New Delhi: After halting the trials of anti-malarial drug hydroxychloroquine (HCQ), the World Health Organization announced Saturday that it will also discontinue the arm of anti-HIV drugs lopinavir and ritonavir in its Solidarity Trial, after the combo showed little impact on reducing the mortality rate among hospitalised Covid-19 patients.
“WHO today accepted the recommendation from the Solidarity Trial’s International Steering Committee to discontinue the trial’s hydroxychloroquine and lopinavir/ritonavir arms,” WHO said in a statement on 4 July.
The Solidarity Trial was established by the WHO to find an effective Covid-19 treatment for hospitalised patients, and India is also one of the participants of the trial.
This comes just days after the UK’s largest drug trial, RECOVERY, also showed that the lopinavir-ritonavir combination does not have any impact on reducing mortality of hospitalised patients and discontinued its use in its trial.
WHO’s decision was taken by the International Steering Committee — a group of independent experts — after reviewing the evidence from all trials at the WHO Summit on Covid-19 research and innovation on 1 and 2 July.
“These interim trial results show that hydroxychloroquine and lopinavir/ritonavir produce little or no reduction in the mortality of hospitalized COVID-19 patients when compared to standard of care. Solidarity trial investigators will interrupt the trials with immediate effect,” it said.
Decision applies only to hospitalised patients
The Solidarity Trial conducted in over 35 countries with more than 3,500 patients started with four drugs — hydroxychloroquine, remedesivir, lopinavir/ritonavir and arm of lopinavir/ritonavir with interferon beta-1 a.
WHO had earlier halted the HCQ arm of the trial on 17 June after results of the UK’s RECOVERY trial and a review of other evidence showed the drug did not improve mortality as compared to standard of care in hospitalised patients.
WHO’s recent statement also clarified that the decision only applies to the hospitalised patients and “does not include the possible evaluation of other studies of HCQ and lopinavir/ritonavir in non-hospitalised settings or as pre or post exposure prophylaxis”.
The anti-HIV drug combination of lopinavir and ritonavir is not a part of India’s revised guidelines for management of Covid-19.
However, HCQ, which was shown to be ineffective in reducing mortality in both RECOVERY and WHO’s interim analysis, is still recommended for use in India for mild and moderate patients in early stages of the disease, even in its latest guidelines issued on 3 July.
Meanwhile, the interim Solidarity results are also being readied for peer-reviewed publication, the WHO added.