Treatment Outcomes of Dolutegravir- Versus Efavirenz-Based Highly Active Antiretroviral Therapy Regimens Among Treatment-Naive People Living With HIV.

ABSTRACT

BACKGROUND: In India, following the implementation of the dolutegravir (DTG) based regimen, only a few studies compared the outcomes of DTG and efavirenz (EFV) based regimens. Therefore, this study aimed to assess virological suppression and gain in CD4+ counts of DTG and EFV-based antiretroviral therapy (ART) regimens. METHODS:  A retrospective study was conducted and the entire sample (n=140) was divided into two major classes as DTG group (n=70) and EFV group (n=70) further classified as tenofovir/lamivudine/dolutegravir (TLD) and tenofovir/lamivudine/efavirenz (TLE) regimen. Data was collected on socio-demographic characteristics, laboratory measures, and clinical and drug-related variables. For quantitative and qualitative data analysis, respectively, the T-tests and Chi-square tests were applied. RESULTS:  The mean CD4+ gain was comparable in both regimens after six months of ART but significant after 12 months of ART in the TLD group. Viral load suppression was achieved in 55.71% of clients in the TLE group after six months of ART while in the TLD group, 88.57% of clients achieved virologic suppression which was highly significant. Clients who remained on the DTG-based regimen gained significantly more weight at 12 months (mean +6.15 kg) as compared to the EFV-based regimen (mean +1.85 kg). After 12 months of ART, the majority of laboratory variables were unaffected by either regimen with the exception of serum creatinine and random blood sugar (RBS) in the TLD group. CONCLUSIONS:  Our study provides real-life evidence of better outcomes of therapy with DTG over EFV in terms of viral load suppression but immunologic recovery is equivalent in EFV-based regimens after six months of treatment. We recommend the use of DTG only in clients with a high baseline viral load as it costs approximately twice as much as EFV when cost-effectiveness is taken into account.