… is making it difficult for public health organizations to obtain an accurate picture of the availability of the medicine, which countries are involved in bilateral deals and what they are paying.”
Hundreds are still dying from Covid every day. Why is Paxlovid sitting on shelves? (NBCNews)
By Robert Hart, Forbes Staff