Drug-sensitive TB (DS-TB) is usually treated with a 6-month regimen composed of 4 different antibiotics: two months of isoniazid, rifampicin, ethambutol, and pyrazinamide (the intensive phase) followed by four months of isoniazid and rifampicin (the continuation phase). This regimen comes with a heavy pill burden, and many patients must take between 9–16 tablets per day during the two-month intensive phase, followed by 3–9 tablets per day for the four-month continuation phase. Fixed dose combinations (FDCs) can reduce the number of tablets taken daily to just three or four for the entire duration of treatment. By reducing pill burden and simplifying treatment, FDCs allow for better drug management and treatment adherence.
Despite the endorsement of daily FDCs by the World Health Organization, India continues to treat DS-TB using single drug formulations administered intermittently (thrice weekly). In December 2014, the RNTCP announced that 104 districts in 5 states would start using daily FDCs to treat people with HIV and children—a modest but important step toward providing daily FDCs in all 29 states and 686 districts. However, nearly two years later, this rollout has yet to take place due to multiple delays. Civil society groups in India and around the world, led by national and state networks of people living with HIV, have repeatedly written to officials in the RNTCP and Ministry of Health and Family Welfare appealing for the introduction of daily FDCs without delay. The government has met each appeal by further pushing back the deadline for delivering on its promise.
Timeline of events:
- December 2014: The RNTCP announces the provision of daily FDCs for people with HIV being treated for TB will start in five states as early as March 2015.
- March 20, 2015: DNP+, MSF Access Campaign, ITPC, APN Plus, Sankalp Rehabilitation Trust, and CoNE issue a policy brief making the case for using daily FDCs over intermittent therapy with singly formulated drugs. The brief reviews the evidence base for implementing daily FDCs in India and makes six recommendations for steps to accelerate the implementation of India’s new treatment protocols in line with WHO guidelines and best practices.
- May 19, 2016: Activists from state and national networks of people living with HIV go to the Ministry of Health and Family Welfare to hand deliver a letter to Health Minister J.P. Nadda re. “Keep the promise: Roll out of daily FDCs for drug sensitive TB treatment.” A press release accompanying the letter warns that “there has been no announcement of the selected districts in which [daily FDC] rollout is being planned, nor any training being made by the TB program in this regard.” After being kept waiting in the heat for over two hours, several activists are roughed up and injured by security officers. Finally, the activists are able to meet with V.S. Salhotra, Addl. DDG of the TB program, who said that daily FDCs for people with HIV would be rolled out nationwide by July.
- Following the incident in May, HIV and TB activists write several follow-up letters to officials in the RNTCP. On June 10, 2016 activists send a letter to Sunil Khaparde, DDG of the TB program, reiterating concerns about the delayed procurement of FDCs in addition to concerns about the unavailability of TB drug rifabutin, the under-utilization of GeneXpert machines for diagnosing TB, and the lack of patient counseling and adherence support at TB treatment centers. On July 14, 2016, activists write a letter to V.S. Salhotra, Addl. DDG TB program, re. “FDC ATT roll-out yet to be seen at the ground level, despite the continuous promise by RNTCP.” On July 15, 2016 V.S. Salhotra responds saying that the procurement order for the nationwide rollout of daily FDCs for all people with HIV and TB throughout the country will be placed with the supplier “within a week” and that the drugs “will be supplied in August.”
- As of August 1, 2016 daily FDCs are nowhere in sight.
- As of October 22, 2016, the Indian government ordered daily FDCs for children, however, they have yet to roll them out at TB treatment centers. Continued action is still needed– join Treatment Action Group and our comrades in India in publicly counting up each day that passes without daily FDCs. We will only stop the count when daily FDCs are available to all people with HIV and children who need them nationwide. Click the “Take Action” tab at the top of this page to get involved.
Why daily FDCs? TB Patients Speak Out:
“Treatment adherence and care-giving is so much easier with the use of daily FDCs. But introduction of FDCs and daily therapy in India’s DOTS program have been long delayed by the Central TB Division based on premises that were program-based (e.g. logistics and cost) rather than patient-focused (e.g. simplification of treatment, reducing pill burden). The time has come to phase out intermittent therapy—which serves as a perfect recipe for treatment interruptions—and switching to daily FDC drug regimens for treatment of TB. The adoption of FDCs daily regimen in vulnerable groups like people living with HIV and people who inject drugs (PWID) is a long standing demand.” –Hari, person living with HIV who underwent treatment for TB
“I vomited many times as I had to take so many pills for HIV and TB treatment. I felt weak all the time and was unable to focus in school. I had to go on regular basis with my father to collect medicines from the hospital. My friends in school often used to ask me why do I take so many leaves from school and where do I go?” –Ram, age 13 years, person living with HIV who underwent treatment for TB
“My husband and I were tested for TB at the same time. My husband’s condition was quite bad. I had to take care of my ailing husband, two kids and also go for my job. On top of this, I had to take TB medicines along with ARVs that used to make me sick all the time. I thought of stopping my medicines several times as it was becoming impossible for me to take so many pills at one go.” –Mamta, age 26, person living with HIV who underwent treatment for TB