Received on 06.02.2025 Revised on 11.03.2025

Accepted on 14.05.2025 Published on 01.12.2025

Available online from December 06, 2025

Research J. Pharmacy and Technology. 2025;18(12):5763-5768.

DOI: 10.52711/0974-360X.2025.00831

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Creative Commons License.

INTRODUCTION:

The HIV also known as Human Immunodeficiency Virus is the infectious agent which causes sexually transmitted diseases (HIV).^1,2,3,4 HIV infection can advance to its terminal stage, AIDS, if treatment is not received, which can result in an eventual decline in health.⁵ HIV has the ability to particularly target and eliminate CD4-T lymphocytes, the defense cells responsible for battling infection. Consequently, the decline of CD4 cells can manifest to a gradual weakening of the immune system, which in turn compromises the immune system's potential for fighting off infections, illnesses, and some types of cancer. However, the immunity is reversible with HAART^6,7,8 and the risk of HIV transmission is almost non-existent if it is managed properly.^9,10,11 Recently, Integrase strand transfer inhibitors have become a novel category of antiretroviral medications, providing enhanced effectiveness, safety and tolerability^12,13. As a treatment for HIV-1, the first-generation Integrase strand transfer inhibitors were the first to receive approval from the FDA¹⁴. In 2007, Raltegravir was the first approved INSTI by the FDA, and Elvitegravir was approved in 2012¹⁵. While they were a significant advancement in HIV treatment at the time, their limitations have led to the development of second-generation INSTIs with improved characteristics like minimal cross resistance, excellent virological suppression and tolerability with fewer drug to drug interactions.^16,17because of these issues, the advent and the profound increased use of the second generation INI dolutegravir (DTG) came in to existence to further strengthen combination ART.^18,19,20Though DTG did very good in clinical trials, showcasing remarkable safety and an outstanding tolerability, efficacy there are fewer studies both on its short and long-term impact in real life^21,22 besides this there is a lack of studies on the use of DTG based INSTIs in adult populations in southern India. Therefore, our research aims to investigate the effectiveness, TLD regimen in HIV-1 adult population in south Indian urban ART Centre.

MATERIALS AND METHODS:

An Ambispective study was carried out at a south Indian district ART Centre on patient living with HIVandAIDS ageing between 19-75 years age who are receiving TLD regimen as their treatment. The inclusion criteria involved patients with positive HIV-1 infection and are on therapy with TLD regimen. The exclusion criterion includes subjects who were with negative HIV Infection and are on other HAART regimen with severe renal or hepatic impairment. Along with this subjects who were hypersensitive to TLD regimen and positive HBV, HBC were also excluded

Data collection:

Permission were taken from the respective authorities like Institutional Ethics Committee with ref no (IEC/03/11) for the collection of data through patient medical records. Patient’s history/data which includes when they have been diagnosed with HIV, treatment they have been receiving and their response to that treatment was collected by obtaining informed consent, all the eligible patients on one tablet each of DTG (50 mg) and TDF and 3TC (300/300 mg) fixed dose combination once daily for 24 weeks would be taken. The efficacy assessment was done at week 6, 12, 24 and 36 Months from the baseline day by noting the plasma viral load and CD4 count values at week 12 and 24 months from baseline day. Medication adherence was assessed based on the self-reported medication adherence in which percentage of missed daily doses would be calculated as Prescribed doses minus missed doses divided by prescribed doses. The final result would be multiplied with 100 to get the percentage of adherence.

Sample size and statistical plan:

According to the quoted study “Dravid A, Morkar D et al, the sample size was calculated and the resulted sample was 1013. The data collection and compilation will be done in Microsoft Excel. The data analysis is performed using SPSS version 27. The frequency and proportion will be used to describe the demographic and clinical factors. Mean and Standard deviation will be used to estimate the virological and immunological outcomes. Chi-square test will be used to perform the Univariate analysis. Binary logistic regression analysis will be used to find the odds of the risk factors associated with the efficacy. Statistical significance will be considered at 5% level of significance (p<0.05).

RESULTS:

Demographics of PLWHS shows that 524 (51.3%) PLWHS were males and 475 (46.5%) were females and 22 (2.2%) were transgender altogether totaling 1021 patients. Apart from this around 685 (67.1%) patients were in the age group of 19-39, followed by 314 (30.8%) patients in 40-59 age group and 22 (2.2%) patients in 60-75. The family history showed spouse positive 541 (53.0%) and spouse negative 337 (33%), Spouse-Expired 42 (4.2%) cases were predominantly higher in comparison to Family not tested were 78 cases. Apart from this the social history showed majority of patients 607 (59.5%) had none of the social habits and the remaining 40.5% had social habits like smoking, tobacco chewing, smoking, habitual or past alcoholism.

