It is understood that this article should be the first to evaluate the short-term efficacy and safety of BIC/FTC/TAF. This retrospective cohort study showed that the virological inhibition rate of ART-naïve was 86.3% after 24 weeks. Previous studies have shown that high viral load at baseline leads to delayed virus suppression and increased chances of virology failure [11, 12]. The same trend was observed in this study. Subgroup analysis of baseline viral load showed that the higher the baseline viral load, the lower the 24-week virological inhibition rate. The analysis of different CD4 cell count stratification shows that patients with baseline CD4 > 200 and CD4 ≤ 200 have similar virological inhibition rates at 24-week, which means that BIC/FTC/TAF can achieve the same curative effect in patients with advanced AIDS, which is very important for southwest China, where the situation of late detection is severe. Patients with different baseline characteristics can achieve similar curative effect, indicating that BIC/FTC/TAF can be used to start antiviral therapy quickly. In addition to a positive impact on the long-term prognosis of HIV-1-infected people, it could faster achieve virological inhibition to control the risk of HIV transmission [13–15]. Among the patients with normal CD4 count and better treatment, a low CD4/CD8 ratio was an independent risk factor for serious non-AIDS events and mortality. Meanwhile, the low CD4/CD8 ratio during ART may indicate persistent immune dysfunction and inflammation. Therefore, the simultaneous monitoring of CD4 count and CD4/CD8 ratio could comprehensively reflect the immune status of the body [16]. Our results revealed that after 24-week of BIC/FTC/TAF treatment, the ART-naïve achieved significant immunological changes. CD4 count increased significantly simultaneously as CD4/CD8 ratio [7–10, 17].
This study found that after 24-week of treatment, the creatinine of patients increased to a certain extent compared with the baseline level, while the CKD-EPI Scr decreased to a certain extent, but it was still at a normal level. The possible reason was that BIC increased serum creatinine by inhibiting the renal transporter OCT-2 [18]; however, this did not reflect the true level of glomerular filtration rate and renal function decline. In addition, we did not find any adverse renal events or patients who stopped taking drugs because of renal function problems. After 24-week of BIC/FTC/TAF treatment, there was no significant change in body weight compared with the baseline, which was different from the results of Emond et al.[19], During the same period, the median body weight increased more than that of GS-US-380-1489 and GS-US-380-1490 studies. The possible reason is that 36.3% of the patients included in this study have opportunistic infections at baseline, and they are in the late stage of AIDS. After starting antiviral therapy, their weight gain is large, that is, the phenomenon of health recovery. Studies have confirmed that BIC/FTC/TAF can lead to weight gain among patients [11, 20], but the weight increase is the result of comprehensive factors. For HIV-1 patients, the possible mechanism includes the phenomenon of health recovery of patients with advanced AIDS, and the mechanism of health recovery may be the result of the alleviation of HIV-related inflammation and the acceleration of catabolism [21]. In addition, starting ART accelerates the regression of opportunistic infection and gastrointestinal dysfunction, thus improving appetite and nutrient absorption. According to previous studies, change in body weight is related to gender, race, CD4, disease load, lifestyle of patients, and similar [22–24]. Compared with weight, clinicians should pay more attention to patients' blood lipids, as dyslipidemia is an independent risk factor for the occurrence and development of cardiovascular diseases [25]. This study confirmed that BIC/FTC/TAF had no significant effect on blood lipid, which was consistent with a previous real-world study [11]. This also explains the safety of BIC/FTC/TAF as ART drugs.
In addition, no patients stopped taking drugs because of adverse events, and most patients had very good tolerance. In 80 patients, the most common AE was skin rash (7.5%), skin pruritus (5.0%), and digestive tract reactions (2.5%), which was consistent with Chang et al. [11] and Hayes et al. [26]. During the follow-up, we found 2 patients had SAE (hospitalization); however, none were related to drugs.
The present study has several limitations. First, this is a single-center retrospective study, and the results may be biased. Second, the observation duration of this study was very short, so it is necessary to conduct long-term observation with large samples. Third, it was impossible to evaluate adverse events in detail.