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Article: Barriers to Worldwide Access for Paxlovid, a New Treatment for COVID-19.

Pepperrell, Toby / Ellis, Leah / Wang, Junzheng / Hill, Andrew

2022 Volume 9, Issue 9, Page(s) ofac174

Abstract: Pfizer and the Medicines Patent Pool (MPP) have reached a voluntary licensing agreement for Paxlovid (nirmatrelvir+ritonavir), a novel antiviral for coronavirus disease 2019 (COVID-19) taken orally in the first 5 days from symptom onset. The Pfizer-MPP ... ...

Abstract	Pfizer and the Medicines Patent Pool (MPP) have reached a voluntary licensing agreement for Paxlovid (nirmatrelvir+ritonavir), a novel antiviral for coronavirus disease 2019 (COVID-19) taken orally in the first 5 days from symptom onset. The Pfizer-MPP deal enables 95 low- and middle-income countries (L/MICs) to access affordable biosimilars. Generics are delayed awaiting bioequivalence testing and may be ineffective in L/MICs with reduced testing capacity, which comprise only 10% of global diagnoses. Thirty-nine percent of diagnoses originate in MICs forced to pay high prices due to exclusion from the Pfizer-MPP deal. The cost-effectiveness of Paxlovid could be limited compared with the creation of sustainable vaccine infrastructure in these nations, delaying socioeconomic pandemic recovery. Furthermore, Paxlovid may not be cost-effective in vaccinated populations, and concerns remain over ritonavir drug interactions with COVID-19 comorbidity medications. We call for expanded coverage by the Paxlovid-MPP deal and greater access to testing.
Language	English
Publishing date	2022-04-07
Publishing country	United States
Document type	Journal Article
ZDB-ID	2757767-3
ISSN	2328-8957
ISSN	2328-8957
DOI	10.1093/ofid/ofac174
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Article ; Online: Missing clinical trial data: the evidence gap in primary data for potential COVID-19 drugs.

Rodgers, Florence / Pepperrell, Toby / Keestra, Sarai / Pilkington, Victoria

Trials

2021 Volume 22, Issue 1, Page(s) 59

Abstract: Background: Several drugs are being repurposed for the treatment of the coronavirus disease 2019 (COVID-19) pandemic based on in vitro or early clinical findings. As these drugs are being used in varied regimens and dosages, it is important to enable ... ...

Abstract	Background: Several drugs are being repurposed for the treatment of the coronavirus disease 2019 (COVID-19) pandemic based on in vitro or early clinical findings. As these drugs are being used in varied regimens and dosages, it is important to enable synthesis of existing safety data from clinical trials. However, availability of safety information is limited by a lack of timely reporting of overall clinical trial results on public registries or through academic publication. We aimed to analyse the evidence gap in this data by conducting a rapid review of results posting on ClinicalTrials.gov and in academic publications to quantify the number of trials missing results for drugs potentially being repurposed for COVID-19. Methods: ClinicalTrials.gov was searched for 19 drugs that have been identified as potential treatments for COVID-19. Relevant clinical trials for any prior indication were listed by identifier (NCT number) and checked for results and for timely result reporting (within 395 days of the primary completion date). Additionally, PubMed and Google Scholar were searched to identify publications of results not listed on the registry. A second, blinded search of 10% of trials was conducted to assess reviewer concordance. Results: Of 3754 completed trials, 1516 (40.4%) did not post results on ClinicalTrials.gov or in the academic literature. Tabular results were available on ClinicalTrials.gov for 1172 (31.2%) completed trials. A further 1066 (28.4%) had published results in the academic literature, but did not report results on ClinicalTrials.gov . Key drugs missing clinical trial results include hydroxychloroquine (37.0% completed trials unreported), favipiravir (77.8%) and lopinavir (40.5%). Conclusions: There is an important evidence gap for the safety of drugs being repurposed for COVID-19. This uncertainty could cause unnecessary additional morbidity and mortality during the pandemic. We recommend caution in experimental drug use for non-severe disease and urge clinical trial sponsors to report missing results retrospectively.
MeSH term(s)	Amides/therapeutic use ; Antiviral Agents/therapeutic use ; COVID-19/drug therapy ; Clinical Trials as Topic ; Drug Combinations ; Drug Repositioning ; Enzyme Inhibitors/therapeutic use ; Evidence-Based Medicine ; Humans ; Hydroxychloroquine/therapeutic use ; Lopinavir/therapeutic use ; PubMed ; Pyrazines/therapeutic use ; Registries ; Research Design ; Research Report ; Ritonavir/therapeutic use ; SARS-CoV-2
Chemical Substances	Amides ; Antiviral Agents ; Drug Combinations ; Enzyme Inhibitors ; Pyrazines ; lopinavir-ritonavir drug combination ; Lopinavir (2494G1JF75) ; Hydroxychloroquine (4QWG6N8QKH) ; favipiravir (EW5GL2X7E0) ; Ritonavir (O3J8G9O825)
Language	English
Publishing date	2021-01-15
Publishing country	England
Document type	Journal Article
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1468-6708
ISSN (online)	1745-6215 ; 1468-6694
ISSN	1468-6708
DOI	10.1186/s13063-021-05024-y
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Article ; Online: The same lesson over and over: drugs alone will not get us to 90--90--90.

