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Q&A about COVID-19, HIV and antiretroviral in Indonesia

1. What is COVID-19?
COVID-19 is an infectious disease caused by new strain of coronavirus. This virus is unknown of origin before an outbreak in Wuhan, China, on December 2019.

2. Does people with HIV have higher risk of getting infected with COVID-19?

People with HIV who has not reach virus suppression through antiretroviral treatment would be prone to opportunity infection and would have declining progress, because of low immune system. But for now there has not been proof that there was an incline risk of infection by COVID-19 and declining health among PLWHA. At this time there has not been a single case of COVID-19 infection been reported among PLWHA, although that could change at any moment when the virus is spreading rapidly. It was reported when there was an outbreak of SARS and MERS a while ago, only few mild cases been reported in among PLWHA.

Current clinical data showed mortality factors of COVID-19 including elderly person and other co-morbidity with the likeness of cardiovascular disease, diabetes, chronic obstructive pulmonary disease and hypertension. A person with excellent health also being reported infected by coronavirus.

PLWHA who knows their HIV status, is advised to take prevention steps like any regular population (frequent hand washing, cough ethics, avoid touching your face, keep your distance, seek medical advice if symptomatic, self isolation if being contact with someone with COVID-19, and other measure of precaution regulated by the government). PLWHA who using ARV medications, should make sure they have minimum 30 days worth of stocks if 3 or 6 month of supply is not available and make sure they vaccine status is renewed (flu vaccine and pneumococcus).

It is important to make sure for PLWHA should start ARV therapy if has not been before. To other people who feel have higher risk, is advised to seek medical attention for diseases related to HIV can be controlled and reducing risks of complications of other disease.

WHO Guidance about COVID-19: WHO Guidance on the COVID-19 outbreak
WHO country and technical guidances: WHO country and technical guidance

3. Can ARV used to treat COVID-19?

Several studies had suggested that patient with SARS-CoV-2 infected, a virus that cause COVID-19, and coronavirus infection related (SARS-CoV and MERS-CoV) have good clinical result, with almost all cases have fully recovered.. On some cases, patient were given antiretroviral drug: lopinavir which strengthened by ritonavir (LPV/r). This research has been applied to a greater number of people with HIV-negative status.

It is worth noting that this research which using LPV/r has limited resources. The research was minimal, time, duration and dosage for the treatment were variable and most of the patient received intervention or other treatment that might contribute to the reported clinical result.

Meanwhile, the benefits of using ARV for COVID-19 treatment is unclear. It has been reported to have serious side effects that rarely happened. Between PLWHA, a routine usage of LPV/r as HIV therapy had moderate toxicity. A minimum LPV/r side effects to the treatment of COVID-19 been reported in, this caused by short-term duration of treatment.

4. Can ARV used to prevent COVID-19 infection?

Two studies had reported using LPV/r as post-exposure profilaxis for SARS-CoV and MERS-CoV. One of the studies showed that there is lower infection rate of MERS-CoV to the health workers who received LPV/r compared to them who did not received any treatment at all. Other research had not found SARS-CoV infection case between 19 PLWHA who treated in the same ward as SARS patient, 11 of whom using antiretroviral therapy. Once more, the strength of the available evidence is very low, due to the small sample size, drugs variability, and uncertainty regarding exposure intensity.

5. What studies regarding the treatment and prevention of COVID-19 with ARVs are being planned ?

Few random clinical trials, was planed to evaluate the safety and efficacy of using antiretroviral drugs, especially LPV/r – to treat COVID-19, combined with other medications. The result will be expected on mid-2020 and forward.

6. What is WHO stand on clinical trial/research while the pandemic is in progress /

WHO provides support and guidance to scientific community and welcomes studies and an effective test development, vaccine, medications and other intervention for COVID-19.

For public health emergencies, WHO has a systematic and transparent process used for research and development, including clinical trials for new drugs and vaccines. “WHO R&D Blueprint” for COVID-19, which began on January 7th, 2020, will function as a gloval strategy for R&D activities. The aim is to quickly track availability of effective tests, vaccines and medicines that can be used to save lives and preventing large-scale crisis..[1] As part of this, WHO is leading the global priority setting of vaccine and treatment candidates for development and evaluation. To support testing, WHO invites Scientific Advisory Group/SAG) to develop guidelines on good trial design for experimental vaccine and treatment [2] [3]

WHO actively follows ongoing clinical trials for current antivirus and other medications for treating COVID-19. WHO continue to emphasize that all clinical trials should follow standard ethical and strict regulation. Regulatory authorities has important role to ensure strict supervision to all clinical trials to be conducted.

