There is a long way to fight against AIDS, how important is a safe treatment plan?

It is only for medical professionals to read for reference.
The road to AIDS resistance is long and lasting, and the safety of drugs needs more attention
.

Since the first case of AIDS was discovered in 1981, humans have been fighting AIDS for 40 years
.

Fortunately, with the development of medicine, humans have made major breakthroughs in the treatment and prevention of AIDS.
The emergence of high-efficiency antiretroviral therapy (HAART) is a milestone in the history of AIDS treatment [1].
The human immunodeficiency virus (HIV) load is reduced to the lowest level, the patient’s immune system is rebuilt, and the infectivity of HIV-infected people is reduced.
Now AIDS has turned into a controllable chronic disease
.

People living with HIV need to take medicine for life, and safety issues cannot be ignored! As long as HIV-infected people use regular drugs for a long time, they can effectively prolong their lives and improve their quality of life.
Unfortunately, there is no cure for AIDS.
HIV-infected people need to face life-long antiretroviral therapy to maintain virological suppression
.

In this case, the possible toxic and side effects of antiretroviral drugs (ARV) on the human body need to be considered more importantly
.

 Adverse drug reactions will not only reduce the patient's treatment compliance, but also increase the risk of drug withdrawal and drug resistance.
In the long-term treatment process, its impact on the patient's mental health and quality of life should also not be ignored
.

On the basis of strong virus suppression, anti-AIDS drugs that have less toxic and side effects on various organs and tissues of the body, safe and easy to tolerate, and convenient to take have become an urgent need for HIV-infected people
.

 Innovative compound single-tablet preparations for "AI" long-distance race In recent years, a variety of new anti-AIDS drugs have entered the global market, providing HIV-infected people with a variety of choices
.

The current domestic antiretroviral drugs include nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), integrase inhibitors (INSTIs), and protease inhibitors (PIs).
) And five categories of fusion enzyme inhibitors (FIs) [2]
.

 Double NRTI backbone drug emtricitabine/propofol tenofovir (F/TAF) and innovative INSTI drug Bictegravir (BIC) combined with a strong combination of single-tablet compound than enbrinox tablets (B /F/TAF), with the characteristics of excellent curative effect, good safety, and convenient taking, it provides a powerful treatment weapon for clinicians and HIV-infected patients [3]
.

 Figure 1: Schematic diagram of the effective ingredients of B/F/TAF From the point of view of the mechanism of action, the innovative backbone drug TAF, one of the effective ingredients of B/F/TAF, can greatly reduce nephrotoxicity [4,5]
.

TAF is a new prodrug of tenofovir (TFV).
It has a relatively long half-life in plasma after being absorbed through the gastrointestinal tract.
Most of the TAF will enter the lymphocytes to exert antiviral effects, so TAF only needs to be taken orally 25mg can achieve the same antiviral effect of 300mg tenofovir disoproxil fumarate (TDF), while the concentration of TFV produced in the plasma is reduced by 90%, thereby reducing the impact on the kidney and bone
.

Therefore, TAF can improve the safety of kidney and bone while ensuring the curative effect
.

 Figure 2: Schematic diagram of the metabolic pathway of TAF in the human body.
In addition, B/F/TAF and a variety of cardiovascular drugs, central nervous system drugs, antidepressants, contraceptives, antiplatelet aggregation and anticoagulation drugs, and antihypertensive drugs The interaction is small [6], and most drugs do not need to be monitored and dose adjusted when used in combination
.

 The 4-year follow-up showed that the dual advantages of B/F/TAF efficacy and safety highlighted this year, and the 4-year research data of B/F/TAF has been published [7]
.

The results of this 4-year follow-up showed that at week 192, 99.
2% of B/F/TAF subjects were able to achieve virological suppression (HIV-1 RNA <50c/ml, M=E analysis)
.

 Figure 3: The virological suppression of study 1489 and study 1490 at week 192.
A summary analysis of studies 1489 and 1490 showed that [7] there was no proximal renal tubular disease or renal function-related arrest after 192 weeks of B/F/TAF use.
The medicine happened
.

In addition, the 1489 study showed that during 192 weeks of treatment, the bone safety of B/F/TAF was good [8], and the bone mineral density of the spine and hip was only slightly lower than the baseline, and the 4-year average change was ≤-1.
4%
.

 Figure 4: Estimated glomerular filtration rate (eGFR) change from baseline Figure 5: Bone safety in the B/F/TAF group at 192 weeks (only included participants who were initially randomly assigned to the B/F/TAF group ) At 192 weeks, the use of B/F/TAF treatment for newly-treated HIV-1 adult infected patients continued to be safe and good, and the proportion of discontinuation due to adverse events (AE) was ≤2% [7].
The 4-year follow-up results verified B /F/TAF Good long-term safety
.

 Table 1: At 192 weeks, the occurrence of adverse events of B/F/TAF in newly-treated HIV-1 adult infected persons The conversion of treated HIV-infected patients to B/F/TAF is equally safe and well tolerated.
The withdrawal rate of treated infected patients due to AEs is less than 1%, and there is no withdrawal event due to bone and kidney safety
.

 Figure 6: Summary of the occurrence of AEs in the 1844 and 1878 studies.
In the long road to AIDS, it is not only necessary to ensure the long-term efficacy of the drug, but also the safety of special attention.
Good safety can improve treatment compliance and reduce The risk of drug withdrawal and resistance
.

The long-term efficacy and safety of B/F/TAF have been verified during the four-year follow-up, and one tablet a day is convenient to take
.

 What is particularly gratifying is that on December 3, 2021, the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2021)" was officially announced, and B/F/TAF successfully entered the national medical insurance catalog, which means that B/ The accessibility of F/TAF will be greatly improved, and HIV-infected people will be able to enjoy efficient, safe and convenient treatment options at a more affordable price, and embrace a higher quality of life
.

 Reference materials: [1] Liang Wanning, Wang Yun, Huang Hailing, Peng Junyun.
Analysis of the safety and efficacy of HAART in the treatment of AIDS patients[J].
Chinese Pharmaceutical Affairs,2017,31(08):965-968.
[2]China AIDS diagnosis and treatment guidelines (2021 edition)[J].
China AIDS and STDs,2021,27(11):1182-1201.
[3]https:// AS , et al.
Antiviral Research.
2016;125:63-70.
[5]Ruane PJ, et al.
J Acquir Immune Defic Syndr 2013;63:449–455.
[6]European AIDS Clinical Society.
Guidelines ver10.
1.
Oct, 2020.
[7]Collins, Sean (Hindman, Jason).
CROI 2021 Poster 2268.
[8]Workowski K, et al.
vCROI 2021.
Poster 415.
[9]Rockstroh J, et al.
HIV Drug Therapy 2020.
Glasgow.
P036.
[10]Brar I, et al.
IDWeek 2020.
Poster#1028.
This information is for medical and scientific reference only.
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