Safety, Tolerability, and Efficacy of Generic Dolutegravir-containing Antiretroviral Therapy Regimens Among South Indian Human Immunodeficiency Virus-infected Patients

Kumarasamy, Nagalingeswaran; Prabhu, Sandeep; Chandrasekaran, Ezhilarasi; Poongulali, Selvamuthu; Pradeep, Amrose; Ramasamy, Balakrishnan; Benson, Constance A.

doi:10.1093/cid/ciy763

Cited by 12 publications

(8 citation statements)

References 9 publications

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“…[ 7 ] Apart from recommended first-line therapy, DTG is also widely used in patients failing first- and second-line antiretroviral treatment (ART) in India. [ 8 ] DTG containing regimen has several advantages compared to ritonavir-boosted protease inhibitors (PI/r) containing ART regimen, which includes, lower cost, small pill size, ease of administration (once a day), potency with a high genetic barrier and better tolerated with a favorable side effect profile. All these factors are also associated with better treatment adherence.…”

Section: Introductionmentioning

confidence: 99%

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Virological outcome and frequency of low-level viremia in patients receiving generic dolutegravir-containing regimen at a large tertiary care clinic in Western India

Patel

Pujari³

et al. 2021

Indian Journal of Sexually Transmitted Diseases and AIDS

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Background: Dolutegravir (DTG) is widely used for the management of naïve and treatment-experienced HIV-infected patients. Low-level viremia (LLV) is common in patients receiving nonnucleoside reverse transcriptase inhibitor- and protease inhibitor-containing regimens. However, the incidence of LLV associated with DTG-containing regimen is not well known. Objective: The objective of this study was to assess the virological response associated with DTG-containing regimens and explored frequencies of LLV and risk factors for the same. Methods: We performed a retrospective cohort study of HIV-infected patients receiving generic DTG-containing regimen from February 2017 to July 2019. All adult patients (≥18 years), who completed at least the first follow-up after initiating treatment, were included in this study. LLV was defined as plasma viral load between 20 and 200 copies/ml. Results: A total of 597 patients started DTG-containing regimen during the study period, of which 522 patients met the inclusion criteria. The study patients were categorized into five groups: naïve ( n = 86), first-line failure ( n = 32), second-line failure ( n = 53), switch ( n = 325), and HIV-2 ( n = 26). Complete virological suppression at 6, 12, and 18 months was achieved in 78.5%, 81.1%, and 70.9% of the patients, respectively. Furthermore, 17.9%, 12.9%, and 23.3% of the patients had LLV at 6, 12, and 18 months, respectively. Persistent LLV was found in 2.9% of the patients. Overall, DTG was well tolerated and was discontinued in only three patients due to neuropsychiatric side effects. Conclusion: DTG is well tolerated and effective in suppressing HIV across all antiretroviral treatment categories. The rate of persistent LLV is low in DTG-containing therapy.

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Section: Introductionmentioning

confidence: 99%

“…Patients receiving stable atazanavir/ritonavir (ATV/r)- or lopinavir/ritonavir (LPV/r)-containing regimen are offered a switch to DTG-containing regimen to simplify ART regimen in India. [ 8 ]…”

Section: Introductionmentioning

confidence: 99%

Virological outcome and frequency of low-level viremia in patients receiving generic dolutegravir-containing regimen at a large tertiary care clinic in Western India

Patel

Pujari³

et al. 2021

Indian Journal of Sexually Transmitted Diseases and AIDS

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“…This is consistent with a DTG study conducted previously in the Indian population. 35 Efficacy analysis showed that 86.8% of patients achieved efficacy endpoint of HIV-1 RNA load < 50 copies per mL by week 24. Results were consistent with FAS and PPS.…”

Section: Discussionmentioning

confidence: 98%

A Phase IV Study on Safety, Tolerability and Efficacy of Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate in Treatment Naïve Adult Indian Patients Living with HIV-1