Cohen, Jennifer / Pepperrell, Toby / Venter, Willem Daniel Francois

AIDS (London, England)

2020 Volume 34, Issue 6, Page(s) 943–946

Abstract: Addressing social determinants of health (SDH) has far greater potential to improve the real-world effectiveness of HIV treatment than expensive, incremental changes in antiretroviral therapy. The ADVANCE study demonstrates that SDH is more impactful ... ...

Abstract	: Addressing social determinants of health (SDH) has far greater potential to improve the real-world effectiveness of HIV treatment than expensive, incremental changes in antiretroviral therapy. The ADVANCE study demonstrates that SDH is more impactful than medication regimen on health outcomes. Younger patients and unemployed patients experience heightened precarity, which can have pervasive effects on adherence and suppression. Enhanced adherence counselling can help socioeconomically precarious patients maintain suppression, but in order to improve treatment effectiveness and population health, we should move beyond the short-term solution of helping patients 'cope' with insecurity toward tackling the underlying factors that lead to precarity. Data on intention-to-treat populations are critical to this effort, yet medical researchers and publications continue to obscure the influence of SDH by focusing on per-protocol populations.
MeSH term(s)	HIV Infections/drug therapy ; HIV Infections/psychology ; Humans ; Intention to Treat Analysis ; Medication Adherence ; Population Health ; Social Determinants of Health
Language	English
Publishing date	2020-02-03
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	639076-6
ISSN	1473-5571 ; 0269-9370 ; 1350-2840
ISSN (online)	1473-5571
ISSN	0269-9370 ; 1350-2840
DOI	10.1097/QAD.0000000000002494
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Article: A review of the safety of favipiravir - a potential treatment in the COVID-19 pandemic?

Pilkington, Victoria / Pepperrell, Toby / Hill, Andrew

Journal of virus eradication

2020 Volume 6, Issue 2, Page(s) 45–51

Abstract: Background: Repurposing broad-spectrum antivirals is an immediate treatment opportunity for 2019 coronavirus disease (COVID-19). Favipiravir is an antiviral previously indicated for influenza and Ebola, which has shown some promise in early trials for ... ...

Abstract	Background: Repurposing broad-spectrum antivirals is an immediate treatment opportunity for 2019 coronavirus disease (COVID-19). Favipiravir is an antiviral previously indicated for influenza and Ebola, which has shown some promise in early trials for treatment of COVID-19. We aim to review existing favipiravir safety evidence, which is vital to informing the potential future use of favipiravir in COVID-19. Methods: A search was conducted across EMBASE and MEDLINE databases, supplemented by relevant grey-literature and ClinicalTrials.gov. All studies assessing the use of favipiravir in humans by 27 March 2020 were considered for inclusion. Further analysis of available safety data from phase 2 and 3 studies was undertaken. Data extracted were adverse events (AEs) grade 1-4, serious AEs and discontinuation for AEs. Specific AEs of interest highlighted in early-phase studies, including gastrointestinal AEs and hyperuricaemia, were also examined. Results: Twenty-nine studies were identified as potential sources of evidence of the clinical safety of favipiravir. Six were phase 2 and 3 studies reporting relevant safety data for statistical comparison, representing a total of 4299 participants, an estimated 175 person-years-of-follow-up (PYFU). Comparator drugs were oseltamivir, umifenovir, lopinavir/ritonavir or placebo. Study follow-up was between 5 and 21 days. The proportions of grade 1-4 AEs on favipiravir was 28.2% Conclusions: Favipiravir demonstrates a favourable safety profile regarding total and serious AEs. However, safety concerns remain: hyperuricaemia, teratogenicity and QTc prolongation have not yet been adequately studied. Favipiravir may be safe and tolerable in short-term use, but more evidence is needed to assess the longer-term effects of treatment. Given the limitations of the evidence and unresolved safety concerns, caution is warranted in the widespread use of favipiravir against pandemic COVID-19.
Keywords	covid19
Language	English
Publishing date	2020-04-30
Publishing country	England
Document type	Editorial
ZDB-ID	2868549-0
ISSN	2055-6659 ; 2055-6640
ISSN (online)	2055-6659
ISSN	2055-6640
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Article: Efficacy of Approved Versus Unapproved Vaccines for Severe Acute Respiratory Syndrome Coronavirus 2 Infection in Randomized Blinded Clinical Trials.

