Minimum costs to manufacture new treatments for COVID-19

Hill, Andrew; Wang, Junzheng; Levi, Jacob; Heath, Katie; Fortunak, Joseph

doi:10.1016/s2055-6640(20)30018-2

Cited by 75 publications

(66 citation statements)

References 24 publications

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“…The price of Remdesivir is unknown at this time, but the drug is patented. It is only known that the basic production of the molecule it uses costs about 12 times more than that of hydroxychloroquine (Hill et al., 2020). It is also a much more expensive intravenous injection and a longer treatment.…”

Section: The Price Of Influence the Cost Of Treatmentmentioning

confidence: 99%

Behind the French controversy over the medical treatment of Covid-19: The role of the drug industry

Mucchielli

2020

Journal of Sociology

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This article explores the stakes of the very intense controversy that has developed in France around the medical treatment of Covid-19 (which finds some parallels in the United States of America). It centres on the therapeutic proposal of a Marseilles doctor, who has become a very divisive ‘star’ in public debates over the efficacy of treatment. The author shows that competition between this doctor’s proposal and the commercial hopes of a major pharmaceutical company plays an important role. This company has managed to create links of interest with many other major doctors, some of whom are at the heart of the decision-making process concerning the management of the health crisis. Finally, the author places this episode within the broader question of the hold the drug industry has on scientific production within the medical field. The interdependence between health authorities and the pharmaceutical industry is anything but healthy. The Covid-19 debate conforms to a well-worn pattern of behaviour: public backlash over the transgressions of wealthy corporate actors, government regulatory responses insisting on greater levels of transparency, corporate circumvention of said regulations, resulting in the continuation of fraud and corruption.

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Section: The Price Of Influence the Cost Of Treatmentmentioning

confidence: 99%

Behind the French controversy over the medical treatment of Covid-19: The role of the drug industry

Mucchielli

2020

Journal of Sociology

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“… 9–11 In addition to efficacy and safety, a potential treatment option for COVID-19 must be widely available and affordable—the estimated API production cost of generic sofosbuvir/daclatasvir is approximately $5 per 14 day treatment course. 12 The current guideline in Iran recommends conservative management with or without hydroxychloroquine, but sofosbuvir/daclatasvir has yet to be tested in an outpatient setting. We therefore conducted a randomized active-controlled trial to evaluate the effectiveness and safety of adding sofosbuvir/daclatasvir to the routine protocol of COVID-19 outpatients.…”

Section: Introductionmentioning

confidence: 99%

Sofosbuvir and daclatasvir for the treatment of COVID-19 outpatients: a double-blind, randomized controlled trial

Roozbeh

Saeedi

Alizadeh‐Navaei

et al. 2020

Journal of Antimicrobial Chemotherapy

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Introduction Effective treatments are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). This trial aims to evaluate sofosbuvir and daclatasvir versus standard care for outpatients with mild COVID-19 infection. Methods This was a randomized controlled clinical trial in outpatients with mild COVID-19. Patients were randomized into a treatment arm receiving sofosbuvir/daclatasvir plus hydroxychloroquine or a control arm receiving hydroxychloroquine alone. The primary endpoint of the trial was symptom alleviation after 7 days of follow-up. The secondary endpoint of the trial was hospital admission. Fatigue, dyspnoea and loss of appetite were investigated after 1 month of follow-up. This study is registered with the IRCT.ir under registration number IRCT20200403046926N1. Results Between 8 April 2020 and 19 May 2020, 55 patients were recruited and allocated to either the sofosbuvir/daclatasvir treatment arm ( n = 27) or the control arm ( n = 28). Baseline characteristics were similar across treatment arms. There was no significant difference in symptoms at Day 7. One patient was admitted to hospital in the sofosbuvir/daclatasvir arm and four in the control arm, but the difference was not significant. After 1 month of follow-up, two patients reported fatigue in the sofosbuvir/daclatasvir arm and 16 in the control arm; P < 0.001. Conclusions In this study, sofosbuvir/daclatasvir did not significantly alleviate symptoms after 7 days of treatment compared with control. Although fewer hospitalizations were observed in the sofosbuvir/daclatasvir arm, this was not statistically significant. Sofosbuvir/daclatasvir significantly reduced the number of patients with fatigue and dyspnoea after 1 month. Larger, well-designed trials are warranted.

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“…12 Sofosbuvir/daclatasvir is widely available in generic formulations costing $6 per 14 day treatment course of 400/60 mg (India). 13 …”

Section: Introductionmentioning

confidence: 99%

Sofosbuvir/daclatasvir regimens for the treatment of COVID-19: an individual patient data meta-analysis

Simmons

Wentzel

Mobarak³

et al. 2020

Journal of Antimicrobial Chemotherapy

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Background The combination of sofosbuvir and daclatasvir has a well-established safety profile and improves clinical outcomes in HCV patients. In silico and in vitro studies suggest that sofosbuvir/daclatasvir may show antiviral activity against SARS-CoV-2. Methods Three clinical trials comparing sofosbuvir/daclatasvir-based regimens with a comparator in hospitalized COVID-19 patients were combined in a meta-analysis. The primary outcomes measured were clinical recovery within 14 days of randomization, time to clinical recovery and all-cause mortality. A two-step approach was used to analyse individual-level patient data. The individual trial statistics were pooled using the random-effects inverse-variance model. Results Our search identified eight studies of which three met the inclusion criteria (n = 176 patients); two studies were randomized and one was non-randomized. Baseline characteristics were similar across treatment arms. Clinical recovery within 14 days of randomization was higher in the sofosbuvir/daclatasvir arms compared with control arms [risk ratio = 1.34 (95% CI = 1.05–1.71), P = 0.020]. Sofosbuvir/daclatasvir improves time to clinical recovery [HR = 2.04 (95% CI = 1.25–3.32), P = 0.004]. The pooled risk of all-cause mortality was significantly lower in the sofosbuvir/daclatasvir arms compared with control arms [risk ratio = 0.31 (95% CI = 0.12–0.78), P = 0.013]. Conclusions Available evidence suggests that sofosbuvir/daclatasvir improves survival and clinical recovery in patients with moderate to severe COVID-19. However, the sample size for analysis was relatively small, one of the trials was not randomized and the designs were not standardized. These results need to be confirmed in larger randomized controlled trials.

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Minimum costs to manufacture new treatments for COVID-19

Cited by 75 publications

References 24 publications

Behind the French controversy over the medical treatment of Covid-19: The role of the drug industry

Behind the French controversy over the medical treatment of Covid-19: The role of the drug industry

Sofosbuvir and daclatasvir for the treatment of COVID-19 outpatients: a double-blind, randomized controlled trial

Sofosbuvir/daclatasvir regimens for the treatment of COVID-19: an individual patient data meta-analysis

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