Effectiveness, Weight Changes, and Metabolic Outcomes on Switch to Generic Dolutegravir/Lamivudine Among People with HIV in Western India: An Observational Study.

We assessed the effectiveness and safety of switching to generic dolutegravir/lamivudine (DTG/3TC) among People living with Human Immunodeficiency Virus (PWH) in Western India. In this single-center, retrospective observational study, PWH, who switched to DTG/3TC, were followed for virologic, immunologic, and clinical effectiveness, and safety, including weight changes, hyperglycemia, and dyslipidemia. Multivariate linear mixed-effects models were used to predict average change in weight adjusted for age, sex, duration of previous antiretroviral (ARV) regimens, and baseline weight. From May 2017 to July 2022, out of 434 PWH switched to DTG/3TC, 304 with at least 1 follow-up visit were included. Median [interquartile range (IQR)] age was 54 (IQR 49-61) years and 70.1% were male. Prevalence of baseline comorbidities was 57.9% (hypertension-41.5%, chronic kidney disease-40.9%, and diabetes mellitus-18.8%). Reasons for switch were affordability (47.4%), desire for simplification (41.8%), ARV toxicities (19.1%), and concern about potential toxicities (10.2%). Median (IQR) duration of follow-up on DTG/3TC was 40 (IQR 31-49) weeks. No virologic failure was observed. Rates of virologic suppression [viral load (VL) ≤20 copies/mL or target not detected (TND)] at 12, 24, 48, 72, 96 and 120 weeks were 95.2%, 95.9%, 90%, 100%, 81.3%, and 88.4%, respectively. Only 9 (3%) PWH permanently discontinued DTG/3TC. Predicted adjusted mean weight gain of +3.3 kg was observed at 96 weeks. Switching from tenofovir disoproxil fumarate (TDF)/emtricitabine or lamivudine (XTC)/non-nucleoside reverse transcriptase inhibitor (NNRTI) and duration on DTG/3TC were significantly associated with weight gain. Apart from trend in worsening hyperglycemia (nine PWH with new onset diabetes), no clinically significant change in lipids and estimated glomerular filtration rate (eGFR) was documented. Switching to DTG/3TC is an effective and safe option among virologically suppressed PWH with high comorbidity burden in India. In view of the several advantages of DTG/3TC, it may be considered for potential scale-up in the right population, both in private and public health care settings in India.

Long-coronavirus disease among people living with HIV in western India: An observational study.

BACKGROUND: Long-COVID is emerging as a significant problem among individuals who recovered from COVID-19. Scant information is available on the prevalence, characteristics, and risk factors for long-COVID among people living with HIV (PLHIV). SETTING: A tertiary level, private, HIV clinic in western India. METHODS: A prospective, observational study was conducted to assess the prevalence of long-COVID among PLHIV. Long-COVID was defined as the presence of at least one symptom after 30 days of illness onset. A questionnaire for assessing general, cardiorespiratory, neuro-psychiatric, and gastro-intestinal symptoms was used to screen individuals with history of confirmed COVID-19. Data on demographics, HIV-related variables, comorbidities, and severity of COVID-19 were abstracted from electronic medical records. Univariate and multivariate logistic regression were used to identify risk factors for long-COVID. RESULTS: Ninety-four PLHIV were screened for long-COVID. Median (interquartile range [IQR]) age was 51 (47-56) years and 73.4% were males. The majority (76.6%) had a history of asymptomatic-mild COVID-19 illness. The prevalence of long-COVID was 43.6% (95% confidence interval [CI], 33.4-54.2). Moderate-severe COVID-19 illness was significantly associated with long-COVID (adjusted odds ratio, 4.7; 95% CI, 1.4-17.9; p = .016). Among individuals with long-COVID, cough (22.3%) and fatigue (19.1%) were the commonest symptoms. The median (IQR) duration for resolution of symptoms was 15 (7-30) days. Ten individuals (10.6%) had persistent symptoms at a median of 109 days since the onset of COVID-19. CONCLUSION: Long-COVID is common among PLHIV with moderate-severe acute COVID-19 illness. There is a need for integration of long-COVID diagnosis and care services within antiretroviral therapy clinics for PLHIV with COVID-19.

Short Communication: Coronavirus Disease 19 Among People Living with HIV in Western India: An Observational Cohort Study.

A retrospective cohort study was conducted to assess clinical characteristics and outcomes of coronavirus disease-19 (COVID-19) among people living with HIV (PLHIV) in western India. Out of 86 PLHIV with COVID-19 illness, 19.7% had severe/critical illness and 6 (6.9%) individuals died. Median (interquartile range) age was 51 (47-56) years and 77.6% were male. Eighty-five PLHIV were on antiretroviral treatment with 98% having a viral load <200 copies/mL. Hypertension (HTN) (38.3%) and diabetes mellitus (17.4%) were commonest comorbidities. Fifty-eight percent PLHIV were hospitalized while 6.9% individuals needed intensive care. Presence of medical comorbidity was significantly associated with severe/critical COVID-19, whereas HTN was significantly associated with mortality. Recovery from COVID-19 was documented in 93% PLHIV. In conclusion, PLHIV in western India have similar COVID-19 clinical outcomes as compared with those reported historically among general population. Presence of medical comorbidities rather than HIV-related disease characteristics is associated with severe COVID-19 illness.

Effectiveness of dolutegravir-based antiretroviral treatment for HIV-2 infection: retrospective observational study from Western India.

BACKGROUND: Data on the use of dolutegravir for treatment of HIV-2 infection are limited. OBJECTIVES: To assess the effectiveness of dolutegravir in people living with HIV-2 (PLHIV-2). METHODS: A retrospective chart review was performed in two clinics in Western India. PLHIV-2 initiated on dolutegravir-based regimens were included. Response to treatment in both treatment-naive (TN) and treatment-experienced (TE; substitution and not in the context of failure) was assessed by CD4 counts and HIV-2 viral load (VL) in a proportion of individuals. The primary objective was to assess immunological effectiveness (absence of a drop in absolute CD4 counts by more than 30% of baseline). Change in absolute CD4 counts was assessed by fitting a mixed-effects model. RESULTS: Sixty-two PLHIV-2 treated with dolutegravir were included. The immunological effectiveness rates (95% CI) were 91.9% (82.4%-96.5%), 92% (81.1%-96.8%) and 91.6% (64.6%-98.5%) amongst all, TE and TN individuals, respectively. Median change in absolute CD4 counts at 6, 12 and 18 months were +29 cells/mm3, +101 cells/mm3 and +72 cells/mm3, respectively. The virological effectiveness rates (HIV-2 VL <100 copies/mL) (95% CI) for all, TE and TN individuals were 88.8% (74.6%-95%), 89.6% (73.6%-96.4%) and 85.7% (48.6%-97.4%), respectively. Three clinical events were documented: spinal tuberculosis, relapsed non-Hodgkin's lymphoma and herpes simplex virus retinitis. One individual reported self-limiting somnolence. CONCLUSIONS: Dolutegravir was well tolerated and associated with immunological, virological and clinical effectiveness in both TN and TE PLHIV-2 in a large cohort from Western India. Dolutegravir-based ART is an excellent option for treatment of individuals with HIV-2 infection.