Perez Navarro, Andrea / Pilkington, Victoria / Pepperrell, Toby / Mirchandani, Manya / Levi, Jacob / Hill, Andrew

Open forum infectious diseases

2022 Volume 9, Issue 9, Page(s) ofac408

Abstract: Background: Five severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are approved in North America and/or Europe: Pfizer/BioNTech, Moderna, Janssen, Oxford-AstraZeneca, and Novavax. Other vaccines have been developed, including ... ...

Abstract	Background: Five severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are approved in North America and/or Europe: Pfizer/BioNTech, Moderna, Janssen, Oxford-AstraZeneca, and Novavax. Other vaccines have been developed, including Sinopharm, SinoVac, QazVac, Covaxin, Soberana, Zifivax, Medicago, Clover, and Cansino, but they are not approved in high-income countries. This meta-analysis compared the efficacy of US Food and Drug Administration (FDA)/European Medicines Agency (EMA)-approved and -unapproved vaccines in randomized clinical trials (RCTs). Methods: A systematic review of trial registries identified RCTs of SARS-CoV-2 vaccines. Risk of bias was assessed using the Cochrane tool (RoB 2). In the meta-analysis, relative risks of symptomatic infection and severe disease were compared for each vaccine versus placebo, using Cochrane-Mantel Haenszel Tests (random effects method). Results: Twenty-two RCTs were identified and 1 was excluded for high-risk of bias. Ten RCTs evaluated 5 approved vaccines and 11 RCTs evaluated 9 unapproved vaccines. In the meta-analysis, prevention of symptomatic infection was 84% (95% confidence interval [CI], 68%-92%) for approved vaccines versus 72% (95% CI, 66%-77%) for unapproved vaccines, with no significant difference between vaccine types ( Conclusions: This meta-analysis of 21 RCTs in 390 459 participants showed no significant difference in efficacy between the FDA/EMA-approved and -unapproved vaccines for symptomatic or severe infection. Differences in study design, endpoint definitions, variants, and infection prevalence may have influenced results. New patent-free vaccines could lower costs of worldwide SARS-CoV-2 vaccination campaigns significantly.
Language	English
Publishing date	2022-08-22
Publishing country	United States
Document type	Journal Article
ZDB-ID	2757767-3
ISSN	2328-8957
ISSN	2328-8957
DOI	10.1093/ofid/ofac408
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Article ; Online: A review of the safety of favipiravir – a potential treatment in the COVID-19 pandemic?

Victoria Pilkington / Toby Pepperrell / Andrew Hill

Journal of Virus Eradication, Vol 6, Iss 2, Pp 45-

2020 Volume 51

Abstract	Background: Repurposing broad-spectrum antivirals is an immediate treatment opportunity for 2019 coronavirus disease (COVID-19). Favipiravir is an antiviral previously indicated for influenza and Ebola, which has shown some promise in early trials for treatment of COVID-19. We aim to review existing favipiravir safety evidence, which is vital to informing the potential future use of favipiravir in COVID-19. Methods: A search was conducted across EMBASE and MEDLINE databases, supplemented by relevant grey-literature and ClinicalTrials.gov. All studies assessing the use of favipiravir in humans by 27 March 2020 were considered for inclusion. Further analysis of available safety data from phase 2 and 3 studies was undertaken. Data extracted were adverse events (AEs) grade 1–4, serious AEs and discontinuation for AEs. Specific AEs of interest highlighted in early-phase studies, including gastrointestinal AEs and hyperuricaemia, were also examined. Results: Twenty-nine studies were identified as potential sources of evidence of the clinical safety of favipiravir. Six were phase 2 and 3 studies reporting relevant safety data for statistical comparison, representing a total of 4299 participants, an estimated 175 person-years-of-follow-up (PYFU). Comparator drugs were oseltamivir, umifenovir, lopinavir/ritonavir or placebo. Study follow-up was between 5 and 21 days. The proportions of grade 1–4 AEs on favipiravir was 28.2% vs 28.4% (P = n.s.) in the comparison arms. The proportion of discontinuations due to AEs on favipiravir was 1.1% vs 1.2% (P = n.s.) in the comparison arms. For serious AEs the proportion was 0.4% in both arms (P = n.s.). There were significantly fewer gastrointestinal AEs occurring on favipiravir vs comparators [8.7% vs 11.5%; P = 0.003]. Favipiravir showed significantly more uric acid elevations than comparators [5.8% vs 1.3%; P<0.0001]. Conclusions: Favipiravir demonstrates a favourable safety profile regarding total and serious AEs. However, safety concerns remain: hyperuricaemia, ...
Keywords	Microbiology ; QR1-502 ; Public aspects of medicine ; RA1-1270
Subject code	005
Language	English
Publishing date	2020-04-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A review of the safety of favipiravir – a potential treatment in the COVID-19 pandemic?