Table-01: The proportion of medication adherence.

Medication adherence	Frequency	Percent
Poor ADR (<80%)	5	0.5
Fair ADR (81%-95%)	28	2.7
Good ADR (>95%)	988	96.8
Total	1021	100.0

The above table-1 shows the medication adherence of PLWHS in which 988 (96.8%) had good adherence followed by 28 (2.7%) had fair adherence and only 5 (0.5%) had poor adherence.

Table-2: The following table shows the CD 4 counts at start, 12 months and 24 months of TLD regimen

CD4 Count	At Start of TLD regimen		At 12 months of TLD regimen		At 24 months of TLD regimen
CD4 Count	Frequency	Percent	Frequency	Percent	Frequency	Percent
<200	55	5.4	20	2.0	12	1.2
200-499	311	30.5	122	11.9	107	10.5
500-999	563	55.1	565	55.3	368	36.0
1000 and Above	92	9.0	314	30.8	534	52.3
Total	1021	100.0	1021	100.0	1021	100.0

Table-03: The Plasma Viral load at 6, 12, 24, and 36, months of TLD regimen.

Viral Load	6 Months		12 Months		24 Months		36 Months
Viral Load	Freq	%	Freq	%	Freq	%	Freq	%
Undetected-TND	311	30.5	691	67.7	912	89.3	964	94.4
Suppressed (<1000)	366	35.8	203	19.9	66	6.5	33	3.2
Unsuppressed (>1000)	344	33.7	127	12.4	43	4.2	24	2.4
Total	1021	100.0	1021	100.0	1021	100.0	1021	100.0

Table-04: Odds ratio estimates for predicting the effect of medication adherence on CD 4 counts.

Medication Adherence	Odds Ratio for CD 4	P-value	95% CI for OR
Medication Adherence	Odds Ratio for CD 4	P-value	Lower Bound	Upper Bound
Poor Adherence (<80%)	1.000	----	----	----
Fair Adherence (81%-95%)	1.767	0.325	0.569	5.486
Good Adherence (>95%)	0.534	0.240	0.187	1.521

a. The reference category is: Poor Adherence (<80%).

Table-05: Effect of medication adherence on viral load among HIV patients.

Medication Adherence	Odds Ratio for Viral Load	P-value	95% CI for OR
Medication Adherence	Odds Ratio for Viral Load	P-value	Lower Bound	Upper Bound
Poor Adherence (<80%)	1.000	----	----	----
Fair Adherence (81%-95%)	0.713	0.526	0.250	2.032
Good Adherence (>95%)	0.164	0.000	0.062	0.436

a. The reference category is: Poor Adherence (<80%).

Table-06: Change in weight after TLD therapcy.

Weight (IN KGS)	At start of TLD regimen				Total	Sign.
Weight (IN KGS)	<200	200-499	500-999	1000 and Above	Total	Sign.
Weight Gain Positive	53	255	456	67	831	chi-square = 12.729, p-value = 0.005*
Weight Gain Positive	6.4%	30.7%	54.9%	8.1%	100.0%
Weight Gain Negative	2	56	107	25	190
Weight Gain Negative	1.1%	29.5%	56.3%	13.2%	100.0%
Total	55	311	563	92	1021
Total	5.4%	30.5%	55.1%	9.0%	100.0%
WEIGHT (IN KGS)	At 12 months of TLD regimen				Total	Sign.
WEIGHT (IN KGS)	<200	200-499	500-999	1000 and Above	Total	Sign.
Weight Gain Positive	20	96	469	246	831	chi-square = 8.062, p-value = 0.045*
Weight Gain Positive	2.4%	11.6%	56.4%	29.6%	100.0%
Weight Gain Negative	0	26	96	68	190
Weight Gain Negative	0.0%	13.7%	50.5%	35.8%	100.0%
Total	20	122	565	314	1021
Total	2.0%	11.9%	55.3%	30.8%	100.0%
WEIGHT (IN KGS)	At 24 months of TLD regimen				Total	Sign.
WEIGHT (IN KGS)	<200	200-499	500-999	1000 and Above	Total	Sign.
Weight Gain Positive	12	84	307	428	831	chi-square = 4.879, p-value = 0.181
Weight Gain Positive	1.4%	10.1%	36.9%	51.5%	100.0%
Weight Gain Negative	0	23	61	106	190
Weight Gain Negative	0.0%	12.1%	32.1%	55.8%	100.0%
Total	12	107	368	534	1021
Total	1.2%	10.5%	36.0%	52.3%	100.0%

*indicates the statistical significance.

