Evidence map›Paper›PMID 39461916›Full record

ArticleInfectious diseases and therapy2024

Pharmacovigilance of Drug-Drug Interactions with Nirmatrelvir/Ritonavir.

Victoria Hendrick, Erast Pohorylo, Lubna Merchant, Jackie Gerhart, Iqra Naz Arham, Florin Draica, Romina Quercia, Ayman Ayoub, Reema Mehta

Abstract read
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Article in Infectious diseases and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Victoria HendrickWorldwide Medical and Safety, Pfizer Research and Development, Sandwich, Kent, UK.ORCID http://orcid.org/0000-0003-2364-7395
Erast PohoryloWorldwide Medical and Safety, Pfizer Research and Development, Collegeville, PA, USA. erast.pohorylo@pfizer.com.
Lubna MerchantWorldwide Medical and Safety, Pfizer Research and Development, Collegeville, PA, USA.
Jackie GerhartTranslational Clinical Sciences, Pfizer Research and Development, Collegeville, PA, USA.
Iqra Naz ArhamUS Medical and Scientific Affairs, Pfizer Inc, New York, NY, USA.
Florin DraicaUS Medical and Scientific Affairs, Pfizer Inc, New York, NY, USA.
Romina QuerciaGlobal Medical Affairs, Pfizer Ltd, London, UK.
Ayman AyoubWorldwide Medical and Safety, Pfizer Research and Development, Sandwich, Kent, UK.
Reema MehtaWorldwide Medical and Safety, Pfizer Research and Development, Peapack, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNirmatrelvir/ritonavir (NMV/r) is approved in the United States (US) and more than 70 other countries for the treatment of mild to moderate COVID-19 in nonhospitalized adults at high risk for severe disease. Because ritonavir inhibits several drug metabolizing enzymes, potential drug-drug interactions (DDIs) between ritonavir and concomitant medications are an important consideration for prescribers. Here, we conducted a real-world analysis of data from Pfizer's global safety database regarding adverse events (AEs) reported during use of NMV/r concomitantly with potentially interacting drugs.

methodsData were extracted regarding DDI cases occurring from the start of NMV/r authorization through October 31, 2023. Results regarding concomitant treatment, specific AEs, and clinical outcomes are summarized. Overall NMV/r exposure was estimated based on packs of medication dispensed and was used to calculate reporting rates.

resultsAmong 19,617,670 patients exposed globally to NMV/r, 966 cases of potential DDIs were reported. Of these, 594 occurred in the US against an estimated US exposure of 14,646,990 patients, representing a reporting rate of 0.004%. Globally and in the United States, 66.8% and 77.3% of cases, respectively, were nonserious. Simvastatin and tacrolimus were the most frequently reported drugs associated with potential DDIs, and the most frequently reported AE regarding a specific event or symptom was dysgeusia (altered sense of taste), an AE known to be associated with NMV/r.

conclusionsLow reporting rates of DDIs support the potential for NMV/r treatment to be safely managed with careful use of available drug interaction resources to aid in risk mitigation.

Indexed as

InteractionsNirmatrelvirRitonavir

Identifiers

PMID39461916
PMCPMC11582113

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.