CME INDIA Presentation by Dr N K Singh, Admin, CME INDIA.

Experts seem to be divided on 2 issues widely – Hydroxyquinoline (HCQ) and Favipirvir.

Evidence based medicine
Courtesy: Dr Satish Kumar, Bokaro

See this comment:

Dr Awadhesh K Singh, DM endo., Kolkata says: this should have been stopped at least 3 months ago. Patients and physician both have gone crazy! We even wrote an editorial for such behaviour. Sending the latest meta-analysis of RCT with HCQ found no benefit and HCQ plus AZ having increased mortality! Thus, please stop it immediately. We alerted about increased mortality 3 month back but unfortunately to deaf ears.

As ICMR endorsement still stands on HCQ and observational data/opinions find benefit, it is widely used. Moreover, one viral WhatsApp post corelates HCQ use responsible to high mortality among doctors. Physicians differ on this issue.

CME INDIA Discussion:

Dr Hem Shankar Sharma, Bhagalpur questions: How many doctors in India, have taken HCQS? How many weeks they have taken? ECGs of these doctors, before and after, or during the treatment??  RCTs on Doctors treatment, co-morbidities?

Dr Mritunjay Kumar Singh, Gaya says: Increased mortality in doctors is a kind of occupational hazards (high viral load and repeated exposure). This phenomenon is seen worldwide, even in countries where HCQS prophylaxis is not in use .so it is premature to blame HCQS, rather we should try to improve our work place and culture to avoid occupational hazard continuously.

Dr. Suresh, Infectious disease specialist, Chennai, has just now endorsed: Low dose HCQS started early in disease is beneficial, Dr A.K. Virmani, Jamshedpur informs (16.09.20).

Dr R Rajasekar, Kumbakonam: One of my Classmates an Endocrinologist Dr Sivagnanasundaram of Chennai Apollo Hospital asked me about HCQ. My reply – Dear Dr. Sivagnanam, I have been prescribing HCQ, even for DM patients. I have had no single case of QT interval prolongation. The vital point is selection of patients before prescribing a drug plays a role. Patients on Nortriptyline, CAD, Tachycardia patients, we are to be careful. Everything has its own limitations. See we can’t jump a shadow of a rope as if it is a snake and we can’t keep our foot over as if it is a simply a rope –a famous Tamil Proverb.

While this debate is not settled, Ivermectin silently entered the scene and now seems to be most widely drug used in COVID.

At present, while remdesivir use is almost settled in physician’s mind, use of Favipirvir is stormed to great extent and important guidelines not mentioning it till now.

Dr Ritesh Chaudhary, Diabetologist, Kanpur asks: Is there any meta-analysis on favipiravir?? It is being sold in Kanpur like potato 🥔

Dr Awadhesh K Singh, DM endo., Kolkata: At least HCQ had some promise and found beneficial in small retrospective studies although that didn’t materialise finally. Potato feeds your tummy but Favipiravir burns your pocket. Yes, blue coloured cornea looks aesthetically nice 😜 for meta-analysis you need to have a fair number of studies. How many studies have been done for Favipiravir worldwide?

In God we trust, all others bring data
Courtesy: Dr Satish Kumar, Bokaro

In 2014, Favipiravir was approved in Japan for use in the event of an outbreak of novel or re-emerging influenza viral infections, where other influenza antiviral drugs are either not or insufficiently effective Favipiravir is a broad-spectrum oral antiviral drug that selectively inhibits RNA-dependent RNA polymerase (RdRp) and the viral replication phase of SARS-CoV-2, and is being studied in multiple ongoing international clinical trials.

Status of Favipiravir

Phase 3 Trial Demonstrates Statistically Significant Faster Time to Clinical Improvement with Favipiravir Treatment in Mild to Moderate COVID 19 Patients Compared to Control.

Dose used: Favipiravir tablets 3,600 mg (1,800 mg BID) (Day 1) + 1,600 mg (800 mg BID) (Day 2 or later) for up to maximum of 14 days, along with standard supportive care.

As Glenmark reports:

  • Results from the Phase 3 trial showed numerical improvements for the primary efficacy endpoint with 28.6% faster viral clearance in the overall population as measured by the median time until cessation of oral shedding of virus in the Favipiravir treatment arm compared to those in the control arm (Hazard Ratio 1.367 [95%CI 0.944,1.979]; p=0.129).
  • 40% faster achievement of “clinical cure” defined as the physician’s assessment of normalization of clinical signs – temperature, oxygen saturation, respiratory rate and cough with a statistically significant reduction in median time to clinical cure in the Favipiravir treatment arm (3 days [95%CI 3.0, 4.0]), compared to the control arm (5 days [95%CI 4.0,6.0]) (HR 1.749 [95% CI 1.096, 2.792]; p=0.029). 69.8% of patients in the Favipiravir treatment arm achieved clinical cure by Day 4, which was statistically significant compared to 44.9% observed in the control arm (p=0.019).
  • Glenmark is also conducting another Phase 3 clinical trial in India to evaluate the efficacy of two antiviral drugs Favipiravir and Umifenovir as a combination therapy in moderate hospitalized adult COVID-19 patients. The combination study, which is called the FAITH trial, is looking to enroll 158 hospitalized patients of moderate COVID-19. Early treatment with combination therapy will be evaluated for safety and efficacy.

Knowing the final result:

CME INDIA Learning Points:

  • Message is quite obvious: Favipiravir no better than Usual Care.
  • Nothing is crystal clear; Science is trying to understand this new virus and specific therapies.
  • Apply your own wisdom in desperate times; might be a justified approach.

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