Dravid¹,

Morkar²,

Prasad³

et al. 2022

POR

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Purpose WHO recommends dolutegravir (DTG) based regimens as first-line treatment for HIV-1 infection. However, few studies have been conducted in Indian population. Hence, our study evaluated the safety, tolerability, and efficacy of DTG 50 mg with Tenofovir and Lamivudine (300/300mg) fixed dose combination in treatment naïve adult Indian patients. Methods This was an open label, multicenter, prospective, interventional, phase IV study conducted across 14 sites between February 2019 and July 2020. 24 weeks was the treatment duration for each subject. The primary end point was to assess the incidence of adverse events (AEs) and secondary end points were to assess the proportion of patients achieving plasma HIV-1 RNA levels <50 copies/mL at week 24 and change in CD4+ cell count from the baseline. Safety analysis was conducted using Safety Analysis Set and efficacy analysis was carried out using Full Analysis Set and Per protocol set. Results A total of 288 patients were screened; 250 were enrolled; and 229 completed the study. 389 AEs were reported from 58% of patients. Of these, 61 were related to study treatment. One event of decreased creatinine clearance led to study discontinuation. One serious event of pyrexia was reported, which was unrelated to the study drug. The most common AEs were headache (18%), pyrexia (14%), vomiting (6.4%) and upper respiratory tract infections (6%). No deaths were reported. At week 24, 86.8% of the patients achieved plasma HIV-1 RNA levels <50 copies/mL and the mean CD4 cell count increased from 350.2 (SD, 239.73) at baseline to 494.6 (SD, 261.40) with an average increase of 143.2 (SD, 226.14) cells. Conclusion This study demonstrated the safety and efficacy of DTG based regimen in treatment naïve HIV-1 patients in Indian population and support use of DTG as first-line treatment regimen.

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“…In our retrospective study, only 4.5% of PLWH with holding regimens were on INSTIs, reflecting limited access to antiretrovirals like DTG. However, recent price reductions in DTG and introduction of generic formulations is likely to change future treatment options [ 23 ]. Efforts to use DTG and other new antiretroviral drugs in middle income countries have been continuing and are expected to have potential to overcome clinical unmet needs [ 24 – 26 ].…”

Section: Discussionmentioning

confidence: 99%

Patterns and prognosis of holding regimens for people living with HIV in Asian countries

et al. 2022

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The use of holding regimens for people living with HIV (PLWH) without effective antiretroviral options can have effects on outcomes and future treatment options. We aimed to investigate the use of holding regimens for PLWH in Asian countries. Data from adults enrolled in routine HIV care in IeDEA Asia-Pacific cohorts were included. Individuals were considered to be on holding regimen if they had been on combination antiretroviral therapy for at least 6 months, had two confirmed viral loads (VL) ≥1000 copies/mL, and had remained on the same medications for at least 6 months. Survival time was analyzed using Fine and Gray’s competing risk regression. Factors associated with CD4 changes and VL <1000 copies/mL were analyzed using linear regression and logistic regression, respectively. A total of 425 PLWH (72.9% male; 45.2% high-income and 54.8% low-to-middle-income country) met criteria for being on a holding regimen. From high-income countries, 63.0% were on protease inhibitors (PIs); from low-to-middle-income countries, 58.4% were on non-nucleoside reverse transcriptase inhibitors (NNRTIs); overall, 4.5% were on integrase inhibitors. The combination of lamivudine, zidovudine, and efavirenz was the most commonly used single regimen (n = 46, 10.8%), followed by lamivudine, zidovudine, and nevirapine (n = 37, 8.7%). Forty-one PLWH (9.7%) died during follow-up (mortality rate 2.0 per 100 person-years). Age >50 years compared to age 31–40 years (sub-hazard ratio [SHR] 3.29, 95% CI 1.45–7.43, p = 0.004), and VL ≥1000 copies/ml compared to VL <1000 copies/mL (SHR, 2.14, 95% CI 1.08–4.25, p = 0.029) were associated with increased mortality, while higher CD4 counts were protective. In our Asia regional cohort, there was a diversity of holding regimens, and the patterns of PI vs. NNRTI use differed by country income levels. Considering the high mortality rate of PLWH with holding regimen, efforts to extend accessibility to additional antiretroviral options are needed in our region.

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Safety, Tolerability, and Efficacy of Generic Dolutegravir-containing Antiretroviral Therapy Regimens Among South Indian Human Immunodeficiency Virus-infected Patients

Cited by 12 publications

References 9 publications

Virological outcome and frequency of low-level viremia in patients receiving generic dolutegravir-containing regimen at a large tertiary care clinic in Western India

Virological outcome and frequency of low-level viremia in patients receiving generic dolutegravir-containing regimen at a large tertiary care clinic in Western India

A Phase IV Study on Safety, Tolerability and Efficacy of Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate in Treatment Naïve Adult Indian Patients Living with HIV-1

Patterns and prognosis of holding regimens for people living with HIV in Asian countries

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