Pilkington, Victoria / Pepperrell, Toby / Hill, Andrew

Journal of Virus Eradication

2020 Volume 6, Issue 2, Page(s) 45–51

Keywords	covid19
Language	English
Publisher	Elsevier BV
Publishing country	us
Document type	Article ; Online
ZDB-ID	2868549-0
ISSN	2055-6659 ; 2055-6640
ISSN (online)	2055-6659
ISSN	2055-6640
DOI	10.1016/s2055-6640(20)30016-9
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: A review of the safety of favipiravir - a potential treatment in the COVID-19 pandemic?

Pilkington, Victoria / Pepperrell, Toby / Hill, Andrew

J Virus Erad

Abstract: Background: Repurposing broad-spectrum antivirals is an immediate treatment opportunity for 2019 coronavirus disease (COVID-19) Favipiravir is an antiviral previously indicated for influenza and Ebola, which has shown some promise in early trials for ... ...

Abstract	Background: Repurposing broad-spectrum antivirals is an immediate treatment opportunity for 2019 coronavirus disease (COVID-19) Favipiravir is an antiviral previously indicated for influenza and Ebola, which has shown some promise in early trials for treatment of COVID-19 We aim to review existing favipiravir safety evidence, which is vital to informing the potential future use of favipiravir in COVID-19 Methods: A search was conducted across EMBASE and MEDLINE databases, supplemented by relevant grey-literature and ClinicalTrials gov All studies assessing the use of favipiravir in humans by 27 March 2020 were considered for inclusion Further analysis of available safety data from phase 2 and 3 studies was undertaken Data extracted were adverse events (AEs) grade 1-4, serious AEs and discontinuation for AEs Specific AEs of interest highlighted in early-phase studies, including gastrointestinal AEs and hyperuricaemia, were also examined Results: Twenty-nine studies were identified as potential sources of evidence of the clinical safety of favipiravir Six were phase 2 and 3 studies reporting relevant safety data for statistical comparison, representing a total of 4299 participants, an estimated 175 person-years-of-follow-up (PYFU) Comparator drugs were oseltamivir, umifenovir, lopinavir/ritonavir or placebo Study follow-up was between 5 and 21 days The proportions of grade 1-4 AEs on favipiravir was 28 2% vs 28 4% (P = n s ) in the comparison arms The proportion of discontinuations due to AEs on favipiravir was 1 1% vs 1 2% (P = n s ) in the comparison arms For serious AEs the proportion was 0 4% in both arms (P = n s ) There were significantly fewer gastrointestinal AEs occurring on favipiravir vs comparators [8 7% vs 11 5%;P = 0 003] Favipiravir showed significantly more uric acid elevations than comparators [5 8% vs 1 3%;P<0 0001] Conclusions: Favipiravir demonstrates a favourable safety profile regarding total and serious AEs However, safety concerns remain: hyperuricaemia, teratogenicity and QTc prolongation have not yet been adequately studied Favipiravir may be safe and tolerable in short-term use, but more evidence is needed to assess the longer-term effects of treatment Given the limitations of the evidence and unresolved safety concerns, caution is warranted in the widespread use of favipiravir against pandemic COVID-19
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #32405421
Database	COVID19

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Article: Review of safety and minimum pricing of nitazoxanide for potential treatment of COVID-19.

Pepperrell, Toby / Pilkington, Victoria / Owen, Andrew / Wang, Junzheng / Hill, Andrew M

Journal of virus eradication

2020 Volume 6, Issue 2, Page(s) 52–60

Abstract: Background: Many treatments are being assessed for repurposing to treat coronavirus disease 2019 (COVID-19). One drug that has shown promising results : Methods: A review of nitazoxanide clinical research was conducted using EMBASE and MEDLINE ... ...