The table-6 shows the results of change in weight of the participants who underwent the TLD treatment. At baseline and at 12^th month’s assessment, we observed there is significant change in the weight at different level of TLD regimen. However, at the 24^th month assessment there is no change in the weight gain and weight loss across the regimen.

DISCUSSION:

The present study evaluated the efficacy of TLD Regimen in treatment of south Indian adult patients living with HIV-1. Upon 12 months of TLD therapy the CD4+ count remarkably progressed to around 30.8% (314) patients of more than 1000 CD4+ counts and 565 (55.3%) had 500-999 counts followed by only 11.9% patients were under 500 CD4+ cell count proving a very good immunological response of TLD regimen in PLWHS. The immunological response was much better at 24 months of therapy which shows around 52.3% (534) patients of having more than 1000 counts of CD4+ cells followed by 368 (30.8%) were in 500-999 CD4+ counts. Similar results were observed with a mean increase in CD4+ cells by 143.2 cells from baseline to 24 weeks.²³While an another study showed around 62% participant’s had CD4+ cell counts of > 500 from baseline followed by further increase in immunologic response upon DTG based ART therapy.²⁴ Coming to the plasma viral load our study showed marked suppression of viral load at 6 months which accounts for 30.5% (311) in undetected levels and 35.8% (366) patients in suppressed levels and 33.7 % (344) patients at unsuppressed levels. However, after 12 months of therapy the efficacy has improved to 67.7 % (691) which was further improved at 24 months constituting 89.3% (912) and at 36 months of treatment there were 94.4% (964) of undetected plasma viral load indicating a better efficacy and profound viral suppression in PLWHS. Similar findings are seen in Phase 3 reports of FLAMINGO (90%) and SPRING-2 studies (88%) and Barbara rosette study (88.2%). However, other combinations of DTG based ART therapies were studied in those trials with viral loads measured at 48 and 96 weeks and 3,6,12 weeks as against to 6 weeks, ,12 weeks, 24weeks and 36weeks in our study.^18,20,23,25. An adherence or compliance of ≥ 95% to ART therapy is recommended to have good viral suppression and maintainance.^26.27,28in the present study self-reported adherence was found to be 96.8% in good adherence followed by 2.7% in fair adherence. Similar results were found in Hurbans N, Naidoo P study had reported 80% of participants with 100% adherence to DTG-based ART.¹⁶Arecent study conducted by Kanters S, Vitoria M has shown higher odds of viral suppression rates (OR: 1.64; 95% CI: 1.35–1.96 at 48 weeks) which are more effective in elevating CD4+ cell count.²⁹ Similarly In our study we observed lesser risk of viral load by 0.713 odds in the fair adherence group which is still lesser to 0.164 times in the good adherence compared to poor adherence group. While coming to CD4+ cells CD 4 count the results suggest there is an increase CD 4 counts in the fair adherence group by 1.767 times compared with poor adherence. Meanwhile, in the good adherence there is decrease in the CD 4 counts to 0.534 odds compared with poor adherence. However, this change in the counts is statistically not significant. The results of change in weight of the participants at baseline and at 12^th month’s assessment, we observed there is significant change in the weight gain with a chi-square = 8.062, p-value = 0.045* whereas 24^th month assessment there was no change in the weight gain or weight loss across the regimen. Phillips AN, Venter F study showed similar results of weight gain which could be linked to lesser need of spending energy owing to lesser or no vial loads.^16,30

CONCLUSION:

The present study concludes that there is significant increase in CD4+ T cell count and achievement of undetectable viral load levels over time; highlights the regimen's potential for HIV infection management with higher rates of viral load suppression, indicating the regimen's efficacy. The study also suggests that there should a fair to good adherence to treatment regimen to have better immunological or viral load suppression. Overall, the study suggests that the TLD regimen is a viable treatment option for PLWH, with a potential to improve patient outcomes, enhancing quality of life, and advancing progress towards achieving the desired goals for HIV management.

AUTHOR CONTRIBUTIONS:

PAK and ML worked in the conceptualization and methodology of topic. PAK did literature review, collection of data and analysis. PAK is responsible in the drafting of manuscript. ML reviewed whole manuscript and approved it for submission.

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Received on 01.02.2025 Revised on 22.05.2025

Accepted on 21.08.2025 Published on 01.12.2025

Available online from December 06, 2025

Research J. Pharmacy and Technology. 2025;18(12):5758-5762.

DOI: 10.52711/0974-360X.2025.00830

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Creative Commons License.