With the number of Covid-19 diseases skyrocketing in China, effective drug therapy would be particularly important at this time. Chinese scientists now claim that a form of the active ingredient remdesivir that is suitable for swallowing has shown no worse results than the well-known Paxlovid (Pfizer) in the West in the treatment of high-risk patients.
Remdesivir, an inhibitor of the viral polymerase enzyme of SARS-CoV-2 and related coronaviruses, was one of the first drugs to treat Covid-19. However, its use has so far been limited to hospitals, as it is only available as an infusion. The drugs Paxlovid (nirmatrelvir-ritonavir, protease inhibitor) and molnupiravir, which can be taken orally, were therefore mainly available to prevent serious disease progression.
Found a swallowable alternative
In any case, worldwide efforts have been made to develop active ingredient variants of remdesivir that are suitable for daily intake in swallowable dosage forms (capsules, tablets). The Chinese pharmaceutical company Junshi Biosciences (Shanghai) did. A few days ago (December 28; DOI: 10.1056/NEJMoa2208822), the internationally respected medical journal “New England Journal of Medicine” published a Phase III efficacy study comparing the treatment of high-risk Covid-19 patients between Paxlovid and the remdesivir variant (VV116).
Successful comparison with Paxlovid
A total of 384 study participants were randomized to receive oral VV116 (600 milligrams every 12 hours on day one, then 300 milligrams every 12 hours on days two through five) or Paxlovid (300 milligrams nirmatrelvir and 100 milligrams ritonavir each) for five days every twelve hours for five days). The study participants had an average age of 53 years, 92 percent suffered from mild Covid 19 symptoms. Three quarters of the subjects had been vaccinated against SARS-CoV-2. The main risk factors were age over 60 years (almost 38 percent), a body mass index over 25 (almost 33 percent), smoking (12.5 percent) and diabetes (just over ten percent).
The main criterion for assessment was the patient’s recovery time (no or almost no symptoms for two days). Both forms of treatment were about the same here. In the group treated with the remdesivir variant, patients recovered on average after four days. This was the case after an average of five days with Paxlovid treatment.
Remdesivir with fewer side effects
“Among adults with mild to moderate disease from Covid-19 and at risk of severe disease, VV116 (oral remdesivir) was no worse than nirmatrelvir-ritonavir (Paxlovid) in time to sustained recovery, but with fewer side effects,” Zhujun Cao wrote. (Shanghai Jiao Tong University School of Medicine) and co-authors in the New England Journal of Medicine.
“In a final analysis, there were no differences in time to sustained symptom resolution, nor was time to first negative SARS-CoV-2 test significantly different between the two groups. There were no serious Covid 19 illnesses and no deaths,” the Deutsches Ärzteblatt wrote. The tolerability of the oral drug remdesivir was even slightly better than with paxlovir. Unlike Paxlovid, which has numerous potential interactions with other commonly used drugs that can be observed when prescribed, remdesvir does not seem to have this problem.
No approval pending for Europe
The results of a phase III trial usually form the basis for approval. However, the manufacturer has not applied for this in the US or Europe, the German medical newspaper wrote. VV116 could therefore mainly be used in China and other countries where Paxlovid is not available. “According to the results of the study, it should be an equivalent, if not better, alternative,” said the German medical journal.
Source: Krone
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