I. Criteria for determining treatment failure to change medication
(a) The inclusion criteria for treatment failure change cases.
Patients previously receiving first-line treatment must have the following two conditions before they can be considered for a new treatment regimen.
1, to determine that the patient has good compliance with the medication, changing the second-line treatment regimen is not an emergency measure, and patient compliance must be assessed beforehand.
2. The patient has received a first-line regimen for at least 12 consecutive months.
The corresponding criteria for the timing of drug change are now set according to the different testing capacity in different places. It can be based on drug resistance testing, viral load (VL), immunology, WHO clinical staging, etc.
1. For patients with VL>1000 copies/ml, it is recommended to first educate patients on compliance, confirm good compliance, and review again after 3 months of medication, if VL decreases >1log:. copies/ml, follow-up observation can be continued. If there is no significant decline (<110gm1), drug resistance testing is performed.
2. Diagnostic immunological failure criteria (at least one of the following criteria is met, except for the special labeled criteria for patients under 5 years of age, which apply to patients of all ages).
(1) CD4+ T-lymphocyte count below the baseline level prior to initiation of first-line therapy (2 consecutive times, more than 3 months apart).
(2) CD4+ T-lymphocyte count decreases >5 0% from peak treatment or cD4% below the threshold for severe immunosuppression for that age group on 2 consecutive occasions (more than 3 months apart) (patients <5 years of age).
(3) For continuous treatment for more than one year cD4+ T lymphocyte counts have not reached 100 cells/∪l or CD4% rise < 5% (patients < 5 years of age). (Confirmation of medication adherence and viral load testing is recommended to be alert for poor immune reconstitution.)
3, VL results are recommended to confirm good compliance and recheck after 3 months of medication and still exceed 10,000 copies/ml before considering meeting the virological criteria for drug change.
In view of the complexity of the timing of drug replacement, the existing clinical staging, CD4+ T lymphocyte count and VL cannot yet fully and accurately assess whether drug resistance has occurred in patients, so resistance testing should be sought for patients as much as possible.
(ii) Recommended replacement second-line drug regimens.
For patients with a previous regimen of d4T/AzT+3TC/ddI+NVP/EFV, the second-line replacement regimen is TDF (pediatric ABC)+3TC+LPV/r when the above replacement criteria are met. patients who have been replaced with a regimen that includes IDV, the regimen is directly replaced with TDF+3TC+LPV/r.
Individualized drug replacement is possible when resistance testing results are available. Patients with resistance mutation sites showing: 3TC is continued in case of M184V site mutation; if only NNRTIs (non-nucleoside reverse transcriptase inhibitors) mutations are present without any NRT I s (nucleoside reverse transcriptase inhibitors) mutations, NNRTIs can be replaced with LPV/r only; if NRTIs are highly resistant, although they may not be sensitive to TDF, they are still replaced with TDF. Because of the complexity of interpreting drug resistance test results, it is recommended to be done by experienced clinical experts.
2. Criteria for drug side effects
After receiving first-line antiviral drug regimen, if some serious or irreversible side effects occur, first consider choosing drugs from the first-line drug list.
For the occurrence of other toxic side effects requiring drug replacement, the decision will be discussed at the discretion of each expert group. When considering drug replacement due to toxic side effects, it should be noted that individual drugs can be replaced only when VL
1. Drug toxicity and side effect monitoring. Before deciding to use TDF, renal function should be tested, and for patients with impaired renal function the dosage can be adjusted according to creatinine clearance under expert guidance, and renal function tests should be performed every 3-6 months during the use of TDF. TDF is not currently approved for use in patients younger than 18 years of age. Pediatric patients should be alert to the occurrence of hypersensitivity reactions after using ABC, and once hypersensitivity reactions are diagnosed, the use of ABC again should be prohibited. patients using LPV/r should pay attention to monitoring blood lipids (including triglycerides and cholesterol, etc.), in addition, because the use of LPV/r in patients with hemophilia may aggravate bleeding tendency, so close monitoring should be noted.
2. The use of cotrimoxazole. For treatment failure, patients with CD4+ T lymphocyte count <200/UL need to be given cotrimoxazole prophylaxis again and discontinued only when CD4+ T lymphocytes are >200/u L and stable for 3-6 months.
3. When using a regimen containing LPV/r, if the patient develops tuberculosis and the LPV/r AUC is reduced by more than 75% due to rifampin, measures such as using rifabutin instead of rifampin, stopping treatment or not using a regimen containing rifampin should be discussed with the specialist.
4. On the discontinuation of drugs. For patients with co-infection with HBV discontinuation of drugs containing TDF, 3TC, etc., should be alert to the problem of HBV virus rebound. When discontinuing the drug regimen containing klepto, all drugs can be discontinued at the same time.
5, try to avoid the use of TDF + 3TC + NVP combination. The results of current clinical studies show that this combination has a poor viral suppression effect and should be avoided as much as possible.
6, If resistance testing is performed on patients who discontinue the drug, it must be done within 6 weeks after discontinuation.