Abstract	Background: Many treatments are being assessed for repurposing to treat coronavirus disease 2019 (COVID-19). One drug that has shown promising results Methods: A review of nitazoxanide clinical research was conducted using EMBASE and MEDLINE databases, supplemented by ClinicalTrials.gov. We searched for phase 2 or 3 randomised controlled trials (RCTs) comparing nitazoxanide with placebo or active control for 5-14 days in participants experiencing acute infections of any kind. Data extracted were grade 1-4 and serious adverse events (AEs). Data were also extracted on gastrointestinal (GI) AEs, as well as hepatorenal and cardiovascular effects.Active pharmaceutical ingredient cost data from 2016 to 2019 were extracted from the Panjiva database and adjusted for 5% loss during production, costs of excipients, formulation, a 10% profit margin and tax. Two dosages, at 500 mg BD and a higher dose of 1100 mg three times daily (TDS), were considered. Our estimated costs were compared with publicly available list prices from a selection of countries. Results: Nine RCTs of nitazoxanide were identified for inclusion. These RCTs accounted for 1514 participants and an estimated 95.3 person-years-of-follow-up. No significant differences were found in any of the AE endpoints assessed, across all trials or on subgroup analyses of active- or placebo-controlled trials. Mild GI AEs increased with dose. No hepatorenal or cardiovascular concerns were raised, but few appropriate metrics were reported. There were no teratogenic concerns, but the evidence base was very limited.Based on a weighted-mean cost of US $61/kg, a 14-day course of treatment with nitazoxanide 500 mg BD would cost $1.41. The daily cost would therefore be $0.10. The same 14-day course could cost $3944 in US commercial pharmacies, and $3 per course in Pakistan, India and Bangladesh. At a higher dose of 1100 mg TDS, our estimated cost was $4.08 per 14-day course, equivalent to $0.29 per day. Conclusion: Nitazoxanide demonstrates a good safety profile at approved doses. However, further evidence is required regarding hepatorenal and cardiovascular effects, as well as teratogenicity. We estimate that it would be possible to manufacture nitazoxanide as generic for $1.41 for a 14-day treatment course at 500 mg BD, up to $4.08 at 1100 mg TDS. Further trials in COVID-19 patients should be initiated. If efficacy against SARS-CoV-2 is demonstrated in clinical studies, nitazoxanide may represent a safe and affordable treatment in the ongoing pandemic.
Keywords	covid19
Language	English
Publishing date	2020-04-30
Publishing country	England
Document type	Editorial
ZDB-ID	2868549-0
ISSN	2055-6659 ; 2055-6640
ISSN (online)	2055-6659
ISSN	2055-6640
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Adherence, resistance, and viral suppression on dolutegravir in sub-Saharan Africa: implications for the TLD era.

McCluskey, Suzanne M / Pepperrell, Toby / Hill, Andrew / Venter, Willem D F / Gupta, Ravindra K / Siedner, Mark J

AIDS (London, England)

2021 Volume 35, Issue Suppl 2, Page(s) S127–S135

Abstract: Dolutegravir (DTG) is now a component of preferred first-line antiretroviral therapy (ART) worldwide. ADVANCE and NAMSAL were two landmark clinical trials conducted exclusively in sub-Saharan Africa, which studied the effectiveness of DTG-based first- ... ...

Abstract	Dolutegravir (DTG) is now a component of preferred first-line antiretroviral therapy (ART) worldwide. ADVANCE and NAMSAL were two landmark clinical trials conducted exclusively in sub-Saharan Africa, which studied the effectiveness of DTG-based first-line regimens for ART-naive individuals. In this review, we examine the data from these studies to consider the contributions of adherence and HIV drug resistance to treatment failure on DTG-based ART, as compared with efavirenz (EFV)-based ART, which has a lower genetic barrier to resistance. We also discuss the implications of virologic failure on DTG and consolidate currently available data to conclude with recommendations for virologic monitoring on DTG-based ART.
MeSH term(s)	Anti-HIV Agents/therapeutic use ; HIV Infections/drug therapy ; Heterocyclic Compounds, 3-Ring/therapeutic use ; Humans ; Oxazines/therapeutic use ; Piperazines/therapeutic use ; Pyridones/therapeutic use
Chemical Substances	Anti-HIV Agents ; Heterocyclic Compounds, 3-Ring ; Oxazines ; Piperazines ; Pyridones ; dolutegravir (DKO1W9H7M1)
Language	English
Publishing date	2021-11-30
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, Non-P.H.S. ; Review
ZDB-ID	639076-6
ISSN	1473-5571 ; 0269-9370 ; 1350-2840
ISSN (online)	1473-5571
ISSN	0269-9370 ; 1350-2840
DOI	10.1097/QAD.0000000000003082
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