7. What is the WHO position regarding the use of evidence from initial research results or treatments that have not been proven to intervene?

Many pathogen agents are currently shown to have no effective intervention. Several intervention on laboratory and animal testing shown promising result for several pathogen germs, and clinical trials are needed to provides reliable evidence to be used on human before official recommendation can be made.

WHO had developed evaluation and listing procedure (Emergency Use Assessment and Listing /EUAL) for drug candidates or other health products that can used for public health emergencies. This procedure was created to provide guidelines to national regulatory authorities.

These procedures can be used to speed up drug availability in public health emergencies. In this situation community might be willing to accept deficiencies related to product’s effectivity and safety considering the morbidity and mortality of the disease as well as lack of treatment and/or preventive options.[4]

In pandemic context which marked with high mortality rate, it might be ethically appropriate to offer experimental intervention to every patients in emergency situation outside the rules of clinical trials, provide that [6]

  • There is no proven effective treatments;
  • It is impossible to start a new clinical studies;
  • Current data gives out basic support for the efficacy and safery intervention, at least from laboratory studies or animal testing, and the use of intervention outside clinical trials has been suggested by scientific advisor committee based on favorable risk-benefit analysis;
  • A relevant national authority, and ethical committee that meet the requirements, have agreed to the use;
  • An adequate resources available to ensure that risks can be minimized;
  • The patient has given consent; and,
  • The use of emergency intervention is monitored, and its results are documented and share in a timely manner with wider medical and scientific communites;

The use of experimental intervention in this circumstances is referred to as “”The Monitored and unregistered Emergency Use of Experimental Interventions” (MEURI) [7].

8. What is WHO position on using ARVs for COVID-19 treatment ?

At present, there are no enough data to assess the effectiveness of LPV/r or other antivirus to treat COVID-19. Several countries is currently evaluated the use of LPV/r and other antivirus and we welcome this result of investigation.

Once more, as part of WHO responses to the outbreak, WHO R&D Blueprint [8] has been activated to speed up diagnostic evaluation, vaccine and therapy for the new coronavirus. WHO also had designed a series of procedures to asses the performance, quality, and safety of medical technology during emergency situations.

9. What is WHO position on the use of corticosteroids for COVID-19 treatment ?

Current guidelines from WHO for clinical management for acute respiratory infections when suspected COVID-19 infection is advised not to use corticosteroids unless they have other strong medical indications. [9].

This guideline based on several systematic reviews that mention the lack of effectiveness and possible danger from routine treatment with corticosteroids for pneumonia virus or acute respiratory distress syndrome.

10. If a country uses ARVs for COVID-19, are there any concerns about lack of treatments for people living with HIV ?

Antiretroviral is an effective treatment with high tolerance level for PLWHA. LPV/r antiretroviral is currently being investegated as possible treatment for COVID-19.

If LPV/r will be used for treatment of COVID-19, there must be a plan to ensure an adequate and sustainable supply-chain management to meet the all PLWHA needs who already using LPV/r and to those who need to start treatment.
Proportions of LPV/r usage for substitute therapy or second-line therapy is relatively small on general ARV treatment. Every country that allows the use of HIV medicines must ensure an adequate and sustainable supplies.

10. Human rights, stigma and discrimination.

As the world improves public health response to the COVID-19 pandemic, countries are urged to take decisive action to control the epidemic. WHO had urged all countries to make sure a right balance between protecting health, prevents social and economy disruption, and respecting human rights.

WHO works with partners including UNAIDS Joint Programme and Global Network of People Living with HIV to ensure that human rights are not eroded in response of COVID-19 and to ensure for people affected with HIV is offered the same treatment as everybody else and to ensure HIV-related services continue without disruption.

11. Prescription for more that 1 month.

A simplification of ARVs regimen, prescription of ARVs more that 1 month (3-6 months) for adult patient, children, adolescents, and pregnant woman and stable breastfeeding mother including including key populations (key drug users / IDUs) ), sex workers, male sex men (MSM), transsexuals and inmates / prisons and those who live in closed environment) provide benefits for logistics sustainability and will reduce visitations frequency and will reduce the possibility of exposure or giving out coronavirus exposure during the outbreak.

Original articlei: Pertanyaan dan jawaban terkait COVID-19, HIV dan antiretroviral di Indonesia.Access on June 15. 2020.

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